(212 days)
No
The device description and intended use clearly indicate it is an enzyme solution for chemical processing, with no mention of AI/ML or related concepts.
No
Explanation: The device is used to remove the cumulus matrix from oocytes in preparation for ART procedures. This is a preparatory step for a medical procedure, but the device itself is not directly used for treating a disease or condition in a patient. It is an enzyme solution used ex vivo.
No
The "Intended Use / Indications for Use" states that Cumulase™ is used for "removing the cumulus matrix surrounding oocytes in preparation for assisted reproduction technology (ART) procedures." This describes a treatment preparation or processing function, not a diagnostic one.
No
The device description clearly states it is a "Recombinant Human Hyaluronidase Solution," which is a biological product, not software.
Based on the provided information, Cumulase™ is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Cumulase™ is used "in preparation for assisted reproduction technology (ART) procedures." ART procedures involve manipulating human cells (oocytes) outside the body.
- Device Description: The description confirms it's a "Recombinant Human Hyaluronidase Solution" used to remove the "cumulus matrix surrounding oocytes." This is a chemical reagent used to process biological samples (oocytes) in a laboratory setting.
- Nature of the Procedure: Removing the cumulus matrix from oocytes is a step performed in vitro (outside the living organism) as part of a diagnostic or therapeutic process (ART).
IVD devices 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 ART isn't strictly a "diagnosis of disease," the preparation of gametes for ART procedures falls under the scope of IVD regulation as it involves the in vitro manipulation and assessment of human biological material for a medical purpose.
The fact that it's a reagent used to process biological samples in vitro for a medical procedure strongly indicates its classification as an IVD.
N/A
Intended Use / Indications for Use
Cumulase™ is indicated for use in removing the cumulus matrix surrounding oocytes in preparation for assisted reproduction technology (ART) procedures.
Product codes
MQL
Device Description
Recombinant Human Hyaluronidase Solution
Cumulase™ is a hyaluronidase enzyme in a HEPES buffered salt solution.
The hyaluronidase enzyme raw material is a highly characterized biotechnology developed recombinant human hyaluronidase (rHuPH20).
Cumulase™ is not preserved.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medi-Cult Hyaluronidase (510(k) # K991334
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
APR 1 4 2005
| Appendix III | |
|---|---|
510(k) Premarket Notification Summary B.5
| Submitted by: | Halozyme Therapeutics Inc
11588 Sorrento Valley Road, #17
San Diego, Ca 92121 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Don Kennard
Halozyme Therapeutics Inc.
11588 Sorrento Valley Road, #17
San Diego, Ca 92121 |
| Trade name: | Cumulase™ Catalog
Number H4001 |
| Common name: | Hyaluronidase |
| Classification name: | Reproductive Media and
Supplements
(21 CFR § 884.6180) |
| Predicate Device: | Medi-Cult Hyaluronidase
(510(k) # K991334 |
| Description of the Device: | Recombinant Human
Hyaluronidase Solution |
| Intended use: | Cumulase™ is indicated for use in
removing the cumulus matrix
surrounding oocytes in
preparation for assisted
reproduction technology (ART)
procedures. |
| Technological Characteristics: | Cumulase™ differs slightly from
the predicate device. Specifically
Cumulase™ uses a recombinant
human biotechnology developed
source of hyaluronidase enzymatic
activity instead of a bovine
testicular derived source. |
1
| Product Formulation: | |
|---|---|
| Cumulase™ is a hyaluronidase enzyme in a HEPES buffered salt solution. | |
| The hyaluronidase enzyme raw material is a highly characterized biotechnology developed recombinant human hyaluronidase (rHuPH20). | |
| Cumulase™ is not preserved. | |
| Product Characterization: | |
| rHuPH20 Hyaluronidase has been extensively characterized to International Committee on Harmonization regulatory requirements. | |
| rHuPH20 Hyaluronidase manufacturing process media is chemically defined and is free of animal derived components or materials | |
| Cumulase™ has been qualified to ISO 10993 standards for biocompatibility | |
| Product Control Testing | |
| Enzymatic Activity | USP Assay |
| pH | USP |
| Endotoxin | USP |
| Osmolality | USP |
| Sterility | USP |
| Mouse Embryo Assay | One Cell |
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
APR 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Don Kennard Vice President Regulatory and Quality Affairs Halozyme Therapeutics, Inc. 11588 Sorrento Valley Road, Suite 17 SAN DIEGO CA 92121
Re: K042495
Trade/Device Name: Cumulase™ Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements
Regulatory Class: II Product Code: MQL Dated: April 1, 2005 Received: April 4, 2005
Dear Mr. Kennard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your bocurent by equivalent (for the indications for use stated in above and nave decemininarketed predicate devices marketed in interstate commerce prior to the cliciosale) to tegarry manteers production Device Amendments, or to devices that have been May 20, 1770, the charance 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 do not require approval of a provisions of the Act. The general controls provisions of the Act device, subject to the general controls prove, 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 If your device is classinod (600 a0010) hitional controls. Existing major regulations affecting your Apploval), it thay be subject to outinateral Regulations, Title 21, Parts 800 to 898. In addition, FDA device build be found in nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FIEase be advised mar 1271's issualled on aevice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Federal statues and regulations as ammitived to registration and listing (21 CFR Part 807); labeling Act s requirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFK Fall 801), good manufacturing practice the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 Jegal This letter will allow you to begin hanketing your interess of your device to a legally premarket notification. The FDA inding of subscification 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), pleased If you desire specific advice for your device on our labering organises (
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misonomians" of the mider the Act from the 807.97). You may obtain other general information on your respections at its toll-free number (800) DIVISion of Dinal July 443-6597 or at its Internet address 056-2041 or (50 gov/cdrh/industry/support/index.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
4
Halozyme Therapeutics
Confidential
Volume l
Indications for Use Statement C.4
| 510(k) Number | (if known): K042495 |
|---|---|
| Device Name: | Cumulase™ |
| Indications for Use: | Cumulase™ is indicated for use in removing the cumulus matrix surrounding oocytes in preparation for assisted reproduction technology (ART) procedures. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lynn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
Cumulase 510K Page 18