Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 17-1: AAMI NS28:1988/(R) 2010, Intracranial pressure monitoring devices. (Neurology)
Date of Standard: 1988. |
| Address of Standards Organization: |
| Association for the Advancement of Medical Instrumentation (AAMI) |
| 4301 North Fairfax Drive |
| Suite 301 |
| Arlington, VA 22203 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Intracranial Pressure (ICP) Monitors |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE |
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| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete Standard except as noted below:
- Warning against reuse, no exceptions: inactivation of CJD and other slow viruses has not been demonstrated therefore the notes identified in sections 3.1.2.2(2) and A3.1.1 and A3.1.2 do not apply.
- Pyrogenicity requirements need to be modified to reflect that the device is non-pyrogenic to a level of 0.06 EU/ml is accordance with LAL.
NOTE: The standard includes requirements for minimum labeling, safety, and performance of Intracranial pressure (ICP) monitoring devices. The safety and performance requirements specified do not set acceptance criteria and do not include relevant electrical safety and mechanical performance requirements. Presentation of the results may be required.
- Biocompatibility requirements should be expanded to be in accordance with ISO 10993-1.
- Sterilant residues - there is no provision to assure that sterilization by ETO meets the minimum residue levels specified in ISO 10993-7.
- Sterile packaging requirements should include expiration dating and data from testing may be needed to support the specified date.
- Devices incorporating microprocessing may need to meet software requirements identified in the guidance cited below. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §882.1620 |
Device, Monitoring, Intracranial Pressure |
Class 2 |
GWM |
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| Relevant Guidance: |
Guideline on Validation of the LAL Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, biological Products, and Medical Devices. Document issued prior to February 1997.
Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Document issued on: May 11, 2005 |
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| FDA Technical Contact: |
| John Doucet |
| FDA/CDRH/ODE |
| 109003 New Hampshire Avenue Building 66, Room 2453 |
| Silver Spring MD 20993 |
| 301/796-6474 |
| Email: john.doucet@fda.hhs.gov |
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