(364 days)
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None
No
The 510(k) summary describes a tissue culture oil, which is a chemical reagent, and contains no mention of AI or ML technology.
No
The device is described as an "Oil for Tissue Culture" used in in-vitro fertilization and related laboratory procedures. Its function is to cover tissue cultures, not to directly treat a patient or disease.
No
The intended use describes the product as an "Oil for Tissue Culture" used in in-vitro fertilization, embryo culture, and micromanipulative procedures. This indicates a role in laboratory procedures rather than diagnosing a medical condition.
No
The 510(k) summary describes "Oil for Tissue Culture," which is a substance used in laboratory procedures, not a software application.
Based on the provided information, the device "Oil for Tissue Culture" is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used in "in-vitro fertilization, embryo culture and micromanipulative procedures". These are all procedures performed outside of the living body (in vitro) and are related to diagnostic or therapeutic processes involving human biological material (embryos).
While the description is brief and lacks details about how the oil functions or what it interacts with specifically, its use in these in-vitro procedures strongly aligns with the definition of an IVD, which are 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. In this case, the oil is a component used in a process that is part of diagnosing or treating infertility.
The lack of information about image processing, AI, anatomical site, patient age, user, or performance studies doesn't negate its potential IVD status. Many IVDs are simple reagents or components used in a larger diagnostic process.
N/A
Intended Use / Indications for Use
Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
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
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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
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2000
Sage BioPharma, Inc. c/o Mr. Grea Holland Consultant Holland & Associates 3722 Ave. Sausalito Irvine, CA 92606
Re: K991380 Oil for Tissue Culture Dated: February 14, 2000 Received: February 15, 2000 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either dass 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 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 notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication 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) 594-4591. Additionally, for question 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
DEPARTMENT OF HEA
1
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):_K 991380
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
(FLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K991380 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ----------------------------------------------------- |
|---|