The Clarus Model 1100 Laser Endoscopic Decompression Kit is intended to be used on patients with contained lumbar or cervical disc herniations or bulges. This is a identical, with the addition of cervical, to the predicate device, Model 1100 Laser Endoscopic Decompression Kit (K922881)

The Clarus Model 1100 Laser Endoscopic Decompression Kit indicated for laser disc decompression in the lumbar and cervical regions of the spine, where the laser is used to remove inner disc material.

Device Description

This 510(k) submission is a modification of the existing Clarus Model 1100 Laser Endoscopic Decompression Kit, previously filed as K922881, and found to be substantially equivalent by the FDA on November 16, 1992. The K922881 510(k) device is intended for lumbar disc decompression in the spine. The modifications, represented by this submission, is the addition of cervical indications.

The Clarus Model 1100 Laser Endoscopic Decompression Kit intended use is to be endoscopic laser decompression of discs in the spine (lumbar and cervical). The kit consists of components necessary for endoscopic laser surgery where visualization and laser surgical techniques are required. The Model 1100 consists of a deflectable endoscope with a fixed laser fiber, a flexible trocar, straight and curved cannulas with dilators, a trephine and obturator, a measuring scale, a skin marking pen, and a scalpel. The cervical LASE is identical to the Clarus Model 2180 Spinescope (previously cleared for cervical visualization, K011454) with a shorter working length and the addition of a fixed laser fiber. The fixed laser fiber is identical to Clarus Model 1150 Laser Fiber (previously cleared for cervical soft tissue, K022610).

The Clarus Model 1100 Laser Endoscopic Decompression Kit, contain the same items, and are manufactured, packaged, and sterilized identically, with one exception, to the device which have been previously filed with FDA under 510(k) application K922881 and found to be equivalent. This exception is that the working length of the device is being shortened for cervical applications. The cannulas, trocars, dilators, and trephine will likewise be changed to accommodate the working length of the device

As with the previous kits, the main components, (the endoscope, cannulas, and dilators) are manufactured by Clarus. The other individual components have been selected by Clarus to offer the user a comprehensive set of instruments for endoscopic laser disc decompression.

The cannulas and dilators are manufactured of stainless steel with a molded plastic proximal end. The trephine (coring needle) is of similar construction as well. These materials are standard to the industry for surgical instruments.

AI/ML Overview

This document is a 510(k) summary for a medical device and describes a modification to an existing device rather than a new device that requires a comprehensive new study proving its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving device performance (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) is not available or applicable in the provided text.

The submission focuses on establishing substantial equivalence to a predicate device for an expanded indication (cervical) based on previous clearances for its components.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Device Performance:

The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or specific quantitative outcomes for the device's function). Instead, the "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to predicate devices for the expanded indication.

The "device performance" is described by its intended use and consistency with previously cleared components.

Acceptance Criteria (Implicit from 510(k) Process)	Reported Device Performance (as described for substantial equivalence)
Expanded Indication Safety & Effectiveness:	The device is "identical, with the addition of cervical, to the predicate device, Model 1100 Laser Endoscopic Decompression Kit (K922881)" for use on patients with contained lumbar or cervical disc herniations or bulges. The cervical endoscope is "identical to the Clarus Model 2180 Spinescope (previously cleared for cervical visualization, K011454) with a shorter working length and the addition of a fixed laser fiber." The fixed laser fiber is "identical to Clarus Model 1150 Laser Fiber (previously cleared for cervical soft tissue, K022610)." The kits are manufactured, packaged, and sterilized identically, with the exception of a shortened working length for cervical applications.
Material/Design Equivalence:	The device contains the same items and materials (e.g., stainless steel, molded plastic) as previous 510(k) devices. The main components (endoscope, cannulas, dilators) are manufactured by Clarus, and other components are selected to offer a comprehensive set.

Acceptance Criteria (Implicit from 510(k) Process)

Reported Device Performance (as described for substantial equivalence)

Expanded Indication Safety & Effectiveness:

The device is "identical, with the addition of cervical, to the predicate device, Model 1100 Laser Endoscopic Decompression Kit (K922881)" for use on patients with contained lumbar or cervical disc herniations or bulges. The cervical endoscope is "identical to the Clarus Model 2180 Spinescope (previously cleared for cervical visualization, K011454) with a shorter working length and the addition of a fixed laser fiber." The fixed laser fiber is "identical to Clarus Model 1150 Laser Fiber (previously cleared for cervical soft tissue, K022610)." The kits are manufactured, packaged, and sterilized identically, with the exception of a shortened working length for cervical applications.

Material/Design Equivalence:

The device contains the same items and materials (e.g., stainless steel, molded plastic) as previous 510(k) devices. The main components (endoscope, cannulas, dilators) are manufactured by Clarus, and other components are selected to offer a comprehensive set.

Study Information (or lack thereof):

Sample size used for the test set and the data provenance: Not applicable. This 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth was created.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 surgical kit, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical kit, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new study for this 510(k). The "ground truth" for the device's predicate history and component clearances would have been associated with their original submissions.
The sample size for the training set: Not applicable. This is not an AI/algorithmic device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Section 4

510(k) Summary

General Information:

Submitted by:		Clarus Medical, LLC1000 Boone Avenue NorthMinneapolis, MN 55427
Contact:	Tom Barthel, PresidentTelephone 763-525-8401Facsimile 763-525-8656
Summary Date	February 4, 2004
Device Name:	Model 1100 Laser Endoscopic Decompression Kit
Common Name:	Spinal endoscope w/ laser fiber.
Classification Name:	Laser Instrument, Surgical, Powered; 878.4810

Predicate Devices:

510(k)	Description	Manufacturer
K922881	Model 1100 Laser Endoscopic Decompression Kit	Clarus Medical, LLC
K011454	Model 2180 Spinescope Endoscope	Clarus Medical, LLC
K022610	Model 1150 Laser Fiber	Clarus Medical, LLC

Intended Use:

Page 4.1

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K040424 2/2

Device Description:

General

Construction

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 1 2004

Mr. Tom Barthel President Clarus Medical, LLC 1000 Boone Avenue North Minneapolis, Minnesota 55427

Re: K040424

Trade/Device Name: Model 1100 Laser Endoscopic Decompression Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 17, 2004 Received: February 18, 2004

Dear Mr. Barthel:

We have reviewed your Section 510(k) premarket notification of intent to market the device wfo have 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 (sec above) into cither 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. Tom Barthel

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and will and on a finding of substantial equivalence of your device to a legally prematics notification: "The stassification 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 If you desire specific arrivation at (301) 594-4659. Also, please note the regulation entitled, Contact the Ories of Court Court Cation" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10(k) Number (if known):	A 11 011 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11

Model 1100 Laser Endoscopic Decompression Kit

Indications For Use:

Device Name:

The Clarus Model 1100 Laser Endoscopic Decompression Kit indicated for laser disc decompression in the lumbar and cervical regions of the spine, where the laser is used to remove inner disc material.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Prescription Use (Per 21 CFR 801.109)

iriam C. Provost
OR

Over-The-Counter Use_

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

(Optional Format 1-2-96)

1040424 510(k) Number_

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.