(287 days)
Hyaluronidase is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
Not Found
This is a 510(k) premarket notification decision letter from the FDA regarding a medical device called "Hyaluronidase." This type of document does not typically contain the detailed information required to answer your specific questions about acceptance criteria and device study data.
The letter primarily:
- Confirms that the FDA has reviewed the 510(k) notification.
- Determines that the device is "substantially equivalent" to legally marketed predicate devices.
- States the regulatory class of the device and its procode.
- Outlines general regulatory requirements the manufacturer must adhere to.
- Provides contact information for further regulatory questions.
The attached "Indications For Use" form simply states the intended purpose of the device.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This level of detail is found in the actual 510(k) submission, not the FDA's decision letter.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present.
- If a standalone performance (algorithm only) was done: Not applicable for a drug/biological product like Hyaluronidase.
- The type of ground truth used: Not applicable in the context of this device's function.
- The sample size for the training set: Not applicable for a drug/biological product.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory approval letter and does not include the detailed technical and clinical study information you are seeking. To find that information, you would need to access the full 510(k) submission document (K991393) itself, which is often available through the FDA's public access policies or databases.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2000
Advanced Reproductive Technologies, Inc. c/o Mr. Greg Holland Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606
Re: K991393 Hvaluronidase 80 U/mL. Dated: December 13, 1999 Received: December 14, 1999 Regulatory 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 requilation (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 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 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
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_K 991393
Device Name:_ Hyaluronidase
Indications For Use:
Hyaluronidase is used prior to intracytoplasmic sperm injections (ICSI) procedures to digest the hyaluronic acid holding the cumulus cells together to permit easy handling of the oocytes.
(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 (Optional Format 1-2-96)
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Signature
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
§ 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.