(59 days)
No
The device description and performance studies focus on the mechanical properties and intended use of a PEEK interference screw, with no mention of AI or ML.
Yes.
The device is used to attach soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction and other ligament repair and tenodesis procedures, directly treating a medical condition.
No.
The device is an interference screw used for attaching grafts during surgical reconstruction procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, non-absorbable, tapered, cannulated, threaded fastener made from PEEK, which is a hardware component.
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 and Intended Use: The MILAGRO® ADVANCE PEEK Interference Screw is a surgical implant used to physically attach grafts to bone during orthopedic procedures. It is a physical device inserted into the body, not a tool for analyzing biological samples.
The provided information clearly describes a surgical implant used for mechanical fixation within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.
Additionally, the 7, 8 and 9 mm x 23 mm screws are indicated for: medial and lateral ligament repar , medial patellofemoral ligament reconstruction) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The MILAGRO® ADVANCE PEEK Interference Screw is a non-absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon-bone grafts. The Interference Screw is made from Polyetheretherkeytone (PEEK). The MILAGRO® ADVANCE PEEK Interference Screw is provided sterile and is for single patient use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tibia and/or femur, knee, shoulder, elbow
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)
Verification activities were performed on the implant and / or its predicate. Testing assessments include pull out testing, and insertion / failure torque.
Results of performance testing have demonstrated that the proposed devices are suitable for their intended use.
The proposed device also met requirement of bacterial endotoxin testing.
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
§ 888.3040 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a central emblem. The emblem consists of a stylized design of three human profiles facing right, with flowing lines beneath them, resembling a bird or abstract form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2016
Medos International SARL % Ms. Kristine Christo Director, Regulatory Affairs Depuy Mitek Inc., a Johnson & Johnson Company 325 Paramount Drive Raynham, Massachusetts 02767
Re: K161001
Trade/Device Name: MILAGRO® ADVANCE PEEK Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: MBI Dated: April 7, 2016 Received: April 11, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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
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Indications for Use
510(k) Number (if known) K161001
Device Name
MILAGRO® ADVANCE PEEK Interference Screw
Indications for Use (Describe)
The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.
Additionally, the 7, 8 and 9 mm x 23 mm screws are indicated for: medial and lateral ligament repar , medial patellofemoral ligament reconstruction) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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SECTION 2 - 510(k) SUMMARY
MILAGRO® ADVANCE PEEK Interference Screw
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767
Date Prepared: March 25, 2016 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Kristine Christo
Director, Regulatory Affairs
DePuy Mitek, Inc.
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 |
| Name of
Medical Device | Proprietary Name: MILAGRO® ADVANCE PEEK Interference Screw
Classification Name: Smooth or threaded metallic bone fixation fasteners
Common Name: Fastener, fixation, nondegradable, soft tissue |
| Substantial
Equivalence | The MILAGRO® ADVANCE PEEK Interference Screw is substantially equivalent to:
■ K123362, K143660, MILAGRO ADVANCE™ Interference Screw
Reference device:
■ K130539 Healix Advance™ Knotless PEEK Anchor |
| Device
Classification | Smooth or threaded metallic bone fixation fastener, classified as Class II,
product code MBI, regulated under 21 CFR 888.3040. |
| Device
Description | The MILAGRO® ADVANCE PEEK Interference Screw is a non-absorbable, tapered,
cannulated, threaded fastener for use in interference fixation of soft tissue grafts or
bone-tendon-bone grafts. The Interference Screw is made from Polyetheretherkeytone
(PEEK). The MILAGRO® ADVANCE PEEK Interference Screw is provided sterile
and is for single patient use only. |
| Technological
Characteristics | The proposed MILAGRO® ADVANCE PEEK Interference Screw is similar to the
predicate MILAGRO ADVANCE™ Interference Screw (K123362, K143660) in that
they share the same indication for use, screw design, sterilization method, and shelf
life. The proposed MILAGRO® ADVANCE PEEK Interference Screw is similar to the
reference device, Healix Advance™ Knotless PEEK Anchor (K130539), in that they
share the same PEEK material. |
| Indications for
Use | The MILAGRO® ADVANCE PEEK Interference Screw is intended for attachment of
soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate
ligament reconstruction procedures. |
| | Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and
lateral collateral ligament repair, medial patellofemoral ligament reconstruction (femur
fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep
tenodesis in the elbow. |
| Non clinical
Testing | Verification activities were performed on the implant and / or its predicate. Testing
assessments include pull out testing, and insertion / failure torque. |
| Safety and
Performance | Results of performance testing have demonstrated that the proposed devices are
suitable for their intended use. |
| | The proposed device also met requirement of bacterial endotoxin testing. |
| | Based on similarities in the indications for use, technological characteristics, and
performance in comparison to the predicate devices, the proposed MILAGRO®
ADVANCE PEEK Interference Screw has shown to be substantially equivalent to the
predicate device under the Federal Food, Drug and Cosmetic Act. |
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