(84 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical tools, with no mention of AI/ML components or data processing.
Yes
The device is indicated for internal fixation and reduction of bone fractures, which are considered therapeutic interventions.
No.
The device description clearly states its purpose is for mechanical fixation (e.g., cerclage in orthopedic trauma surgery) and describes tools for tensioning, crimping, and trimming cables, which are all surgical procedures, not diagnostic ones.
No
The device description clearly outlines physical components (cable, crimp, cable passer, tensioner, crimper, cutter) and their mechanical function in orthopedic surgery. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The SDB Cerclage System is a surgical device used to physically stabilize bone fractures and dislocations. It is implanted directly into the body during surgery.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens.
Therefore, the SDB Cerclage System falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
87JDQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
olecranon, patella, femur, pelvic, acetabular, humeral and ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Technologies
375 River Park Circle
Marquette, MI 49855-1781
Telephone: 906-226-9909
FAX: 906-226-9932 |
|------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | | Burns Severson
Senior 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.
-
- Dall Miles "Trochanter Cable Grip System (Additional Indications)" - K900926; and
-
- Stainless Steel cerclage wire, manufactured prior to 1976
1
V. 510(K) SUMMARY (Continued)
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.
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.
2
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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 .
3
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
4
K992616
Pioneer Surgical Technologies
SDB Cerclage System Device
Indications for Use
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.
Prescription Use
(Per 21 CFR 801.109)
bocote Da
(Division Sign-Off) Division of General Restorative Devi 0,92616 510(k) Number