(42 days)
No
The device description and intended use are for a physical suture anchor and its associated suture, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device is a non-absorbable suture anchor used for fixation of soft tissue to bone, which is a surgical tool rather than a therapeutic device that directly treats or cures a disease or condition.
No
The device is a non-absorbable suture anchor intended for fixation of suture to bone during surgical repairs, not for diagnosing conditions.
No
The device description clearly states it is a non-absorbable suture anchor made of Titanium material, preloaded on a disposable inserter assembly. This 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Healix Ti Anchor Function: The Healix Ti Anchor is a surgical implant used to fix suture to bone during various orthopedic repair procedures. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes surgical procedures for repairing ligaments, tendons, and other tissues in various joints. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description details the materials and construction of a surgical anchor and suture, not a diagnostic reagent or instrument.
Therefore, based on the provided information, the Healix Ti Anchor is a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Healix Ti Anchor is intended for:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
- Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hip: Capsular Repair, Acetabular Labral Repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded on a disposable inserter assembly intended for fixation of suture to bone. The Healix Ti Anchors are manufactured of Titanium material. Permacord suture is non-absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow, Hip
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)
Non clinical Testing: Verification activities were performed on the implant and / or its predicates. Testing assessment includes pull out testing.
Safety and Performance: Results of performance testing have demonstrated that the proposed device is suitable for its intended use.
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.
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 and 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 is an abstract symbol that resembles a stylized human figure or a group of people in profile. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
Depuy Mitek, A Johnson & Johnson Company Ms. Tracey Hannon Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K142574
Trade/Device Name: Healix Ti with Permacord Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 25, 2014 Received: September 26, 2014
Dear Ms. Hannon:
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
1
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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142574
Device Name Healix Ti with Permacord
Indications for Use (Describe)
The Healix Ti Anchor is intended for:
- Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair Foot/Ankle:
- Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair
- Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
- Hip: Capsular Repair, Acetabular Labral Repair
| 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)
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SECTION 2 - 510(k) SUMMARY
Healix™™ Anchor with Permacord™
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Date Prepared: September 11, 2014 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tracey Hannon
Regulatory Affairs Specialist
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-880-8033
Facsimile: 508-977-6911
e-mail: thannon@its.jnj.com |
| Name of
Medical Device | Proprietary Name: Healix Ti™ Anchor with Permacord™
Classification Name: Smooth or threaded metallic bone fixation fasteners
Common Name: Suture Anchor |
| Substantial
Equivalence | The Healix Ti™ Anchor with Permacord™ is substantially equivalent to:
K082282 Healix Ti™ Anchor with Orthocord®
Reference Devices:
• K133794 Healix Advance™ Anchor with Permacord™
• K140324 Rigidloop™ Adjustable Cortical Fixation System |
| Device
Classification | Healix Ti™ Anchor with Permacord™ is classified as:
• Smooth or threaded metallic bone fixation fastener, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. |
| Device
Description | The Healix Ti™ Anchor with Permacord™ is a non-absorbable suture anchor preloaded
on a disposable inserter assembly intended for fixation of suture to bone. The Healix
Ti Anchors are manufactured of Titanium material. Permacord suture is non-
absorbable. The anchor is provided in three sizes: 4.5mm, 5.5mm and 6.5mm. The
Healix Ti Anchor with Permacord suture is supplied sterile and is for single use only. |
| Technological
Characteristics | The proposed Healix Ti anchor with Permacord suture has the same anchor materials
and design as the predicate Healix Ti anchor with Orthocord (K082282). The
proposed device principal operation is the same as predicate Healix Ti anchor |
| Indications for
Use | The Healix Ti Anchor is intended for: |
| | Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction; |
| | Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; |
| | Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,
Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Patella tendon repair
and secondary fixation in ACL / PCL reconstruction repair. |
| | Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction. |
| | Hip: Capsular repair, acetabular labral repair. |
| Non clinical
Testing | Verification activities were performed on the implant and / or its predicates. Testing
assessment includes pull out testing. |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed device is suitable
for its intended use. |
| | Based on similarities in the indications for use, technological characteristics, and
performance in comparison to the predicate device, the proposed Healix Ti Anchor
with Permacord suture has shown to be substantially equivalent to the predicate device
under the Federal Food, Drug and Cosmetic Act. |
| Conclusion | The proposed Healix Ti Anchor with Permacord suture is substantially equivalent to
Healix Ti Anchor with Orthocord suture (K082282) in terms of design, indications for
use, performance data, sterilization method and shelf life. |
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(K082282). The Permacord suture is the same suture as referenced in Healix
Advance™ Anchor with Permacord™ (K133794).