(105 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is intended for the repair and reattachment of bones, which are therapeutic interventions.
No
The device is used for repair and reattachment of bones and for sternotomy closure, which are therapeutic and reconstructive purposes, not diagnostic.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes surgical procedures involving hardware (implants, wires), but it doesn't clarify if the device itself is the hardware or software used in conjunction with the hardware. Without a description of the device's components and functionality, it's impossible to definitively classify it as software-only.
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 procedures performed on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples or any diagnostic purpose based on such analysis.
The device described is a surgical implant or fixation device used directly in surgical procedures.
N/A
Intended Use / Indications for Use
- a. Repair of long bone fractures due to trauma or reconstruction;
- b. Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
- c. Sternotomy closure; and
- d. 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
Prescription Use
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and a ribbon-like element below. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Kinamed Inc. % Mr. Anthony Rose Senior Director of Quality Assurance and Regulatory Compliance 820 Flynn Road Camarillo, California 93012
JAN 1 2 20:
Re: K102834
Trade/Device Name: Iso-Elastic Cerclage System (1mm and 2mm cable diameter) Regulation Number: 21 CFR 888.3010 Regulation Name: Smooth or threaded metallic bone fixation fasteners Regulatory Class: Class II Product Code: JDQ Dated: December 21, 2010 Received: December 22, 2010
Dear Mr. Rose:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Anthony Rose
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH1's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
erely yours,
For Peter Simmons
k N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
JAN 1 2 :2011
510(k) Number (if known): K102834
Device Name: Iso-Elastic Cerclage System (1mm and 2mm cable diameter)
Indications For Use:
- a. Repair of long bone fractures due to trauma or reconstruction;
- b. Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
- c. Sternotomy closure; and
- d. Sublaminar and Intrafacet wiring of the spinal column.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
i
: ..
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) relection Page 1 of (Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices . " 510(k) Number ﺑ