Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 1-57: ASTM F1101-90 (Reapproved 2003)e1, Standard Specification for Ventilators Intended for Use During Anesthesia. (Anesthesias)
Date of Standard: 2003. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
| |
|
| CDRH Offices and Divisions Associated with Recognized Standards: |
| (1) | OFFICE OF COMPLIANCE (OC) |
|
| (2) | OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB) |
|
| (3) | OFFICE OF DEVICE EVALUATION (ODE) |
|
|
| Devices Affected: |
|
| Processes Affected: |
Vigilance Reporting
Premarket Notification |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete standard and any annexes with the following exceptions:
All pressures other than supply pressures should be expressed in terms of gage pressure in units of cmH2O (or kilopascals) to follow the cmH2O units. Supply pressures should be expressed in units of psig.
Clause 4.1- Information in premarket submission related to the resistance to cleaning, disinfection, and sterilization agents should be provided per Book Memo K90-1.
Clause 5.1 - Data from the testing should be supplied as part of the submission along with comparative data from a predicate device.
Clause 5.9.2 is recognized in part. The 22-mm connector for a bag for manual ventilation shall be marked bag with the word. 21 CFR 801.15(c)(1) states that all words, statements, and other information required by the Act to appear on the label or labeling shall appear in the English language. English labeling allows immediate and positive verification for the proper use of medical equipment. As outlined in 21 CFR 807.87(e), proposed labels and labeling shall be sufficient to describe the directions for use of the device, and Section 502(f) of the Act requires adequate directions for use. All device labeling should contain English text adjacent to any icons/symbols used if space permits. If space does not permit, the icons/symbols should be replaced with English text only.
Clause 5.9.5 is recognized in part. The expired gas outlet (other than an outlet for spirometer) shall be designed in such a way that it cannot easily be connected to either 22, 15, or 30-mm cones or sockets, or to 22-mm internal diameter tubing.
Clause 5.10 is recognized with clarification. Mechanical, electrical, and EMC information should be consistent with Reviewer Guidance, Excerpts related to EMI from November 1993.
Clause 8.1.1 Information related to the resistance to cleaning, disinfection, and sterilization agents should be provided in accordance with the Reviewer Guidance for Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5160 |
Gas-Machine, Anesthesia |
Class 2 |
BSZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5430 |
Apparatus, Gas-Scavenging |
Class 2 |
CBN |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §868.5975 |
Set, Tubing And Support, Ventilator (W Harness) |
Class 1 |
BZO |
| |
|
| Relevant Guidance: |
Updated 510(K) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
Review guidance for labeling reuseable medical devices for reprocessing in health care facilities, April 1996
Reviewer Guidance, Excerpts related to EMI from November 1993
Draft Reviewer Guidance for Ventilators |
|
| FDA Technical Contact: |
| Bahram Parvinian |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2534 |
| Silver Spring MD 20993 |
| 301/796-6445 |
| Email: bahram.parvinian@fda.hhs.gov |
|
|
