The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical procedures such as: arthroplasty, nucleotomy, discectomy, and foraminotomy. These manual surgical instruments are hand-held devices intended to manipulate tissue in spinal surgery.

The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

Device Description

The Integra Spine Instrument System for Endoscopic Spinal Surgery is an assembled, comprehensive set of instruments for use in endoscopic decompression techniques. The instrument set includes guide wires, pituitaries, ronguers, trephines, trocar / dilators, cannulas, reamers, dural elevator, nerve hook, mallet, forceps, chisels, and associated handles. The instrument set will be used with an FDA cleared endoscope with a length of no more than 254mm and working channel of at least 4.1mm.

AI/ML Overview

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Product Specifications)	Reported Device Performance
Individual instrument functions performed as designed.	All instruments performed as designed.
All product specifications met or exceeded.	All instrument specifications met or exceeded.

2. Sample Sized Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved verification of individual instrument functions and a cadaver study.
Data Provenance: The cadaver study was performed with a cadaver (human cadaver), indicating a form of retrospective human anatomical testing in a controlled environment. The country of origin for the cadaver or the specific institution is not given.

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

Number of Experts: One surgeon.
Qualifications of Experts: The surgeon was described as "skilled in percutaneous and endoscopic spinal procedures." No further details on years of experience or specific board certifications are provided.

4. Adjudication Method for the Test Set

Adjudication Method: Implicitly, "none" in the traditional sense of multiple reviewers. The evaluation of instrument performance was conducted by a single "skilled surgeon" in the cadaver setting. There is no mention of a consensus process between multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This device is a surgical instrument system, not an imaging or diagnostic device that typically undergoes MRMC studies.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Study: Yes, in a manner applicable to a surgical instrument. "Mechanical testing consisted of verification testing of the individual instrument functions." This can be considered a standalone evaluation of the instruments' physical properties and operational capabilities without direct human surgical interaction beyond the test setup. The cadaver study then integrated human users, but the mechanical testing itself was standalone.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth was based on the design specifications and intended functionality of the physical instruments. In the cadaver study, the ground truth was essentially the successful and satisfactory performance of the instruments during simulated surgical procedures as observed and judged by a skilled surgeon. It is a functional efficacy ground truth within a simulated surgical environment.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a manual surgical instrument system, not an AI/ML-based device that would typically have a "training set" in the computational sense. The device's design is based on established surgical principles and predicate devices, refined through engineering and testing, not machine learning.

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

Ground Truth for Training Set: Not applicable. As mentioned, there is no "training set" in the context of an AI/ML device. The "ground truth" for the development and design of these instruments would stem from anatomical and physiological knowledge, surgical best practices, and the performance characteristics of existing predicate devices. This would have been established through years of medical knowledge development and engineering experience, not through a specific formal "ground truth establishment" for a data set.

Summary

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121482

510(k) Summary (21 CFR Part 807.92)

Submitter's Name: Establishment Registration # Address:

Telephone Number: Fax Number: Contact Person: Email: Date Prepared:

Trade Name:

Common Name:

Device Classification:

Product Code:

Classification Panel:

Predicate Device:

Device Description:

Intended Use:

Material Composition:

Technological Characteristics:

Theken Spine, LLC 3008657535 1153 Medina Rd Medina, Ohio 44256 330-239-7709 330-239-4216 Dale Davison dale.davison@integralife.com May 14, 2012

Instrument System for Endoscopic Spinal Surgery

Spinal Endoscopic System

Class II per 21 CFR 888.1100 - Arthroscope and accessories

HRX, HAE

Orthopedic

maxMore Spinal Endoscopy System, Hoogland Spine Products (K090132). THESSYS Multiscope System, Joimax (K051827)

The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

The Integra Spine Instrument System for Endoscopic Spinal Surgery is manufactured from stainless steel, silicone, and nitinol.

The technological characteristics of the Instrument System are equivalent to the predicate instrument system including use of similar designs, materials, procedure, sterilization methods, and operating principle.

Integra - 1153 Medina Rd., Medina, OH 44256 866-942-8698 toll free · 330-773-7697 fax · integralife.com AUG 28 2012

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Summary of test data:

Conclusion:

There were no clinical or animal tests performed for this submission. Mechanical testing consisted of verification testing of the individual instrument functions as there are no known performance standards. The instruments all performed as designed and met or exceeded all product specifications.

The Instrument System for Endoscopic Spinal Surgery was utilized in a cadaver setting by a surgeon skilled in percutaneous and endoscopic spinal procedures. All instruments performed as designed and met or exceeded all product specifications.

The specifications and intended use of the Instrument System for Endoscopic Spinal Surgery is the same as the predicate devices. There are no significant differences in design or manufacturing materials between this submission and the predicate device. This is based on the designs, the use of established known materials, feature comparisons, and indications for use. The instrument systems represent a basic design concept in terms of safety and effectiveness, and differ only in minor details.

Integra - 1153 Medina Rd., Medina, OH 44256 866-942-8698 toll free - 330-773-7697 fax - integralife.com

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

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

AUG 2 8 2012

Theken Spine, LLC % Mr. Dale Davison Vice President, Engineering 1153 Medina Road Medina, Ohio 44256-0000

Re: K121482

Trade/Device Name: Instrument System for Endoscopic Spinal Surgery Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, HAE Dated: July 19, 2012 Received: July 20, 2012

Dear Mr. Davison

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

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Page 2- Mr. Dale Davison

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark Melkerson
Director
Division of Surgical, Orthopedic
MAY KAEPR
DEPFCレッ
Deuis

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121482

Device Name: Instrument System for Endoscopic Spinal Surgery

Indications For Use:

The Instrument System for Endoscopic Spinal Surgery is intended for use in spinal surgical The moralisms by tour roplasty, nucleotomy, discectomy, and foraminotomy. These manual proceal or truments are hand-held devices intended to manipulate tissue in spinal surgery.

The rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the spinal column.

Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Neil R. Ogles fac mxm

Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K121482

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.