JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS

K092227 · Integra Lifesciences Corp. · HAE · Feb 17, 2010 · Neurology

Device Facts

• Record ID: K092227
• Device Name: JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
• Applicant: Integra Lifesciences Corp.
• Product Code: HAE · Neurology
• Decision Date: Feb 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Integra™ (Jarit®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.

Device Story

Integra™ Kerrison Rongeurs are manual, reusable stainless steel surgical instruments. They function as mechanical bone cutters used by surgeons during skull or spinal procedures. The device features various configurations including different bite sizes (1-6 mm), jaw openings (9-15.5 mm), cutting angles (40° and 90°), and shaft lengths (4.75-15"). Some models include ejector tips for bone removal and Detach® handle styles. The instruments are provided non-sterile and require sterilization before use. They are used in operating rooms to assist surgeons in bone resection, potentially improving surgical access and procedural efficiency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reusable stainless steel manual surgical instruments. Features include various bite sizes, jaw openings, cutting angles, and shaft lengths. Includes optional proprietary surface treatments and ejector mechanisms. Sterilizable.

Indications for Use

Indicated for cutting bone during skull or spinal column surgery. For use by trained clinicians in a surgical setting.

Regulatory Classification

Identification

A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

Predicate Devices

• Jarit Laminectomy Rongeurs (Pre-amendment)
• Ruggles Laminectomy Rongeurs (Pre-amendment)
• Ruggles Laminectomy Rongeurs (K902819)
• Redmond Ejector Kerrison Rongeur (K933978)
• Miltex Kerrison Rongeurs (Pre-amendment)

Submission Summary (Full Text)

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092227

Image /page/0/Picture/1 description: The image shows the logo for Integra LifeSciences Corporation. The logo consists of a series of curved lines above the word "INTEGRA" in large, bold, black letters. Below "INTEGRA" is the text "LIFESCIENCES CORPORATION" in a smaller font size. The overall design is clean and professional, conveying a sense of stability and innovation.

311 Enterprise Drive • Plainsboro, NJ 08536 USA • Tel: [phone] • Fax: [phone] • www.Integra-LS.com

# 510(k) Summary

FEB 1 7 2010

| Submitted by: | Integra LifeSciences Corporation<br>311 Enterprise Drive |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Plainsboro, NJ 08536 USA |
| Contact Person: | Jennifer J. Bosley, Regulatory Affairs Manager<br>Integra Medical Instrument Group<br>589 Davies Drive<br>York, PA 17402 USA<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 21, 2009 |
| Device Trade Name: | Integra™ Kerrison Rongeurs |
| Common/Usual Name: | Kerrison Rongeur |
| Proposed Classification: | Manual Rongeur |
| | 21 CFR 882.4840<br>Class II, 84 HAF. Neurology |

#### Device Description:

Integra™ Kerrison Rongeurs are reusable stainless steel instruments that are sterilizable and packaged non-sterile. Devices are available with the following features: with or without proprietary surface treatments; 1-6 mm bite sizes; 9 - 15.5 mm jaw openings; 40° and 90° up/down cutting angles; regular and thin/low profile footplates; standard and ejector tips; 4.75 - 15" shaft lengths; and various handle and shaft styles, including Detach®. Integra™ Kerrison Rongeurs are distributed under the following brand names: Jaril®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHamd®.

### Intended Use:

Integra™ (Jarit®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.

## Predicate Devices:

| 510(k) # | Device | Manufacturer |
|---------------|----------------------------------|-------------------------------------------------------|
| Pre-amendment | Jarit Laminectomy Rongeurs | J. Jamner Surgical Instruments (Integra LifeSciences) |
| Pre-amendment | Ruggles Laminectomy Rongeurs | Ruggles Corp. (Integra LifeSciences) |
| K902819 | Ruggles Laminectomy Rongeurs | Ruggles Corp. (Integra LifeSciences) |
| K933978 | Redmond Ejector Kerrison Rongeur | Redmond Neurotechnologies (Integra LifeSciences) |
| Pre-amendment | Miltex Kerrison Rongeurs | Miltex, Inc. (Integra LifeSciences) |

# Substantial Equivalence:

Modified IntegraT™ Kerrison Rongeurs conform to design specifications and are substantially equivalent to the above legally marketed pre-amendments and predicate devices with respect to intended use, fundamental technology, design and materials.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.

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

Integra LifeSciences Corporation c/o Jennifer Bosley, MBA, RAC Regulatory Affairs Manager Integra Instrument Group 311 Enterprise Drive Plainsboro, NJ 08536

FEB 1 7 2010

Re: K092227

Trade/Device Name: Integra Kerrison Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: January 8, 2010 Received: January 11, 2010

Dear Ms. Bosley:

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.

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Page 2 - Jennifer Bosley, MBA, RAC

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 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/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,

Q.R.M.M.fr

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use

K092227 510(k) Number (if known):

Device Name:

Integra™ Kerrison Rongeurs

Indications for Use:

Integra™ (Jarit®, Ruggles™, R&B Redmond™(Redmond™), Miltex®, MeisterHand®) Kerrison Rongeurs are manually operated instruments indicated for cutting bone during surgery involving the skull or spinal column.

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

Over-The-Counter-Use (Part 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)

Daviel Cceipp

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092227

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