(292 days)
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No
The summary describes a biological supplement (Human Serum Albumin) used in assisted reproductive technologies, with no mention of software, algorithms, or AI/ML terms.
No
The device, Human Serum Albumin, is described as a macromolecular supplement used in various reproductive technologies, which serves as an ingredient in media rather than a therapeutic device that directly treats a condition or disease.
No
The Human Serum Albumin described is a supplement used in various reproductive technologies (IVF, ART, GIFT, etc.) and cryopreservation. It does not perform diagnostic functions like detecting, monitoring, or predicting diseases or conditions.
No
The 510(k) summary describes Human Serum Albumin, which is a biological product used in IVF and related procedures. It is not a software device.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Human Serum Albumin is used as a supplement in media for various Assisted Reproductive Technology (ART) procedures like IVF, embryo culture, sperm washing, etc. These procedures involve handling and manipulating human biological materials (sperm, eggs, embryos) in vitro (outside the body) for diagnostic or therapeutic purposes related to fertility.
- IVD Definition: 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 product is a supplement and not a diagnostic test itself, it is an essential component used within the IVD process of ART.
However, it's important to note:
- The provided information is limited. A definitive determination would require a more complete device description and potentially regulatory classification information.
- The product itself is a reagent (Human Serum Albumin), which is a common component of IVD systems.
In summary, based on the intended use within ART procedures, this Human Serum Albumin product is highly likely to be classified as an IVD or a component of an IVD system.
N/A
Intended Use / Indications for Use
Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.
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
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, which features a staff with a snake winding around it, overlaid on a circular emblem. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is black and white.
FEB 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Reproductive Technologies, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Avenue Sausalito Irvine, CA 92606
Re: K991392
Human Serum Albumin in Normal Saline Dated: November 29, 1999 Received: December 1, 1999 Requlatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Mr. Holland:
We have reviewed vour 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 pror 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 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 requlation (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 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 requlation 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__________________________________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991392/5 001 |
|---|---|
| --------------- | -------------------------- |
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Concurrence of CDRH, Office of Device Evaluation (ODE)