(35 days)
No
The device description and performance studies focus on the mechanical properties and sterilization of a suture anchor, with no mention of AI or ML capabilities.
No.
The device is a suture anchor used for fixation of soft tissue to bone, which is a structural repair rather than providing a therapeutic effect like healing or pain relief in itself.
No
The device is a suture anchor used for anatomical repair, specifically soft-tissue-to-bone fixation, not for diagnosing conditions.
No
The device description explicitly states it is a physical suture anchor made of Titanium, preloaded on a disposable inserter assembly, and provided sterile. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft-tissue-to-bone fixation with postoperative immobilization" in various anatomical locations. This is a surgical procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "suture anchor" made of titanium, designed to be implanted in the body to fix tissue to bone. This is a medical device used in surgery, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation with postoperative immobilization.
Shoulder: Rotator Cuff Repair, Bankart 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, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The proposed HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture is a line extension to the currently marketed HEALIX Ti™ Anchor family. The HEALIX Ti Anchor is a non-absorbable dual threaded suture anchor comprised of Titanium material. The threaded anchor comes preloaded on a disposable inserter assembly and is intended for fixation of one strand of #2 DYNACORD Suture and one strand of 2.5 mm DYNATAPE Suture to bone. The HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture 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, Foot/Ankle, Knee, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 its predicates. Performance testing included evaluation of fixation strength following cyclic loading, knot tensile strength and suture approximation testing.
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.
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
§ 888.3040 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.
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February 1, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II Depuy Synthes Mitek, a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K203794
Trade/Device Name: HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 30, 2020 Received: January 4, 2020
Dear Elizabeth 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Laura C. Rose, Ph.D. 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
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Indications for Use
510(k) Number (if known)
Device Name
HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture
Indications for Use (Describe)
The HEALIX Ti™ Dual Threaded Suture Anchor is intended for soft-tissue-to-bone fixation with postoperative immobilization.
Shoulder: Rotator Cuff Repair, Bankart 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, Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or 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)
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510(K) SUMMARY HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture Date Prepared: 12/21/2020
| 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
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 | Trade Name / Proprietary Name:
HEALIX Ti™ Dual Threaded Suture Anchor with DYNATAPE™ Suture
Common Name:
Suture Anchor |
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| Substantial
Equivalence | The HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM
Suture is substantially equivalent to the predicates:
K183279, HEALIX TiTM ANCHORS with DYNACORDTM
Suture (Primary Predicate) K200949, HEALIX ADVANCETM Anchor with
DYNATAPETM Suture (Reference Predicate) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification | HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM 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 TiTM Dual Threaded Suture Anchor with
DYNATAPETM Suture is a line extension to the currently marketed
HEALIX TiTM Anchor family. The HEALIX Ti Anchor is a non-
absorbable dual threaded suture anchor comprised of Titanium material.
The threaded anchor comes preloaded on a disposable inserter assembly
and is intended for fixation of one strand of #2 DYNACORD Suture
and one strand of 2.5 mm DYNATAPE Suture to bone.
The HEALIX TiTM Dual Threaded Suture Anchor with DYNATAPETM
Suture is provided sterile via Ethylene Oxide (EO) sterilization and is
for single use only. |
| Technological
Characteristics | The suture anchor design and principal of operation are identical to the
predicate device HEALIX TiTM ANCHORS with DYNACORDTM
Suture (K183279), while the indications for use are similar to the
predicate as only a subset is pursued. |
| Indications for
Use | The HEALIX TiTM Dual Threaded Suture Anchor is intended for soft-
tissue-to-bone fixation in association with postoperative
immobilization.
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, Patellar Tendon repair and secondary fixation in
ACL/PCL reconstruction repair; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral
Ligament Reconstruction. |
| Non-clinical
Testing | Verification activities were performed on the proposed device and its
predicates. Performance testing included evaluation of fixation strength
following cyclic loading, knot tensile strength and suture approximation
testing.
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 TiTM Dual Threaded Suture Anchor with
DYNATAPETM Suture has shown to be substantially equivalent to the
predicate devices under the Federal Food, Drug and Cosmetic Act. |
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