(75 days)
No
The summary describes a mechanical external fixation system with no mention of AI or ML components or functionalities.
Yes
The device is used for external fixation of bone fractures, which is a therapeutic intervention.
No
Explanation: The device is an external fixation system used for treating long bone fractures. Its primary function is therapeutic (stabilizing fractures) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description explicitly states it consists of "components that can be assembled" and mentions "frame materials" and "kits," indicating it is a physical hardware device.
Based on the provided information, the TempFix External Fixation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- TempFix Function: The TempFix External Fixation System is a medical device used externally to stabilize bone fractures. It is applied directly to the patient's limb and does not involve testing samples from the body.
- Intended Use: The intended use clearly states it's for "external fixation of open or closed long bone fractures." This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details components for assembling a frame and positioning pins, consistent with an external fixation device.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the TempFix External Fixation System falls under the category of a surgical or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures of the distal femur, proximal tibia or distal tibia where soft tissue injury precludes the use of other fracture treatments.
The TempFix External Fixation System is intended to be non-weight bearing.
Product codes (comma separated list FDA assigned to the subject device)
KTT, LXT
Device Description
The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal femur, proximal tibia or distal tibia
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)
When tested to simulate clinical use, the TempFix constructs were stiffer and had a higher load to failure than either the Howmedica Hoffman II constructs or the Immedica / Zimmer Transfx constructs.
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.
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
AUG 2 6 2002
510(k) Summary
| Name of Sponsor: | DePuy ACE
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988
Est. Reg. No. 1818910 |
|------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Cheryl K. Hastings
Director, Regulatory Affairs
Phone: (574) 372-7006
FAX: (574) 371-4987 |
| Trade Name: | TempFix™ External Fixation System |
| Common Name: | External Fixation Devices |
| Classification: | Class II per 21 CFR 888.3030:
Multiple component metallic bone fixatio
appliances and accessories |
87 KTT ; LX T Device Product Codes:
Substantially Equivalent Devices:
| Howmedica Osteonics Hoffman II External Fixator | K000957 |
|---|---|
| Immedica Transfx External Fixation System (distributed by Zimmer) | K984357 |
| ACE Medical Company Align Fixator | K936045 |
| ACE Medical Company ACE -Fischer Pins | K875022 |
| ACE Medical Company ACE -Fischer Pins | K875012 |
| ACE Medical Company ACE-DuPont Composite Rings | K955388 |
Device Description:
The TempFix External Fixation System consists of components that can be assembled to provide multiple degrees of freedom for positioning implantable threaded fixation pins on either side of a fracture or deformity. The unique frame materials provide radiolucent viewing of the fracture and are lightweight for patient comfort. The components are preassembled in kits with three basic frame configurations: a knee frame, a half pin ankle frame and a transfixing pin ankle frame. Each kit is provided in sterile and non-sterile versions.
1
Indications for use:
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures of the distal femur, proximal tibia or distal tibia where soft tissue injury precludes the use of other fracture treatments.
The TempFix External Fixation System is intended to be non-weight bearing.
Substantial equivalence:
The TempFix External Fixation System is a lightweight external fixation system similar in intended use and design to the Howmedica Osteonics Hoffman II External Fixator, the Immedica Transfx External Fixation System (distributed by Zimmer) and the DePuy ACE Align Fixator. The implantable stainless steel pins are identical to those cleared previously for the ACE-Fischer Fixator with the exception that the TempFix pins will be etched with positioning lines to provide the surgeon a tool for measuring the insertion depth of the pin. The bar assemblies included in each kit and the U-ring included in the ankle transfixing pin kit are manufactured from carbon fiber / resin composite material as previously cleared for the ACE-DuPont Composite Rings. The articulating slide end and articulating clamp ends used in the TempFix System are similar to those cleared for the ACE Align Fixator. When tested to simulate clinical use, the TempFix constructs were stiffer and had a higher load to failure than either the Howmedica Hoffman II constructs or the Immedica / Zimmer Transfx constructs.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Re:
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
AUG 26 2002
Ms. Cheryl Hastings Director, Regulatory Affairs DePuv ACE P. O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
| K021933 | Trade Name: | TempFix™ External Fixation System |
|---|---|---|
| Regulation Number: | 21 CFR 888.3030 | |
| Regulation Name: | Single/multiple component metallic bone fixation appliances and | |
| accessories | ||
| Regulatory Class: | Class II | |
| Product Code: | KTT, LXT | |
| Dated: | June 11, 2002 | |
| Received: | June 12, 2002 |
Dear Ms. Hastings:
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.
3
Page 2 – Ms. Cheryl Hastings
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmamain.html.
Sincerely yours,
Sincerely yours,
Mark A. Milkeus
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
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510(k) Number (if known): K021933
Device Name: TempFix External Fixation System
Indications for Use:
The TempFix External Fixation System is indicated for external fixation of open or closed long bone fractures of the distal femur, proximal tibia or distal tibia where soft tissue injury precludes the use of other fracture treatments.
The TempFix External Fixation System is intended to be non-weight bearing.
Concurrence of CDRH, Office of Device Evaluation
Mark N Milken
Division Sign-Off) Division of General, Restorative and Neurological Devices 2021933 510(k) Number -
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use