K Number
K963717
Device Name
MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)
Manufacturer
Date Cleared
1997-06-10

(267 days)

Product Code
Regulation Number
868.5130
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
Device Description
Millex - MP Sterilizing Filter Unit
More Information

Not Found

Not Found

No
The summary describes a physical filter unit and makes no mention of software, algorithms, or AI/ML terms.

No
The device is described as a "syringe filter to sterilize/ultraclean low volume solutions," which is a functional component used in the preparation of solutions, not a device directly used to treat a medical condition or disease.

No
The device is described as a "syringe filter to sterilize/ultraclean low volume solutions," indicating its function is for preparation and purification purposes, not for diagnosing medical conditions.

No

The device description clearly identifies it as a "Sterilizing Filter Unit," which is a physical hardware component used for filtration. The intended use also describes a physical process ("sterilize/ultraclean low volume solutions"). There is no mention of software as the primary or sole component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "For use as a syringe filter to sterilize/ultraclean low volume solutions in direct patient care and pharmacy admixture applications." This describes a device used to prepare solutions for administration to a patient, not a device used to test a sample taken from a patient to diagnose a condition or monitor health.
  • Device Description: "Millex - MP Sterilizing Filter Unit" further supports the idea of a filtration device for preparing solutions.
  • Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to prepare solutions for in vivo (within the body) use.

N/A

Intended Use / Indications for Use

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

Product codes

73 BSN

Device Description

Millex - MP Sterilizing Filter Unit

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

direct patient care and pharmacy admixture applications

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol of three abstract human figures, possibly representing individuals or families, with their heads and shoulders connected in a flowing, continuous line.

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.

1

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

2

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)

Signature

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

510(k) NumberK963717
------------------------
Prescription UseorOver-The-Counter Use
(Per 21 CFR 801.109)____