(264 days)
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No
The summary describes a chemical solution (PVP) used in a manual procedure (ICSI) and makes no mention of AI, ML, image processing, or any computational analysis.
No.
The device (PVP) is used in a laboratory procedure (ICSI) to handle spermatozoa, not for direct therapeutic intervention on a patient. It assists in a procedure to achieve conception, but it is not a therapeutic device in itself.
No
Explanation: The device is described as being used to decrease sperm motility and prevent sticking during the ICSI procedure. This is an assistive function for a medical procedure, not a diagnostic one. It does not identify, detect, or monitor a disease or condition.
No
The device description explicitly states it is a solution (PVP in Hepes-HTF), which is a chemical substance, not software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed in vitro (outside the body) on biological material (spermatozoa). The purpose is to facilitate a diagnostic or therapeutic procedure (ICSI, which is part of assisted reproductive technology).
- Device Description: The device is a solution (PVP in Hepes-HTF) used to treat biological samples (sperm) in vitro.
- Lack of In Vivo Application: There is no indication that this device is used directly on or within a living patient.
While the information is limited, the core function of the device is to manipulate biological material in vitro for a procedure related to human reproduction, which falls under the scope of IVDs.
To be definitively classified as an IVD, it would need to meet the regulatory definition of an IVD in the relevant jurisdiction (e.g., FDA in the US, CE marking in Europe). However, based on the provided description, it strongly aligns with the characteristics of an IVD.
N/A
Intended Use / Indications for Use
PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.
Product codes
85 MQL
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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
Rockville MD 20850
Food and Drug Administration 9200 Corporate Boulevard
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, featuring a triple-stranded helix intertwined with a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
JAN 1 0 2000
Advanced Reproductive Technologies. Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K991391
PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media) Dated: November 29, 1999 Received: November 30, 1999 Requiatory Class: II 21 CFR 884.6180/Procode: 85 MQL
Dear Mr. Holland:
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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 requlations.
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) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
Page 1
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
PVP_ Device Name:_
Indications For Use:
PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.
(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) Over-The-Counter Use (Optional Format 1-2-96)
OR
(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Devices 510(k) Number_