Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

K150468 · K2 Medical GmbH & Co. KG · HAE · Feb 29, 2016 · Neurology

Device Facts

• Record ID: K150468
• Device Name: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
• Applicant: K2 Medical GmbH & Co. KG
• Product Code: HAE · Neurology
• Decision Date: Feb 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4840
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Laminectomy Rongeurs, Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.

Device Story

Reusable manual stainless steel surgical instruments; includes Laminectomy, Kerrison, and IVD Rongeurs. Devices feature fixed/sliding shafts, angled footplates, or hinged mouthparts; various handle styles, surface finishes, and coatings available. Operated by surgeons in clinical settings to cut or bite bone. Kerrison models include optional cleaning channels and push-button or lever-based opening mechanisms for reprocessing. Devices are provided non-sterile and require steam sterilization before use. Performance relies on mechanical force applied by the user to the handle to actuate the jaw/biting mechanism. Equivalent to predicate rongeurs in design, function, and intended use; differences in opening mechanisms do not impact safety or effectiveness.

Clinical Evidence

Bench testing only. Validated automatic reprocessing (AAMI TIR 30) confirmed removal of soil/microbiological contamination. Sterilization validation achieved SAL 10^-6. Corrosion resistance verified via boiling test (ASTM F1089-10). Biocompatibility testing (ISO 10993-5, ISO 10993-10) confirmed non-cytotoxic and non-irritating properties. Mechanical testing compared handle/cutting forces against predicates, demonstrating equivalent or superior performance.

Technological Characteristics

Materials: Stainless Steel AISI 420 A, Titanium (ASTM F136 / ISO 5832-3). Design: Manual, reusable, stainless steel instruments; various shaft lengths (6-15 inches), jaw sizes (1-6 mm), and angles. Features: Cleaning channels, push-button/lever opening mechanisms, silicone-coated handles, and various surface coatings (ceramic, black, gold). Energy: Manual. Sterilization: Steam sterilization (non-sterile delivery).

Indications for Use

Indicated for cutting or biting bone during skull or spinal column surgery in patients aged two years or older.

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

• Integra™ Kerrison Rongeurs (K092227)
• Instrumed Rongeur (K081651)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human face in profile, composed of three overlapping silhouettes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the face.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

March 24, 2016

K2 Medical GmbH & Co. KG Mr. Harald Jung Manager Quality & Regulatory Unter Buchsteig 5 Tuttlingen, Baden-Wuerttemberg 78532 Germany

Re: K150468

Trade/Device Name: Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: February 25, 2016 Received: February 26, 2016

Dear Mr. Jung:

This letter corrects our substantially equivalent letter of February 29, 2016.

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 Actinclude 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

{1}------------------------------------------------

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet

address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet

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

Sincerely yours,

Carlos L. Pena -S 同公

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known) K150468

#### Device Name

Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

Indications for Use (Describe)

Laminectomy Rongeurs, Kerrison Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for K2 Medical GmbH & Co. KG. The logo features a stylized "k2" in black and green, followed by the word "medical" in black. Below "medical" is the text "GmbH & Co. KG" in a smaller font size.

## 1. Submitter Information

| Submitter: | K2 Medical GmbH & Co. KG<br>Unter Buchsteig 5<br>D-78532 Tuttlingen<br>GERMANY |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person: | Harald Jung, Manager Quality & Regulatory<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | 12.02.2015 |
| Device Trade Name: | K2 Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs |
| Common / Usual Name: | Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs |
| Classification Name | Rongeur, Manual (21 CFR 882.4840) |
| Regulatory Class: | II |
| Product Code: | HAE |

#### 2. Predicate Device:

| Trade name | Integra™ Kerrison Rongeurs | Instrumed Rongeur |
|------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| 510(k) No. | K092227 | K081651 |
| 510(k) submitter /<br>holder | Integra LifeSciences Corporation<br>311 Enterprise Drive<br>Plainsboro, NJ 08536 USA | INSTRUMED INTERNATIONAL, INC.<br>626 Cooper Court<br>Schaumburg, IL 60173 |

## 3. Device Description:

K2 Laminectomy Rongeurs, Kerrison Rongeurs and IVD Rongeurs (Intervertebral Disk Rongeurs) are reusable manual stainless steel instruments. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use.

The devices are available with the following features:

Kerrison style Rongeur with a fixed and a sliding shaft and an angled footplate

- with different handles (Micro Handle, Spurling Handle, Ferris-Smith handle, Tarpon handle)
- with different surface treatments (mirror finish, satin finish, matt/dull finish, brush-finished and different coatings (ceramic, black, gold)
- different shaft overall length (6 " inch to 15 " inch) -
- different sizes (1mm to 6 mm)
- different angles (up 40°, up 90°, down 90° -
- without ejector or with different types of ejectors
- with straight shaft, curved (Foraminotomy style) or with Bayonet Shaft,
- traditional style or with special cleaning channel
- traditional style or with opening mechanism (convertible, take-apart)
- with rotating shaft angled 90° and 40°

{4}------------------------------------------------

# 510(k) Summary

Image /page/4/Picture/1 description: The image shows the logo for K2medical GmbH & Co. KG. The logo features the letter "K" in black, followed by a green number "2". The word "medical" is written in black to the right of the "K2", and the text "GmbH & Co. KG" is written in a smaller font size below the word "medical".

IVD Rongeurs (Intervertebral disk Rongeurs) with one fixed shaft, one sliding shaft and a hinged mouthpart

- in different styles: Decker Forceps, MIS* Rongeurs/Micro-Pituitary, MIS* Cushing Rongeurs, -Spence iVD Rongeurs, Poppen IVD Rongeurs, Peapod IVD Rongeurs, Love-Gruenwald, Selverstone Rongeurs, Williams Dissecting Forceps, Spurling IVD Rongeurs, Sypert Rongeur, Wilde IVD Rongeurs, Hoen IVD Rongeurs, Oldberg Disc Rongeur, Jackson IVD Rongeurs, Schlesinger IVD Rongeurs, Caspar type Rongeur, Schlesinger Rongeur (MIS* Minimally Invasive Surgery)
- with different length and jaw sizes
- angled and straight
- with closed jaw and with fenestrated jaws
- with smooth jaw and with teeth

Laminectomy Rongeurs with double action joints and strong handle

- Fulton Laminectomy Rongeurs -
## 4. Indications for Use

Laminectomy Rongeurs, Kerison Rongeurs and IVD Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.

#### 5. Comparison of technological Characteristics to predicate device

| | new device | predicate<br>Integra K092227 | predicate<br>Instrumed K081651 |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| indication for<br>use<br>and target<br>population | Laminectomy Rongeurs, Kerrison Rongeurs and<br>IVD Rongeurs are manually operated instruments<br>indicated for cutting or biting bone during surgery<br>involving the skull or spinal column in patients two<br>years of age or older. | IntegraTM Kerrison<br>Rongeurs are manually<br>operated instruments<br>indicated for cutting or<br>biting bone during sur-<br>gery involving the skull or<br>spinal column. | The intended use of<br>Instrumed Rongeur is<br>to access, cut and<br>bite soft tissue and<br>bone during surgery<br>involving the spinal<br>column. |
| design | Kerrison style Rongeur with a fixed and a sliding<br>shaft and an angled footplate<br>IVD Rongeurs with one fixed shaft, one sliding shaft<br>and a hinged mouthpart<br>Laminectomy Rongeurs with double action joints<br>and strong handle | same | same |
| design | Kerrison Rongeur with cleaning channel | without cleaning channel | same |
| design | Kerrison Rongeur with pushbutton opening mecha-<br>nism and with lever opening mechanism | Kerrison Rongeur with<br>lever opening mechanism | Kerrison Rongeur<br>with lever opening<br>mechanism |
| Materials /<br>Biocompati-<br>bility | Stainless Steel AISI 420 A<br>Titanium acc. ASTM F136 / ISO 5832-3 | Stainless Steel | Stainless Steel<br>Titanium |
| | several surface coatings:<br>anthracite, gold, black | several decorative coat-<br>ings (Diamond, Stealth) | same |
| | silicone coated handle | | same |
| Cleaning | Instruments can be processed in a validated wash-<br>er-disinfector prior to sterilization. | same | same |
| Sterilization | non-sterile<br>Sterilization prior to use, using steam sterilization. | same | same |

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for K2 Medical GmbH & Co. KG. The logo features the text "k2 medical" in a sans-serif font, with the "k2" portion in a green color and the "medical" portion in black. Below the main text, in a smaller font size, is the text "GmbH & Co. KG".

## 6. Testing

#### Performance data

The following performance data were provided in support of the substantial equivalence determination:

| Test | Test Method Summary | Results |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Automatic Repro-<br>cessing Validation<br>"Panther Kerrison<br>Rongeur"<br>+<br>Amendment to<br>Automatic Repro-<br>cessing Validation<br>"Panther Kerrisson<br>Rongeur. | The test was performed to verify that the devices could be<br>cleaned with the provided cleaning steps in the IFU.<br><br>This test method is performed by contamination of accessi-<br>ble, interior, and exterior surfaces of instruments intending<br>to reach the sites identified as the least accessible or most<br>difficult to reach sites (worst case).<br><br>According AAMI TIR 30, the effectiveness of the repro-<br>cessing cycle is evaluated by comparing visible contamina-<br>tion (red blood cells), residual protein, the number of organ-<br>isms and TOC level recovered from the control instruments<br>and the test instruments. | This validation provides evidence<br>that viable microbiological contami-<br>nation as well as a soil contamina-<br>tion of the "Panther Kerrison<br>Rongeur" are removed by the given<br>cleaning and disinfection instruc-<br>tions |
| Sterilization testing | The test is to verify that the devices could be sterilized with<br>the provided sterilization procedure described in the IFU.<br><br>The test specimens were contaminated with bioindicators<br>or with a challenge suspension and were tested for sterility<br>after the sterilization process.<br><br>To assure a SAL of $10^{-6}$ only a part cycle of the recom-<br>mended sterilization process was performed in validation. | A reduction of test bacteria was<br>observed and assured showing that<br>contaminated test specimens are<br>free of viable/augmentable bacteria<br>after sterilization. |
| Boiling Test | This test is to verify the corrosion resistance of the instru-<br>ments.<br><br>It is performed according ASTM F1089-10 section 6.1.<br>Devices are boiled in distilled water for 30 min, cooled<br>down in the water for 3 h and dried at air for 2 h.<br>Devices were not allowed to show signs of corrosion. | The tested instruments did not show<br>any signs of corrosion. |
| Cytotoxic testing | Test is to show, that no toxic residuals from manufacturing<br>remained on the device.<br><br>The test was performed with finished devices from all the<br>different materials and coatings according ISO 10993-5.<br>Devices must be considered non cytotoxic. | All the tested samples were consid-<br>ered to be NON CYTOTOXIC. |
| Irritation testing | The objective of this study was to determine if device-<br>extracts produced an irritation reaction when injected intra-<br>cutaneously in rabbits.<br><br>Test was performed according ISO 10993-10 with finished<br>devices in all material-coating configurations.<br><br>Devices were extracted in 0.9 % saline and cottonseed Oil<br>for 72 h. Extracts were injected intracutaneously and site<br>was graded for tissue reaction at 24, 48 and 72 hours after<br>dose administration.<br><br>Skin irritation was evaluated according ISO 10993-10. | Test data indicated that the device<br>extracts did not cause a skin irrita-<br>tion reaction. |
| Mechanical testing<br>- handle force<br>- bite force<br>- extended use | Mechanical tests were performed to compare functional<br>requirements of the K2 Rongeurs with the predicate devic-<br>es.<br><br>Therefore the handle force for actuating the device was<br>measured as well as the force to cut artificial bone material.<br><br>Further on the cutting force and cutting size of new instru-<br>ments was measured and compared to worn out instru-<br>ments with the artificial bone material.<br><br>Devices has to perform similar or better than predicate<br>devices. | Test showed that the measured<br>functional specifications of the K2<br>Rongeurs were equivalent or better<br>than the comparable specifications<br>of the predicate devices. |

The nonclinical testing demonstrated, that the K2 Rongeur is substantial equivalent to the predicate device and performs as well as or better than the legally marketed predicate devices.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for K2 Medical GmbH & Co. KG. The logo features the letter "k" in black, followed by a green number "2". The word "medical" is written in black to the right of the "k2". Below the word "medical" is the text "GmbH & Co. KG".

## 7. Substantial Equivalence

Substantial equivalence for the K2 Ronqeurs is based on similarities in intended use, design (function, dimensions, operational principles and performance tests), materials and labeling based on their promotional materials, labeling and clearance letter.

The only difference to the predicate devices is another opening mechanism with a push button for the K2 Kerrison Rongeurs. By pressing the push button the upper part of the shaft can slide back and is released from the guide of the lower part. It can easily be opened for cleaning. After cleaning the upper part is laid down to the lower part and snapped in by pressing the handle.

The predicate device from Integra and from Instrumed has a lever to release the upper part from the quide of the lower part.

The minor technological differences between the K2 Rongeurs and the predicate devices raise no new issues of safety or effectiveness.

Performance data demonstrate, that the K2 Rongeurs do comply to relevant standards and that their main functional features are equivalent to the predicate devices from Integra and Instrumed. Thus, the K2 Rongeur is substantially equivalent to the predicate device.