(27 days)
Not Found
No
The summary describes a mechanical implant for soft tissue reattachment and does not mention any AI or ML components or functionalities.
No
The device is an implantable anchor used to reattach soft tissue to bone, which is a structural rather than a therapeutic function.
No
The device description indicates it is an implantable anchor designed to secure soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a one-piece implantable cannulated, threaded anchor made from "biocryl rapide" material, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reattachment of soft tissue to bone in surgical procedures (specifically shoulder procedures). This is a therapeutic/surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device is an implantable anchor designed to secure tissue to bone. This is a physical implant used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 (comma separated list FDA assigned to the subject device)
MAI
Device Description
The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5 mm Healix Advance Knotless BR Anchor is manufactured from "biocryl rapide" material.
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)
Non-clinical Testing
Product Design Verification and Design Validation activities, such as, Insertion Torque, Torque to Failure and Anchor Pullout were performed on the proposed implant device. Results of performance and safety testing have demonstrated that the proposed device is substantially equivalent to the predicate devices.
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.
K130917 Mitek Healix Advance Knotless BR Anchor (4.75 and 5.5mm)
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.
Not Found
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
§ 888.3030 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.
0
K131974 (1/2)
| never stop moving • | ||
|---|---|---|
| Mitek Inc | ||
| a Johnson&Johnson company |
PRODUCT: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm) SUBMISSION DATE: June 27, 2013 SUBMISSION TYPE: SPECIAL
510(k) SUMMARY
JUL 2 5 2013
| Submitter: | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo
Manager, Regulatory Affairs
DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA
Telephone: 508-828-3359
Facsimile: 508-977-6911
e-mail: kchristo@its.jnj.com |
| Date Prepared | June 27, 2013 |
| Name of Medical
Device | Proprietary Name: HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm)
Classification Name: Fastener, Fixation, Biodegradable, Soft tissue
Common Name: Bone Anchor |
| Substantial
Equivalence | The HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5mm) is substantially equivalent to:
• K130917 Mitek Healix Advance Knotless BR Anchor (4.75 and 5.5mm) |
| Device
Classification | Single/multiple component metallic bone fixation appliances and accessories, classified as a Class
II device, regulated under 21 CFR 888.3030, product code MAI. |
| Device
Description | The proposed Healix Advance Knotless Anchor is a one piece implantable cannulated, threaded
anchor designed to secure soft tissue to bone. The anchor is provided loaded on a disposable
inserter driver device. The proposed anchors will be offered in a 6.5 mm size. The proposed 6.5
mm Healix Advance Knotless BR Anchor is manufactured from "biocryl rapide" material. |
| 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 |
1
K131974 (2/2)
| DePuy
Mitek Inc.
never stop moving | PRODUCT: HEALIX ADVANCE KNOTLESS
BR ANCHOR (6.5mm)
SUBMISSION DATE: June 27, 2013
SUBMISSION TYPE: SPECIAL |
| ------------------------------------------ | --------------------------------------------------------------------------------------------------------------------- |
|---|
| Comparison of
Technological
Characteristics | The proposed Healix Advance Knotless BR Anchors will have the same design as compared to the
predicate devices (4.75mm and 5.5mm) but will be larger in size (6.5mm). Both the proposed
and predicate Healix Advance Knotless BR Anchors are molded from the same BR "biocryl
rapide" material. No new technological characteristics were introduces as a result of the proposed
changes. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance | Non-clinical Testing
Product Design Verification and Design Validation activities, such as, Insertion Torque, Torque to
Failure and Anchor Pullout were performed on the proposed implant device. Results of
performance and safety testing have demonstrated that the proposed device is substantially
equivalent to the predicate devices.
Based on the indications for use, technological characteristics, and comparison to predicate
devices, the proposed 6.5mm Healix Advance Knotless Anchors have been shown to be
substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek, Incorporated % Ms. Kristine Christo Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767 July 25, 2013
Re: K131974
Trade/Device Name: Healix Advance Knotless BR 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: June 27, 2013 Received: June 28, 2013
Dear Ms. Christo:
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
3
Page 2 - Ms. Kristine Christo
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/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/Salcty/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K131974
Device Names: Healix Advance Knotless BR 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 .
ಳ Prescription Use
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices