(270 days)
Not Found
Not Found
No
The summary describes a device for fracture repair and surgical procedures, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The intended uses listed (repair of fractures, reattachment, closure, wiring) are structural and reparative, not focused on treating a disease or condition therapeutically.
No
The intended uses listed (repair of long bone fractures, reattachment of greater trochanter, sternotomy closure, and spinal column wiring) describe surgical procedures or implants, not a device used for diagnosis.
No
The provided 510(k) summary only describes the intended use of a device for surgical procedures involving bone fractures and spinal column wiring. It lacks any description of the device itself, including whether it is software, hardware, or a combination. Therefore, it's impossible to determine if it's a software-only medical device based on this information.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (repair of bone fractures, reattachment of the greater trochanter, sternotomy closure, spinal column wiring) are all surgical procedures performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
The device described is clearly an implant or surgical tool used within the body during surgery, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
- Repair of long bone fractures due to trauma or reconstruction;
- reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
- sternotomy closure; and
- sublaminar and intrafacet wiring of the spinal column.
Product codes
JDQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bone, greater trochanter, spinal column, sternotomy
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): 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.
Not Found
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
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, composed of three curved lines, symbolizing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2003
Vineet Sarin, Ph.D. Director of Research and Development Kinamed, Inc. 820 Flynn Road Camarillo, California 93012-8701
Re: K030256
Trade/Device Name: Iso-Elastic Cerclage System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: II Product Codes: JDQ Dated: July 23, 2003 Received: July 24, 2003
Dear Dr. Sarin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Vineet Sarin, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Kinamed Iso-Elastic Cerclage System, K03-0256 510(k) Response to FDA Memorandum Dated April 9, 2003
Statement of Indication for Use
510(k) Number (if known):
Device Name: Iso-Elastic Cerclage System
Indications for Use:
- Repair of long bone fractures due to trauma or reconstruction; a.
- reattachment of the greater trochanter in total hip arthroplasty, surface replacement b. arthroplasty, or other procedures involving trochanteric osteotomy;
- c. sternotomy closure; and
- d. sublaminar and intrafacet wiring of the spinal column.
Mark N. Mulkern
vision Sien-Off) Division of General, R torative and Neurological Devisis
510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
KO30256