(27 days)
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Not Found
No
The 510(k) summary describes a chemical solution (oil) used as an overlay in embryo culture. There is no mention of any software, image processing, or analytical capabilities that would suggest the use of AI or ML. The performance study described is a biological assay, not a computational analysis.
No
The device is used as an overlay during embryo and gamete manipulation in assisted reproductive technology, but it does not directly treat a disease or condition in a patient. It supports a procedure rather than being a therapeutic agent itself.
No
The device is an oil used in assisted reproductive technology to cover culture media, supporting embryonic growth and ensuring no toxic components are present. It does not diagnose any conditions.
No
The device description clearly states it is a "solution" and is used as an "overlay" in a physical process, indicating it is a chemical or biological product, 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 to cover culture media during embryo and gamete manipulation in assisted reproductive technology procedures. This is a laboratory reagent or accessory used in the process, not a device that directly tests a sample from the human body to provide diagnostic information.
- Device Description: The description reinforces its role as an overlay for culture media, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing a biological sample, detecting a marker, or providing information about a patient's health status or condition.
- Performance Study: The performance study described is a mouse embryo assay to ensure the product supports embryonic growth and is non-toxic. This is a quality control test for the product itself, not a clinical performance study demonstrating diagnostic accuracy.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This oil does not fit that description.
N/A
Intended Use / Indications for Use
Oil for Embryo Culture is intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Oil for Embryo Culture is a solution intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
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)
Oil for Embryo Culture 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 conclusion from performance testing as well as a review of the historical information contained in professional literature shows that Oil for Embryo Culture is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
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.
Not Found
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).
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.
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JUL 1 8 2001
2011938
p. 1 of 2
June 15, 2001
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Irvine Scientific Sales Co., Inc. Submitted by: 2511 Daimler Street Santa Ana, CA 92705-5588
Telephone: (800) 437-5706 Facsimile: (949) 261-6522
Contact: Wendell Lee, Pharm. D.
Date Submitted: June 15, 2001
Device Identification:
| Trade Name: | Oil for Embryo Culture |
|---|---|
| Common Name: | Oil for Embryo Culture |
| Classification Name: | Reproductive Media (21 CFR 884.6180) |
Predicate Device:
Notice of Final Rule, 63 FR 48428, Docket number 97N-0335
Description:
Oil for Embryo Culture is a solution intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
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K011938
p. 2 of 2
June 15, 2001
Intended Use:
Oil for Embryo Culture is intended for use in as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
Technological Characteristics:
Oil for Embryo Culture is primarily used as an accessory solution to ina overlay medium to support in vitro fertilization and post fertilization embryo growth. The embryo is allowed to grow in the solution until the desired state of development is reached.
Performance Data:
Oil for Embryo Culture 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.
Additional Information:
Mouse embryo, 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 Oil for Embryo Culture is suitable for the intended use and meets the criteria outlined in the Notice of Final Rule, 63 FR 48428, Docket number 97N-0335.
2
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JUL 1 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wendell Lee, Pharm. D. Vice President, Quality Systems and Regulatory Affairs IRVINE SCIENTIFIC 2511 Daimler Street SANTA ANA CA 92705-5588
Re: K011938 OIL FOR EMBRYO CULTURE Dated: June 15, 2001 Received: June 21, 2001 Regulatory Class: II 21 CFR 884.6180/Procode: 85 MQL
Dear Dr. Lee:
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 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 regulation (21 CFR Part 820) and that, through periodic OS 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 submission 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) 594-4639. 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" (21CFR 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.
Nancy C. Bogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
3
Irvine Scientific
June15, 2001
INDICATIONS FOR USE STATEMENT (page 1 of 1)
510(K) Number:_KO11938
Device Name: Oil for Embryo Culture
Indications for Use:
Oil for Embryo Culture is intended for use in assisted reproductive technology procedures as an overlay to cover small volumes of culture media during embryo and gamete manipulation.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
Nancy C. Broadlon