Laminectomy Rongeurs, Kerrison Rongeurs, 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.

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°

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 -

AI/ML Overview

This document describes the regulatory clearance (K150468) for K2 Medical GmbH & Co. KG's Laminectomy Rongeurs, Kerrison Rongeurs, and IVD Rongeurs. These devices are manual surgical instruments intended for cutting or biting bone during skull or spinal column surgeries in patients aged two years or older.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test	Test Method Summary	Reported Device Performance
Automatic Reprocessing Validation ("Panther Kerrison Rongeur")	Assure devices can be cleaned with provided cleaning steps in the Instructions for Use (IFU). Involves contamination of accessible, interior, and exterior surfaces, especially least accessible sites (worst case). Evaluates effectiveness by comparing visible contamination (red blood cells), residual protein, number of organisms, and TOC levels recovered from control and test instruments, according to AAMI TIR 30.	This validation provides evidence that viable microbiological contamination as well as soil contamination of the "Panther Kerrison Rongeur" are removed by the given cleaning and disinfection instructions.
Sterilization Testing	Verify devices can be sterilized with the provided sterilization procedure in the IFU. Test specimens contaminated with bioindicators or challenge suspension, then tested for sterility after sterilization. A part cycle of the recommended sterilization process was performed to assure a Sterility Assurance Level (SAL) of $10^{-6}$.	A reduction of test bacteria was observed and assured, showing that contaminated test specimens are free of viable/augmentable bacteria after sterilization.
Boiling Test (Corrosion Resistance)	Verify corrosion resistance of instruments according to ASTM F1089-10 section 6.1. Devices boiled in distilled water for 30 minutes, cooled in water for 3 hours, and air-dried for 2 hours. Requirement: Devices not allowed to show signs of corrosion.	The tested instruments did not show any signs of corrosion.
Cytotoxic Testing	Demonstrate no toxic residuals from manufacturing remained on the device. Performed with finished devices from all different materials and coatings according to ISO 10993-5. Requirement: Devices must be considered non-cytotoxic.	All the tested samples were considered to be NON CYTOTOXIC.
Irritation Testing	Determine if device extracts produced an irritation reaction when injected intracutaneously in rabbits. Performed according to ISO 10993-10 with finished devices in all material-coating configurations. Devices extracted in 0.9% saline and cottonseed oil for 72 hours. Extracts injected intracutaneously, and sites graded for tissue reaction at 24, 48, and 72 hours after dose administration. Skin irritation evaluated according to ISO 10993-10.	Test data indicated that the device extracts did not cause a skin irritation reaction.
Mechanical Testing (Handle force, Bite force, Extended use)	Compare functional requirements of K2 Rongeurs with predicate devices. Measured handle force for actuating the device and force to cut artificial bone material. Also, cutting force and cutting size of new and worn instruments were measured with artificial bone material. Requirement: Devices must perform similar or better than predicate devices.	Test showed that the measured functional specifications of the K2 Rongeurs were equivalent or better than the comparable specifications of the predicate devices.

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

The document does not explicitly state the exact sample sizes (number of devices) used for each specific test. For the "Automatic Reprocessing Validation", "Sterilization testing", "Boiling Test", "Cytotoxic testing", and "Irritation testing", the tests were performed on "the devices" or "test specimens" or "finished devices from all the different materials and coatings configurations," implying representative samples of the product line were tested. For "Mechanical testing", "new instruments" and "worn out instruments" were tested.

The data provenance is not explicitly stated in terms of country of origin for the data collection, nor whether it was retrospective or prospective. However, the submitter is K2 Medical GmbH & Co. KG, located in Germany, suggesting the testing was likely conducted in Germany or a location aligned with their quality management system. Given the nature of these engineering and biocompatibility tests, they are inherently prospective, conducted specifically to demonstrate device performance for regulatory submission.

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

This type of information is not applicable to the tests described in this document. The ground truth for these performance, reprocessing, and biocompatibility tests is established through objective, quantitative measurements against predefined standards (e.g., AAMI TIR 30, ASTM F1089-10, ISO 10993-5, ISO 10993-10) and performance comparisons with predicate devices, not through expert consensus or clinical interpretation.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the ground truth is established through objective measurements against standards, not through human interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a manual surgical instrument, not an AI-powered diagnostic or assistive tool that would involve human readers or an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for these tests is based on:

A-priori defined objective criteria derived from recognized standards: e.g., AAMI TIR 30 for reprocessing, ASTM F1089-10 for corrosion resistance, ISO 10993-5 for cytotoxicity, ISO 10993-10 for irritation.
Quantitative measurements and observations: e.g., reduction in bacteria for sterilization, absence of corrosion, non-cytotoxicity, lack of irritation reaction, and comparison of mechanical forces (handle and bite force) against predicate devices.
Material specifications: for biocompatibility and mechanical properties.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. As above, there is no training set for this type of device.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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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)

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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. KGUnter Buchsteig 5D-78532 TuttlingenGERMANY
Contact Person:	Harald Jung, Manager Quality & RegulatoryPhone: +49 7462 94799-182Fax: +49 7462 94799-282
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 /holder	Integra LifeSciences Corporation311 Enterprise DrivePlainsboro, NJ 08536 USA	INSTRUMED INTERNATIONAL, INC.626 Cooper CourtSchaumburg, IL 60173

3. Device Description:

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°

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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	predicateIntegra K092227	predicateInstrumed K081651
indication foruseand targetpopulation	Laminectomy Rongeurs, Kerrison Rongeurs andIVD Rongeurs are manually operated instrumentsindicated for cutting or biting bone during surgeryinvolving the skull or spinal column in patients twoyears of age or older.	IntegraTM KerrisonRongeurs are manuallyoperated instrumentsindicated for cutting orbiting bone during sur-gery involving the skull orspinal column.	The intended use ofInstrumed Rongeur isto access, cut andbite soft tissue andbone during surgeryinvolving the spinalcolumn.
design	Kerrison style Rongeur with a fixed and a slidingshaft and an angled footplateIVD Rongeurs with one fixed shaft, one sliding shaftand a hinged mouthpartLaminectomy Rongeurs with double action jointsand strong handle	same	same
design	Kerrison Rongeur with cleaning channel	without cleaning channel	same
design	Kerrison Rongeur with pushbutton opening mecha-nism and with lever opening mechanism	Kerrison Rongeur withlever opening mechanism	Kerrison Rongeurwith lever openingmechanism
Materials /Biocompati-bility	Stainless Steel AISI 420 ATitanium acc. ASTM F136 / ISO 5832-3	Stainless Steel	Stainless SteelTitanium
	several surface coatings:anthracite, gold, black	several decorative coat-ings (Diamond, Stealth)	same
	silicone coated handle		same
Cleaning	Instruments can be processed in a validated wash-er-disinfector prior to sterilization.	same	same
Sterilization	non-sterileSterilization prior to use, using steam sterilization.	same	same

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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-cessing Validation"Panther KerrisonRongeur"+Amendment toAutomatic Repro-cessing Validation"Panther KerrissonRongeur.	The test was performed to verify that the devices could becleaned with the provided cleaning steps in the IFU.This test method is performed by contamination of accessi-ble, interior, and exterior surfaces of instruments intendingto reach the sites identified as the least accessible or mostdifficult to reach sites (worst case).According AAMI TIR 30, the effectiveness of the repro-cessing cycle is evaluated by comparing visible contamina-tion (red blood cells), residual protein, the number of organ-isms and TOC level recovered from the control instrumentsand the test instruments.	This validation provides evidencethat viable microbiological contami-nation as well as a soil contamina-tion of the "Panther KerrisonRongeur" are removed by the givencleaning and disinfection instruc-tions
Sterilization testing	The test is to verify that the devices could be sterilized withthe provided sterilization procedure described in the IFU.The test specimens were contaminated with bioindicatorsor with a challenge suspension and were tested for sterilityafter the sterilization process.To assure a SAL of $10^{-6}$ only a part cycle of the recom-mended sterilization process was performed in validation.	A reduction of test bacteria wasobserved and assured showing thatcontaminated test specimens arefree of viable/augmentable bacteriaafter sterilization.
Boiling Test	This test is to verify the corrosion resistance of the instru-ments.It is performed according ASTM F1089-10 section 6.1.Devices are boiled in distilled water for 30 min, cooleddown in the water for 3 h and dried at air for 2 h.Devices were not allowed to show signs of corrosion.	The tested instruments did not showany signs of corrosion.
Cytotoxic testing	Test is to show, that no toxic residuals from manufacturingremained on the device.The test was performed with finished devices from all thedifferent materials and coatings according ISO 10993-5.Devices must be considered non cytotoxic.	All the tested samples were consid-ered to be NON CYTOTOXIC.
Irritation testing	The objective of this study was to determine if device-extracts produced an irritation reaction when injected intra-cutaneously in rabbits.Test was performed according ISO 10993-10 with finisheddevices in all material-coating configurations.Devices were extracted in 0.9 % saline and cottonseed Oilfor 72 h. Extracts were injected intracutaneously and sitewas graded for tissue reaction at 24, 48 and 72 hours afterdose administration.Skin irritation was evaluated according ISO 10993-10.	Test data indicated that the deviceextracts did not cause a skin irrita-tion reaction.
Mechanical testing- handle force- bite force- extended use	Mechanical tests were performed to compare functionalrequirements of the K2 Rongeurs with the predicate devic-es.Therefore the handle force for actuating the device wasmeasured as well as the force to cut artificial bone material.Further on the cutting force and cutting size of new instru-ments was measured and compared to worn out instru-ments with the artificial bone material.Devices has to perform similar or better than predicatedevices.	Test showed that the measuredfunctional specifications of the K2Rongeurs were equivalent or betterthan the comparable specificationsof 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.

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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.

Regulation Number and Section

§ 882.4840 Manual rongeur.

(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).