(53 days)
No
The device description and performance studies focus on the mechanical properties and materials of a suture anchor, with no mention of AI or ML.
Yes
The device is a threaded suture anchor used for the fixation of soft tissue to bone, specifically in various repair and reconstruction procedures post-injury, aligning with the definition of a therapeutic device.
No
The device is an anchor used for soft tissue to bone fixation, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly describes a physical implant (threaded suture anchor) made of absorbable or non-absorbable materials, preloaded on a disposable inserter assembly. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The HEALIX ADVANCE Anchor is a physical implant (a threaded suture anchor) used to fix soft tissue to bone within the body during surgery.
- Intended Use: The intended use clearly describes surgical procedures for repairing injuries in various anatomical locations (shoulder, foot/ankle, knee, elbow, hip). It does not involve testing specimens outside the body.
The information provided describes a surgical implant, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
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 Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
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)
MAI, HWC
Device Description
The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation soft tissue to bone. Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK materials. Permacord suture is a non-absorbable suture that conforms to USP, except for oversized diameter. Healix Advance Anchors with Permacord are provided 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
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)
Verification activities were performed on the implant and / or its predicates. Testing assessments include pull out testing, insertion and failure torque, in-vitro testing and suture testing per USP.
Results of performance testing have demonstrated that the proposed devices are suitable for their 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.
K120078, K120449, K100012, K073412
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
FEB - 4 2014
·
SECTION 2 - 510(k) SUMMARY
Healix Advance"" Anchor with Permacord™
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Date Prepared: December 11, 2013 | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Specialist
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3122
Facsimile: 508-977-6911
e-mail: tkorsuns@its.jnj.com | |
| Name of
Medical Device | Proprietary Name: a) Healix Advance™ BR Anchor with Permacord™
b) Healix Advance™ PEEK Anchor with Permacord™
Classification Name: a) Single/multiple component metallic bone fixation
appliances and accessories
b) Smooth or threaded metallic bone fixation fasteners
Common Name: Suture Anchor | |
| Substantial
Equivalence | The Healix Advance™ Anchor with Permacord™ is substantially equivalent to:
• K120078 Healix Advance™ BR Anchor with Orthocord® suture
• K120449 Healix Advance™ PEEK Anchor with Orthocord® suture
• K100012, K073412 Gryphon™ T BR Anchor with Orthocord® suture
The following predicate devices were referenced:
• K070673 Force Fiber® White/Black Co-Braid. Teleflex
• K092533 Force Fiber® Blue Braid. Teleflex
• K100506 Force Fiber® White/Green Co-Braid. Teleflex | |
| Device
Classification | ➤ Healix Advance BR anchor is classified as:
Single/multiple component metallic bone fixation appliances and accessories,
classified as Class II, product code MAI, regulated under 21 CFR 888.3030.
➤ Healix Advance PEEK anchor is classified as:
Smooth or threaded metallic bone fixation fasteners, classified as Class II, product
code HWC, regulated under 21 CFR 888.3040. | |
| Device
Description | The Healix Advance" Anchor with Permacord™ suture is a threaded suture anchor
preloaded on a disposable inserter assembly intended for fixation soft tissue to bone.
Healix Advance Anchors are available in absorbable BR and non-absorbable PEEK
materials. Permacord suture is a non-absorbable suture that conforms to USP, except
for oversized diameter. Healix Advance Anchors with Permacord are provided sterile
and is for single use only. | |
| Technological
Characteristics | The proposed Healix Advance Anchors with Permacord suture have the same anchor
materials and design as predicate Healix Advance Anchors (K120078, K120449). The
proposed device principal operation is the same as predicate Healix Advance Anchors
(K120078. K120449) and Gryphon" BR (K100012) anchors. The Permacord suture
has the same design and materials as Teleflex's Force Fiber suture (K070673,
K092533, K100506), and conforms to USP, except for oversized diameter. | |
| Indications for
Use | The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in
association with post-operative immobilization as follows: | |
| | Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps
Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction: |
| | Foot/Ankle:
Knee: | Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;
Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Posterior Oblique Ligament Repair. Iliotibial Band
Tenodesis; |
| | 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
assessments include pull out testing, insertion and failure torque, in-vitro testing and
suture testing per USP. | |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use. | |
| | Based on similarities in the indications for use, technological characteristics, and
performance in comparison to the predicate devices, the proposed Healix Advance
Anchor with Permacord suture has shown to be substantially equivalent to the
predicate devices under the Federal Food, Drug and Cosmetic Act. | |
1
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 4, 2014
DePuy Mitek, a Johnson & Johnson company Ms. Tatyana Korsunsky Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
Re: K133794
Trade/Device Name: Healix Advance™ Anchor with Permacord™ suture Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, HWC Dated: December 11, 2013 Received: December 13, 2013
Dear Ms. Korsunsky:
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 (reporting of medical
3
Page 2 - Ms. Tatyana Korsunsky
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Vincent訂房Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K133794
Device Name: Healix Advance™ Anchor with Permacord™suture
Indications for Use:
The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation in association with post-operative immobilization as follows:
| 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 Collateral Ligament Repair, Posterior
Oblique Ligament Repair, Iliotibial Band Tenodesis; |
| Elbow: | Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction; |
| Hip: | Capsular Repair, Acetabular Labral Repair. |
| Prescription Use | x |
|---|---|
| AND/OR | |
| (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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