(86 days)
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.
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.
The provided 510(k) summary (K082017) pertains to the "Starr Frame Steinmann Pins," which are bone fixation fasteners. This submission is for a medical device that demonstrates substantial equivalence based on established performance standards, rather than a diagnostic device relying on algorithm performance for clinical outcomes. Therefore, many of the requested elements for an AI/algorithm study (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training data) are not applicable in this context.
The study presented focuses on compliance with recognized consensus standards for material and mechanical properties, not on an algorithm's performance in diagnosing or predicting.
Here's the breakdown of the information that is applicable from your request, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|
| ASTM F366-04: "Standard Specification for Fixation Pins and Wires" | The Starr Frame Steinmann Pins will comply with this standard. |
| ISO 5838-1:1995: "Implants for Surgery – Skeletal Pins and Wires – Part 1: Material and Mechanical Requirements" | The Starr Frame Steinmann Pins will comply with this standard. |
Note: The document states the device will comply with these standards, implying that testing to demonstrate this compliance was conducted or is guaranteed to be conducted as part of manufacturing and quality control. The specific test results (e.g., tensile strength, fatigue life) are not detailed in this summary; rather, the commitment to meet the standards is the reported "performance" for the purpose of 510(k) substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary as the study is not clinical performance data for an algorithm. The "test set" here refers to the physical pins themselves being tested against engineering standards, not a dataset of patient information. No patient data provenance is relevant for this type of submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for this device is based on established engineering and materials science standards (ASTM and ISO), not on expert clinical interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. This 510(k) summary does not describe a study involving expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human readers' diagnostic accuracy, which is not applicable to a physical bone fixation device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the Starr Frame Steinmann Pins is defined by the material and mechanical requirements specified in the recognized consensus standards: ASTM F366-04 and ISO 5838-1:1995. This is a technical, engineering-based ground truth related to the physical properties and performance of the device under stress, rather than a clinical ground truth (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.
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5. 510(k) Summary
| Date: | June 30, 2008 |
|---|---|
| Company Name: | Starr Frame LLC1302 E. Collins Blvd.Richardson, TX 75081-2403 |
| Contact Name: | Frank GeromeStarr 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, SmoothJDW 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 fixationpins and are offered in assorted dimensions andconfigurations to accommodate physician preferences,physical profiles of different patients, and varying injuriesand conditions. The devices are constructed of implantgrade 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 bonefractures, bone reconstructions, and implantation throughthe skin so that traction may be applied to the skeletalsystem. |
:
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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.
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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.
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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
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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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§ 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.