CURVTEK TSR SYSTEM

K972860 · Biolectron, Inc. · HSZ · Oct 31, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972860
• Device Name: CURVTEK TSR SYSTEM
• Applicant: Biolectron, Inc.
• Product Code: HSZ · General, Plastic Surgery
• Decision Date: Oct 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The CurvTek TSR System is used to drill holes in bones except for cranio and maxifacial bones. The system is intended for surgical use for the purpose of soft tissue attachment or wiring/cabling.

Device Story

CurvTek TSR System is a pneumatically powered surgical bone drill; consists of handpiece and disposable single-patient-use drill bit cartridges. Used by surgeons in clinical/OR settings to create holes in bone for soft tissue attachment or wiring/cabling. Operates via nitrogen-powered pneumatic system; compatible with standard nitrogen hoses and sterilization containers. Provides mechanical drilling capability to facilitate orthopedic, urological, and trauma-related surgical repairs. Benefits patient by enabling secure fixation of soft tissues or bone segments during reconstructive procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Pneumatically powered surgical drill; handpiece and disposable drill bit cartridges. Materials: stainless steel, aluminum, medical grade plastic. Energy source: nitrogen-powered pneumatic system. Connectivity: none. Sterilization: compatible with standard sterilization containers.

Indications for Use

Indicated for drilling bone (excluding cranio/maxillofacial) for soft tissue attachment or wiring/cabling in orthopedic, urological, and trauma procedures, including shoulder, hip, elbow, knee, foot/ankle, spine, and limb salvage repairs.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Romano Modified Glenoid Arcuate Drill (K885229)
• Romano Glenoid Arcuate Bone Drill & Disposable Flexi-Bit Units (K880074)
• Hall Series 3 Drill and Micro 100 (*)
• MicroAire Power Master and Series 2000 Pneumatic Power Instrument System (*)
• 3M Maxidriver II (K932307)
• Synthes Compact Air Drive II (K971544)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 3 1 1997

Biolectron, Inc.

200 HOLT STREET HACKENSACK, N.J. 07601

510(k) Summary

CurvTek TSR System (Per 21 CFR 807.92c)

K972860

- 1) Submitter
Biolectron, Inc. 200 Holt Street Hackensack, NJ 07601 USA

Telephone Number: 201-487-1838 201-487-5935 Fax Number:

Richard S. Dugot Contact Person:

Date of Summary Preparation: July 10, 1997

- 2) Device

| Trade Name: | CurvTek TSR System |
|----------------------|-------------------------------------------------------------------|
| Classification Name: | Power Instrument, Surgical, Pneumatic and Accessories/Attachments |
| Common Name: | Surgical Bone Drill |

- Predicate Devices 3)
The CurvTek TSR System claims substantial equivalence to the following pneumatic surgical instruments/systems/devices:

| Romano Modified Glenoid Arcuate Drill | K 885229 |
|--------------------------------------------------------------------------|----------|
| Romano Glenoid Arcuate Bone Drill & Disposable Flexi-Bit Units | K 880074 |
| Hall Series 3 Drill and Micro 100 | * |
| MicroAire Power Master and Series 2000 Pneumatic Power Instrument System | * |
| 3M Maxidriver II | K 932307 |
| Synthes Compact Air Drive II | K 971544 |
| * Do not appear to be in FDA database, could be pre-amendment devices | |

{1}------------------------------------------------

# 510(k) Summary (continued)

#### Device Description 4)

The CurvTek TSR System is a pneumatically powered instrument system consisting of a handpiece, disposable single patient use drill bit cartridges, and 510(k) approved accessories. Accessories include Zimmer® (Hall®) style nitrogen hose and sterilization container system.

#### Intended Use 5)

The CurvTek TSR System is used to drill holes in bones except for cranio and maxifacial bones. The system is intended for surgical use for the purpose of soft tissue attachment or wiring/cabling.

#### Basis for Claims of Substantial Equivalence 6)

Biolectron claims substantial equivalence of the Curv Tek TSR System to other pneumatic surgical instrument systems/devices, specifically:

| Romano Modified Glenoid Arcuate Drill | K 885229 |
|--------------------------------------------------------------------------|----------|
| Romano Glenoid Arcuate Bone Drill & Disposable Flexi-Bit Units | K 880074 |
| Hall Series 3 Drill and Micro 100 | * |
| MicroAire Power Master and Series 2000 Pneumatic Power Instrument System | * |
| 3M Maxidriver II | K 932307 |
| Synthes Compact Air Drive II | K 971544 |
| * Do not appear to be in FDA database, could be pre-amendment devices. | |

## This claim is based on equivalence to:

The intended use of the CurvTek TSR System (with Intended Use: associated accessories) is equivalent to the above instrument systems/devices, i.e. "to drill holes in bones, except for cranio and maxifacial bones," for soft tissue attachment or wiring/cabling.

Materials: ™ The materials of the CurvTek TSR System (CurvTek handpiece and CurvTek cartridges) are stainless steel, aluminum and medical grade plastic. The materials of the predicate devices are the same materials: aluminum, stainless steel, and medical grade plastic.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0CT 3 / 1997

Mr. Richard S. Dugot Vice President - Research & Development Biolectron, Inc. 200 Holt Street Hackensack, New Jersey 07601

Re: K972860 Trade Name: The CurvTek® TSR System Regulatory Class: I Product Code: HSZ Dated: August 1, 1997 Received: August 4, 1997

Dear Mr. Dugot:

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 II (Special Controls) or 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 equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{3}------------------------------------------------

Page 2 - Mr. Richard S. Dugot

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 device 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 vitro 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/cdrh/dsmamain.html".

Sincerely yours,

pcooef

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

Enclosure

{4}------------------------------------------------

# STATEMENT OF INDICATIONS FOR USE

6972860 510(k) Number (if known): __

Device Name: CurvTek® TSR System

### Indications For Use:

The intended use of the CurvTek TSR System is substantially equivalent to the predicate devices listed in this 510(k) application. The device is to be used to drill holes in bone, except for cranio and maxifacial bones, for soft tissue attachment, or wiring/cabling as in the following techniques:

### Soft Tissue Repair Techniques

### Shoulder

Bankart Lesion Repair Capsular Shift/Capsulorrhaphy SLAP Lesion Repair Magnuson and Stack Repair Rotator Cuff Repair

### Hip

Reattach Gluteus Medius Take-Down Capsule Repair/ Capsulorrhaphy Adductor Longus & Gracilis Transfer External Oblique Transfer Iliopsoas Tendon Transfer

### Elbow

Scapholunate Ligament Reconstruction Fascia Lata Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Flexorolasty Radial Collateral Ligament Reconstruction Bicepts Tenodesis Volar Plate Reconstruction Triceps Tendon Repair Triangular Fibro-Cartilage Ligament Repair Ulnar or Radial Collateral Ligament Repair (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation,

tcott

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K972860

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

Knee

Five-in-One Knee Repair Capsule Repair/ Capsulorrhaphy Triad Knee Repair Quadriceps Femoris Tendon Repair Patellar Tendon Repair

# Limb Salvage

Forearm/Wrist/Hand Reattachment Upper Arm Reattachment Foot Reattachment Lower Leg/Ankle Reattachment Thigh Reattachment

Hand and Wrist

{5}------------------------------------------------

# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CurvTek® TSR System _____________________________________________________________________________________________________________________________________________

Indications For Use:

Urological

Indications For Use:
The intended use of the CurvTek TSR System is substantially equivals and maxifacial bones for soft tissue The intended use of the Curvice TSK System is subsamiany equilable of the cranio and maxifacial bones, for soft tissue attachment, or wiring/cabling as in the following techniques: Wiring/Cabling Techniques

Soft Tissue Repair Techniques (Con't.)

- Foot & Ankle Bunionectomy Collateral Ligaments Repair PT Tendon Advancement Achilles Tendon Repair Attachment of Distal EHL at Hallux IPJ
Retropubic urethral suspension

Bladder neck suspension

Cervical Cabling

______________________________________________________________________________________________________________________________________________________________________________

Lumbar Cabling Osteotomy of Cervical Spine Arthrodesis, Lateral Transverse Process

Trauma

Spine

Repair For 3 Part Fracture of Humeral Head Treatment of Sternoclavicular Dislocation Repair For Olecranon Fractures Treatment of Open Patellar Fracture Midfoot Reconstruction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) |
|-----------------------------------------|---------------------|
| Division of General Restorative Devices | |
| 510(k) Number | 2972860 |

| Prescription Use | <div style="text-align:center;">X</div> |
|----------------------|-----------------------------------------|
| (Per 21 CFR 801.109) | |

OR
Over-The Counter Use ______