(27 days)
The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Bilok®ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).
This submission pertains to a 510(k) premarket notification for a medical device called the Bilok® ST Screw. In 510(k) submissions, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria (especially regarding performance metrics like sensitivity, specificity, etc.) is generally not applicable for a 510(k) submission like this one.
Here's a breakdown of why and what information is available in the provided text:
- No specific acceptance criteria or a study proving those criteria are met for performance as a diagnostic device. The 510(k) process relies on demonstrating the new device is as safe and effective as a predicate device already on the market.
- The provided text explicitly states "Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness." This is the core of a 510(k) review.
Let's address each of your points based on the provided document and the nature of a 510(k) for this type of device:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria for a 510(k) Submission: The primary acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device. This is typically achieved by showing the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: The document states that "Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device..." This is the "performance" demonstrated for a 510(k) in terms of regulatory approval. There are no quantitative performance metrics (like sensitivity, specificity, accuracy) provided as this is not a diagnostic device and doesn't require such clinical performance data for 510(k) clearance.
| Acceptance Criteria (for 510(k) submission) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Device demonstrated to be substantially equivalent to the legally marketed predicate device. Any differences do not raise concerns regarding safety and effectiveness. |
| Same Intended Use | Yes, as stated for ACL reconstruction with same fixation method. |
| Similar Technological Characteristics | Yes, as stated. |
| No New Questions of Safety/Effectiveness | Yes, as stated. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this 510(k). This device is a bone screw used in surgery. The substantial equivalence argument relies on comparing its design, materials, and mechanical properties to a predicate device, along with non-clinical testing (e.g., biocompatibility, sterilization validation, mechanical testing). Clinical "test sets" of patients are generally not required for this type of 510(k) submission to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "test set" in the context of clinical images or diagnostic outcomes that requires expert consensus for ground truth for this medical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication in this context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a surgical implant (bone screw), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth for a 510(k) of a Physical Device: For a device like a bone screw, the "ground truth" for demonstrating safety and effectiveness for a 510(k) involves adherence to established standards for materials, biocompatibility, sterilization, and mechanical performance (e.g., tensile strength, fatigue life), as well as comparison to a predicate device with a known history of safe and effective use. This is primarily established through non-clinical laboratory testing and engineering analysis, not clinical outcome data or expert consensus on diagnostic images.
8. The sample size for the training set
- Not applicable. There is no "training set" in the sense of machine learning for this device.
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this device in this context.
In summary, this 510(k) submission for the Bilok® ST Screw relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than extensive clinical studies or the establishment of ground truth through expert review of clinical data.
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K07115 page 1/2
510(k) SUMMARY
Bilok® ST Screw
MAY 1 7 2007
Biocomposites Ltd Applicant Keele Science Park Keele Staffordshire England ST5 SNL
Contact Person Mr Simon Fitzer Tel: +44 (0) 1782 338580 +44 (0) 1782 338599 Fax Email: sf@biocomposites.com
| Classification Name: | Screw, fixation, bone |
|---|---|
| Common/Usual Name: | Bone screw |
| Trade/Proprietary Name | Bilok® ST Screw |
| Product Code | HWC |
| CFR Section | 21CFR888.3040 |
Device Description
The Bilok® ST Screw is a cannulated, sterile, single use bone screw manufactured from a composite mix of calcium phosphate and poly L-lactic acid (PLLA).
Intended Use / Indications
The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Bilok® ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
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Summary of Technology
The Bilok® ST Screw has the same technological characteristics as the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Non Clinical Testing
Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
Safety and Performance
Documentation provided demonstrates that the Bilok® ST Screw is substantially equivalent to the legally marketed predicate device and any differences do not raise any concerns regarding safety and effectiveness.
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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 eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biocomposites Ltd % Mr. Simon Fitzer Quality and Regulatory Affairs Manager Keele Science Park Keele, Staffordshire England, ST5 5NL
MAY 17 2007
Re: K071115
Trade/Device Name: Bilok® ST Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: April 12, 2007 Received: April 20, 2007
Dear Mr. Fitzer:
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
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Page 2 – Mr. Simon Fitzer
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Spoubare buehr
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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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Bilok® ST Screw
Indications For Use:
The Bilok® ST Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures.
The Bilok®ST Screw is used to provide suspensary fixation during femoral fixation in ACL reconstruction using double looped (semitendinosis/gracilis) or quadruple (semitendinosis) graft.
Prescription Use (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter use (Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sarhare Buchn
Division of General, Restorative. and Neurological Devices
Page 1 of 1
510(k) Number K071115
§ 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.