MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)

K963717 · Millipore Corp. · BSN · Jun 10, 1997 · Anesthesiology

Device Facts

• Record ID: K963717
• Device Name: MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
• Applicant: Millipore Corp.
• Product Code: BSN · Anesthesiology
• Decision Date: Jun 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5130
• Device Class: Class 2

Intended Use

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

Device Story

Millex-MP Filter Unit is a syringe-attachable device used for sterilization or ultracleaning of low-volume liquid solutions. Operated by clinicians or pharmacy staff in clinical or pharmacy settings. Device functions as a physical barrier to remove contaminants from solutions prior to administration or admixture. Benefits include ensuring sterility and purity of fluids used in patient care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Syringe-attachable filter unit for liquid sterilization/ultracleaning. Mechanical filtration principle. No software or electronic components.

Indications for Use

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

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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 10 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 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 (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 regulation 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 obligation 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 regulation (21 CFR Part 801 and additionally 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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
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

2) Indications for Use Statement

* 510(k) Number (if known): K963717

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)


Prescription Use ☑ (Per 21 CFR 801.109)

or

Over-The-Counter Use ☐

(C:\TOM\REPORTS\510K-PRE.DOC, P-2-, 08/07/96)