(114 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant (anchor) and its inserter, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes.
The device is used for reattaching soft tissue to bone in various procedures like rotator cuff repair, MCL repair, and Achilles tendon repair, which are all therapeutic interventions aimed at treating medical conditions or injuries.
No
The device is an implantable anchor designed to secure soft tissue to bone, used in procedures like rotator cuff repair. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "one piece implantable cannulated, threaded anchor" made from "Biocryl Rapide® (BR) material" and provided "loaded on a disposable inserter driver device." This describes a physical, implantable hardware 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The HEALIX ADVANCE KNOTLESS BR Anchor is an implantable device designed to physically secure soft tissue to bone during surgical procedures. It is a physical anchor, not a tool for analyzing biological samples.
- Intended Use: The intended use clearly describes surgical procedures for reattaching soft tissue to bone, not diagnostic testing.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE KNOTLESS BR 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 Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis
Foot/Ankle: Achilles Tendon Repair
Product codes
MAI
Device Description
The HEALIX ADVANCE KNOTLESS BR 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 BR Anchors are molded from Biocryl Rapide® (BR) material. The HEALIX ADVANCE KNOTLESS BR 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
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 proposed device and / or its predicates. Performance testing included evaluation of fixation strength and insertion torque at time zero as well as in-vitro testing. 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 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)
K171114, K130917, K131974, K130539, K131683 HEALIX ADVANCE KNOTLESS Anchor, K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.
Medos International SARL % Ashley Goncalo Senior Regulatory Affairs Specialist DePuv Synthes Mitek Sports Medicine. a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
May 10, 2018
Re: K180101
Trade/Device Name: HEALIX ADVANCE™ KNOTLESS BR 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 Dated: April 9, 2018 Received: April 10, 2018
Dear Ms. Goncalo:
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) K180101
Device Name HEALIX ADVANCE™ KNOTLESS BR Anchor
Indications for Use (Describe)
The HEALIX ADVANCE KNOTLESS BR 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 Collateral Ligament (LCL), Iliotibial (IT) Band Tenodesis
Foot/Ankle: Achilles 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 HEALIX ADVANCE™ KNOTLESS BR Anchor
Date Prepared: 1/12/2018
| Submitter's
Name and
Address | DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
On behalf of:
Medos International SARL
Chemin-Blanc 38, Le Locle Neuchatel
CH 2400, Switzerland | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Contact Person | Ashley Goncalo
Sr. Regulatory Affairs Specialist
DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | Telephone: 508-977-3907
Email: agoncalo@its.jnj.com |
| Name of Medical
Device | Proprietary Name: HEALIX ADVANCE KNOTLESS BR Anchor
Classification Name: Single/multiple component metallic bone fixation
appliances and accessories
Common Name: Suture Anchor | |
| Substantial
Equivalence | The HEALIX ADVANCE KNOTLESS BR Anchor is substantially
equivalent to:
K171114, K130917, K131974, K130539, K131683 HEALIX
ADVANCE KNOTLESS 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. | |
| Device
Description | The HEALIX ADVANCE KNOTLESS BR 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 BR Anchors are
molded from Biocryl Rapide® (BR) material. The HEALIX
ADVANCE KNOTLESS BR 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 (K171114, K130917,
K131974, K130539, K131683). | |
| Indications for
Use | The HEALIX ADVANCE KNOTLESS BR 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 | |
| Non-clinical
Testing | Verification activities were performed on the proposed device and / or
its predicates. Performance testing included evaluation of fixation
strength and insertion torque at time zero as well as in-vitro testing.
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 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 BR Anchor has shown | |
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to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act