(41 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
The device is used to treat fractures, which is a therapeutic intervention.
No
The device description states that the product is a "component of an external fixation frame that forms a construct generally intended to treat the hand, wrist, mandible and foot." This indicates its purpose is therapeutic (to treat fractures), not diagnostic.
No
The device description clearly states it is a "component of an external fixation frame" and mentions physical components like clamps, rods, screws, and K-wires. This indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Synthes Small Combination Clamps are components of an external fixation frame. Their purpose is to mechanically stabilize fractures and injuries in the hand, wrist, mandible, and foot. They are used on the body, not to analyze samples from the body.
- Intended Use: The intended use clearly describes the treatment of fractures and related injuries, which is a surgical/orthopedic application, not a diagnostic one based on analyzing biological samples.
Therefore, based on the provided information, this device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius.
Product codes
KTT
Device Description
Synthes Small Combination Clamp -MR Safe is a component of an external fixation frame that forms a construct generally intended to treat the hand, wrist, mandible and foot. This device is intended for use in the MR environment. Frame components accept Synthes O4.0 mm carbon fiber rods, Synthes Schanz Screws in diameters of 4.0/4.0, 4.0/3.0 and 4/0/2.5 mm and Synthes O2.5 mm K-wires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, mandible and foot.
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)
Imedica's TransFx Small External Fixation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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JUL 1 4 2003
Page 1 of 1
| 3.0 | 510(k) Summary | Page | 1 | of | 1 |
|---|---|---|---|---|---|
| Sponsor: | Synthes (USA) | ||||
| 1690 Russell Road | |||||
| Paoli, PA 19301 | |||||
| (610) 647-9700 | |||||
| Contact: | Bonnie Smith | ||||
| Device Name: | Synthes Small Combination Clamp - MR Safe | ||||
| Classification: | Class II, 21 CFR 888.3030: "Single/multiple component bone fixation appliances and accessories." | ||||
| Predicate Device: | Imedica's TransFx Small External Fixation System | ||||
| Device Description: | Synthes Small Combination Clamp -MR Safe is a component of an external fixation frame that forms a construct generally intended to treat the hand, wrist, mandible and foot. This device is intended for use in the MR environment. Frame components accept Synthes Ø4.0 mm carbon fiber rods, Synthes Schanz Screws in diameters of 4.0/4.0, 4.0/3.0 and 4/0/2.5 mm and Synthes Ø2.5 mm K-wires. | ||||
| Intended Use: | Intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius. | ||||
| Materials: | Clamps - Stainless steel, titanium alloy and cobalt alloy | ||||
| Substantial | |||||
| Equivalence | Documentation is provided which demonstrates that the Synthes Small Combination Clamp -MR Safe is substantially equivalent* to other legally marketed Synthes devices. |
- The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three overlapping lines, possibly representing an abstract human figure or a symbol of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2003
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301
Re: K031724 Trade/Device Name: Synthes (USA) Small Combination Clamp - MR Safe Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: May 30, 2003 Received: June 3, 2003
Dear Ms. Smith:
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
2
Page 2 - Ms. Bonnie J. Smith -
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.
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.
Miriam C. Provost
(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
3
2.0 Indications for Use Statement
K0317d24/
510(k) Number (if known):
DEVICE NAME:
Synthes (USA) Small Combination Clamp - MR Safe
INDICATIONS:
Synthes Small Combination Clamps – MR Safe are intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K031724 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
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