(56 days)
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Not Found
No
The summary describes a physical syringe filter and contains no mention of AI, ML, image processing, or data analysis related to AI/ML.
No
Explanation: The device is intended for sterilizing, ultracleaning, or clarifying solutions, which are preparation steps for solutions rather than direct therapeutic actions on a patient. It functions as a filter for solutions used in patient care, but it does not directly treat or diagnose a disease or condition.
No
The device is described as a syringe filter for sterilizing, ultracleaning, or clarifying solutions, and there is no indication that it is used for diagnosing medical conditions.
No
The intended use describes a physical syringe filter, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "sterilize, ultraclean, or clarify 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 or monitor a medical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device described is a filter used in the preparation of solutions, which falls under the category of medical devices used in patient care and pharmacy settings, but not as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Intended for use as a syringe filter to sterilize, ultraclean, or clarify low volume solutions in direct patient care and pharmacy admixture applications.
Product codes
BSN, FPB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with a flowing design element below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Mr. Thomas G. Borrows Director, Quality Systems and Regulatory Affairs Millipore Corporation 80 Ashby Road Bedford, Massachusetts 01730-2271
Re: K023892
Trade/Device Name: Millex®- HV, VV, GV Syringe Filter Unit Regulation Number: 868.5130, 880.5440 Regulation Name: Anesthesia Conduction Filter, Intravascular Administration Set Regulatory Class: II Product Code: BSN, FPB Dated: November 21, 2002 Received: November 22, 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.
1
Page 2 - Mr. Borrows
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. 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 (OS) 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), 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) you may obtain. Other general information on vour 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,
Timo A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known): K023892
Device Name: Millex® - VV/ GV/ HV Syringe Filter Units
Indications for Use: Intended for use as a syringe filter to sterilize, ultraclean, or clarify 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_
Paltian Cucente
(Division Sign. Ors.
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection of Anesthesiology, Gene
510(k) Number: K023892