(88 days)
Not Found
Not Found
No
The summary describes a mechanical orthopedic implant (a screw and cable) and contains no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is used for fracture fixation in various anatomical sites, which is a therapeutic purpose.
No
The provided text describes a medical device used for fixation of fractures, not for diagnosing medical conditions. Its intended use is for surgical intervention (holding fractures), not for detecting or identifying diseases or conditions.
No
The device description clearly identifies it as a "Cable Screw with Integral Crimp," which is a physical implantable medical device used for fracture fixation, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use clearly indicate that this device is a surgical implant used to fix fractures within the body. It is a physical device used in a surgical procedure, not a test performed on a sample.
Therefore, based on the provided information, the Cable Screw with Integral Crimp is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Cable Screw with Integral Crimp is indicated where a fracture may not be securely held by either a screw or a cerclage cable alone. The device can be used in conjunction with plating:
- humeral fractures
- medial malleolus fractures
- butterfly fractures requiring interfragmentary fixation with cerclage cabling
- femur fractures
- pelvic fractures
- forearm shaft fractures
- patellar fractures
- olecranon fractures
- proximal tibial and tibial shaft fractures
Product codes
JDQ, JWC
Device Description
Pioneer Laboratories Cable Screw with Integral Crimp
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral, medial malleolus, femur, pelvic, forearm shaft, patellar, olecranon, proximal tibial, tibial shaft
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) Summary
K980690 Pioneer Laboratories 510(K) Notification Summary For Cable Screw with Integral Crimp
Administrative Information
Manufacturer Identification and Sponsor:
Pioneer Laboratories 375 River Park Circle Marquette, MI 49855-1781 Telephone: 906-226-9909 FAX: 906-226-9932
Official Contact:
Burns Severson Vice President, Regulatory Affairs/Quality Assurance
Date Prepared: 7/22/97
Device Identification
Proprietary:
Pioneer Laboratories Cable Screw with Integral Crimp
Common Names:
Screw, Fixation, Bone Cerclage Cable
Classification Name and Reference:
In the code of Federal Regulations, Volume 21, FDA identified bone screws, fixation as Class II devices.
| Regulation Number: | 888.3040 |
|---|---|
| Classification Number: | 87HWC |
| Cerclage, Bone Fixation | |
|---|---|
| Regulation Number: | 888.3010 |
| Classification Number: | 87JDQ |
| Class II |
1
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUM. SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 1998
Mr. Burns Severson Senior Vice President Pioneer Laboratories, Inc. 375 River Park Circle Marquette, Michigan 49855
Re: K980690 Cable Screw with Integral Crimp Regulatory Class: II Product Code: JDQ and JWC Dated: February 20, 1998 February 23, 1998 Received:
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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 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 requlations.
2
Page 2 - Mr. Burns Severson
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) 594-4659. 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,
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
3
Pioneer Laboratories
Cable Screw with Integral Crimp
Indications for Use
The Cable Screw with Integral Crimp is indicated where a fracture may not be securely held by either a screw or a cerclage cable alone. The device can be used in conjunction with plating:
- humeral fractures
- medial malleolus fractures
- butterfly fractures requiring interfragmentary fixation with cerclage cabling
- femur fractures
- pelvic fractures
- forearm shaft fractures
- patellar fractures
- olecranon fractures
- proximal tibial and tibial shaft fractures
Acoosta
(Division Sign-Off)
Division of General Restorative Devices,
510(k) Number. K980690
Prescription Use (Per 21 CFR 801.109)