(105 days)
No
The device description and performance studies focus on the mechanical and material properties of a surgical anchor, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an implantable anchor used for reattachment of soft tissue to bone, which is a surgical tool rather than a therapeutic device that delivers therapy or treatment directly.
No.
The device description and intended use clearly state that the HEALIX ADVANCE SP BIOCOMPOSITE Anchor is a permanent implant used for reattachment of soft tissue to bone, making it a therapeutic device, not a diagnostic one.
No
The device description clearly details a physical, implantable anchor made of absorbable and non-absorbable materials, along with a disposable inserter shaft and handle. This is a hardware medical 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 clearly states the device is for "reattachment of soft tissue to bone" in surgical procedures. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical implantable device (anchor and dilator) made of materials designed to be permanently placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE SP BIOCOMPOSITE 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
Product codes
MAI
Device Description
The HEALIX ADVANCE SP BIOCOMPOSITE 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). The proposed HEALIX ADVANCE SP BIOCOMPOSITE Anchor is offered in two sizes, 4.9 mm and 5.5 mm and is molded from Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material. The dilator is comprised of Non-absorbable PEEK (Polyetheretherketone). The HEALIX ADVANCE SP BIOCOMPOSITE 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
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 in-vitro fixation strength at zero, six and twelve weeks, 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)
K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Medos International SARL % Elizabeth Messana Regulatory Affairs Specialist II DePuy Synthes Mitek, a Johnson and Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K191242
Trade/Device Name: HEALIX ADVANCE™ SP BIOCOMPOSITE 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: July 11, 2019 Received: July 15, 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, 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
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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) 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 medical devices and radiation-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,
Laurence D. Coyne, 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) K191242
Device Name HEALIX ADVANCE™ SP BIOCOMPOSITE Anchor
Indications for Use (Describe)
The HEALIX ADVANCE SP BIOCOMPOSITE 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)
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™ SP BIOCOMPOSITE Anchor Date Prepared: 05/7/2019
| 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 BIOCOMPOSITE
Anchor
Classification Name: Single/multiple component metallic bone fixation
appliances and accessories
Product Code: MAI
Common Name: Suture Anchor | |
| Substantial
Equivalence | The HEALIX ADVANCE SP BIOCOMPOSITE Anchor is
substantially equivalent to:
K101679, K082810, K071177, K061863, K051219 Arthrex PushLock Anchors Reference Devices: K182941, HEALIX ADVANCE™ SP PEEK Anchor K032167, Bio-INTRAFIX Tibial Tapered Screws and Sheaths K161638, SPEEDTRAP™ Graft Preparation System | |
| Device
Classification | HEALIX ADVANCE SP BIOCOMPOSITE 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 Panel | Orthopedic Devices | |
| Device
Description | The HEALIX ADVANCE SP BIOCOMPOSITE 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). The proposed HEALIX ADVANCE SP
BIOCOMPOSITE Anchor is offered in two sizes, 4.9 mm and 5.5 mm
and is molded from Absorbable Biocryl Biocomposite ((Polylactic Acid
(PLA) and Tricalcium Phosphate (TCP)) material. The dilator is
comprised of Non-absorbable PEEK (Polyetheretherketone). The
HEALIX ADVANCE SP BIOCOMPOSITE 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 Anchors (K101679, K082810, K071177, K061863,
K051219). | |
| | The suture anchor design, principal of operation and indications for use
are identical when compared to the reference device- HEALIX
ADVANCE™ SP PEEK Anchor (K182941) | |
| | The Biocryl (PLA/ ß-TCP) Biocomposite material of the anchor is
identical to the Biocryl in the reference device- Bio-INTRAFIX Tibial
Tapered Screws and Sheaths (K032167). | |
| | The PEEK (Polyetheretherketone) design and material of the dilator
component is identical to the PEEK dilator in the reference device-
HEALIX ADVANCE™ SP PEEK Anchor (K182941). | |
| | The stay-suture material (UHMWPE/PET) is identical to the winding
suture present in the reference device- SPEEDTRAPTM Graft
Preparation System (K161638). | |
| Indications for Use | The HEALIX ADVANCE SP BIOCOMPOSITE 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 in-vitro
fixation strength at zero, six and twelve weeks, 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 BIOCOMPOSITE Anchor has
shown to be substantially equivalent to the predicate devices under the
Federal Food, Drug and Cosmetic Act. | |
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