(56 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical application of an absorbable screw, with no mention of AI or ML.
Yes
The device is described as an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts, which aids in healing after orthopedic surgical procedures.
No
The device, Milagro® BR interference screws, is used to attach soft tissues to bone in orthopedic surgical procedures; it does not collect or analyze data to provide a medical diagnosis.
No
The device description clearly states the device is a physical, absorbable screw made of polymer and TCP, used in surgical procedures. This is a hardware 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 is to "attach soft tissues to bone in orthopedic surgical procedures." This describes a surgical implant used directly on a patient's body during a procedure.
- Device Description: The device is described as an "absorbable, tapered, cannulated, threaded fastener" made from a composite material. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used within the body.
N/A
Intended Use / Indications for Use
The Milagro® BR interference screws are designed to attach soft tissues to bone in orthopedic surgical procedures. The screws may be used for interference fixation of soft tissues (such as ligaments or tendons) to bone, when the implant sizes offered are patient appropriate. The implant operates, in conjunction with the appropriate postoperative immobilization, throughout the healing period.
Product codes
MAI, HWC
Device Description
The DePuy Mitek Milagro® Interference Screws are absorbable, tapered, cannulated, threaded fasteners for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissues (such as ligaments or tendons)
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)
Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0, 3, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant.
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)
K103831, K060830, K032717, K051726, K041356, K020043, K102410
Reference Device(s)
Not Found
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.
0
APR 24 2012 K (20589(1/2)
Image /page/0/Picture/1 description: The image shows the DePuy Synthes logo. The logo consists of a black circle with the word "DePuy" in bold, black letters next to it. Below the word "DePuy" are the words "Synthes" in smaller, black letters. The tagline "never stop moving" is to the right of the logo.
MILAGRO INTERFERENCE SCREWS SUBMISSION DATE: FEBRUARY 27™, 2012 SUBMISSION TYPE: TRADITIONAL STORIO BOOK BIA
ATTACHMENT 1
5 I 0(k) SUMMARY - DEPUY MITEK MILAGRO* INTERFERENCE SOREWS
SUBMITTER'S NAME AND ADDRESS
DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
CONTACT PERSON
| Deep Pal | ||||
|---|---|---|---|---|
| Senior Regulatory Affairs Specialist | ||||
| TELEPHONE | 508-977-3998 | |||
| FACSIMILE | 508-977-6911 | |||
| DATE PREPARED | dpal3@its.jnj.com | |||
| 02/17/2012 |
NAME OF MEDICAL DEVICE
| CLASSIFICATION NAME | Comments of the contraction of contribution of contribution and consistence and controllation and consistence and controllation and more consection of contribution of the con | ||
|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | |||
| of the controller of the program and any and a province of the comments of | |||
| COMMON/USUAL NAME |
Bone Anchor
PROPRIETARY NAME
DePuy Mitek Milagro® Interference Screws
SUBSTANTIAL EQUIVALENCE
The proposed DePuy Mitek Milagro® Interference Screws are substantially equivalent to the following devices.
- · K103831, K060830, K032717: Milagro Interference Screws
- · K051726, K041356, K020043: Arthrex Tenodesis Screws
- · K102410: Linvatec's Matryx Screws
FDA PRODUCT CODE
MAI, HWC
DEVICE CLASSIFICATION
This type of fixation screw was originally classified as a Class II medical device by the Orthopedic Review Panel, regulated as 21 CFR 888.3040 Smooth or Threaded Metallic Bone Fixation Fastener.
1
Image /page/1/Figure/1 description: The image shows the DePuy Synthes logo. The logo includes the company name, "DePuy," in a bold, sans-serif font, with a black circle to the left of the name. Below the name, there is the text "Mitek Inc." and a tagline that reads "never stop moving." The logo is positioned in the upper-left corner of the image.
MILAGRO INTERFERENCE SCREWS ISSION DATE: FEBRUARY 27 MISSION TYPE: TRADITIONA
ATTACHMENT 1
Continues ...
5 I 0(k) SUMMRY - DEPUY MITEK MILAGRO® INTERFERENCE SCREWS
DEVICE DESCRIPTION
The DePuy Mitek Milagro® Interference Screws are absorbable, tapered, cannulated, threaded fasteners for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP).
INDICATIONS FOR USE
The Milagro® BR interference screws are designed to attach soft tissues to bone in orthopedic surgical procedures. The screws may be used for interference fixation of soft tissues (such as ligaments or tendons) to bone, when the implant sizes offered are patient appropriate. The implant operates, in conjunction with the appropriate postoperative immobilization, throughout the healing period.
TECHNOLOGICAL CHARACTERSTICS
The design specifications of the proposed DePuy Mitek Millagro® Interference Screws are substantially equivalent to the existing DePuy Mitek Milagro® Interference Screws cleared under 510(k) K103831, K060830 and K032717. Technological characteristics including design construct, packaging and indications are similar to the predicate devices and use similar or identical material and packaging as the predicates.
NONCLINICAL TESTING
Product Design Verification activities, such as, Insertion Torque, Anchor Pullout (at T=0, 3, 6 and 12 week in-vitro physiological aging), and Torque to Failure were performed on the implant.
SAFETY AND PERFORMANCE
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 Small Size DePuy Mitek Milagro® Interference Screws have been shown to be substantially equivalent to 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 U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek, Incorporated a Johnson & Johnson Compnay % Mr. Deep Pal Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767
APR 2 4 2012
Re: K120589
Trade/Device Name: Milagro® Interference Screws Regulation.Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MAI, HWC Dated: February 27, 2012 Received: February 28, 2012
Dear Mr. Pal:
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 - Mr. Deep Pal
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ely yours,
For Dothm
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/1 description: The image shows the DePuy Synthes logo. The logo features the company name in bold, black letters, with a black circle to the left of the name. Below the name is the tagline "never stop moving" in a smaller, italicized font.
PRODUCT: -MILAGRO INTERFERENCE SCREWS SUBMISSION DATE: FEBRUARY 27™, 2012 SUBMISSION TYPE: TRADITIONAL
ATTACHMENT 2
INDICATIONS FOR USE
510(k) Number (if known):
Device Names: Milagro® Interference Screws
Indications for Use: The Milagro® BR interference screws are designed to attach soft tissues to bone in orthopedic surgical procedures. The screws may be used for interference fixation of soft tissues (such as ligaments or tendons) to bone, when the implant sizes offered are patient appropriate. The implant operates, in conjunction with the appropriate postoperative immobilization, throughout the healing period.
Over-The-Counter Use AND/OR Prescription Use V (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
(Division Sig Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K120589