DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX

K092827 · Dimeda Instrumente GmbH · HDA · Jan 8, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K092827
• Device Name: DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX
• Applicant: Dimeda Instrumente GmbH
• Product Code: HDA · Obstetrics/Gynecology
• Decision Date: Jan 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Dimeda Obstetrical Forceps are manual surgical instruments used by obstetricians to grasp the fetal head and provide traction/guidance during vaginal delivery. The device consists of two movable arms made of surgical stainless steel. Used in clinical settings where cesarean delivery is available as a backup. The physician manually positions the forceps around the fetal head to facilitate delivery when the cervix is fully dilated. The device aids in shortening the second stage of labor or addressing fetal compromise, potentially reducing risks associated with prolonged labor. No electronic or automated components.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and performance comparisons to legally marketed predicate devices with a long history of safe use.

Technological Characteristics

Manual surgical instrument; material: surgical stainless steel; design: two-arm forceps; form factor: various models (Wrigley, Simpson, etc.); non-powered; non-sterile (implied, requires sterilization); no software or electronic components.

Indications for Use

Indicated for patients requiring assisted vaginal delivery due to prolonged second stage of labor, suspected fetal compromise, or for maternal benefit. Contraindicated for use by individuals not fully trained in forceps procedures or in settings lacking capability for immediate cesarean delivery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] - 0 Fax: [phone] - 33 E-mail: [e-mail]

Application Correspondent/Contact: think! Andrea Pecsi Schwarzwaldstraße 5 78532 Tuttlingen Germany Phone: [phone] Fax: [phone] E-mail: [e-mail]

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 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.

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:

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
- 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 [phone] or [phone] 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:

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

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)

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Helene Leem

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