(86 days)
Not Found
No
The description focuses on the material and mechanical properties of the pins, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as "fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the skeletal system," which directly aligns with the definition of a therapeutic device that treats or alleviates a condition.
No
Explanation: The device is described as a fixation device for bone fractures and reconstruction, and for traction. Its function is to provide physical support and fixation, not to diagnose medical conditions or diseases.
No
The device description explicitly states it consists of "fixation pins" constructed of "implant grade 316LVM stainless steel," which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Starr Frame Steinmann Pins are "fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the skeletal system." This describes a device used directly on or in the body for structural support and treatment.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The provided information does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes. The device is a physical implant for mechanical support.
Therefore, based on the provided information, the Starr Frame Steinmann Pins are a surgical implant/device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Starr Frame Steinmann Pins are non-sterile, single use, fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the skeletal system.
Product codes (comma separated list FDA assigned to the subject device)
HTY, JDW
Device Description
The Starr Frame Steinmann Pins consist of various fixation pins and are offered in assorted dimensions and configurations to accommodate physician preferences, physical profiles of different patients, and varying injuries and conditions. The devices are constructed of implant grade 316LVM stainless steel. They are provided non-sterile and intended for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone fractures, skeletal system
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)
The Starr Frame Steinmann Pins will comply with the following recognized consensus standards: ASTM F366-04 "Standard Specification for Fixation Pins and Wires"; and ISO 5838-1:1995 "Implants for Surgery - Skeletal Pins and Wires – Part 1: Material and Mechanical Requirements''.
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.
Depuy Steinmann Pins (K960385), Teleflex Medical KMedic® Fixation Devices (K070561), Depuy Steinmann Pins (Pre-amendment)
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.
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
§ 888.3040 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
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OCT 1 0 2008
5. 510(k) Summary
| Date: | June 30, 2008 |
|---|---|
| Company Name: | Starr Frame LLC |
| 1302 E. Collins Blvd. | |
| Richardson, TX 75081-2403 | |
| Contact Name: | Frank Gerome |
| Starr Frame LLC | |
| (214) 576-9818 (Phone) | |
| (214) 576-9848 (Fax) | |
| fgerome@starrframe.com | |
| Trade Name: | Starr Frame Steinmann Pins |
| Common Name: | Bone Fixation Fasteners |
| Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Regulation Number: | 888.3040 |
| Product Class: | II |
| Product Code: | HTY Pin, Fixation, Smooth |
| JDW Pin, Fixation, Threaded | |
| Predicate Devices: | Depuy Steinmann Pins (K960385) |
| Teleflex Medical KMedic® Fixation Devices (K070561) | |
| Depuy Steinmann Pins (Pre-amendment) | |
| Device Description: | The Starr Frame Steinmann Pins consist of various fixation |
| pins and are offered in assorted dimensions and | |
| configurations to accommodate physician preferences, | |
| physical profiles of different patients, and varying injuries | |
| and conditions. The devices are constructed of implant | |
| grade 316LVM stainless steel. They are provided non- | |
| sterile and intended for single-use only. | |
| Indications for Use: | The Starr Frame Steinmann Pins are non-sterile, single use, |
| fixation devices intended for use in fixation of bone | |
| fractures, bone reconstructions, and implantation through | |
| the skin so that traction may be applied to the skeletal | |
| system. |
:
1
Technological The Starr Frame Steinmann Pins are substantially Characteristics equivalent to the predicate devices with respect to design Comparison: and material. Summary of The Starr Frame Steinmann Pins will comply with the Non-Clinical following recognized consensus standards: ASTM F366-04 Performance Data: "Standard Specification for Fixation Pins and Wires"; and ISO 5838-1:1995 "Implants for Surgery - Skeletal Pins and Wires – Part 1: Material and Mechanical Requirements''. Conclusions: There are no significant differences between the Starr Frame Steinmann Pins and the devices listed as predicate devices. The Starr Frame Steinmann Pins and the predicate devices have similar design attributes, material and intended use and thus are substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
OCT 1 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Starr Frame LLC % Mr. Frank Gerome Manager 1302 E. Collins Boulevard Richardson, Texas 75081
Re: K082017
Trade/Device Name: Starr Frame Steinmann Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: July 15, 2008 Received: July 16, 2008
Dear Mr. Gerome:
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 - Mr. Frank Gerome.
1 his 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
Ko8201 510(k) Number (if known):
Device Name: Starr Frame Steinmann Pins
Indications for Use:
The Starr Frame Steinmann Pins are non-sterile, single use, fixation devices intended for use in fixation of bone fractures, for bone reconstructions, and implantation through the skin so that traction may be applied to the ske, etal system.
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neilke Oul Losaxm
(Division Sign-Division of General. Restorative, and Neurological Devices
510(k) Number K082017
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Starr Frame LLC Starr Frame Steinmann Pin 510(k)
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