The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

Device Description

The Linvatec 10k Irrigation System is a peristaltic, microprocessor controlled pump system designed to provide liquid distention and irrigation during arthroscopic and laparoscopic procedures. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.

AI/ML Overview

This 510(k) submission for the Linvatec 10k Irrigation System is a summary of safety and effectiveness, comparing the device to legally marketed predicate devices to establish substantial equivalence. It does not contain a study that proves the device meets specific performance acceptance criteria in the way a clinical or technical validation study for a novel device would.

Instead, the submission focuses on demonstrating that the new device has similar intended use, design, and technological characteristics to existing devices, and that any differences do not raise new safety or efficacy issues.

Therefore, the requested information elements related to detailed acceptance criteria, study methodologies, sample sizes, expert involvement, and ground truth are not applicable or not provided in this type of submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. This document does not specify quantitative performance acceptance criteria or report specific device performance metrics against such criteria. The submission is focused on demonstrating substantial equivalence to predicate devices rather than proving performance against novel, pre-defined acceptance criteria through a dedicated study.

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

Not Applicable. No explicit "test set" in the context of a performance study is described. The assessment focuses on comparing the design and characteristics of the new device to predicate devices.
Data Provenance: Not applicable as no specific test data set is referenced in this summary.

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

Not Applicable. This submission does not describe a study involving human experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study was not conducted or mentioned. This type of study is typically for assessing human performance with and without AI assistance, which is not relevant to an irrigation system's substantial equivalence claim.

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

Not Applicable. This is an irrigation system, not an AI algorithm, so the concept of standalone algorithm performance does not apply.

7. The Type of Ground Truth Used:

Not Applicable. Ground truth, in the context of performance validation for diagnostic or AI devices, is not relevant here. The "truth" in this submission is the established safety and effectiveness of the legally marketed predicate devices.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design and characteristics of the Linvatec 10k Irrigation System are compared to existing predicate devices.

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

Not Applicable. See point 8.

Summary of Substantial Equivalence Claim:

The document states:

"The Linvatec 10k Irrigation System is similar in intended use, design and technological characteristics as the Apex® Universal Irrigation System (Linvatec Corporation) and Hydro-Flex Li Laparoscopic Irrigation System (Davol Incorporated)."
"Testing has been conducted to assure the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy."

This indicates that the "study" for this 510(k) was a design and technical comparison supported by internal testing (not detailed in this summary) to ensure that the variations from the predicate devices do not introduce new risks or compromise effectiveness. The acceptance criteria essentially stem from the safety and performance profile of the predicate devices.

Summary

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033573 1/2

FEB 1 1 2004

November 03, 2003

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Linvatec 10k Irrigation System 510(k) Number _________________________________________________________________________________________________________________________________________________________

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

Company Contact B.

Laura D. Krejci, RAC Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	Linvatec 10k Irrigation System
Common Name:	Irrigation System
Classification Names:	Arthroscope, 888.1100Endoscope and Accessories, 876.1500
Proposed Class/Device:Product Code:	Class IIHRX, GCJ

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Summary of Safety and Effectiveness 10K Irrigation System 510(k) # _ November 03, 2003

Predicate/Legally Marketed Devices D.

Apex Universal Irrigation System 510(K) # K961590 Linvatec Corporation

Hydro-Flex Li Laparoscopic Irrigation System: 510(K) # K961224 Davol Incorporated

Device Description ய்

F. Intended Use

The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

G. Substantial Equivalence

The Linvatec 10k Irrigation System is similar in intended use, design and technological characteristics as the Apex® Universal Irrigation System (Linvatec Corporation) and Hydro-Flex Li Laparoscopic Irrigation System (Davol Incorporated). Testing has been conducted to assure the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is the department's symbol, which is a stylized version of the Caduceus, a symbol often associated with medicine and healthcare. The symbol consists of a staff with two snakes coiled around it and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2004

Ms. Laura D. Krejci, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K033573

Tradc/Device Name: Linvatec 10k Irrigation System Regulation Number: 21 CFR 888.1100, 21 CFR 876.1500 Regulation Name: Arthroscope, Endoscope and accessories Regulatory Class: II Product Code: HRX, GCJ Dated: November 3. 2003 Received: November 13, 2003

Dear Ms. Krejci:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the enactment date of the Medical Device Amendments, or to econiner to 1125 2011-125 20:12:12 in accordance with the provisions of the Federal Food, Drug, de rioss that have tective approval of a premarket approval application (PMA). and coometry refore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 – Ms. Laura D. Krejci, RAC

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 p arketed 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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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November 03, 2003

510(k) Number (if known): KOBBS 73

Device Name: Linvatec 10k Irrigation System

Indications for Use:

The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use_ Prescription Use_ √ он (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Muriam C Provost

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

510(k) Number K033573

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.