The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and bone. The field of application is Otolaryngology surgical procedures.

Device Description

The Integrated Drive/Pump System is a combination of the Linvatec Universal Drive System and Hall® Irrigation System with the addition of three new handpieces used in Otolaryngology surgical procedures. Integrated Drive/Pump System consists of an AC powered drive/pump console, a sterilizable handpiece perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the Linvatec Integrated Drive/Pump System, submitted to the FDA in 1998. This type of document is a premarket notification for certain medical devices and typically focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing specific acceptance criteria for performance in the same way clinical trials do for novel devices.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of device performance metrics, sample sizes, expert ground truth establishment, or clinical comparative effectiveness studies.

Here's why the requested information is not present and what the document does provide:

Acceptance Criteria & Reported Performance: The document does not define specific performance metrics (e.g., speed of resection, accuracy of cut, flow rate of irrigation) with corresponding acceptance criteria or report quantitative performance results against such criteria. Instead, it relies on demonstrating that its design, function, and intended use are similar to predicate devices.
Study That Proves the Device Meets Acceptance Criteria: There is no detailed study described that measures performance against pre-defined acceptance criteria. The document states: "Testing has been done to prove safety and effectiveness of the devices." However, it does not elaborate on the nature of this testing, its methodology, or the results in a way that aligns with the requested information format (e.g., sample sizes, ground truth, expert opinions). This generally refers to verification and validation testing (e.g., electrical safety, biocompatibility, mechanical testing) to ensure the device performs as intended and is safe, but not typically comparative effectiveness or performance criteria studies like those for AI or drug-like interventions.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are relevant to studies demonstrating clinical effectiveness or accuracy, especially for AI/algorithms. Since this document focuses on substantial equivalence based on design and intended use to existing predicate devices, rather than a novel clinical performance claim, these types of details are not included. The "testing" mentioned would likely be engineering or bench testing, not clinical studies.

In summary, the provided text describes a submission for substantial equivalence based on the device's design, function, and intended use being similar to existing cleared devices, rather than a study demonstrating performance against specific, quantitative acceptance criteria.

The key takeaway is that for a 510(k), the primary focus is often on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness. This is a different regulatory pathway than, for example, a Premarket Approval (PMA) application, which typically requires more extensive clinical data to demonstrate safety and effectiveness.

Summary

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Jul 20 1998

<98163-1

July 13, 1998

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs

Device Name C.

Trade Name:	Integrated Drive/Pump System
Common Name:	Integrated Drive/Pump System
Classification Names:	Surgical, ENT (electric or pneumatic), including handpiece - 874.4250Electric cranial drill motor - 882.4360Infusion Pump - 880.5725Surgical instrument motors and accessories/attachments - 878.4820

" "

Predicate/Legally Marketed Devices D.

Universal Drive System Linvatec Corporation

Hall® Irrigation System Linvatec Corporation

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Summary of Safety and Effectiveness Integrated Drive/Pump System 510 (k) # K981637 July 13, 1998 Page 2 of 5

D. Predicate/Legally Marketed Devices (Con't)

TPS Total Performance System Stryker Endoscopy

Hummer 2® Stryker Endoscopy

Device Description E.

Integrated Drive/Pump System consists of an AC The powered drive/pump console, a sterilizable handpiece perforator, various blades, burs, bur guards, irrigation tubing sets, shaver adapter, and a footswitch.

F. Intended Use

The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform The field of resection of soft tissue and bone. application is Otolaryngology surgical procedures. .

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Summary of Safety and Effectiveness Integrated Drive/Pump System 510 (k) # K981637
July 13, 1998 Page 3 of 5

Substantial Equivalence G.

Integrated Drive/Pump System is substantially The equivalent in design, function and intended use to the Universal Drive System (Linvatec Corporation), Hall®
Irrigation System (Linvatec Corporation), TPS Total Irrigation System (Linvatec Corporation), Performance System (Stryker Endoscopy), and Hummer 2 இ (Stryker Endoscopy).

Testing has been done to prove safety and effectiveness of the devices.

The similarities/dissimilarities to the predicates are shown in the attached table.

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Summary of Safety and Effectiveness
Integrated Drive/Pump System 510 (k) # K981637_July 13, 1998 Page 4 of 5

CHART OF SIMILARITIES

Company	Device Name	Intended Use
NEWPRODUCTLinvatec	IntegratedDrive/PumpSystem	Resection of soft tissue andbone during Otolaryngologysurgical procedures.	SHVE
PREDICATELinvatec510 (k)#K971059	Universal DriveSystem	To perform cutting of softtissue and bone in theapplications of :Arthroscopic/Orthopedic,Otolaryngological andReconstructive Surgery	S
PREDICATELinvatec510 (k)#K961192#K852143	Hall® IrrigationSystem	General, Reconstructivesurgery, and Otolaryngological	S
PREDICATEStrykerEndoscopy510 (k)#K943569#K943589	TPS TotalPerformanceSystem	Resection of soft tissue andbone in the applications of:Spinal, Foot and Ankle,Plastics, ENT, and Neuro	S

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AND DISSIMILARITIES

Components and Design - The

Drive/Pump Console, High Speed Handpiece, ystem consists of: igh Speed Drill, Cranial Perforator, Irrigation Tubing Sets, arious Blades, Burs, Bur Guards, Footswitch, Shaver Adapter, ower Cord, and Handpiece Cord.

ystem consists of: Universal Controller, Foot Control, "Apex tyle" Handpieces and associated attachments, blades, and urrs.

haver blades & burrs: length 75-200mm, diameter 2.0-6.0mm.

ystem consists of: Irrigation console, irrigation sensor, rrigation tubing set, and irrigation attachment clips

ystem consists of: Drive Console, Handpieces, Footswitch, rills, Saws, Dura Guards, and Angled Attachments.

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Summary of Safety and Effectiveness Summary Of Dump/Drive System Integration K981637___________________________________________________________________________________________________________________________________________________________

CHART OF SIMILARITIES יי מחוזה

ు

Company	Device Name	Intended Use
PREDICATEStrykerEndoscopy510(k)#K952681	Hummer 2®	Resection of soft tissue andbone in the applications of:Head & Neck and ENT

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; AND DISSIMILARITIES

ratem Components and Design
7stem consists of - Drive/Pump Console, Handpiece, footswitch,
itters, and Irrigation Tubing Set.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 20 1998

Re:

Carol A. Weideman, Ph.D. Director, Compliance and Regulatory Affairs Linvatec. Corporation 11311 Concept Boulevard Largo, Florida 33773

K981637 Integrated Drive/Pump System for Otolaryngology Dated: Mav 7, 1998 Received: May 8, 1998 Regulatory class: II 21 CFR 874.4250/Procode: 77 ERL

Dear Dr. Weidman:

We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your derice 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 and additionally 809.10 for in vito diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr.idsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/8/Picture/0 description: The image shows the Linvatec logo. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is made up of three chevrons nested inside each other. The word "Linvatec" is written in a bold, sans-serif font.

11311 Concept Boulevard Largo, Florida 33773-4908 813 392-6464

July 7, 1998

Page 1 of 1

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Integrated Drive/Pump System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ১

Over-the-Counter Use

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"

(Per 21 CFR 801.109)

David C. Symm
Division Sign Off

510/k) Num

(Optional Format 1-2-96)

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.