(59 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical suture anchor and its associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is described as an implantable device intended for the reattachment of soft tissue to bone for various indications in the shoulder, foot, and ankle, which are therapeutic medical procedures.
No
Explanation: The ICONN Revolution Knotless Suture Anchor is an implantable device used for reattaching soft tissue to bone. Its function is to provide mechanical support and facilitate healing, rather than to diagnose medical conditions or diseases.
No
The device description clearly states it is an implantable device made from PEEK material, supplied with a disposable inserter and reusable driver made of stainless steel and silicone, and intended to be used with sutures/tape made from UHMWPE. These are all physical hardware components.
Based on the provided information, the ICONN Revolution Knotless Suture Anchor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The ICONN Revolution Knotless Suture Anchor is an implantable device used to physically reattach soft tissue to bone within the body during surgical procedures. It is a surgical implant, not a device for analyzing biological samples.
The description clearly indicates it's a physical implant used in surgical procedures for structural repair, which falls under the category of a surgical device or implant, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.
0
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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
1
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
2
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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3
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 Drive |
| Suite 150 | |
| Birmingham, AL 35209 | |
| Submitter Contact Person: | Whitt Israel |
| CEO | |
| (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.
4
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