(22 days)
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No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use is as a protein supplement for cell culture.
No
The device is described as a protein supplement for in-vitro mammalian-cell culture media, used for procedures like in vitro fertilization. This indicates it is a laboratory reagent or supplement for cell culture, not a device used directly on a patient for therapeutic purposes.
No
The device is described as a protein supplement for in-vitro mammalian-cell culture media, used in procedures like in vitro fertilization and embryo culture. This functionality indicates it is a reagent or an aid for laboratory procedures, not a device that diagnoses a medical condition or disease.
No
The provided text describes a protein supplement for cell culture media, which is a biological product, not a software device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "protein supplement for in-vitro mammalian-cell culture media." It then lists specific procedures that are performed in vitro (outside of a living organism), such as "in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation." These procedures are directly related to the manipulation and analysis of biological materials in vitro.
IVDs are defined as reagents, instruments, and systems intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, monitoring, or treatment of disease or for the assessment of health. While this specific intended use doesn't explicitly mention "diagnosis, monitoring, or treatment of disease," the procedures listed (like in vitro fertilization and embryo culture) are integral parts of assisted reproductive technologies, which are clinical procedures involving the manipulation of human cells in vitro for the purpose of achieving pregnancy.
Therefore, a protein supplement used in these in vitro procedures falls under the scope of an IVD because it is a component used in the in vitro examination and manipulation of human biological material for a clinical purpose.
N/A
Intended Use / Indications for Use
HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.
Product codes
85 MOL
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 8 2003
Conception Technologies, L.P. % Grace Holland. Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K030850
Trade/Device Name: Enhance-HSA Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MOL Dated: March 13, 2003 Received: March 17, 2003
Dear Ms. Holland:
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. Ilsting 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 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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 your 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,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
2
Indications for Use Statement
Page 1 of _________________________________________________________________________________________________________________________________________________________________________ 1
510(k) Number (if known): K030850
HSA Device Name:_
Indications For Use:
HSA is intended as a protein supplement for in-vitro mammalian-cell culture media. These procedures include in vitro fertilization, gamete washing, embryo culture, micromanipulation and embryo cryopreservation.
(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
(Division Sign Off)
Division of Reproductive. Abdominal,
and Radioingical Devices
510(k) Number 12030850
Over-The-Counter Use
(Optional Format 1-2-96)
REGULATORY SPECIALISTS, INC.