(94 days)
To be used for the introduction of embryo(s) into the uterine cavity.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Tucker Embryo Catheter." This document approves the device based on substantial equivalence to a legally marketed predicate device.
Crucially, the document does NOT contain a study that proves the device meets acceptance criteria, nor does it detail any specific acceptance criteria for performance.
Instead, it confirms that the device is substantially equivalent to existing devices. This means that a comprehensive study demonstrating performance against a set of acceptance criteria for a novel AI/software device, as requested in the prompt, is not present here.
Therefore, most of the information requested in the prompt cannot be extracted from this document, as it outlines a regulatory approval based on equivalence, not a performance study report.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. This document is an FDA approval letter based on substantial equivalence, not a performance study report. It does not list specific acceptance criteria or performance metrics for the Tucker Embryo Catheter.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No test set or data provenance details are mentioned as this is not a study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted. No ground truth establishment is described, as this is not a study report.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No adjudication method is mentioned as this is not a study report.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be extracted. This device is a physical embryo catheter, not an AI or software device. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. This is a physical medical device (embryo catheter), not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be extracted. No ground truth is discussed as this is a regulatory approval letter, not a device performance study.
8. The sample size for the training set
- Cannot be extracted. No training set is mentioned as this is not an AI/ML device or a study report.
9. How the ground truth for the training set was established
- Cannot be extracted. No ground truth for a training set is mentioned as this is not an AI/ML device or a study report.
Summary of Device Information Available:
- Device Name: Tucker Embryo Catheter (Models ftr123 & ftr120)
- Intended Use: To be used for the introduction of embryo(s) into the uterine cavity.
- Regulation Number: 21 CFR 884.6110
- Regulation Name: Assisted Reproduction Catheter
- Regulatory Class: II
- Product Code: 85 MOF
- Approval Type: 510(k) Premarket Notification (substantial equivalence to predicate devices)
- Approval Date: December 13, 2002
- Prescription Use: Yes (Per CFR 801.109)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human figures in profile, facing to the right, with their heads overlapping.
DEC 13 2002
200 Corporate Boulevard Bockville MD 20850
Mr. Thomas J. Zinnanti President and CEO Fertility Technology Resources, Inc 4343 Shallowford Road, Suite D-4 · MARIETTA GA 30062
Re: K023017
Trade/Device Name: Tucker Embrvo Catheter (Models ftr123 & ftr120) Regulation Number: 21 CFR 884.61-10 Regulation Name: Assisted Reproduction Catheter Regulatory Class: II
Product Code: 85 MOF Dated: November 19, 2002 Received: November 26, 2002
Dear Mr. Zinnanti:
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.
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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,
Henry C. Brigdon
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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Section #4
Indications for Use
| 510(k) Number: | 11023017 (to be assigned) |
|---|---|
| Device Name: | Tucker Embryo Catheter |
| Intended Use: | To be used for the introduction of embryo(s) into the uterine cavity. |
and the comments of the comments of
.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per CFR 801.109)
OR
Over-the-counter use__________________________________________________________________________________________________________________________________________________________
David A. Segeam
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 023017 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Page 5 of 15
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§ 884.6110 Assisted reproduction catheters.
(a)
Identification. Assisted reproduction catheters are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to introduce or remove gametes, zygote(s), preembryo(s), and/or embryo(s) into or from the body. This generic type of device may include catheters, cannulae, introducers, dilators, sheaths, stylets, and component parts.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).