(67 days)
reNOVO Suture Anchors are intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
The reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter. The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone.
The reNOVO™ Suture Anchor will be provided sterile for single use applications.
The sizes and materials are designed to address the indications cited.
This 510(k) submission for the reNOVO™ Suture Anchor System does not describe specific acceptance criteria and a study demonstrating the device meets those criteria in the way a performance study for, for example, an AI/ML device would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria or reported device performance metrics (e.g., tensile strength thresholds, pull-out force requirements) is provided in the document. The claim is one of substantial equivalence, meaning the device is considered to perform similarly to already legally marketed devices.
2. Sample size used for the test set and the data provenance
No test set or associated sample size is mentioned in the document. The submission is based on a comparison to existing devices, not a new performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no test set in the conventional sense, and thus no ground truth to be established by experts.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication process described.
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 is a medical device (suture anchor), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device submission, the "ground truth" for demonstrating safety and effectiveness is established by showing that its intended use, materials, operational principles, and indications are equivalent to those of predicate devices that have already been cleared by the FDA.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
Summary of the Study (Basis for Substantial Equivalence):
The "study" that proves the device meets the "acceptance criteria" (which, in this context, is substantial equivalence) is a comparison to predicate devices.
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Acceptance Criteria (Implicit for Substantial Equivalence): The reNOVO™ Suture Anchor System must be shown to be substantially equivalent in intended use, materials, operational principles, and indications for use to legally marketed predicate devices. This implicitly means that its performance characteristics (e.g., mechanical properties, biocompatibility) are expected to be similar or equal to those of the predicate devices.
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Reported Device Performance (Implicit): The submission claims that "Core Essence Orthopaedics reNOVO suture anchors are substantially equivalent to the currently marked devices and present no substantial differences in design, material, intended use and function to the products on the table above." This statement serves as the "reported device performance" in the context of a 510(k) for a device like this.
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Predicate Devices Used for Comparison:
In essence, for this 510(k), the "study" is the analytical comparison of the reNOVO™ Suture Anchor System's characteristics (design, materials, indications, operational principles) against those of multiple already-cleared predicate suture anchors, rather than a separate clinical or bench performance study with specific metrics. The FDA's clearance (K071520) indicates they found this comparison sufficient to establish substantial equivalence.
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510(K) SUMMARY
AUG 1 0 2007
Subject 510(k) Number
Sponsor
Core Essence Orthopaedics, LLC
301 Oxford Valley Road Suite 905B Yardley, PA 19067
FDA Establishment Registration Number
3004613836
Official Contact
Shawn T. Huxel, CEO & President Core Essence Orthopaedics, LLC 301 Oxford Valley Road Suite 905B Yardley, PA 19067 Phone - (215) 310-9534 Fax - (609) 482-4957 Mobile - (908) 896-5893
Proprietary Name
reNOVO™ Suture Anchor System
Common Name
Suture Anchor
Classification Name and Reference
Sec. 888.3040 Smooth or threaded metallic bone fixation fastener
Regulatory Class Class II
Device Product Code/Subsequent Code
(Panel 87) MBI/GAT
Date Prepared 9 August, 2007
Brief Description of Device
The reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter.
Core Essence Orthopaedics, LLC
Confidential
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Page 2 of 3
The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone.
The reNOVO™ Suture Anchor will be provided sterile for single use applications.
The sizes and materials are designed to address the indications cited.
Indications for Use
reNOVO Suture Anchors are intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
Core Essence Orthopaedics, LLC
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Page 3 of 3
Basis for Substantial Equivalence
The substantial equivalence of the reNOVO Suture Anchors is based on the equivalence in intended use, materials, operational principals, and indications to:
| Mitek | Zimmer | Arthrotek | Arthrex | Smith &Nephew | UnitedStatesSurgical |
|---|---|---|---|---|---|
| K962511 | K962397 | K012503 | K971723 | K053344 | K040594 |
| K962793 | K926384 | K973775 | K960516 | K972326 | |
| K982420 | K943806 |
In conclusion: Core Essence Orthopaedics reNOVO suture anchors are substantially equivalent to the currently marked devices and present no substantial differences in design, material, intended use and function to the products on the table above.
END OF 510(K) SUMMARY
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Core Essence Orthopaedics, LLC % Mr. Shawn T. Huxel CEO & President 301 Oxford Valley Road Suite 905B Yardley, PA 19067
AUG 1 0 2007
Re: K071520
Trade/Device Name: reNOVOTM Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC, JDR Dated: June 1, 2007 Received: June 4, 2007
Dear Mr. Huxel:
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. Shawn T. Huxel
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). 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 vours.
Barbara Buchin
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: K071520 MANUFACTURER: Core Essence Orthopaedics, LLC DEVICE NAME: reNOVO Suture Anchors
reNOVO Suture Anchors are intended to secure soft tissue to bone of:
The Shoulder:
Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair
The Elbow:
Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair
The Hand and Wrist:
Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons
The Ankle and Foot:
Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
Y
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Juliane Avenue for mym
Division of General, Restor and Neurological Devices
Page 1 of /
510(k) Number K071520
§ 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.