(267 days)
For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
Millex - MP Sterilizing Filter Unit
I am sorry, but based on the provided document excerpts, there is no information available regarding acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the "Millex® - MP Filter Unit," which primarily addresses the substantial equivalence of the device to a predicate device for its intended use.
The letter and the enclosed "Indications for Use Statement" do not contain details about:
- Specific performance metrics or acceptance criteria for the filter.
- Any performance study results (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
- Details about training sets or their ground truth establishment.
The document states the device's indications for use: "For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications." The FDA's clearance is based on its determination of substantial equivalence, which implies that the device performs as intended and is as safe and effective as a legally marketed predicate device, but the specific data proving this from a primary study are not included in these excerpts.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 100 1997
Mr. Thomas G. Borrows Millipore Corporation 80 Ashby Road Bedford, Massachusetts 01730-2271
Re: "K963717 Millex® - MP Filter Unit Regulatory Class: II (two) Product Code: 73 BSN Dated: April 14 , 1997 Received: April 17, 1997
Dear Mr. Borrows:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Thomas G. Borrows
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301% 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. K allahan. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 510(k) Notification Millex ® - MP Filter Unit
- Indications for Use Statement 2)
- 510(k) Number (if known): KG 6 37/7 -华
Device Name: Millex - MP Sterilizing Filter Unit
Indications for Use: For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
. •
Concurrence of CDRH, Office Of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | K963717 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ | or | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | ____ |
§ 868.5130 Anesthesia conduction filter.
(a)
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.(b)
Classification. Class II (performance standards).