(61 days)
Not Found
Not Found
No
The device is a chemical solution and the description focuses on its enzymatic properties and composition, with no mention of AI/ML or related concepts.
No
The device, Hyaluronidase Solution, is described as an "enzymatic solution" used for manipulating gametes or embryos in ART procedures, specifically for removing cumulus cells. It is not designed to treat a disease or condition in a patient.
No.
The device is used to remove cumulus cells from oocytes in ART procedures, which is a preparatory step for treatment, not a diagnostic one.
No
The device is a solution, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for manipulating gametes or embryos in vitro (outside the body) for assisted reproductive technology procedures. This is a laboratory procedure, not a diagnostic test performed on a patient sample to diagnose a condition.
- Device Description: The device is an enzymatic solution used to remove cells from oocytes. This is a reagent used in a laboratory process, not a diagnostic test kit.
- Lack of Diagnostic Claims: There are no claims about diagnosing a disease, condition, or state of health using this device.
- Performance Study: The performance study described is a mouse embryo assay to assess the product's ability to support embryonic growth and lack of toxicity, not a study evaluating its diagnostic accuracy.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.
Hyaluronidase Solution is intended for use in assisted reproductive technology procedures involving the manipulation of gametes or embryos. Specifically, Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.
Product codes
85 MQL
Device Description
Hyaluronidase Solution is a enzymatic solution containing 80 U/mL of bovine derived hyaluronidase in a HEPES buffered HTF Medium supplemented with 5.0 mg/mL (or 0.5%) therapeutic grade human serum albumin (HSA) and 10µg/mL gentamicin sulfate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Hyaluronidase Solution is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will support embryonic growth and that no toxic components are present. The equivalent of Hyaluronidase Solution has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for denuded oocytes.
Mouse Embryo Assay, enzyme activity, endotoxin and sterility testing will be performed as a condition of release for this product. Results of all release assays performed will be indicated on the labeling and reported on a lot-specific certificate of analysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Reference Device(s)
Not Found
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
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
| Submitted by: | Irvine Scientific Sales Co., Inc.
2511 Daimler Street
Santa Ana, CA 92705-5588
Telephone: (800) 437-5706
Facsimile: (949) 261-6522
Contact: Wendell Lee, Pharm. D.
Date Submitted: October 9, 2000 | NOV 4 2002 |
| --------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------ |
|---|
Device Identification:
| Trade Name: | Hyaluronidase Solution |
|---|---|
| Common Name: | Hyaluronidase Solution |
| Classification Name: | Reproductive Media (21 CFR, 884.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Hyaluronidase Solution is a enzymatic solution containing 80 U/mL of bovine derived hyaluronidase in a HEPES buffered HTF Medium supplemented with 5.0 mg/mL (or 0.5%) therapeutic grade human serum albumin (HSA) and 10µg/mL gentamicin sulfate.
Intended Use:
Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.
1
Technological Characteristics:
Enzymatic digestion and removal of cumulus cells surrounding freshly retrieved oocytes will occurred within a 30 - 60 second exposure to Hvaluronidase Solution. Denuded oocytes should be immediately washed and transferred to appropriate medium for subsequent fertilization (by ICSI) and onqoing development.
Performance Data:
Hyaluronidase Solution is assayed by mouse embryo assay prior to its release to market. This assay assures that the product will support embryonic growth and that no toxic components are present. The equivalent of Hyaluronidase Solution has been used in a variety of clinical settings for the same intended use for a number of years and has become the standard medium used for denuded oocytes.
Additional Information:
Mouse Embryo Assay, enzyme activity, endotoxin and sterility testing will be performed as a condition of release for this product. Results of all release assays performed will be indicated on the labeling and reported on a lot-specific certificate of analysis.
Conclusion:
The conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Hyaluronidase Solution is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a black and white logo or emblem. The logo features a stylized depiction of what appears to be a bird in flight, represented by three curved lines that suggest movement and wings. To the left of the bird, there is a semi-circular arrangement of dots and text, which is partially obscured but seems to follow the curve of the circle. The overall design is simple yet dynamic, conveying a sense of motion and possibly representing an organization or institution.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV : 4 2002
Wendall Lee, PharmD Vice President Quality Systems and Regulatory Affairs Irvine Scientific Sales Co., Inc. 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K022931
Trade/Device Name: Hyaluronidase Solution Regulation Number: 21 CFR 884.6180 · Regulation Name: Reproductive media and supplements Regulatory Class: II Product Code: 85 MQL
Dated: August 23, 2002 Received: September 4, 2002
Dear Dr. Lee:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec 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.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Irvine Scientific .
August 23, 2002
INDICATIONS FOR USE STATEMENT (page 1 of 1
KO22931 510(K) Number:
Device Name: Hyaluronidase Solution
Indications for Use:
Hyaluronidase Solution is intended for use in assisted reproductive technology procedures involving the manipulation of gametes or embryos. Specifically, Hyaluronidase Solution is intended for use in removing cumulus cells surrounding oocytes (denudation) in preparation for ICSI or other ART procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
Prescription Use_
David A. Siegmann
(Division Sign-Off) Division of Reproductive, Abd and Radiological Device 510(k) Number