(92 days)
The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
The Rimclose Bone Anchor consists of one (1) bone anchor assembly, pre-loaded on a disposable delivery tool. The Bone Anchor is packaged with a disposable Bone Awl to facilitate placement of the device. The device is provided in one size only.
The bone anchor assembly is comprised of one (1) titanium (Ti-6Al-4V ELI) toggle-anchor, connected to an adjustable polyethylene terephthalate (PET) 2-0 braided suture loop, via an intermittent length of size 0 ultra high molecular weight polyethylene (UHMWPE) Force Fiber suture.
The device's titanium component conforms to ASTM F-136. The device's polyethylene terephthalate (PET) and ultra high molecular weight polyethylene (UHMWPE) suture components conform to USP requirements. The constructs are provided sterile and preloaded on disposable delivery instruments.
The provided text is a 510(k) summary for the Rimclose Bone Anchor. It describes the device, its intended use, and states that substantial equivalence to a predicate device was established through biocompatibility and bench testing. However, it does not contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML devices or diagnostic tools.
Therefore, many of the requested sections will be answered as "Not applicable" or "Information not provided in the document."
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional/Safety Bench Testing (details not specified) | "demonstrated equivalent fixation strength which greatly exceeded the tensile strength of the suture." |
| Material Conformance (implied) | Titanium component conforms to ASTM F-136. PET and UHMWPE suture components conform to USP requirements. |
| Biocompatibility (details not specified) | Testing completed and supports safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Information not provided in the document. The document refers to "bench testing," which typically involves mechanical tests rather than human patient data.
- Data Provenance: Information not provided. Since it's bench testing, country of origin or retrospective/prospective is not applicable in the context of patient data.
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)
- Information not provided. For a physical device undergoing bench testing, "ground truth" and "experts" in the context of clinical interpretation are not applicable. The performance is typically measured against engineering specifications or known material properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or expert consensus. For bench testing of a bone anchor, performance metrics are typically quantitative and objective.
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
- MRMC Study: No, this is not an AI/ML device or an imaging/diagnostic tool, so MRMC studies are not applicable.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (bone anchor), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's testing would likely be based on:
- Engineering specifications/standards: For material properties, dimensions, and mechanical strength (e.g., tensile strength, fixation strength).
- Predicate device performance: For comparison of equivalent fixation strength.
- USP requirements and ASTM standards: For material conformance.
8. The sample size for the training set
- Not applicable. This is a physical medical device, and the concept of a "training set" is not relevant in the context of its testing for 510(k) clearance, which relies on bench testing and biocompatibility.
9. How the ground truth for the training set was established
- Not applicable.
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K082729 1/2
Section 5 - 510(k) Summary
| Submitter: | Anulex Technologies, Inc.5600 Rowland Road, Suite 280Minnetonka, MN 55343 | DEC 19 2008 |
|---|---|---|
| Contact Person: | Rachel KennedySenior Regulatory Affairs ManagerAnulex Technologies, Inc.Direct: 952.224.4034Fax: 952.224.4040E-Mail: rkennedy@anulex.com | |
| Date Prepared: | September 15, 2008 | |
| Trade Name: | Rimclose Bone Anchor | |
| Classification: | II | |
| Product Code: | MBI21 CFR 888.3040 | |
| Predicate Device(s): | The subject device is substantially equivalent to the followingpredicate device:• Arthrex Small Bone FASTak™ Suture Anchor(K971723 cleared July 30, 1997) | |
| Device Description: | The Rimclose Bone Anchor consists of one (1) bone anchorassembly, pre-loaded on a disposable delivery tool. The BoneAnchor is packaged with a disposable Bone Awl to facilitateplacement of the device. The device is provided in one sizeonly.The bone anchor assembly is comprised of one (1) titanium (Ti-6Al-4V ELI) toggle-anchor, connected to an adjustablepolyethylene terephthalate (PET) 2-0 braided suture loop, via anintermittent length of size 0 ultra high molecular weightpolyethylene (UHMWPE) Force Fiber suture.The device's titanium component conforms to ASTM F-136.The device's polyethylene terephthalate (PET) and ultra highmolecular weight polyethylene (UHMWPE) suture componentsconform to USP requirements. The constructs are providedsterile and preloaded on disposable delivery instruments. | |
| Indications for Use: | The Rimclose Bone Anchor is intended for fixation of suture tobone. This product is intended for the following indications: | |
| Foot/Ankle: Lateral Stabilization, Medial Stabilization, AchillesTendon Repair, Hallux Valgus Reconstruction, MidfootReconstruction, Metatarsal Ligament Repair | ||
| Hand/Wrist: Scapholunate Ligament Reconstruction, UlnarCollateral Ligament Reconstruction, Radial Collateral LigamentReconstruction | ||
| Functional andSafety Testing: | Biocompatibility and bench testing were completed and supportthe safety and effectiveness of the Rimclose Bone Anchor. | |
| Conclusion: | The Rimclose Bone Anchor is substantially equivalent to theArthrex FASTak Suture Anchor (7.5mm). In this case,substantial equivalence is based on having the same intended usewith minor differences in technological characteristics, such thatit can be demonstrated that the device is as safe and effective asthe predicate device. Both anchors are both made of titanium.FASTak uses threads for fixation in bone while the Rimcloseanchor is a T-anchor which toggles on deployment. Bothanchors are provided with suture to facilitate attachment to softtissue. The bone anchors demonstrated equivalent fixationstrength which greatly exceeded the tensile strength of thesuture. USP performance characteristics serve as a guide inmatching suture to procedural applications. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Anulex Technologies, Inc. % Ms. Rachel Kennedy Senior Regulatory Affairs Manager 5600 Rowland Road, Suite 280 Minnetonka, Minnesota 55343
DEC 1 9 2008
Re: K082729 Trade/Device Name: Rimclose Bone Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 18, 2008 Received: December 19, 2008
Dear Ms. Kennedy:
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 - Ms. Rachel Kennedy
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 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 the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Mulkerson
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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Section 4 - Indications for Use Statement
Device Name: Rimclose Bone Anchor
Indications for Use:
The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications:
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
David Krome for MXM 12/09/2005
Division of General, Restorative, and Neurological Devices
510(k) Number K082729
Rimclose Bone Anchor Anulex Technologies, Inc. K082729
Traditional 510(k) Premarket Notification
§ 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.