Recognition List Number: 021 Publication Date: 03/18/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-58: ANSI Z80.11-2007, American National Standard for Ophthalmics - Laser Systems for Corneal Reshaping. (Ophthalmic)
Date of Standard: 2007. |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
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| Devices Affected: |
| Laser Systems for Corneal Reshaping |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete Standard, with the following additional information needed:
1. Annex D
1.1. Section D.6.2 (p. 20) - Add exclusion criterion: eyes with predicted residual stromal bed <250 µm.
1.2. Section D.7 (p. 22) - in Table D1, add the following evaluations:
o Distance UCVA: post-operative day #1
o Dilated fundus evaluation: final visit or post-op month 12, whichever is sooner
o In note 3, change ">2 lines" to "?2 lines"
o Pachymetry at post-operative month 1
o Add to note 10: "Mesopic contrast sensitivity should be measured on all subjects pre-operatively, and post-operatively on subjects who experience significant visual symptoms, such as glare, haloes, or double vision."
1.3. Section D.8 (p. 23) - add to bulleted list: "mesopic contrast sensitivity (pre-operatively)"
1.4. Section D.8.3 (p. 25) - add to list of question topics in second paragraph, first sentence: "dry eye symptoms".
1.5. Sections D.8.4 and D.8.5.1 - Add to descriptions of test procedures for mesopic pupil size measurements and grating contrast sensitivity testing that subjects should be dark adapted for at least 10 minutes prior to testing.
1.6. Section D.9 (p. 29) -- add to second bulleted list of adverse device effects in the operative eye:
o clinical signs and/or subjective symptoms consistent with dry eye
o clinically significant glare
o clinically significant haloes
2. Annex F:
2.1. Section F.2 (p. 36) - Add analysis of accountability for the total number of eyes as well as the number of subjects enrolled.
2.2. Section F.2 (p. 37) -Table F.1:
o Note 3, change "reached" to "been seen at and not yet passed the visit window of"
o Note 4, add "Subjects seen outside the visit window should be included in the 'missed visit but seen at a later visit' subgroup."
2.3. Section F.3 (p. 38) - Add "Stability analysis of mixed astigmatism should be based on changes in refractive cylinder component rather than MRSE."
3. Additional Requirements for Wavefront-Guided and Topography-Guided Laser Refractive Systems.
3.1. A wavefront-guided or corneal-elevation-guided laser system that uses aberrometry or corneal topography data as the basis for refractive treatments shall be designed such that only the aberrometer(s) or topographer(s) (i.e., the same manufacturer and model) used in the clinical trial can be used to calculate the ablation pattern. For example, the aberrometer or topographer output data may be encrypted before transfer to the laser system, and decrypted by system treatment planning software or laser system software before they can be used to determine the prescribed corneal ablation pattern. The system software shall incorporate valid methods for ensuring that centration and torsional orientation of the eye are equivalent for the aberrometry or topographer measurements and laser treatments, and for ensuring that the wavefront data are obtained for a pupil size at least as large as the intended optical zone of the ablation.
3.2. Outcomes analyses based upon wavefront measurements shall include at least the analyses listed below, for defocus, astigmatism, coma, spherical aberration, total higher order aberrations. All analyses shall be performed at the preoperative visit and at all scheduled postoperative visits 1 month and later. Zernike analysis is recommended.
o Analysis of root mean square (RMS) aberration magnitudes (Mean ± SD);
o Analysis of signed aberration amplitudes (Mean ± SD);
o Paired (within-eye) RMS changes from preoperative status (magnitude and % of preop magnitude);
o Paired signed-value changes in spherical aberrations (value and % of preop value);
o Percentages of eyes with increased, decreased, and unchanged total higher order aberrations;
o Stability of total higher order aberrations (within-eye change between each pair of consecutive postop visits (Mean change ± SD).
3.3. Evaluation of accuracy of wavefront-based corrections (defocus and astigmatism in diopters) shall include the mean ± SD at each scheduled time point for:
o Measured value;
o Attempted change from preop;
o Achieved change from preop;
o % of eyes within ±0.50 D and ±1.00 D of targeted change |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Excimer Laser System |
Class 3 |
LZS |
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| Relevant Guidance: |
Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers - October 10, 1996
Discussion Points for Expansion of the "Checklist of Information Usually Submitted in an Investigational Device Exemption (IDE) Application for Refractive Surgery Lasers - Draft released for comment September 5, 1997
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| FDA Technical Contact: |
| Bruce Drum, Ph.D. |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2418 |
| Silver Spring MD 20993 |
| 301/796-6466 |
| Email: bruce.drum@fda.hhs.gov |
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