(54 days)
The Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures.
Sydney IVF Culture Oil consists of colorless mineral oil, and is provided in glass vials with silicone rubber stoppers. The Sydney IVF Culture Oil will be available in 200 mL fill volumes.
The provided text describes a 510(k) premarket notification for the "Sydney IVF Culture Oil" device. However, it does not include detailed information regarding specific acceptance criteria, a formal study design, or quantitative performance data typically associated with studies demonstrating a device meets acceptance criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device. It states, "The Sydney IVF Culture Oil was subjected to testing to assure satisfactory operating performance. The Sydney IVF Culture Oil passed the requirements of all tests." This is a general statement and lacks the specificity required to answer most of your detailed questions.
Therefore, for many of your points, the answer will be that the information is not provided in the given text.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (general requirement to assure satisfactory operating performance) | "Passed the requirements of all tests." "Similar, with respect to intended use and technological characteristics, to the FDA published predicate device description." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not provided.
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective). While the device name includes "Sydney IVF," the document does not specify where the testing data originated or its nature (e.g., in-vitro studies, animal studies, human clinical data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of information is not applicable to the submission for this device. The submission does not describe a study involving expert assessment of a test set to establish ground truth. The device is a culture oil, not an diagnostic imaging device or an AI algorithm requiring human interpretation.
4. Adjudication Method for the Test Set
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, often with or without AI assistance. This device is a culture oil for IVF procedures.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Not applicable. This device is a culture oil, not an algorithm.
7. The Type of Ground Truth Used
- Not explicitly stated in terms of "ground truth" as typically understood in diagnostic studies. The "tests" mentioned likely refer to quality control tests relevant to a culture medium, such as sterility, pH, osmolality, and possibly performance in culturing gametes/embryos, but the specific metrics are not detailed. The "ground truth" would be objective measurements against predefined specifications for these quality parameters.
8. The Sample Size for the Training Set
- Not applicable. This device is a culture oil, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
Summary of Device and Approval:
The submission K022002 for "Sydney IVF Culture Oil" is a 510(k) premarket notification. The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (63 FR 48428, September 10, 1998, a reproductive media and supplement). The review process determined that the device is substantially equivalent based on intended use and technological characteristics. The document mentions that testing was conducted and the device "passed the requirements of all tests" to assure satisfactory operating performance, but it does not provide specifics about these tests, the acceptance criteria, or the study design and results in detail. This type of submission generally relies more on comparing the new device's specifications and performance to known characteristics of the predicate rather than presenting extensive, detailed clinical trials or performance studies with defined acceptance criteria in the way you've outlined.
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- Brenda Davis Submitted Bv: Requlatory Affairs COOK OB/GYN™ 1100 West Morgan Street Spencer, Indiana, 47460 812 829-6500
June 17, 2002
Names of Device:
510(k) Summary
g
| Trade Name: | Sydney IVF Culture Oil |
|---|---|
| Common/Usual Name: | IVF culture oil |
| Classification Name: | Reproductive media and supplements21 CFR §884.6180 (87MQL); Class II |
| Predicate Device: | 63 FR 48428, September 10, 1998 |
Device Description:
Sydney IVF Culture Oil consists of colorless mineral oil, and is provided in glass vials with silicone rubber stoppers. The Sydney IVF Culture Oil will be available in 200 mL fill volumes.
AUG 1 2 2002
Intended Use:
The Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micro-manipulation procedures.
Substantial Equivalence:
The Sydney IVF Culture Oil is comparable with respect to intended use to the published predicate device description and meets the requirements for 510(k) substantial equivalence.
Discussion of Tests and Test Results:
The Sydney IVF Culture Oil was subjected to testing to assure satisfactory operating performance. The Sydney IVF Culture Oil passed the requirements of all tests.
Conclusions Drawn from Tests:
This device is similar, with respect to intended use and technological characteristics, to the FDA published predicate device description.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
Ms. Brenda Davis Regulatory Affairs Technical Writer Cook OB/GYN 1100 W. Morgan Street SPENCER IN 47460
Re: K022002
Trade/Device Name: Sydney IVF Culture Oil Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements
Regulatory Class: II Product Code: 85 MQL Dated: June 17, 2002 Received: June 19, 2002
Dear Ms. Davis:
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 (OS) 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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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. Snigdin
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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510(k) Number (if known): K02 200 2
Device Name:
Indications For Use:
The Sydney IVF Culture Oil is intended for use as an oil overlay for culture of gametes, zygotes, or embryos in assisted reproduction technology (ART) and micromanipulation procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Lawson
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)
§ 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.