The Dimeda Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate vaginal delivery, provided that the cervix is fully dilated and the fetal head is positioned appropriately in the vagina. Use of the forceps is indicated for:

0 prolonged second stage
0 suspicion of immediate or potential fetal compromise
shortening of the second stage for maternal benefit 0

Device Description

The Dimeda Obstetrical Forceps is a surgical medical device for medical procedure to grasp the fetal head when it is in the vagina and bring about delivery by traction and guidance without causing injury to the mother or baby. The forceps consists of two arms which are movable. The device is manufactured from surgical stainless steel.

AI/ML Overview

This submission for Dimeda Obstetrical Forceps (K092827) is a 510(k) premarket notification, which establishes substantial equivalence to previously cleared devices. It does not present a study with specific acceptance criteria and detailed device performance metrics in the way a clinical trial or performance study for a novel device would. Instead, it relies on demonstrating equivalence in intended use, design, materials, and performance to predicate devices already on the market.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or cannot be extracted from this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a substantial equivalence submission for a traditional surgical instrument, there are no explicit "acceptance criteria" for novel performance features or quantitative reported device performance in the document. The acceptance criterion is the determination of "substantial equivalence" to the predicate devices, implying that the Dimeda Obstetrical Forceps perform as safely and effectively as the predicates.

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (implicit acceptance criterion for substantial equivalence)	The Dimeda Obstetrical Forceps are "absolutely safe and effective for their intended use and do not raise any questions regarding safety and effectiveness" based on comparison to predicate devices and long market presence in Europe.
Intended Use Equivalence	Identical to predicate devices (grasp and apply traction to fetal head to facilitate vaginal delivery).
Indications for Use Equivalence	Identical to predicate devices (prolonged second stage, suspicion of fetal compromise, shortening of second stage for maternal benefit).
Target Population Equivalence	Identical to predicate devices.
Hospital Use Equivalence	Identical to predicate devices.
Material Equivalence	Manufactured from surgical stainless steel, well-researched materials, identical to predicate devices.
Design Equivalence	Consists of two movable arms, identical to predicate devices.
Biocompatibility Equivalence	Identical to predicate devices.
Sterilization Method Equivalence	Identical to predicate devices.
Performance Equivalence	Identical to predicate devices (no modifications regarding design, method of operation, mechanical performance affecting safety and effectiveness).
Mechanical Safety Characteristics Equivalence	Identical to predicate devices.
Sizes Equivalence	"Partly" identical to predicate devices. (No further detail provided on differences).
No Modifications Made (compared to predicates affecting safety/effectiveness)	"By the Dimeda Obstetrical Forceps have been no modification made (regarding to design, method of operation, mechanical performance)."
No Device Failures Recorded in Europe (for models covered by 510(k))	"All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No specific test set with a defined sample size for performance evaluation is mentioned in the document. The submission relies on comparative data and market history.
Data Provenance: The statement "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures" refers to retrospective market data from Europe.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No ground truth establishment by experts for a specific test set is described.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is more typical for diagnostic imaging AI systems, not generally for surgical instruments demonstrating substantial equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

Not applicable in the usual sense of a diagnostic or algorithmic device. The "ground truth" for demonstrating safety and effectiveness relies on:

Predicate Device Performance: The established safety and efficacy of the legally marketed predicate devices (K013747 - Tekno-Medical Obstetrical Forceps and K951529 - V. MUELLER Obstetrical (OB) Forceps).
Market History: The lack of device failures over many years of use in Europe.

8. The Sample Size for the Training Set

Not applicable. This device is a manual surgical instrument and does not involve a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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K092827

Image /page/0/Picture/1 description: The image shows a logo for a company called "dimeda". The logo is in a stylized font, with each letter outlined. Below the logo, the words "SURGICAL INSTRUMENTS" are written in a smaller, simpler font. There is a dot on either side of the logo.

JAN - 8 2010

Date: 1/7/2010

510(k) Summary

Submission Applicant: Dimeda Instrumente GmbH Gänsäcker 54-58 78532 Tuttlingen Germany Establishment Registration Number: 9611283 Phone: +49 7462 9461 - 0 Fax: +49 7462 9461 - 33 E-mail: info@dimeda.de

Application Correspondent/Contact: think! Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany Phone: +49-7462-924 051 Fax: +49-7462-924 128 E-mail: andrea@thinkworks.biz

Trade name: Dimeda Obstetrical Forceps / K092827

Common name: Obstetrical forceps

Classfication name: Obstetric forceps (21 CFR 884.4400. Product code HDA)

Substantial Equivalence Obstetrical forceps:

K013747 - Tekno-Medical Obstetrical Forceps / K951529 - V. MUELLER Obstetrical (OB) Forceps

Description of the Device:

The Dimeda Obstetrical Forceps should only be used in settings in which personnel are readily

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Image /page/1/Picture/0 description: The image shows a logo for a company called "dimeda SURGICAL INSTRUMENTS". The word "dimeda" is written in a stylized font with each letter enclosed in a box-like shape. Below the company name, the words "SURGICAL INSTRUMENTS" are written in a smaller, simpler font.

available to perform casarean delivery in the event that operative delivery is unsuccessful. Obstetrical forceps should not be used by individuals who are not fully trained in the proper use of forceps and the potential complications associated with their use.

The common names of obstetrical forceps included in this submission: Wrigley, Simpson, Simpson Braun, De Lee, Elliot, Naegele, Luikart, Simpson Luikart, McLean Tucker Luikart, McLean Tucker, McLean Luikart, McLean, Boerma, Dewey, Tarnier, Bill, and Luikart Bill.

Indications for Use:

0 prolonged second stage
suspicion of immediate or potential fetal compromise O
shortening of the second stage for maternal benefit O

Comparison with predicate devices:

The Dimeda Obstetrical Forceps are identical in intended use, indications for use, target population, hospital use, material, design, biocompatibility, sterilization method, performance, mechanical safety characteristics and partly in terms of sizes to the Tekno-Medical Obstetrical Forceps (K013747) and V. MUELLER Obstetrical (OB) Forceps (K951529). There are mainly no differences of the Dimeda Obstetrical Forceps to the predicate devices.

By the Dimeda Obstetrical Forceps have been no modification made (regarding to design, method of operation, mechanical performance), hence it's safety and effectiveness haven't been affected compared to the predicate devices.

Therefore the Dimeda product can be deemed substantially equivalent and safe and effective for its indicated use.

Summary:

The presented data that was conducted on the Dimeda Obstetrical Forceps shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding safety and effectiveness. All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product.

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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Dimeda Instrumente GmbH % Ms. Andrea Pecsi Regulatory Affairs Specialist Think! SCHWARZWALDSTRABE 5 TUTTLINGEN GERMANY 78532

JAN - 8 2010

Re: K092827

Trade/Name: Dimeda Obstetrical Forceps Regulation Number: 21 CFR §884.4400 Regulation Name: Obstetric forceps Regulatory Class: II Product Code: HDA Dated: November 25, 2009 Received: November 30, 2009

Dear Ms. Pecsi:

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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Janine M. Morris

Acting 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

510(k) Number (if known): K092827

Device Name: Dimeda Obstetrical Forceps

Indications for Use:

0 prolonged second stage
0 suspicion of immediate or potential fetal compromise
shortening of the second stage for maternal benefit 0

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Helene Leem

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number 04282

Regulation Number and Section

§ 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.