(36 days)
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No
The summary describes a simple oil overlay for gametes and zygotes, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an "in vitro oil overlay for gametes and zygotes during storage or manipulation," which indicates use outside of the human body and not for treating or diagnosing a disease or condition in a living organism.
No
Explanation: The device is an "in vitro oil overlay" used for storage and manipulation of gametes and zygotes. This function is for direct support of biological material, not for identifying a disease, condition, or state of health.
No
The 510(k) summary describes an "oil overlay" which is a physical substance, not software.
Based on the provided information, the device described is likely an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro oil overlay for gametes and zygotes during storage or manipulation." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs. Gametes and zygotes are biological samples used in diagnostic or therapeutic procedures performed outside the body.
While the description is brief and lacks details about the device itself, the intended use strongly points towards it being used in a laboratory or clinical setting for procedures involving biological samples outside of a living organism.
Therefore, based solely on the provided "Intended Use / Indications for Use," it fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lite oil is used as an in vitro oil overlay for gametes and zygotes during storage or manipulation.
Product codes
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
Image /page/0/Picture/1 description: The image shows the words "Public Health Service" in bold black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and appears to be part of a document or sign.
Image /page/0/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 overlapping wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
AUG 2 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael D. Cecchi President International, Inc. 393 Soundview Rd. GUILFORD CT 06437
Re: K022332
Trade/Device Name: Lite™ Mineral Oil Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements
Regulatory Class: II Product Code: 85 MQL Dated: July 17, 2002 Received: July 18, 2002
Dear Mr. Cecchi:
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 (see 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.
1
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
international, inc. 510(K) Submission
INDICATIONS FOR USE
510 (k) Number (if known)_____________________________________________________________________________________________________________________________________________________
022332
B
Device Names: Lite™ Mineral Oil
Indication for Use:
Lite oil is used as an in vitro oil overlay for gametes and zygotes during storage or manipulation.
(PLEASE 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,
and Radiological Devices
510(k) Number K022332
or
Prescription Use √
Over-the Counter Use