(81 days)
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a surgical anchor used for reattachment of soft tissue to bone, specifically for procedures like rotator cuff repair and biceps tenodesis. It is a mechanical fixation device, not one that delivers a therapeutic substance or energy for treatment.
No
The device is a surgical anchor used for reattachment of soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states it is a "Suture Anchor" made of PEEK material, which is a physical implantable 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "Suture Anchor" used for "reattachment of soft tissue to bone." This is a surgical implant, not a device used for testing samples.
- Intended Use: The intended use describes surgical procedures (Rotator Cuff, Biceps Tenodesis) where the anchor is implanted to fix soft tissue to bone. This is a therapeutic/surgical use, not a diagnostic use.
The information provided describes a surgical implant used directly in the body during a procedure, which is the opposite of an in vitro diagnostic device that tests samples outside the body.
N/A
Intended Use / Indications for Use
The Healix Advance™ Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
- Rotator Cuff .
- . Biceps Tenodesis
Product codes
MBI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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)
Results of performance and safety testing have demonstrated that the proposed devices are substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Healix Advance™ Knotless PEEK Anchors have shown to be substantially equivalent to the predicate devices under the Federal Food. Drug and Cosmetic Act.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
DePuy
never stop moving
a fohmon-fohmon company
SIO/K
MAY 2 1 2013
PRODUCT: HEALIX ADVANCE™ KNOTLESS PEEK ANCHOR SUBMISSION DATE: FEBRUARY 27, 2013 SUBMISSION TYPE: TRADITIONAL
SECTION 1
Traditional 510(k) REQUIRED INFORMATION
DEVICE NAME
COMMON NAME: TRADE NAME/PROPRIETARY NAME:
Suture Anchor Healix Advance™ Knotless PEEK Anchor (4.75mm) Healix Advance™ Knotless PEEK Anchor (5.5mm)
ADDRESS AND REGISTRATION NUMBER
| | DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Owner/Operator #: 1221934
FDA Registration #: 1221934 | Medos SARL
Puits Godet 20
CH 2000 Neuchâtel
Switzerland
Owner/Operator #: 9050053
FDA Registration #: 3003702646 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | | |
| | Sterigenics Belgium Petit-Rechain S.A.
Zoning Industriel de Petit-Rechain
Avenue du Parc, 29
B-4800 Verviers, Belgium
Owner/Operator #: 9065481
FDA Registration #: 3003898115 | Medistri SA
Rte de L'Industrie 96- 1564 Domdidier,
Switzerland
FDA Registration #: 3006946276 |
| STERILIZATION
SITE | | |
DEVICE CLASSIFICATION
Fastener, Fixation, Nondegradable, Soft Tissue, classified as a Class II, product code MBI, regulated under 21 CFR 888.3040.
FDA PRODUCT CODE:
MBI
COMMON CLASSIFICATION NAME: Fastener, Fixation, Nondegradable, Soft Tissue
CONSENSUS STANDARDS AND GUIDANCE DOCUMENTS
The following FDA Recognized Consensus Standards were used in preparing this 510(k) Premarket Notification:
- · ASTM F2026:2008 Standard Specification for PEEK Polymers for Surgical Implant Applications (Orthopedics)
- · ISO 10993-1:2009 Biological Evaluation of Medical Devices
- · ISO 10993-7:2008 Ethylene Oxide Sterilization Residuals
- · ISO 11135-1:2007 Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization
- · ISO 14630:2009 Non-active Surgical Implants - General Requirements
- · ISO 14971:2012 Medical devices - Application of Risk Management to Medical Devices
PREDICATE DEVICE INFORMATION
- PREDICATE DEVICES
- · K112249 Healix Knotless™ BR Anchor
- INTRAFIX® PEEK Tapered Screw · K122123
- K061863 Arthrex PushLock PEEK Anchors .
1
Image /page/1/Picture/0 description: The image shows the DePuy Synthes logo. The logo includes the company name, "DePuy", in a bold, sans-serif font, with a small black circle to the left. Below the name, in a smaller font, is the text "Synthes Inc.", and below that is "a Johnson & Johnson company". To the right of the company name is the tagline "never stop moving" in a cursive font.
PRODUCT: HEALIX ADVANCE™ KNOTLESS PEEK ANCHOR SUBMISSION DATE: FEBRUARY 27, 2013 SUBMISSION TYPE: TRADITIONAL
SECTION 1
K130539
Traditional Required Information
REASON FOR PREMARKET NOTIFICATION
The purpose of this 510(k) Notification is to outline the following changes: addition of a new size anchor (5.5mm), addition of PEEK (polyetheretherketone) material. For ease of use purposes, the following minor changes were made: removal of the anchor window feature, removal of the ramp feature, modification to the driver handle and threader tab and inclusion of a driver collar on the shaft. This 510(k) Notification will demonstrate the substantial equivalency of the proposed Healix Advance™ Knotless PEEK Anchors used for shoulder fixation of soft tissue to bone in the shoulder against the predicate DePuy Mitek's Healix Knotless™ BR Anchor and Arthrex PushLock PEEK Anchors.
To qualify the proposed Healix Advance™ Knotless PEEK Anchors, various device performance characteristics were tested and evaluated by DePuy Mitek and were found to be substantially equivalent to those of the predicate DePuy Mitek's Healix Knotless™ BR Anchors (K112249) and Arthrex PushLock PEEK Anchors (K061863). The proposed Healix Advance™ Knotless Anchor and the predicate DePuy Mitek's INTRAFIX® PEEK Tapered Screw (K122123) are manufactured using the same PEEK (Polyetheretherketone) material.
Results of performance and safety testing have demonstrated that the proposed devices are substantially equivalent to the predicate devices. Based on the indications for use, technological characteristics, and comparison to predicate devices, the proposed Healix Advance™ Knotless PEEK Anchors have shown to be substantially equivalent to the predicate devices under the Federal Food. Drug and Cosmetic Act.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2013
Depuy Mitek Incorporated, a Johnson & Johnson Company % Ms. Julie Vafides Regulatory Specialist II 325 Paramount Drive Raynham, Massachusetts 02767
Re: K130539
Trade/Device Name: Healix Advance™ Knotless 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: March 21, 2013 Received: March 22, 2013
Dear Ms. Vafides:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Julie Vafides
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin >Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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never stop moving
| ATTACHMENT 2 | K130539 |
|---|---|
| PRODUCT: | HEALIX ADVANCE™ KNOTLESS |
| PEEK ANCHOR | |
| SUBMISSION DATE: | FEBRUARY 27, 2013 |
| SUBMISSION TYPE: | SPECIAL |
INDICATIONS FOR USE
510(k) Number (if known):
Device Names: Healix Advance™ Knotless PEEK Anchor
Indications for Use: The Healix Advance™ Knotless Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone:
Shoulder
- Rotator Cuff .
- . Biceps Tenodesis
V Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of _ 1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices