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, Hip, Elbow, Knee, Limb Salvage, Hand and Wrist, Foot & Ankle, Urological) and Wiring/Cabling Techniques (Cervical Cabling, Lumbar Cabling, Osteotomy of Cervical Spine, Arthrodesis, Lateral Transverse Process, Trauma).

Device Description

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the Biolectron CurvTek TSR System, a pneumatically powered surgical bone drill. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as might be found in a De Novo or PMA application.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets them, nor does it provide details on sample size, data provenance, expert qualifications, or specific performance metrics typically associated with such studies.

Here's why and what information is available:

510(k) Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, rather than conducting extensive new clinical performance studies with predefined acceptance criteria.
Focus on Predicate Devices: The document heavily emphasizes the comparison to predicate devices, listing them multiple times and stating that the new device's intended use and materials are equivalent.

Based on the provided text, I cannot complete the table or answer most of the questions as the information is not present in this 510(k) summary.

However, I can extract the following relevant, albeit limited, information:

1. A table of acceptance criteria and the reported device performance:

Not applicable. The document does not describe specific acceptance criteria (e.g., precision of drilling depth, torque, speed) or numerical performance metrics for the CurvTek TSR System. The claim is based on substantial equivalence to existing devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. No test set or performance study data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No ground truth establishment related to performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method is described.

5. 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 drill, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical drill, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. No ground truth is described in the context of performance evaluation. The "ground truth" for this submission is essentially the legally marketed predicate devices and their established safety and effectiveness.

8. The sample size for the training set:

Not applicable. No training set for an algorithm is mentioned.

9. How the ground truth for the training set was established:

Not applicable. No training set or ground truth for it is mentioned.

Summary of what is available from the document:

Device Name: CurvTek TSR System
Intended Use: To drill holes in bones (except cranio and maxifacial bones) for soft tissue attachment or wiring/cabling.
Basis for Claims of Substantial Equivalence: Equivalence to several pneumatic surgical instruments/systems/devices, focusing on intended use and materials (stainless steel, aluminum, medical grade plastic).
Predicate 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).

Summary

{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

1. 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)

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.

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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 (301) 594-4595. 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/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

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STATEMENT OF INDICATIONS FOR USE

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

Device Name: CurvTek® TSR System

Indications For Use:

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)

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	X
(Per 21 CFR 801.109)

OR
Over-The Counter Use ______

Regulation Number and Section

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.