(98 days)
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No
The summary describes a cell isolation media, which is a chemical substance, and there is no mention of any computational or algorithmic components, let alone AI/ML.
No
The device is described as "cell isolation media used for separation and purification of human sperm for assisted reproduction procedures." While it is used in a medical procedure, its function is for preparation and processing of cells, not directly to treat a disease, injury, or to restore function.
No
Explanation: The device is described as cell isolation media used for separation and purification, which is a preparative function, not a diagnostic one. It doesn't identify diseases or conditions.
No
The intended use describes a physical substance (cell isolation media) used for sperm separation, which is a tangible product, not software.
Based on the provided information, yes, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
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Intended Use: The intended use explicitly states "Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures." This describes a product used in vitro (outside the body) to analyze or prepare biological samples (human sperm) for a medical purpose (assisted reproduction).
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Definition of IVD: IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While this specific device isn't for diagnosis in the traditional sense, the preparation of biological samples for assisted reproduction falls under the broader scope of IVD use, as it's a critical step in a medical procedure involving the manipulation of human biological material in vitro.
The lack of other information like device description, performance studies, etc., doesn't negate its likely IVD status based on the clear intended use.
N/A
Intended Use / Indications for Use
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines above and below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 1999
Conception Technologies, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K991322 Enhance-S Plus Dated: May 11, 1999 Received: June 10, 1999 Requlatory 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, You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls of the Act indude requirements for annual registration. Iising 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 Requirations, 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 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.
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 Compiiance 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__________________________________________________________________________________________________________________________________________________________________________
| 510(k) Number (if known): | K991322 |
|---|---|
| --------------------------- | --------- |
Enhance-S Plus Device Name:_______________
Indications For Use:
Cell isolation media used for separation and purification of human sperm for assisted reproduction procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NUEDED)
.............................................................................................................................................................................. ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
| Prescription Use | ✓ | OR | Over-The-Counter Use________ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1 2 96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| §10(k) Number | K991322/S⁰⁰¹ |
|---|---|
| --------------- | -------------- |
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