(59 days)
The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
The ICONN Revolution Knotless Suture Anchor (P/N 350000) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in one size (Diameter x Length): 5mm x 23mm. The implants with attached disposable inserter are supplied sterile and the instrument is supplied Non-Sterile and is to be sterilized in the ICONN instrument tray prior to surgery. The disposable inserter is made out of 17-4 stainless steel and the reusable driver is made out of 17-4 stainless steel (shaft) and silicone (handle). All anchors are intended to be used with the supplied #2 sutures and/or 1.5mm ICONN TetherTape, both made from Ultra High Molecular Weight Polyethylene (UHMWPE). The sutures/tape are supplied sterile, are packaged individually, and are single strands measuring 36/38 inches in length.
The provided text is a 510(k) summary for the ICONN Revolution Knotless Suture Anchor, a medical device. It describes the device, its intended use, and comparative studies against a predicate device to establish substantial equivalence for FDA clearance. The summary does not provide information about an AI/algorithm-based device as requested in the original prompt. Therefore, I cannot extract the specific details you've asked for regarding acceptance criteria and an AI study.
However, I can provide the available information related to the device's performance testing and acceptance criteria as described in the document, which are related to its mechanical and biocompatibility properties, not AI performance.
Here's a breakdown of the information that is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document mentions performance testing but does not present a formal table of "acceptance criteria" with specific numerical targets alongside "reported device performance." Instead, it states the following regarding the outcomes of the performance tests:
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pullout Characteristics | Compliance with FDA's Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996) | "performed similarly or better than the predicate or within acceptable ranges for the intended use." |
| - Anchor displacement after cyclic loading | (Implicitly, within limits acceptable for safe and effective use and comparable to predicate) | (Met implicit criteria) |
| - Ultimate anchor pull-out | (Implicitly, within limits acceptable for safe and effective use and comparable to predicate) | (Met implicit criteria) |
| Insertion Testing | Compliance with ASTM F543-2013 (specifically sections A1 and A2) | "demonstrate the device can be safely implanted." |
| - Torsional properties | (Implicitly, within limits acceptable for safe implantation) | (Met implicit criteria) |
| - Driving torque | (Implicitly, within limits acceptable for safe implantation) | (Met implicit criteria) |
| Biocompatibility Testing | Compliance with ISO 10993/(R)2013 | "all testing met acceptance criteria." |
| - Cytotoxicity | (Met ISO 10993/(R)2013 acceptance criteria) | (Met acceptance criteria) |
| - Irritation | (Met ISO 10993/(R)2013 acceptance criteria) | (Met acceptance criteria) |
| - Sensitization | (Met ISO 10993/(R)2013 acceptance criteria) | (Met acceptance criteria) |
| LAL testing (Endotoxin) | In accordance with ANSI/AAMI ST72:2006, result <0.05 EU/device | "results demonstrated the test article were <0.05 EU/device." |
| Pyrogenicity | (Non-pyrogenic status) | "device was determined to be non-pyrogenic." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for the mechanical or biological testing described. It also does not provide information about data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. The tests performed are laboratory bench tests and material tests, not clinical studies.
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)
This question is not applicable. The evaluations described are mechanical and biocompatibility tests conducted in a laboratory setting, not clinical studies requiring expert interpretation of medical data or ground truth establishment by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable, as the tests described are objective laboratory and material tests, not subjective interpretations requiring adjudication.
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
There is no mention of an MRMC study or any AI component in the provided text. The device is a physical Suture Anchor.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable, as the device is a physical Suture Anchor and does not involve any algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This question is not applicable in the context of the physical device's performance and biocompatibility testing. "Ground truth" in this context refers to objective measurements and established standards (e.g., precise force measurements, chemical analysis, cell viability assays according to ISO standards).
8. The sample size for the training set
This question is not applicable, as the device does not involve a "training set" in the context of an AI or algorithm.
9. How the ground truth for the training set was established
This question is not applicable, as the device does not involve a "training set" in the context of an AI or algorithm.
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October 19, 2018
ICONN Orthopedics, LLC Whitt Israel Chief Executive Officer 400 Union Hill Drive, Suite 150 Birmingham, Alabama 35209
Re: K182264
Trade/Device Name: ICONN Revolution Knotless Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 20, 2018 Received: August 21, 2018
Dear Mr. Israel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K182264
Device Name
ICONN Revolution Knotless Suture Anchor
Indications for Use (Describe)
The ICONN Revolution Knotless Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/Ankle: Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for "ICONN Orthopedics". The logo consists of the word "ICONN" in a gray sans-serif font, with a blue circle in the middle of the word. Below the word "ICONN" is the word "ORTHOPEDICS" in a smaller gray sans-serif font, with two gray lines on either side of the word.
400 Union Hill Drive, Suite 150 Birmingham, AL 35209
510(k) SUMMARY
| Submitter's Name: | ICONN Orthopedics, LLC |
|---|---|
| Submitter's Address: | 400 Union Hill DriveSuite 150Birmingham, AL 35209 |
| Submitter Contact Person: | Whitt IsraelCEO(205) 913-2068 |
| Date Summary was Prepared: | August 20, 2018 |
| Trade Name or Proprietary Name: | ICONN Revolution Knotless Suture Anchor |
| Common or Usual Name: | Suture Anchor |
| Classification: | Class II per 21 CFR §888.3040 |
| Product Code: | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Panel: | Division of Orthopedic Devices |
Device Description: The ICONN Revolution Knotless Suture Anchor (P/N 350000) is a sterile (gamma irradiation), single use implantable device made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material indicated for soft tissue reattachment procedures in the shoulder, foot, and ankle. The anchor is available in one size (Diameter x Length): 5mm x 23mm. The implants with attached disposable inserter are supplied sterile and the instrument is supplied Non-Sterile and is to be sterilized in the ICONN instrument tray prior to surgery. The disposable inserter is made out of 17-4 stainless steel and the reusable driver is made out of 17-4 stainless steel (shaft) and silicone (handle). All anchors are intended to be used with the supplied #2 sutures and/or 1.5mm ICONN TetherTape, both made from Ultra High Molecular Weight Polyethylene (UHMWPE). The sutures/tape are supplied sterile, are packaged individually, and are single strands measuring 36/38 inches in length. The ICONN Revolution Knotless Suture Anchor is intended for the Intended Use: reattachment of soft tissue to bone for the following indications: Shoulder: Rotator cuff repair, Bankart repair, Slap lesion repair, Biceps tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
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Foot/Ankle: Lateral stabilization. Medial stabilization. Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair. Predicate Device: The predicate device was selected to help demonstrate substantial equivalence of several characteristics to include intended use, design, size, PEEK material, and supplying the device in the sterile state. The predicate device is listed below: . Smith & Nephew FOOTPRINT Ultra PK Suture Anchor (K093897) Technological The ICONN Revolution Knotless Suture Anchor Characteristics: is of similar design to the predicate and is manufactured with the same basic material in similar size. Performance Data: Performance testing was conducted for both pullout characteristics and torsional properties. For pullout characteristics, the FDA's Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996) was used for quidance in side by side mechanical testing performed on the subject device and predicate for the following test modes: . Anchor displacement after cyclic loading . Ultimate anchor pull-out Pullout testing showed that the ICONN Revolution Knotless Suture Anchor performed similarly or better than the predicate or within acceptable ranges for the intended use. For insertion testing. ASTM F543-2013 was followed, specifically the sections on torsional properties (section A1 of the standard) and driving torque (section A2 of the standard) were analyzed and compared to demonstrate the device can be safely implanted. Cytotoxicity, irritation, and sensitization testing were carried out in accordance with ISO 10993/(R)2013 and all testing met acceptance criteria. In accordance with ANSI/AAMI ST72:2006 LAL testing conducted using the Kinetic-Chromogenic assay and the results demonstrated the test article were <0.05 EU/device. Materialmediated pyrogenicity testing was conducted and the device was determined to be non-pyrogenic. Conclusion: The Revolution Knotless Suture Anchor is substantially equivalent to the predicate and does not raise different questions of safety and effectiveness.
N/A