(51 days)
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
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).
The provided text is a 510(k) summary for a medical device (HEALIX ADVANCE KNOTLESS BR ANCHOR) and does not contain the detailed information necessary to answer all aspects of your request. Specifically, it lacks a dedicated "acceptance criteria" section and a detailed study report.
However, based on the Safety and Performance section, we can infer some aspects related to device performance and the type of study conducted to support substantial equivalence.
Here's an attempt to answer your questions based on the available information, with clear indications where information is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions "Performance requirement of the proposed device is to secure soft tissue to bone during soft tissue healing period." It then states that "Fixation force testing was performed under in vitro condition throughout two times of healing period." The conclusion is that "The data shows that the proposed device performs similarly to the predicate devices."
Therefore, the implicit acceptance criteria would be for the device's fixation force to be "similar to the predicate devices" during and after the specified healing period. The reported performance is that it "performs similarly to the predicate devices."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Fixation force of the proposed device should be similar to the predicate devices (K112249 Mitek Healix Knotless BR Anchor) under in vitro conditions for two times the healing period. | The data shows that the proposed device performs similarly to the predicate devices (K112249 Mitek Healix Knotless BR Anchor) during fixation force testing. |
| Material biocompatibility confirmed. | Material biocompatibility has been also confirmed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document only mentions "in vitro condition" for the fixation force testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The study described is an in vitro performance test, not a clinical study involving human or animal data that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. The study described is an in vitro performance test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a bone anchor, not an AI-powered diagnostic tool, and therefore no MRMC study involving human readers and AI assistance would be conducted for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a bone anchor, not an algorithm. The "standalone" performance here would refer to the mechanical performance of the anchor itself, which was evaluated as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "fixation force testing," the "ground truth" would be the measured mechanical properties (e.g., maximum load to failure, displacement, stiffness) of the device and its predicate, obtained through controlled engineering tests. For "material biocompatibility," the ground truth would be established through standard biocompatibility testing as per ISO or ASTM standards.
8. The sample size for the training set
This information is not applicable. The device is a physical medical device, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable.
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MAY 2 4 2013
SECTION 2 - 510(k) SUMMARY
| HEALTA ADVANCE '''' KNOTLESS BR ANCHOR | ||
|---|---|---|
| Submitter: | DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham. MA 02767 | |
| Contact Person | Yayoi FujimakiRegulatory Affairs Senior AssociateDePuy MitekTelephone: 508-828-3541a Johnson & Johnson companyFacsimile:508-977-6911325 Paramount Drivee-mail: yfujima1@its.jnj.comRaynham, MA 02767. USA | |
| Name ofMedical Device | Proprietary Name:HEALIX ADVANCE KNOTLESS BR ANCHORClassification Name:Fastener, Fixation, Biodegradable, Soft tissueCommon Name:Bone Anchor | |
| SubstantialEquivalence | The HEALIX ADVANCE KNOTLESS BR ANCHOR is substantially equivalent to:K112249 Mitek Healix Knotless BR Anchor● | |
| DeviceClassification | Single/multiple component metallic bone fixation appliances and accessories.classified as Class II, product code MAI regulated under 21 CFR 888.3030. | |
| DeviceDescription | The proposed HEALIX ADVANCE KNOTLESS BR ANCHOR is a cannulated,threaded knotless anchor designed to secure soft tissue to bone. The proposed anchoris manufactured from the absorbable material "Biocryl® Rapide™" (15/85% B -TCP/PLA PGA copolymer) loaded on a disposable inserter driver with #2ORTHOCORD® suture (K040004, K043928). The anchors are offered in two sizes(4.75 mm and 5.5 mm). | |
| Indications forUse | The HEALIX ADVANCE KNOTLESS BR Anchors are indicated for use in thefollowing procedures for reattachment of soft tissue to bone:ShoulderRotator CuffBiceps Tenodesis | |
| Comparison ofTechnologicalCharacteristics | Substantial equivalence to the predicate device has been justified by similarityanalysis of indications, design, material, operation principle and device performancedata. Performance testing ensured that the feature does not raise any new issues ofsafety and efficacy. | |
| Safety andPerformance | Non-clinical TestingPerformance requirement of the proposed device is to secure soft tissue to boneduring soft tissue healing period. Fixation force testing was performed under in vitrocondition throughout two times of healing period. The data shows that the proposeddevice performs similarly to the predicate devices. Material biocompatibility has beenalso confirmed. Thus, the proposed device does not raise any new issue of safety andefficacy. |
HEALIX ADVANCE™ KNOTLESS BR ANCHOR
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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
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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
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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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§ 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.