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

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 eiector tips: 4.75 -15" shaft lengths; and various handle and shaft styles, including Detach®. Integra® Kerrison Rongeurs are distributed under the following brand names: Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand®.

AI/ML Overview

The provided text describes a 510(k) submission for Kerrison Rongeurs, focusing on a labeling change regarding sterilization instructions. It is not an AI/ML device, therefore, many of the requested categories related to AI performance, ground truth, and reader studies are not applicable.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance (Not applicable for AI/ML device)

This section would typically detail the specific performance metrics (e.g., sensitivity, specificity, AUC) the AI device needs to meet. Since this is a manual surgical instrument, these metrics are not relevant.

The acceptance criteria for this device, as indicated by the 510(k) submission, revolve around its substantial equivalence to a predicate device, particularly concerning its design, materials, intended use, and the safety and effectiveness of its sterilization methods.

Acceptance Criteria Category	Reported Device Performance
Substantial Equivalence	Demonstrated: The device is substantially equivalent to the predicate device K092227.
Materials	Identical (420 Stainless steel, same surface coatings as predicate)
Intended Use	Identical (cutting or biting bone during surgery involving the skull or spinal column)
Technological Characteristics	Identical (manual, non-electrical, non-sterile, reusable, non-malleable, sterilizable)
Sterilization Validation	Passed: Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes and Drying Time of 20 minutes for both Assembled and Open Configuration.
Biocompatibility	Not applicable (no change in materials)

Study Information

1. Sample size used for the test set and the data provenance:

Not applicable for an AI/ML device. The submission references sterilization validation testing, but it's not a "test set" in the context of AI/ML evaluation. The sterilization validation would have involved a specific number of test cycles and biological or chemical indicators, but the specific quantity is not detailed beyond "successful sterilization validation."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable for an AI/ML device. Ground truth, in this context, would be external validation against disease or condition. For a medical device like a Kerrison Rongeur, safety and effectiveness are established through physical and mechanical testing, biocompatibility, and sterilization validation; not by expert consensus on diagnostic interpretations.

3. Adjudication method for the test set:

Not applicable for an AI/ML device. Adjudication methods are used in AI/ML studies to resolve discrepancies in expert ground truth labels. This submission doesn't involve such a process.

4. 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 and does not involve AI assistance or human readers in the diagnostic sense.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical instrument, not an algorithm.

6. The type of ground truth used:

Not applicable in the AI/ML sense. For this device, the "ground truth" for its safety and effectiveness is established through:
- Predicate device comparison: demonstrating that its design, materials, and intended use are substantially equivalent to a device already legally marketed.
- Sterilization validation: adherence to recognized standards (ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009). This is a technical validation against established protocols.

7. The sample size for the training set:

Not applicable. This device does not use machine learning or require a training set.

8. How the ground truth for the training set was established:

Not applicable. This device does not use machine learning or require a training set.

Summary

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

April 16, 2015

Integra York PA, Inc. Ms. Stephanie Sheeslev Senior Manager, Regulatory Affairs 589 Davies Drive York, Pennsylvania 17402

Re: K150428

Trade/Device Name: Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: February 18, 2015 Received: February 19, 2015

Dear Ms. Sheesley,

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 (reporting of medical device

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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 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

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) K150428

Device Name

Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs

Indications for Use (Describe)

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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510(k) Summary

I. SUBMITTER

Integra York PA, Inc. 589 Davies Drive York, PA 17402 USA

Phone: (717) 717-840-3522 Fax: (717) 840-9347

Contact Person: Stephanie Sheesley Date Prepared: April 15, 2015

II. DEVICE

Name of Device: Integra® (Jarit®, Ruggles™-Redmond™, Miltex®, MeisterHand®) Kerrison Rongeurs Common Name: Kerrison Rongeur Classification Name: Manual, Rongeur (21 CFR 882.4840) Regulatory Class: Class II Product Code: HAE

III. PREDICATE DEVICE

Integra® Jarit®, Ruggles™ -Redmond™, Miltex®, and MeisterHand® Kerrison Rongeurs, K092227

This predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

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VI. COMPARISON OF TECHNOLOGICAL CHRACTERISTICS WITH THE PREDICATE DEVICE

	Integra York PA, Inc.Integra® Kerrison Rongeurs	Integra Medical Instrument Group(now Integra York PA, Inc.)Integra® Kerrison Rongeurs
510(k) #	Subject of Submission	K092227
Class	II	II
Pro Code	HAE	HAE
Regulation #	882.4840	882.4840
Classification	Manual, Rongeur	Manual, Rongeur
Indications for Use	Kerrison Rongeurs are manually	Kerrison Rongeurs are manually
	operated instruments indicated for	operated instruments indicated for
	cutting or biting bone during surgery	cutting or biting bone during surgery
	involving the skull or spinal column.	involving the skull or spinal column.
Contact Materials	420 Stainless steel	420 Stainless steel
	Surface coatings: Titanium	Surface coatings: Titanium
	Nitride(TiN); Diamond Coat and Hard-	Nitride(TiN); Diamond Coat and Hard-
	Coat™ (TiAIN): Stealth Coat and	Coat™ (TiAIN); Stealth Coat and
	Smooth-Coat™ (Dicronite DL-5);	Smooth-Coat™ (Dicronite DL-5);
	Ultra-Coat™ (ZrN); PTFE	Ultra-Coat™ (ZrN); PTFE
	(polytetrafluoroethylene [Teflon®]);	(polytetrafluoroethylene [Teflon®]);
	Silicone (Elastosil® LR3003/80 A,B)	Silicone (Elastosil® LR3003/80 A,B)
Instructions for Use	Sterilize in either the Assembled or	Sterilize in Disassembled. Open
	Disassembled, Open Position.	Position.
	Successful Sterilization Validation
	supports Assembled and Open
	Configuration
Technological	Identical to Predicate	Manual, non-electrical, non-sterile,
Characteristics		reusable
Malleability	Non-malleable	Non-malleable
Sterility	Non-sterile	Non-sterile
Sterilization	Sterilizable	Sterilizable
Utility	Reusable	Reusable
Energy Source	N/A (manual)	N/A (manual)
Image of Example
Kerrison Rongeur -Detach Shaft

The below table provides a comparison of the subject devices and the predicate devices.

There are no differences in technology, materials, intended use, or design between the subject devices and the above predicates. The only change is with respect to the labeling. The Instructions For Use for the predicate device stated that the device was to be sterilized in the disassembled but open configuration. The Instructions for Use for the subject devices allows the devices to be sterilized in the either the disassembled, but open configuration. This change is supported by a successful sterilization validation.

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VII. PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. No new testing was required to be performed in support of this labeling change. This Special 510(k) pre-market notification includes the sterilization validation submitted with the predicate device submission #K092227 as a reference only.

The below testing is provided as a reference to support the labeling change subject to this Special 510(k). This testing is not new and was previously included in the 510(k) submission #K092227 and was deemed acceptable to support the proposed labeling change per Pre-Submission #Q141112.

Testing Performed	Results
Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010& A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an ExposureTime of 4 minutes and Drying Time of 20 minutes	Pass

No biocompatibility testing was performed as a result of this Special 510(k) as the subject devices are not under-going a change in materials - this submission is for a labeling change only.

VIII. CONCLUSIONS

The labeling was the only change submitted under this Special 510(k) and supports the substantial equivalence 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).