(420 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or data analysis.
No.
The device is described as a fixation device for bone fragments, which is a structural rather than therapeutic function.
No
Explanation: The device, Chondral Dart, is described as intended for the fixation of small bone fragments. This is a therapeutic or surgical function, not a diagnostic one. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The device description clearly states the Chondral Dart is a physical object molded from Poly(L-lactide) with specific dimensions and features (barbed). This indicates it is a hardware device, not software.
Based on the provided information, the Chondral Dart 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.
- Chondral Dart Function: The description clearly states the Chondral Dart is a device intended for the fixation of small bone fragments. It is a physical implant used within the body during surgery.
- Lack of Diagnostic Activity: There is no mention of the device analyzing biological samples or providing diagnostic information. Its purpose is purely mechanical fixation.
Therefore, the Chondral Dart falls under the category of a surgical implant or device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral condyle) and cancellous fragments (talus).
Product codes
HTY
Device Description
The Chondral Dart is molded from Poly(L-lactide), has a diameter of 1.3 mm, and is supplied in a length of 18 mm. The device is barbed to facilitate fixation in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small bone fragments (radial head, patellar rim, navicular, metacarpal/metatarsal, talus vault, femoral condyle, talus)
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
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
AUG 4 2000
510(k) Summary
| Company: | Arthrex, Inc. |
|---|---|
| Address: | 2885 S. Horseshoe Drive, Naples, FL 34104 |
| Phone: | (941) 643-5553 |
| Fax: | (941) 643-6218 |
| Contact: | Vernon C. Brown |
| Manager of Regulatory Affairs (ext. 117) |
| Trade Name: | Arthrex Chondral Dart |
|---|---|
| Common Name: | NA |
| Classification: | Fastener, Fixation, Biodegradable, Hard Tissue |
Description:
The Chondral Dart is molded from Poly(L-lactide), has a diameter of 1.3 mm, and is supplied in a length of 18 mm. The device is barbed to facilitate fixation in bone.
Intended Use:
The Chondral Dart is intended for the use in fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following: Apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal), osteochondral fragments (talus vault, femoral condyle) and cancellous fragments (talus).
Substantial Equivalence:
By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.
A substantial equivalence comparison is given in Table A. The Arthrex Chondral Dart is as safe and effective as the predicate devices. Furthermore, it does not raise any different questions, regarding safety and effectiveness from the predicate device.
1
Table A: Substantial Equivalence Comparison
: 上一篇:
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| Company | Device | Material | Size(s) | Insertion |
|---|---|---|---|---|
| Arthrex | Chondral Dart | Poly (L-lactide) | Diameter: 1.3 mm | |
| Length: 18 mm | Interference Fit | |||
| "Pushed" into place | ||||
| Johnson and Johnson | Orthosorb® | |||
| Absorbable Pin | Polydioxanone | Diameter: 1.3 & 2.0 mm | ||
| Length: 40 mm | Interference Fit | |||
| "Pushed" into place | ||||
| Synthes (U.S.A.) | Polypin™ | Poly(L, DL-lactide) | Diameter: 2.0 mm | |
| Length: 35 mm | Interference Fit | |||
| "Pushed" into place | ||||
| Bioscience Inc. | Biofix® Pin | Poly(L-lactide) | Diameter: 1.1 - 3.2 mm | |
| Length: 10 - 70 mm | Interference Fit | |||
| "Pushed" into place | ||||
| Biomet Inc. | Lactosorb® | |||
| Bone Pin | Polylactic acid & Polyglycolic | |||
| acid copolymer | Diameter: 2.0 mm | |||
| Length: 35 mm | Interference Fit | |||
| "Pushed" into place | ||||
| Surgical Dynamics™ | Bone Pin | Unknown | Unknown | Interference Fit |
| "Pushed" into place |
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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 depiction of an eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
4 2000 AUG
Mr. Vernon C. Brown Manager of Regulatory Affairs and Quality Assurance Arthrex, Inc. 2885 South Horseshoe Drive Naples, Florida 34104
Re: K991971
Trade Name: Arthrex Chondral Dart Regulatory Class: II Product Code: HTY Dated: May 9, 2000 Received: May 9, 2000
Dear Mr. Brown:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 - Mr. Vernon C. Brown
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dune R. Lochner
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
4
991971
Indications for Use
The Chondral Dart is intended for the use in fixation of small bone fragments, The Ononaral butt to nts, osteochondral fragments and cancellous fragments. Subli do applications include the following: Apical fragments (radial head, patellar Opeono upplications metacarsal), osteochondral fragments (talus vault, femoral condyle) and cancellous fragments (talus).
Dana R. Lochner.
(Division Sign-Off) Division of General Restorative Devices 510(k) Number_K 991977