(51 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a surgical anchor, with no mention of AI or ML.
No
The device is described as a "knotless anchor designed to secure soft tissue to bone," which falls under the category of a surgical implant used for anatomical repair, not a device primarily intended for therapy or treatment.
No
Explanation: The device description states its purpose is to secure soft tissue to bone, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical anchor made of absorbable material, loaded on a disposable inserter driver with suture. This is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "reattachment of soft tissue to bone" in surgical procedures like rotator cuff repair and biceps tenodesis. This is a therapeutic/surgical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a surgical anchor designed to physically secure tissue. It's not designed to analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description doesn't mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic results.
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 clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The HEALIX ADVANCE KNOTLESS BR 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 BR ANCHOR is a cannulated, threaded knotless anchor designed to secure soft tissue to bone. The proposed anchor is manufactured from the absorbable material "Biocryl® Rapide™" (15/85% B - TCP/PLA PGA copolymer) loaded on a disposable inserter driver with #2 ORTHOCORD® suture (K040004, K043928). The anchors are offered in two sizes (4.75 mm and 5.5 mm).
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
Performance requirement of the proposed device is to secure soft tissue to bone during soft tissue healing period. Fixation force testing was performed under in vitro condition throughout two times of healing period. The data shows that the proposed device performs similarly to the predicate devices. Material biocompatibility has been also confirmed. Thus, the proposed device does not raise any new issue of safety and efficacy.
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
§ 888.3030 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
·
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MAY 2 4 2013
SECTION 2 - 510(k) SUMMARY
| HEALTA ADVANCE '''' KNOTLESS BR ANCHOR | ||
|---|---|---|
| Submitter: | DePuy Mitek | |
| a Johnson & Johnson company | ||
| 325 Paramount Drive | ||
| Raynham. MA 02767 | ||
| Contact Person | Yayoi Fujimaki | |
| Regulatory Affairs Senior Associate | ||
| DePuy Mitek | ||
| Telephone: 508-828-3541 | ||
| a Johnson & Johnson company | ||
| Facsimile: | ||
| 508-977-6911 | ||
| 325 Paramount Drive | ||
| e-mail: yfujima1@its.jnj.com | ||
| Raynham, MA 02767. USA | ||
| Name of | ||
| Medical Device | Proprietary Name: | |
| HEALIX ADVANCE KNOTLESS BR ANCHOR | ||
| Classification Name: | ||
| Fastener, Fixation, Biodegradable, Soft tissue | ||
| Common Name: | ||
| Bone Anchor | ||
| Substantial | ||
| Equivalence | The HEALIX ADVANCE KNOTLESS BR ANCHOR is substantially equivalent to: | |
| K112249 Mitek Healix Knotless BR Anchor | ||
| ● | ||
| Device | ||
| Classification | Single/multiple component metallic bone fixation appliances and accessories. | |
| classified as Class II, product code MAI regulated under 21 CFR 888.3030. | ||
| Device | ||
| Description | The proposed HEALIX ADVANCE KNOTLESS BR ANCHOR is a cannulated, | |
| threaded knotless anchor designed to secure soft tissue to bone. The proposed anchor | ||
| is manufactured from the absorbable material "Biocryl® Rapide™" (15/85% B - | ||
| TCP/PLA PGA copolymer) loaded on a disposable inserter driver with #2 | ||
| ORTHOCORD® suture (K040004, K043928). The anchors are offered in two sizes | ||
| (4.75 mm and 5.5 mm). | ||
| Indications for | ||
| Use | The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the | |
| following procedures for reattachment of soft tissue to bone: | ||
| Shoulder | ||
| Rotator Cuff | ||
| Biceps Tenodesis | ||
| Comparison of | ||
| Technological | ||
| Characteristics | Substantial equivalence to the predicate device has been justified by similarity | |
| analysis of indications, design, material, operation principle and device performance | ||
| data. Performance testing ensured that the feature does not raise any new issues of | ||
| safety and efficacy. | ||
| Safety and | ||
| Performance | Non-clinical Testing | |
| Performance requirement of the proposed device is to secure soft tissue to bone | ||
| during soft tissue healing period. Fixation force testing was performed under in vitro | ||
| condition throughout two times of healing period. The data shows that the proposed | ||
| device performs similarly to the predicate devices. Material biocompatibility has been | ||
| also confirmed. Thus, the proposed device does not raise any new issue of safety and | ||
| efficacy. |
HEALIX ADVANCE™ KNOTLESS BR ANCHOR
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol representing a human figure, composed of three abstract shapes that suggest a person with arms outstretched.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 24, 2013
DePuy Mitek, A Johnson & Johnson Company % Yavoi Fujimaki Regulatory Affairs Senior Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K130917
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: May 16, 2013 Received: May 17, 2013
Dear Yayoi Fujimaki:
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 -- Yayoi Fujimaki
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/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/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 Eith
For
· Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
MITEK SPORTS MEDICINE
Indications for Use
510(k) Number (if known): K130917
Device Name: HEALIX ADVANCE™ KNOTLESS BR Anchor
Indications for Use:
The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in the following procedures for reattachment of soft tissue to bone: Shoulder
- Rotator Cuff ●
- Biceps Tenodesis .
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)
Casey E. Hanley, Ph.D.
Division of Orthopedic Devices
Page 1 of 1
DePuy Mitek Traditional 510(k)
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