(126 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of a physical implant (suture anchor). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is an orthopedic anchor intended for reattaching soft tissue to bone, which is a structural and mechanical function, not a therapeutic one that would directly treat a disease or disorder.
No
The device is described as an implantable anchor used for reattaching soft tissue to bone during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a physical implantable anchor made of PEEK material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for reattaching soft tissue to bone in various anatomical locations (shoulder, knee, foot/ankle). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a physical implantable device (anchor and dilator) made of PEEK material, designed for surgical implantation. This is consistent with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.), detect biomarkers, or provide information for diagnosis.
- Performance Studies: The performance studies focus on mechanical properties like fixation strength, insertion torque, and sterilization, which are relevant to surgical implants, not diagnostic devices.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is implanted in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE SP PEEK Anchor is 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 repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis
· Foot/Ankle: Achilles tendon repair
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The HEALIX ADVANCE SP PEEK Anchor is a two-piece “self-punching” design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The proposed HEALIX ADVANCE SP PEEK Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Polyetheretherketone (PEEK) material. The HEALIX ADVANCE SP PEEK Anchor is provided sterile via Ethylene Oxide (EO) sterilization 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)
Verification activities were performed on the proposed device and / or its predicates. Performance testing included evaluation of fixation strength, insertion torque, torque to failure and cyclic migration at time zero.
Ethylene Oxide Sterilization was validated according to ANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6.
EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008.
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): 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.
K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Suture Anchors
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.
K161638, K171114, K120824, K090530
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
February 26, 2019
Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K182941
Trade/Device Name: HEALIX ADVANCE™ SP PEEK 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 16, 2019 Received: January 17, 2019
Dear Ms. Messana:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
HEALIX ADVANCE™ SP PEEK Anchor
Indications for Use (Describe)
The HEALIX ADVANCE SP PEEK Anchor is 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 repair, medial collateral ligament (MCL) reconstruction, lateral ligament reconstruction, iliotibial (IT) band tenodesis
· Foot/Ankle: Achilles tendon 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
3
510(K) SUMMARY HEALIX ADVANCE™ SP PEEK Anchor Date Prepared: 1/9/2019
| 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 | Elizabeth Messana
Regulatory Affairs Specialist II
DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 | Telephone: 508-828-3150
Email: emessan1@its.jnj.com |
| Name of Medical
Device | Proprietary Name: HEALIX ADVANCE™ SP PEEK Anchor
Classification Name: Smooth or threaded metallic bone fixation
fastener
Product Code: MBI
Common Name: Suture Anchor | |
| Substantial
Equivalence | The HEALIX ADVANCE SP PEEK Anchor is substantially equivalent to:
K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Suture Anchors Reference Devices: K161638, SPEEDTRAP™ Graft Preparation System K171114, HEALIX ADVANCE™ KNOTLESS PEEK Anchor K120824, K090530, Stryker ReelX STT™ Suture Anchor System | |
| Device Classification | HEALIX ADVANCE SP PEEK Anchor is classified as:
Fastener, Fixation, Nondegradable, Soft Tissue, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. | |
| Device Panel | Orthopedic Devices | |
| Device Description | The HEALIX ADVANCE SP PEEK Anchor is a two-piece “self-punching” design consisting of a cannulated, threaded anchor and dilator which are permanently implanted into the body. The anchor-dilator are preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable stay suture comprised of Ultra-High Molecular Weight Polyethylene (UHMWPE) and Green poly (ethylene terephthalate) (PET). During implantation the stay suture may be discarded or incorporated into the repair at the surgeon's discretion. The proposed HEALIX ADVANCE SP PEEK Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Polyetheretherketone (PEEK) material. The HEALIX ADVANCE SP PEEK Anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only. | |
| Technological Characteristics | The suture anchor design, anchor materials, principal of operation and indications for use are similar when compared to the predicate Arthrex PushLock Suture Anchors (K101679, K082810, K071177, K061863, K051219).
The suture anchor design, anchor materials, principal of operation and indications for use are similar when compared to the reference device- ReelX STTTM Suture Anchor by Stryker Corp. (K120824, K090530).
The stay-suture design and material are identical to the winding suture present in the reference device- SPEEDTRAPTM Graft Preparation System (K161638).
The PEEK material is identical to that present in the reference device- HEALIX ADVANCETM KNOTLESS PEEK Anchor (K171114). | |
| Indications for
Use | The HEALIX ADVANCE SP PEEK Anchor is 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 repair, medial collateral ligament (MCL)
reconstruction, lateral collateral ligament reconstruction, 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, insertion torque, torque to failure and cyclic migration at time
zero. | |
| | Ethylene Oxide Sterilization was validated according to
ANSI/AAMI/ISO 11135: 2014 to a SAL of 1 x 10-6. | |
| | EO residuals were tested per AAMI/ANSI/ISO 10993-7:2008 | |
| | 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 SP PEEK Anchor has shown to be
substantially equivalent to the predicate devices under the Federal Food,
Drug and Cosmetic Act. | |
4
5