(28 days)
Not Found
No
The device description and intended use are purely mechanical, describing a physical implant and its surgical application. There is no mention of any software, data processing, or analytical capabilities that would suggest the use of AI or ML.
No
This device is an implantable suture anchor used for the fixation of soft tissue to bone, which is a structural repair rather than a therapeutic treatment in itself. Its purpose is to physically stabilize a repair rather than to restore a physiological function or prevent a disease in a therapeutic sense.
No
The device description indicates it is an implantable suture anchor used for the fixation of soft tissue to bone, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is an "implantable device manufactured from Titanium Alloy" and includes sutures and an inserter, indicating it is a physical medical device, not software.
No, 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, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Extremity Medical Suture Anchor is an implantable device made of titanium alloy and sutures. It is used to physically attach soft tissue to bone within the body during surgical procedures.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's body to repair injuries.
The device is a surgical implant, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Extremity Medical Suture Anchor is an implantable device manufactured from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is preloaded with two or three sutures depending on the size of the anchor. The suture material is Size #2 Teleflex Force Fiber. The device is recommended to be used for the repair of soft tissue to bone. The suture anchor and sutures are assembled to an inserter which is used to screw the anchor into bone. The product is provided pre-packaged and sterile via EtO sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, and elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing, including pull-out strength was performed and compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 23, 2015
Extremity Medical, LLC Mr. Brian Smekal Director, Regulatory Affairs 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K150166
Trade/Device Name: Extremity Medical 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: January 22, 2015 Received: January 26, 2015
Dear Mr. Smekal:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Brian Smekal
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/Resourcesfor You/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 vours.
Mark N. Melkerson -S
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)
Device Name Extremity Medical Suture Anchor
Indications for Use (Describe)
The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Special 510(k) Summary of Safety and Effectiveness:
Suture Anchor
| Submitter: | Extremity Medical, LLC.
300 Interpace Parkway
Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
Director, Regulatory Affairs
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | January 22, 2015 |
| Trade Name | Extremity Medical Suture Anchor |
| Classification Name
and Number | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040 |
| Product Code | MBI (fastener, fixation, nondegradable, soft tissue) |
| Predicate Devices | K083151 - Suture Anchor (Extremity Medical) |
| Device Description | The Extremity Medical Suture Anchor is an implantable device manufactured
from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is
preloaded with two or three sutures depending on the size of the anchor. The
suture material is Size #2 Teleflex Force Fiber. The device is recommended to be
used for the repair of soft tissue to bone. The suture anchor and sutures are
assembled to an inserter which is used to screw the anchor into bone. The
product is provided pre-packaged and sterile via EtO sterilization. |
| Indications for use | The Extremity Medical Suture Anchor is intended for the fixation of suture
and/or soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and
elbow in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular
Shift of Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,
Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament
Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,
Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band
Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral
LigamentReconstruction |
| | Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial
Collateral Ligament Reconstruction. |
| Statement of
Technological
Comparison | The modified Suture Anchor and predicate devices are equivalent in terms of
indications for use, design, and material mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out strength was performed and compared to the
predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The modified Suture Anchor is substantially equivalent to its predicate device.
This conclusion is based upon indications for use, materials, design, test data and
principles of operation. |
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