(90 days)
tekno-medical obstetrical forceps are used for helping delivering the baby. The forceps is consisting of two parts and you are introducing every part from the forceps(blades) seperately into the vagina.
The Obstetrical forceps consist of two parts. Each of these two parts is introduced from the forceps (blades) seperately into the vagina.
This document is a 510(k) premarket notification decision letter from the FDA regarding "Techno-Medical Obstetrical Forceps." It communicates that the device is substantially equivalent to legally marketed predicate devices.
This type of document (a 510(k) clearance letter for a physical medical device like obstetrical forceps) typically does not contain the detailed information about acceptance criteria and a specific study proving device performance as would be found for a software-as-a-medical-device (SaMD) or AI-based device.
For a physical device like obstetrical forceps, "acceptance criteria" generally refer to design specifications, material properties, sterilization methods, and manufacturing quality control, rather than performance metrics like sensitivity, specificity, or AUC as seen in diagnostic algorithms. The "study" would typically involve biocompatibility testing, mechanical testing (e.g., tensile strength, fatigue), and potentially cadaveric or animal studies for safety and function, rather than human subject clinical trials focused on diagnostic accuracy.
Therefore, based solely on the provided text, I cannot extract the information required for your specific prompt. The document indicates that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are considered comparable to devices already on the market, but it does not detail the specific studies and acceptance criteria that led to this determination in the way you've outlined for an AI/software product.
Here's a breakdown of why each specific point you requested cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. The document only states the device is "substantially equivalent."
- Sample size used for the test set and the data provenance: Not applicable/not present. This is a physical device, and the focus is on equivalence, not diagnostic test performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. Ground truth as typically defined for AI/diagnostic algorithms is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not present.
- 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: Not applicable. This is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not present.
- The sample size for the training set: Not applicable/not present. This is a physical device.
- How the ground truth for the training set was established: Not applicable/not present.
To find the kind of information you are looking for (acceptance criteria and detailed study results), you would need to examine the actual 510(k) submission document (if publicly available) which would contain engineering specifications, test reports, and comparisons to predicate devices, but these would not be structured in the same way as studies for an AI/SaMD product.
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| Submitted by: | Bell QualitymanagementKaiserstr. 9D-78609 Tuningen | tekno-medicOptik-Chirurgie GmbH & Co. KGSattlerstraße 11 • NendingenD - 78532 TuttlingenTelefon 0 74 61 / 17 01 - 60Telefax 0 74 61 / 17 01 50E-mail: mail@tekno-medical.com |
|---|---|---|
| Contact person: | Markus DenkPhone:--49-7464-96600Fax:--49-7464-96601 | |
| Trade name: | Obstetrical forceps | |
| Common name: | Various types of obstetrical forceps | |
| Product Code&Classification name: | HDA/Forceps/Obstetrical | |
| Product classification: | 884.4400 | |
| Device description: | The Obstetrical forceps consist of two parts. Each ofthese two parts is introduced from the forceps (blades)seperately into the vagina. | |
| Intended use: | Obstetrical forceps are used for helping delivering thebaby. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2002 FEB
Techno-Medical GmbH & Co KG % Mr. Markus Denk Consultant Bell Quality Management Kaiserstr. 9 78609 Tuningen GERMANY
Re: K013747
Trade/Device Name: Techno-Medical Obstetrical Forceps Regulation Number: 21 CFR 884.4400 Regulation Name: Obstetrical forceps Regulatory Class: II Product Code: 85 HDA Dated: October 22, 2001 Received: November 13, 2001
Dear Mr. Denk:
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,
Nancy C. Brogdon
Nancv 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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Indications for Use Statement
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Page Contents
Ver/3 - 4/24/96
Applicant: Bell Qualitymanagement
510(k) Number (if known): K013747
Device Name: Obstetrical forceps
Indications For Use: tekno-medical obstetrical forceps are used for helping delivering the baby. The forceps is
consisting of two parts and you are introducing every part from the forceps(blades) seperately into the vagina.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801,109)
(Optional Format 1-2-96)
Prescription Use ✓
Nancy C. Hodson
(Division Sign-Off)
Division of Renm and Radiological Devi 510(k) Numb
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§ 884.4400 Obstetric forceps.
(a)
Identification. An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.