A rongeur (Kerrison) is a strongly constructed instrument with a sharp-edged, scoop-shaped tip, used during laminectomy for gouging out bone and tissue.

IVD (Intervertebral Disc) Rongeurs are used on cartilage that separates adjacent vertebrae of the spine A rongeur can be used to open a window in a bone. It is used in neurosurgery to expose areas for operation or to reduce pressure by segregating exposed areas.

To ensure the multi-purpose use of this devices, many different models are available.

Common names used for this kind of Rongeurs are: Kerrison, Sella Punch, IVD (Decker, MIS, Spence, Peapod, Selverstone, Williams, Cushing, Love-Gruenwald, Spurling, Cloward, Sypert, Ferris-Smith, Wilde, Hoen, Oldberg, Jackson, Schlesinger)

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

All Rongeurs are offered in a non-sterile condition.

AI/ML Overview

The provided 510(k) summary for the Instrumed Rongeur does not contain the kind of detailed performance study and acceptance criteria information typically found in submissions for diagnostic AI devices, or even for many other types of medical devices that require quantitative performance data. This Rongeur is a manual surgical instrument, and its 510(k) submission primarily relies on a comparison to predicate devices, rather than robust quantitative performance metrics.

Therefore, many of the requested sections regarding acceptance criteria, specific performance metrics, sample sizes, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.

Here's an assessment based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Substantial equivalence to predicate devices in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilization method, mechanical safety characteristics, and sizes and configurations.	The Instrumed Rongeur is similar to the predicate devices in the listed characteristics. The submission states, "Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the P.D. cited and raise no new issues of safety and effectiveness."
Safety and effectiveness for intended use.	"The presented data that was conducted on the Instrumed Rongeurs 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."
Materials are well researched and do not raise 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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The submission focuses on design analysis and comparison to predicate devices, not on a clinical "test set" in the context of diagnostic performance. There is no mention of a specific sample size of patients or a test set of data.

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

Not applicable / Not provided. No "ground truth" establishment by experts, in the sense of reviewing diagnostic images or clinical outcomes, is mentioned. The assessment of substantial equivalence appears to be an internal engineering and regulatory comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. No adjudication method is mentioned as there is no "test set" and associated expert review.

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 / Not done. This refers to studies for diagnostic AI devices. The Instrumed Rongeur is a manual surgical instrument and does not involve AI assistance or human readers in an MRMC study context.

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

Not applicable / Not done. This refers to performance of a standalone AI algorithm. The device is a manual surgical tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not explicitly defined in terms of quantitative data. The "ground truth" for this type of submission is implicitly the established safety, effectiveness, and functional characteristics of the predicate devices based on their historical use and regulatory clearances. The new device is evaluated against these benchmarks.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable / Not provided. As there is no training set, this information is not relevant.

Summary of the Study / Basis for Clearance:

The "study" in this context is a design analysis and comparison of the Instrumed Rongeur against several legally marketed predicate rongeurs (K062711, K023868, K943635, and others). The manufacturer claims that the new device is substantially equivalent to these predicates.

The core of the argument for safety and effectiveness is that:

The Instrumed Rongeur shares similar technical characteristics, design, indications for use, target population, performance expectations, biocompatibility, sterilization methods, mechanical safety characteristics, and available sizes and configurations with the predicate devices.
The materials used are "well researched" and do not introduce new safety or effectiveness concerns.

Essentially, the clearance is based on the premise that because the new rongeur is sufficiently similar to devices already proven safe and effective for their intended use, it too can be considered safe and effective without requiring extensive new clinical performance data.

Summary

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Ko81651

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

date prepared 06/02/2008

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: 847-908-0292

Trade name:

Instrumed Rongeur

Common name:

Rongeur

Classification name:

RONGEUR, MANUAL (21 CFR 882.4840, Product code HAE)

Regulation Description

Manual rongeur.

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

Substantial Equivalence Claim:

K062711;	Baxano;	Ultra Low profile Rongeur
K023868;	Dannoritzer Medical Instruments;	Dan Kerrison Rongeurs, Models K1 & BILLY
K943635;	CARDINAL HEALTH(V.MUELLER) Rongeurs
	K-MEDIC/TELEFLEX;	IVD Rongeurs and Spinal Punches
	And many other Rongeurs marketed, some under the pre-amendment assessment rule

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Description of the Device:

A rongeur (Kerrison) is a strongly constructed instrument with a sharp-edged, scoop-shaped tip, used during laminectomy for gouging out bone and tissue.

To ensure the multi-purpose use of this devices, many different models are available.

Device description / Identification

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

All Rongeurs are offered in a non-sterile condition.

Indications for Use:

The intended use of Instrumed Rongeurs is to access, cut and bite soft tissue and bone during surgery involving the spinal column.

Performance Data

Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the P.D. cited and raise no new issues of safety and effectiveness

Comparison with P.D.

The Instrumed Rongeur is similiar to the P.D. in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characterisits 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 Instrumed Rongeurs 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 ralse 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The seal is a symbol of the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2008

Instrumed International, Inc. % Mr. Michael Massong RA/QA Director 626 Cooper Court Schaumburg, Illinois 60173

Re: K081651

Trade/Device Name: Instrumed Ronguer Regulation Number: 21 CFR 882.4840 Regulation Name: Manual ronguer Regulatory Class: II Product Code: HAE Dated: June 2, 2008 Received: June 12, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Michael Massong

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 长081651

Device Name:

Instrumed Rongeur

Indications For Use:

The intended use of Instrumed Rongeur is to access, cut and bite soft tissue and bone during surgery involving the spinal column.

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

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)

R.N.

ision Sign-Off) (Div Division of General, Restorative, and Neurological Devices

510(k) Number L081651

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).