(55 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation strength of a suture anchor, with no mention of AI or ML capabilities.
No.
The device is a surgical implant (suture anchors) used for soft-tissue to bone fixation, which is a restorative/corrective function, not a therapeutic one in the sense of treating a disease or condition with direct intervention/therapy (e.g., drug delivery, physical therapy modalities).
No
Explanation: The device is an all-suture anchor intended for soft-tissue to bone fixation, not for diagnosing medical conditions.
No
The device description clearly describes a physical medical device (suture anchors, inserter, needles, drill guide) intended for surgical implantation. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states the device is a "suture anchor" used for "soft-tissue to bone fixation." This is a surgical implant used directly within the body for structural support.
- Intended Use: The intended use is for surgical procedures to repair ligaments and tendons in various joints. This is a therapeutic and structural application, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a surgical implant used for mechanical fixation within the body, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Stryker ICONIX with Needles Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor And Extensor Tendons at the PIP, DIP, and MCP Joint for All Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
Product codes
MBI
Device Description
ICONIX with Needles (herein referred to as the proposed device(s)) are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working sutures. Needles are housed in a compartment within the inserter handle and are swaged to the free ends of all working sutures. Fixation is achieved by the polyester sheath bunching when the anchor is deployed. The inserter handle will contain needles for use at the surgeon's discretion. The anchor and inserter will be packaged in a single-use sterile barrier system (SBS) containing a disposable drill guide to aid in anchor implantation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot, ankle, knee, hip, wrist, elbow, shoulder
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
Non-clinical benchtop testing was performed to verify the fixation strength following cyclical loading of the ICONIX with Needles products. This fixation strength was compared to that of Predicate A through statistical analysis. The comparison indicates that the proposed devices provide equivalent fixation strength to the devices of Predicate A, and will be functional within the intended use. Clinical testing was not required to demonstrate substantial equivalence for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines connecting them. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2015
Stryker Endoscopy Mr. Taylor White Regulatory Affairs Analyst 5670 Greenwood Plaza Boulevard, Suite 200 Greenwood Village, Colorado 80111
Re: K151201
Trade/Device Name: Stryker ICONIX with Needles Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 4, 2015 Received: May 5, 2015
Dear Mr. White:
This letter corrects our substantially equivalent letter of June 29, 2015.
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. 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -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
510(k) Number (if known) K151201
Device Name Stryker ICONIX with Needles
Indications for Use (Describe)
The Stryker ICONIX with Needles Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below.
Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodess, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor And Extensor Tendons at the PIP, DIP, and MCP Joint for All Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon 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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510(k) Summary
I. SUBMITTER
Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138
Contact Person: Taylor White, Regulatory Affairs Analyst Phone: 303-336-7285 Cellular Phone: 937-402-1879 Fax: 303-993-6195
Date Prepared: June 23, 2015
II. DEVICE
| Name of Device: | Stryker ICONIX with Needles |
|---|---|
| Model Numbers: | 3910-500-412, 3910-500-422, 3910-500- |
| 425 | |
| Common or Usual Name: | Suture, Fastener, Fixation, Nondegradable, Soft Tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener (21 CFR |
| 888.3040) | |
| Regulatory Class: | II |
| Product Code: | MBI |
III. PREDICATE DEVICES
Predicate A (Primary Predicate): Stryker ICONIX All Suture Anchors, K133671 This predicate has not been subject to a design-related recall.
Predicate B: Stryker PEEK and Titanium Soft Eyelet Anchors, K071157 This predicate has not been subject to a design-related recall regarding the components of interest.
IV. DEVICE DESCRIPTION
ICONIX with Needles (herein referred to as the proposed device(s)) are all suture anchors with a push-in design, provided sterile and preloaded on a disposable inserter. The anchors consist of a polyester sheath interwoven over non-absorbable working
4
sutures. Needles are housed in a compartment within the inserter handle and are swaged to the free ends of all working sutures. Fixation is achieved by the polyester sheath bunching when the anchor is deployed. The inserter handle will contain needles for use at the surgeon's discretion. The anchor and inserter will be packaged in a single-use sterile barrier system (SBS) containing a disposable drill guide to aid in anchor implantation.
V. INTENDED USE
The Stryker ICONIX with Needles Anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, wrist, elbow, and shoulder. See indications below.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor And Extensor Tendons at the PIP, DIP, and MCP Joint for All Digits, Digital Tendon Repair
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-Foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The ICONIX with Needles products are substantially equivalent to both Predicate A and Predicate B in regard to intended use. The proposed devices are substantially equivalent to Predicate A (the Primary Predicate) with regard to indications for use, operational principles, materials intended for implantation, and performance attributes. The performance of the proposed devices has been shown to be statistically equivalent to Predicate A.
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The proposed devices are substantially equivalent to Predicate B in regard to intended use. Predicate B incorporates identical needles to the proposed devices.
The differences between the proposed products and the predicate devices are summarized below, and do not raise new questions of safety and effectiveness.
Proposed and Predicate Device Differences:
Components Included in Product
The ICONIX with Needles products are single-use, sterile barrier system (SBS) kits that contain the anchor preloaded on the inserter, a disposable drill, and a disposable drill guide. Predicates A and B include only the anchor preloaded on the inserter.
Anchor Geometry
The smallest ICONIX with Needles anchor is shorter in length than the smallest anchor of Predicate A. Both anchors require a 1.4mm pilot hole to be drilled, however the anchor of the proposed devices is 8mm in length as compared to the smallest anchor of Predicate A that is 12mm in length. Benchtop testing demonstrated that the smaller proposed devices have equivalent fixation strength to Predicate A. The 2.3mm anchors of the proposed devices are identical to those of Predicate A. See Section 18 for in-depth statistical analysis of this testing.
Needles
The proposed devices include an openable inserter handle that houses needles swaged to the working sutures. The needles may be used at the discretion of the surgeon, but are not necessary for anchor implantation. Predicate B has been identified because this predicate contains identical needles to those of the proposed devices. The needles are retained in a small foam insert for user safety and ease of use.
VII. PERFORMANCE DATA
Non-clinical benchtop testing was performed to verify the fixation strength following cyclical loading of the ICONIX with Needles products. This fixation strength was compared to that of Predicate A through statistical analysis. The comparison indicates that the proposed devices provide equivalent fixation strength to the devices of Predicate A, and will be functional within the intended use. Clinical testing was not required to demonstrate substantial equivalence for this submission.
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VIII. CONCLUSIONS
The information presented within this traditional premarket submission demonstrates that Stryker ICONIX with Needles products are substantially equivalent to the predicate devices and will perform safely and effectively within the intended use.