INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY

K981637 · Linvatec Corp. · ERL · Jul 20, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K981637
• Device Name: INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
• Applicant: Linvatec Corp.
• Product Code: ERL · Ear, Nose, Throat
• Decision Date: Jul 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4250
• Device Class: Class 2
• Attributes: Therapeutic

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 resection of soft tissue and bone. The field of application is Otolaryngology surgical procedures.

Device Story

Integrated Drive/Pump System is a powered surgical instrument system for Otolaryngology. Components include AC-powered drive/pump console, sterilizable handpieces (drill, perforator), blades, burs, bur guards, irrigation tubing, shaver adapter, and footswitch. Operated by surgeons in clinical/surgical settings. Device provides mechanical power for cutting/resecting soft tissue and bone while simultaneously providing irrigation. Output is physical resection of tissue; healthcare providers use visual feedback during surgery to guide instrument placement and tissue removal. System benefits patients by enabling precise, powered surgical access and tissue resection in ENT procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

System consists of AC-powered console, electric/pneumatic handpieces, and irrigation components. Materials include standard surgical-grade components compatible with sterilization. Connectivity is limited to physical cable connections between console, footswitch, and handpieces. No software-based control or digital connectivity described.

Indications for Use

Indicated for patients requiring resection of soft tissue and bone during Otolaryngology surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Universal Drive System (Linvatec Corporation) (K971059)
• Hall® Irrigation System (Linvatec Corporation) (K961192, K852143)
• TPS Total Performance System (Stryker Endoscopy) (K943569, K943589)
• Hummer 2® (Stryker Endoscopy) (K952681)

Submission Summary (Full Text)

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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 - 874.4250<br>Electric cranial drill motor - 882.4360<br>Infusion Pump - 880.5725<br>Surgical 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.

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 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 | |
|----------------------------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| NEW<br>PRODUCT<br>Linvatec | Integrated<br>Drive/Pump<br>System | Resection of soft tissue and<br>bone during Otolaryngology<br>surgical procedures. | S<br>H<br>V<br>E |
| PREDICATE<br>Linvatec<br>510 (k)<br>#K971059 | Universal Drive<br>System | To perform cutting of soft<br>tissue and bone in the<br>applications of :<br>Arthroscopic/Orthopedic,<br>Otolaryngological and<br>Reconstructive Surgery | S |
| PREDICATE<br>Linvatec<br>510 (k)<br>#K961192<br>#K852143 | Hall® Irrigation<br>System | General, Reconstructive<br>surgery, and Otolaryngological | S |
| PREDICATE<br>Stryker<br>Endoscopy<br>510 (k)<br>#K943569<br>#K943589 | TPS Total<br>Performance<br>System | Resection of soft tissue and<br>bone in the applications of:<br>Spinal, Foot and Ankle,<br>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 |
|---------------------------------------------------------|-------------|-------------------------------------------------------------------------------------|
| PREDICATE<br>Stryker<br>Endoscopy<br>510(k)<br>#K952681 | Hummer 2® | Resection of soft tissue and<br>bone in the applications of:<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ১

OR

:

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)