(56 days)
No
The 510(k) summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical properties and sterilization.
Yes
Explanation: The device is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization for various orthopedic repairs, which clearly describes a medical intervention designed to treat a condition.
No
The device is described as a surgical anchor used for soft-tissue-to-bone fixation, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "threaded suture anchor preloaded on a disposable inserter assembly" and is available in "absorbable BR and non-absorbable PEEK materials," indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for soft-tissue-to-bone fixation during surgical procedures. This is a direct intervention on the body.
- Device Description: The device is described as a threaded suture anchor made of absorbable or non-absorbable materials, preloaded on an inserter. This is a physical implantable device.
- Lack of Diagnostic Function: There is no mention of this device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the mechanical properties and safety of the anchor and sutures (tensile strength, fixation, sterility, biocompatibility), not on the accuracy or reliability of a diagnostic test.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Product codes
MAI, MBI
Device Description
The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non-absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures 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, Foot/Ankle, Knee, Elbow
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)
Device safety and effectiveness is supported by non-clinical testing performed on the proposed device and / or its predicate. Performance testing included straight and knot tensile strength, suture approximation force, anchor fixation post cyclic loading and sterility. In-vitro anchor fixation, torque testing, chemical characterization, biocompatibility, in-vivo testing, packaging and shelf-life of the predicate device were included by reference (K173859, K183506).
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)
Reference Device(s)
K170639, K191483, K021434, K041553
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
June 4, 2020
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K200949
Trade/Device Name: HEALIX ADVANCETM Anchor with DYNATAPE™ 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, MBI Dated: April 8, 2020 Received: April 9, 2020
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, 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
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200949
Device Name
HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures
Indications for Use (Describe)
The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
| Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular |
|---|
| 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 Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
| 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) |
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™ Anchor with DYNATAPE™ Sutures Date Prepared: April 3, 2020
| 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
Telephone: 508-828-3150
Email: emessan1@its.jnj.com
DePuy Synthes Mitek Sports Medicine
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
| Name of Medical
Device | Proprietary Name: HEALIX ADVANCETM Anchor with
DYNATAPETM Sutures
A) HEALIX ADVANCE™ BR Anchor with DYNATAPE™ Suture
B) HEALIX ADVANCE™ PEEK Anchor with DYNATAPE™
Suture
Classification Name:
A) Single/multiple component metallic bone fixation appliances and
accessories
B) Smooth or threaded metallic bone fixation fasteners
Product Code:
A) MAI
B) MBI
Common Name: Suture Anchor |
4
| Substantial
Equivalence | The HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is
substantially equivalent to:
K173859, K183506 - HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Reference Devices: K170639 - HEALIX ADVANCE™ Anchor with PERMATAPE™ Suture K191483 - HEALIX ADVANCE™ Anchor with DYNA+TAPE™ Sutures K021434, K041553- FiberWire® (Arthrex) | | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device
Classification | The HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is classified as: | | |
| | A) HEALIX ADVANCE BR Anchor with DYNATAPE Suture 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. | | |
| | B) HEALIX ADVANCE PEEK Anchor with DYNATAPE Suture is classified as: Smooth or threaded metallic bone fixation fasteners, classified as Class II, product code MBI, regulated under 21 CFR 888.3040. | | |
| Device Panel | Orthopedic Devices | | |
| Device
Description | The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non- absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is provided sterile and is for single use only. | | |
| Technological
Characteristics | The HEALIX ADVANCETM Anchor with DYNATAPETM Sutures is
intended for soft-tissue-to-bone fixation in association with
postoperative mobilization. | | |
| | When DYNATAPET™ Suture is placed in an aqueous environment, the
salt particles within the silicone core elute out, leaving behind a micro-
porous structure within the silicone core. These small voids are
consequently filled with surrounding fluid as the core hydrates,
resulting in a radial expansion of the suture. If laxity is present, this
radial expansion of the braid causes an axial shortening of the total
suture length. The DYNATAPETM Suture is designed to resist laxity
and minimize gap formation by maintaining approximation
(compression) force. | | |
| Indications for
Use | The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-
bone fixation in association with postoperative immobilization as
follows: | | |
| | Shoulder: | Rotator Cuff Repair, Bankart Repair, SLAP Lesion
Repair, Biceps Tenodesis, Acromioclavicular
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 Collateral
Ligament Reconstruction, Radial Collateral Ligament
Reconstruction | |
| Comparison to
Predicate
Devices | The proposed HEALIX ADVANCE™ Anchors with DYNATAPE™
Sutures is a line extension to the HEALIX ADVANCE™ Anchor
family, inclusive of the HEALIX ADVANCE™ Anchors with
DYNACORD™ Suture (K173859, K183506). The anchors, suture
materials, intended use, packaging and sterilization are identical to the
currently marketed HEALIX ADVANCE™ Anchors with
DYNACORD™ Suture (K173859, K183506). | | |
5
6
| | The inner and outer sheath of the DYNATAPE™ Suture has been
redesigned with thicker fibers and a unique braiding pattern to create
the flattened structure specific to DYNATAPE ™ Suture. The proposed
HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures will be
preloaded with one strand of 2.5 mm DYNATAPE ™ Suture and one
strand of #2 DYNACORD ™ Suture. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical
Testing | Device safety and effectiveness is supported by non-clinical testing
performed on the proposed device and / or its predicate. Performance
testing included straight and knot tensile strength, suture approximation
force, anchor fixation post cyclic loading and sterility. In-vitro anchor
fixation, torque testing, chemical characterization, biocompatibility, in-
vivo testing, packaging and shelf-life of the predicate device were
included by reference (K173859, K183506). |
| | 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™ Anchor with DYNATAPE™ Sutures has shown to be
substantially equivalent to the predicate devices under the Federal Food,
Drug and Cosmetic Act. |