(227 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of a surgical anchor, with no mention of AI or ML.
Yes
The device is an implantable anchor designed to reattach soft tissue to bone, which is a therapeutic intervention.
No
Explanation: The device is an implantable anchor used for reattachment of soft tissue to bone. Its intended use is therapeutic (repair) rather than diagnostic (identifying a condition or disease).
No
The device description clearly states it is a one-piece implantable cannulated, threaded anchor made from physical materials (Biocryl Rapide® and PEEK) and provided loaded on a disposable inserter driver device. This indicates a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "reattachment of soft tissue to bone" in surgical procedures. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details an implantable anchor made of specific materials, designed to secure tissue. This is a physical device used within the body during surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status or disease. IVDs are used to diagnose, monitor, or screen for conditions.
This device is a surgical implant used for tissue repair, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE KNOTLESS Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair
Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis
Foot/Ankle*: Achilles Tendon Repair
*HEALIX ADVANCE KNOTLESS PEEK Anchors only
Product codes (comma separated list FDA assigned to the subject device)
MAI, MBI
Device Description
The HEALIX ADVANCE™ KNOTLESS Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchor is offered in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE™ KNOTLESS Anchors are molded from Biocryl Rapide® (BR) and polyetheretherketone (PEEK) materials. The HEALIX ADVANCE™ KNOTLESS Anchor is 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, Knee, Foot/Ankle
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 has been performed on the proposed device and / or its predicates. Performance testing included in-vitro anchor pull out, time zero anchor pull out and torque testing. Safety evaluations were conducted to address biological, sterility, packaging and shelf-life. Note: The proposed device has been determined to be non-pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin testing (BET) method.
Results of safety and 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™ KNOTLESS Anchor has shown to be substantially equivalent to the predicate device under the Federal Food, Drug and Cosmetic Act.
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.
K130917, K131974, K130539, K131683, K101679, K082810, K071177, K061863, K051219
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
§ 888.3030 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.
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November 27, 2017
Medos International SARL % Ms. Julie Vafides Manager, Regulatory Affairs DePuy Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K171114
Trade/Device Name: HEALIX ADVANCE KNOTLESS™ Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: October 19, 2017 Received: October 23, 2017
Dear Ms. Vafides:
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 forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
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
510(k) Number (if known)
Device Name
HEALIX ADVANCE™ KNOTLESS Anchor
Indications for Use (Describe)
The HEALIX ADVANCE KNOTLESS Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder: Rotator Cuff, Biceps Tenodesis, Deltoid Repair
Knee: Posterior Oblique, Medial Collateral Ligament (MCL), Lateral Ligament (LCL), Iliotibial (IT) Band Tenodesis
- Foot/Ankle*: Achilles Tendon Repair
*HEALIX ADVANCE KNOTLESS PEEK Anchors only
| 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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510(k) SUMMARY
HEALIX ADVANCE™ KNOTLESS Anchor
| Submitter's
Name and
Address | Medos International SARL
Chemin-Blanc 38, Case Postale
Le Locle
CH 2400
Switzerland | | |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | Date Prepared: April 13, 2017 | | |
| Contact Person | Julie Vafides
Manager, Regulatory Affairs
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA | | Telephone: 508-977-6645
e-mail: jvafides@its.jnj.com |
| Name of
Medical Device | Proprietary Name: | a) HEALIX ADVANCE™ KNOTLESS BR Anchor
b) HEALIX ADVANCE™ KNOTLESS PEEK Anchor | |
| | 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™ KNOTLESS Anchor is substantially equivalent to:
K130917, K131974 HEALIX ADVANCE™ KNOTLESS BR Anchor K130539, K131683 HEALIX ADVANCE™ KNOTLESS PEEK Anchor K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors | | |
| Device
Classification | > HEALIX ADVANCE™ KNOTLESS 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™ KNOTLESS PEEK Anchor is classified as:
Smooth or threaded metallic bone fixation fasteners, classified as Class II, product | | |
| Device
Description | The HEALIX ADVANCE™ KNOTLESS Anchor is a one piece implantable
cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is
provided loaded on a disposable inserter driver device. The proposed anchor is offered
in three sizes, 4.75 mm, 5.5 mm and 6.5mm. The HEALIX ADVANCE™
KNOTLESS Anchors are molded from Biocryl Rapide® (BR) and
polyetheretherketone (PEEK) materials. The HEALIX ADVANCE™ KNOTLESS
Anchor is provided sterile and is for single use only. | | |
| Technological
Characteristics | The suture anchor design, anchor and suture materials, and finished good assembly
design remain the same when compared to the predicate HEALIX ADVANCE™
KNOTLESS Anchors (BR: K130917, K131974; PEEK: K130539, K131683). Minor
modifications have been made to the distal tip geometry of the BR Anchors.
Additional minor changes have been made to the disposable inserter to increase suture
management usability. | | |
| Indications for
Use | The HEALIX ADVANCE KNOTLESS Anchors are indicated for use in the following
procedures for reattachment of soft tissue to bone: | | |
| | Shoulder: | Rotator Cuff Repair, Biceps Tenodesis, Deltoid Repair | |
| | Knee: | Posterior Oblique, Medial Collateral Ligament (MCL), Lateral
Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis | |
| | Foot/Ankle*: | Achilles Tendon Repair | |
| | HEALIX ADVANCE™ KNOTLESS PEEK Anchors only | | |
| Non-clinical
Testing | Non-clinical testing has been performed on the proposed device and / or its predicates.
Performance testing included in-vitro anchor pull out, time zero anchor pull out and
torque testing. Safety evaluations were conducted to address biological, sterility,
packaging and shelf-life. Note: The proposed device has been determined to be non-
pyrogenic per the requirements set forth in ANSI/AAMI ST-72:2011, United States
Pharmacopeia (USP), and European Pharmacopeia (EP) using the bacterial endotoxin
testing (BET) method. | | |
| Safety and
Performance | Results of safety and 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™ KNOTLESS Anchor has shown to be substantially equivalent to the
predicate device under the Federal Food, Drug and Cosmetic Act. | | |
| Proposed Device | | | |
| HEALIX
ADVANCE™
KNOTLESS Anchor | The HEALIX ADVANCE KNOTLESS Anchors are indicated for use in the following
procedures for reattachment of soft tissue to bone: | | |
| | Shoulder: | Rotator Cuff Repair, Biceps Tenodesis, Deltoid Repair | |
| | Knee: | Posterior Oblique, Medial Collateral Ligament (MCL), Lateral
Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis | |
| | Foot/Ankle: | Achilles Tendon Repair | |
| | | * HEALIX ADVANCE™ KNOTLESS PEEK Anchors only | |
| Predicate Devices | | | |
| HEALIX
ADVANCE™
KNOTLESS Anchors
(K130917, K131974,
K130539, K131683) | Shoulder: | Rotator Cuff Repair, Biceps Tenodesis | |
| Arthrex PushLock™
(K101679, K082810,
K071177, K061863,
K051219) | 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,
Metatarsal Ligament Repair/Tendon Repair, Hallux Valgus Reconstruction, Mid-Foot
Reconstruction, 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
Ligament Reconstruction | |
| | Elbow: | Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral
Ligament Reconstruction, Lateral Epicondylitis Repair | |
| | Hip: | Capsular Repair, Acetabular Labral Repair | |
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