The SDB Cerclage System devices will be offered in two sizes of cable constructs. The large cable construct shall be indicated for general orthopedic trauma surgery involving the following: olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral and ankle fractures; acromioclavicular dislocations; prophylactic banding during total joint procedures; and temporary reduction during ORIF (Open Reduction Internal Fixation) procedures. The small cable size shall be contraindicated for use in the femur ORIF and prophylactic banding during total joint procedures. These devices are intended as single use items.

Device Description

The SDB Cerclage System consists of two diameter cable sizes each in association with a double holed crimp. The cable is routed around the bone through a Cable Passer and back through the adjacent hole in the crimp. The free end of the cable is passed through the Tensioner instrument and tensioned to the desired level of construct compression with guidance provided by the tensioner scale. A Crimper instrument is introduced and interfaced with the crimp followed by the squeezing of the instruments handles and the release of the pawl indicating a full crimping cycle has been obtained. The excess cable is then trimmed with a cutter.

The SDB Cerclage System shall be supplied with the cable and crimp assembled and packaged sterile as a single-use item.

AI/ML Overview

Acceptance Criteria and Study for Pioneer Surgical Technologies SDB Cerclage System

1. Table of Acceptance Criteria & Reported Device Performance

Acceptance Criteria (Bench Test Type)	Predicate Device (Howmedica Dall-Miles 1.6mm Cable System) Performance	SDB Cerclage System (Large Cable Construct) Performance	Outcome
Static Yield	[Performance data not explicitly stated, but used as equivalence benchmark]	Displayed equivalence to Dall-Miles 1.6mm System	Met
Fatigue	[Performance data not explicitly stated, but used as equivalence benchmark]	Displayed equivalence to Dall-Miles 1.6mm System	Met

Note: The document explicitly states that "the cerclage cable was the failure mode" for both the SDB Cerclage System and the predicate device in both tests. This implies that the failure mechanism was consistent, and the SDB system performed comparably to the predicate.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes used for the static yield and fatigue tests. It generally refers to "each type of construct" suggesting multiple tests were conducted for both the SDB Cerclage System and the predicate device.

Data Provenance: The study appears to be a retrospective bench test comparison. The "country of origin of the data" is not specified but is implied to be from a testing facility, likely in the US, given the FDA submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This was a bench test comparative study, not a study involving human expert assessment of clinical data.

4. Adjudication Method

Not applicable. This was a bench test comparative study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was a bench test study comparing the mechanical performance of a medical device to its predicate, not a clinical study involving human readers.

6. Standalone Performance (Algorithm Only) Study

Not applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

The ground truth for this study was established through objective bench testing (static yield and fatigue tests) comparing the mechanical performance of the SDB Cerclage System to a legally marketed predicate device.

8. Sample Size for the Training Set

Not applicable. This was a physical device testing study, not a machine learning or data-driven study that would involve a "training set."

9. How Ground Truth for the Training Set was Established

Not applicable. There was no training set in the context of this device's testing. Ground truth was established through direct physical and mechanical testing as described above.

Summary

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0CT 27 1999

V. 510(K) SUMMARY

Pioneer Surgical Technologies 510(K) Notification Summary For SDB Cerclage System

Administrative Information

Manufacturer Identification and Sponsor:		Pioneer Surgical Technologies375 River Park CircleMarquette, MI 49855-1781Telephone: 906-226-9909FAX: 906-226-9932
Official Contact:		Burns SeversonSenior Vice President,Regulatory Affairs/Quality Assurance
Date Prepared:		7/23/99
Device Identification
Proprietary Name:		SDB Cerclage System
Common Name:		Cerclage, Bone Fixation
Classification Name and Reference:		Cerclage, Bone Fixation
Regulation Number:		CFR 888.3010
Classification Number:		87JDQ
Device Class:		II

Devices on Which Substantial Equivalence is Claimed:

Dall Miles "Trochanter Cable Grip System" K844068; 1.
Dall Miles "Modified Trochanter Cable Grip System" K872224; 2.
1. Dall Miles "Trochanter Cable Grip System (Additional Indications)" - K900926; and
1. Stainless Steel cerclage wire, manufactured prior to 1976

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V. 510(K) SUMMARY (Continued)

Device Description

The SDB Cerclage System shall be supplied with the cable and crimp assembled and packaged sterile as a single-use item.

Intended Use

The SDB Cerclage System devices will be offered in two sizes of cable constructs. The large cable construct shall be indicated for the following: general orthopedic trauma surgery involving olecranon, patella, femur, pelvic, acetabular, humeral and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures. The small cable size shall be contraindicated for use in the femur ORIF and prophylactic banding during total joint procedures.

Technological Characteristic Compared to Predicate Device

The Large SDB Cerclage System devices have the same double holed crimp and squeezing technique as the predicate Howmedica Dall-Miles Cable Grip System (K844068, K872224, & K900926). The Small SDB Cerclage System devices have similar cable diameters as the 18g stainless steel monfilament wire.

Performance Data

The Large SDB Cerclage System cable constructs and its predicate device Howmedicas Dall-Miles 1.6mm cable constructs were tested in static yield and fatigue. In both tests and for each type of construct, the cerclage cable was the failure mode with the SDB Cerclage System displaying euivalence to the Dall-Miles 1.6mm System under each of the testing conditions.

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Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 1999

Mr. Burns O. Severson Senior Vice President, Requlatory Affairs/Quality Assurance Pioneer Surqical Technology 375 River Park Circle Marquette, Michigan 49855

Re: K992616 Trade Name: SDB Cerclage System Requlatory Class: II Product Code: JDQ Dated: August 2, 1999 Received: August 4, 1999

Dear Mr. Severson:

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 reqistration, 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 requirement, 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 requlation may result in requlatory In addition, FDA may publish further announcements action. 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 .

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Page 2 - Mr. Burns O. Severson

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification your device
finding of substantial aguinelation. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and the device results in a crassification for your device 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) 594–4659, please contact the Office of =
Compliance at (301) 594–4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, 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,

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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K992616

Pioneer Surgical Technologies

SDB Cerclage System Device

Indications for Use

Prescription Use
(Per 21 CFR 801.109)

bocote Da

(Division Sign-Off) Division of General Restorative Devi 0,92616 510(k) Number

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.