(90 days)
Not Found
Not Found
No
The summary describes a purely mechanical obstetrical forceps with no mention of software, data processing, or AI/ML terms.
Yes
The device is used for helping deliver a baby, which is a therapeutic intervention.
No
Explanation: The device, obstetrical forceps, is used for delivering a baby, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it consists of two physical parts (blades) that are introduced into the vagina, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the device is an obstetrical forceps used for helping deliver a baby by being introduced into the vagina. This is a physical tool used directly on the patient for a mechanical purpose.
- Lack of IVD Characteristics: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a surgical or obstetric instrument, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
HDA, 85 HDA
Device Description
The Obstetrical forceps consist of two parts. Each of these two parts is introduced from the forceps (blades) seperately into the vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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| Submitted by: | Bell Qualitymanagement
Kaiserstr. 9
D-78609 Tuningen | tekno-medic
Optik-Chirurgie GmbH & Co. KG
Sattlerstraße 11 • Nendingen
D - 78532 Tuttlingen
Telefon 0 74 61 / 17 01 - 60
Telefax 0 74 61 / 17 01 50
E-mail: mail@tekno-medical.com |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Markus Denk
Phone:--49-7464-96600
Fax:--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 of
these two parts is introduced from the forceps (blades)
seperately into the vagina. | |
| Intended use: | Obstetrical forceps are used for helping delivering the
baby. | |
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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
୍ୟାସ
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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