INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX

K100517 · Instrumed International, Inc. · HDA · Apr 29, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K100517
• Device Name: INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX
• Applicant: Instrumed International, Inc.
• Product Code: HDA · Obstetrics/Gynecology
• Decision Date: Apr 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage · suspicion of immediate or potential fetal compromise · shortening of the second stage for maternal benefit

Device Story

Manual obstetrical forceps; two mirror-image metal instruments; components include blades (curved to fit fetal head), shanks, lock, and handles. Used by obstetricians in clinical settings to cradle fetal head and apply traction to facilitate delivery. Device selection based on maternal anatomy and surgical procedure. Non-sterile delivery; requires sterilization before use.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility and sterilization studies successfully completed.

Technological Characteristics

Constructed of ASTM F 899-09 stainless steel. Manual mechanical instrument. Components: blades, shanks, lock, handles. Non-sterile. No software or energy source.

Indications for Use

Indicated for patients requiring assisted delivery due to prolonged second stage, suspected fetal compromise, or need to shorten second stage for maternal benefit, provided fetal head is appropriately positioned in the vagina.

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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## 510(k) Summary as required by section 807.92(c)

date prepared 04/26/2010

### Submission Applicant:

INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173

### Establishment Registration Number:

1421101

### Official Correspondent:

Mr. Berndt Fetzer INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173

Phone: [phone]

### Trade name:

Instrumed Obstetrical Forceps .

#### Common name:

Various Obstetric-Gynaecologic specialized manual instruments/Obstetrical Forceps:

Simpson, Wrigley, Elliott, De Lee, Luikart Simpson, Piper, McLean-Luikart, Mclean-Tucker-Luikart, Boerma, Naegele

### Classification name:

-- OBSTETRICAL AND GYNECOLOGICAL DEVICES 21 CFR PART 884 Subpart E--Obstetrical and Gynecological Surgical Devices

Sec. 884.4400 Obstetric forceps. Product Code HDA

### Regulation Description

Obstetric-gynecologic specialized manual instrument/forceps

### Substantial Equivalence Claims:

- HDA TEKNO-MEDICAL OBSTETRICAL FORCEPS K013747 Applicant TEKNO MEDICAL OPTIK-CHIRURGIE GMBH & CO.
V. MUELLER OBSTETRICAL (OB) FORCEPS K951529 Applicant BAXTER HEALTHCARE CORP.

# K100517

APR 2 9 2010

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### Description of the Device:

Instrumed obstetrical forceps are instruments designed to aid in the delivery of the fetus. Many different types of forceps have been described and developed. Generally, forceps consist of 2 mirror image metal instruments that are manoeuvred to cradle the fetal head and are articulated, after which traction is applied to effect delivery.

Forceps have 4 major components, as follows:

- Blades: The blades grasp the fetus. Each blade has a curve to fit around the fetal head. The . blades are oval or elliptical and can be fenestrated (with a hole in the middle) or solid. Many blades are also curved in a plane 90° from the cephalic curve to fit the maternal pelvic curve).
- Shanks: The shanks connect the blades to the handles and provide the length of the device. They . are either parallel or crossing.
- Lock: The lock is the articulation between the shanks. Many different types have been designed. .
- Handles: The handles are where the operator holds the device and applies traction to the fetal . head.

The surgeon chooses the obstetrical/gynaecological forceps based on the anatomy of the site and the type desired, based on the type of the surgical procedure.

Instrumed obstetrical forceps are made of the ASTM F 899-09 standardized Stainless Steel. The instruments are offered in non-sterile condition.

## Indications for Use:

INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina: · prolonged second stage

-
- · suspicion of immediate or potential fetal compromise
- · shortening of the second stage for maternal benefit

## Comparison with Predicate Device:

The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed.

The Instrumed product is similiar to the predicate device in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics as well as sizes and configurations. Therefore it can be deemed substantially equivalent and safe and effective for its indicated use.

### Summary

The presented data that was conducted on the Instruments 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 new questions regarding safety and effectiveness. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Mr. Michael Massong RA/QA Director Instrumed International, Inc. 626 Cooper Court SCHAUMBURG IL 60173

# APR 2 9 2010

Re: K100517

Trade/Device Name: Instrumed Obstetrical Forceps Regulation Number: 21 CFR 8884.4400 Regulation Name: Obstetric forceps Regulatory Class: II Product Code: HDA Dated: February 16, 2010 Received: February 23, 2010

Dear Mr. Massong:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 of medical device-related

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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/ReportaProblem/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/Resourcesfor You/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

KI00517 510(k) Number (if known):

Device Name:

Instrumed Obstetrical Forceps

Indications For Use:

INSTRUMED Obstetrical Forceps are intended to grasp and apply traction to the fetal head to facilitate delivery for the following indications, provided that the fetal head is positioned appropriately in the vagina:

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

Prescription Use
(Part 21 CFR 801 Subpart D) X AND/OR Over-The-Counter Use
(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sh. L. Nolan

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K100517 510(k) Number

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