MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R

K013988 · Millipore Corp. · BSN · Apr 4, 2002 · Anesthesiology

Device Facts

• Record ID: K013988
• Device Name: MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
• Applicant: Millipore Corp.
• Product Code: BSN · Anesthesiology
• Decision Date: Apr 4, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5130
• Device Class: Class 2

Intended Use

Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.

Device Story

Millex-GP Sterilizing Filter Unit functions as a syringe-attached filtration device; used to sterilize or ultraclean low-volume liquid solutions. Operated by clinicians or pharmacy staff in direct patient care or pharmacy admixture environments. Device removes particulates and microorganisms from solutions prior to administration or use. Benefits include ensuring sterility and purity of fluids delivered to patients.

Clinical Evidence

Bench testing only.

Technological Characteristics

Syringe-mounted filter unit; designed for sterilization and ultracleaning of low-volume solutions. Classified as an anesthesia conduction filter (21 CFR 868.5130).

Indications for Use

Indicated for use as a syringe filter for sterilization or ultracleaning of low volume solutions in direct patient care and pharmacy admixture settings. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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.

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#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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

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