(14 days)
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is not available, but the intended use and predicate device suggest a mechanical implant.
Yes
The device is intended to assist in the healing of an intraosseous fracture, which aligns with the definition of a therapeutic device.
No
The device is intended to stabilize a bone graft to assist healing, which is a therapeutic function, not a diagnostic one.
No
The 510(k) summary describes a "Custom-Hip Tool™" intended to stabilize a bone graft. The predicate device is listed as "Hip Tool™ Implant". This strongly suggests a physical implantable device, not a software-only device. The lack of any mention of software, algorithms, or data processing further supports this conclusion.
Based on the provided information, the Custom-Hip Tool™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture." This describes a surgical tool used directly on the patient's body for a therapeutic purpose (assisting healing).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Custom-Hip Tool™ does not perform such tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, providing diagnostic information, or using reagents.
Therefore, the Custom-Hip Tool™ is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Product codes
HRS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral head and neck
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)
Reference Device(s)
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Special 510(k): Device Modification
Custom-Hip Tool™
MAY 2 3 2005
510(k) SUMMARY
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Orthopedic Sciences,
Inc. 6080 Center Drive,
Sixth Floor Los
Angeles, CA 90045 |
|--------------------|-----------------------------------------------------------------------------------------|
| Official Contact: | James K. Brannon. M.D. President/CEO |
Telephone (310) 242-6643 FAX (310) 242-6603
DEVICE NAME
| Classification Name: | Plate, fixation, bone |
|---|---|
| Trade/Proprietary Name: | Custom-Hip ToolTM |
| Common Name: | Bone plate |
.
PREDICATE DEVICE INFORMATION
The predicate device for this modification is the Hip Tool™ Implant, a component of the Hip Tool™ Bone Graft Stabilization System, cleared by FDA on September 23, 2002 under K022139.
INTENDED USE
The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2005
James K. Brannon, M.D. President/CEO Orthopedic Sciences Incorporated 6080 Center Drive 6th Floor Los Angeles, California 90045
Re: K051181 Trade/Device Name: Custom-Hip Tool™ Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 27, 2005 Received: May 9, 2005
Dear Dr. Brannon:
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 the endobate) to regulty management date of the Medical Device Amendments, or to devices that have been reasy 12, 1978, 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 do not require approvisions of the Act. The general controls provisions of the Act device, subjoct to the general 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 If your device to such addition (seconders). Existing major regulations affecting your device can be found in be subject to such additions, 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 I lease be advised that in that your device complies with other requirements of the Act or any I Drivias made a acterninations administered by other Federal agencies. You must comply with all the I cated statues and regulating, 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) (21 Crical 007), good no); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -James K. Brannon, M.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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
K051181 510(k) Number:
Device Name: Custom-Hip Tool™
Indications For Use:
The Custom-Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K051181
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