(287 days)
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No
The summary describes a chemical substance (hyaluronidase) used in a laboratory procedure, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, Hyaluronidase, is used to digest hyaluronic acid for easier handling of oocytes in ICSI procedures, which is a preparatory step for a medical procedure rather than a direct treatment for a disease or condition.
No
The device description states Hyaluronidase is used to digest hyaluronic acid for easier handling of oocytes during ICSI procedures, which is a preparatory step for a therapeutic procedure, not a diagnostic one.
No
The provided text describes the intended use of a substance (Hyaluronidase) in a medical procedure, not a medical device, and certainly not a software-only medical device. There is no mention of software, hardware, or any device components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed outside the body (in vitro), but it's a preparation step for a clinical procedure (ICSI), not a diagnostic test performed on a sample to provide information about a patient's health status.
- Lack of Diagnostic Information: The description doesn't mention analyzing a sample to diagnose, monitor, or screen for any disease or condition. It's purely a reagent used to facilitate a laboratory procedure.
- No Mention of Sample Analysis: The description focuses on the action of the hyaluronidase on the cumulus cells, not on analyzing a patient sample for diagnostic purposes.
IVDs are typically used to test samples like blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device is a reagent used in a laboratory procedure that ultimately leads to a clinical intervention (ICSI).
N/A
Intended Use / 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
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
1
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 _