(121 days)
Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
Millex- GP Sterilizing Filter Unit
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria for device performance, a study proving the device meets those criteria, or any details related to AI/algorithm performance.
Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text.
The document primarily focuses on:
- Device Name: Millex- GP Sterilizing Filter Unit
- Regulation Number/Name: 868.5130, Anesthesia Conduction Filter
- Regulatory Class: II
- Product Code: BSN
- Indications for Use: Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
- FDA's finding: Substantially equivalent to legally marketed predicate devices.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850
Mr. Thomas Borrows Director, Quality Systems & Regulatory Affairs Millipore Corporation 80 Ashby Road Bedford, Massachusetts 01730
APR 0 4 2002
Re: K013988
Trade/Device Name: Millex- GP Sterilizing Filter Unit Regulation Number: 868.5130 Regulation Name: Anesthesia Conduction Filter Regulatory Class: II Product Code: BSN Dated: March 18, 2002 Received: March 20, 2002
Dear Mr. Borrows:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
{1}------------------------------------------------
Page 2 - Mr. Borrows
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Attachment 7 510(k) 013988 Response Letter
Indications for Use Statement
510(k) Number (if known): _K013988
Device Name: Millex
Indications for Use: Intended for use as a syringe filter to sterilize or 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)
Patrica Ciconte
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Divisional Hospital Devices
510(k) Number __
Prescription Use
(Per 21 CFR 801.109) _/
or
Over-The-Counter Use
K013988 Page 70
§ 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).