(42 days)
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No
The summary describes a chemical solution (Hyaluronidase in HTF Medium) used for a specific biological process (digesting hyaluronic acid). There is no mention of any computational or algorithmic components, let alone AI/ML.
No.
The device is used to prepare oocytes for ICSI procedures by digesting hyaluronic acid, which is an in vitro handling step and not a direct therapeutic intervention on a patient.
No
Explanation: The device is described as being used to digest hyaluronic acid for easier handling of oocytes prior to ICSI, which is a preparatory step for a therapeutic procedure (fertility treatment), not a diagnostic process to identify a disease or condition.
No
The device description clearly states "Hyaluronidase in HTF Medium; Hyaluronidase in EBSS Medium," indicating a biological or chemical substance, not software.
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 the product 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." This describes a process performed in vitro (outside the body) on biological samples (oocytes and surrounding cells) to prepare them for a medical procedure.
- Device Description: The device is a "Hyaluronidase in HTF Medium" or "Hyaluronidase in EBSS Medium." These are laboratory reagents used to manipulate biological samples.
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 isn't directly diagnosing a disease, it is a critical component used in vitro as part of a medical procedure (ICSI) that addresses infertility, which can be considered a "condition" or "state of health."
The lack of information about image processing, AI, anatomical site, patient age, user, training/test sets, performance studies, and metrics is typical for a reagent-based IVD that doesn't involve complex data analysis or imaging.
Therefore, the primary function and application of this product strongly align with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Hyaluronidase in HTF Medium 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
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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
Not Found
§ 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wave-like lines emanating from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2001
Conception Technologies, L.P. % Ms. Grace Holland Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K011573
Hyaluronidase in HTF Medium; Hyaluronidase in EBSS Medium Dated: May 10, 2001 Received: May 21, 2001 Regulatory Class: II 21 CFR §884.6180/Procode: 85 MQL
Dear Ms. Holland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have reviewed your Security 10(x) notications of them to make to tegally marketed predicate devices device is substantially equivalent (or the mucenture to the Medical Device Amendments, or to devices marketed in merstale commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may ,
that have been reclassified in accordance with the provisions of the F that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Act .
therefore, market the device, subject to the general co therefore, market the device, subject of the general on the current couring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premates Approval), it may be subject of President Previously of States I Previ If your device is classince (See above) nine class if (Openal Obtarve) or abe found in the Code of Federal Regulations, to such additional controls. Existing major regulation assumes compliance with the Current Good Manufacturing I itle 21, Parts 800 to 693. A Substant Godration (QS) for Medical Devices: General regulation (21 CFR Part Practice requirements, as set four in the Quality Of them (40) will verify such as unptions. Fallure 820) and that the GMP regulations, the room and Drag Trans. In addition, FDA may publish further announcements to comply will the Unit Tegulation in Testimation in this response to your premarket notification sumission doss not concerning your device in the reacle Regists. I Tease necessed on your career 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 would I fills ledel will allow you to begally 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 If you destre specific advice to your de var used (30 ) 594-4639. Additionally, for questions on the promotion diagnosite devices), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entified, "Misoraning by telefited to prehation" (21 ce re of Manufacturers Assistance at its toll-free number (800) 1638-2041 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 (s)
1
Premarket Notification - Conception Technologies, L.P. - Hyaluronidase
Page 1 of
510(k) Number (if known):
Hyaluronidase in HTF Medium Device Name:
Indications For Use:
Hyaluronidase in HTF Medium 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)
www.unwana....................................................................................................................................................................
Prescription Use
(Per 21 CFR 801.109)
OR
David C. Kappen
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices KUITA 510(k) Number _
REGULATORY SPECIALISTS
Over-The-Counter Use
(Optional Format 1-2-96)
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