(105 days)
No
The device description and performance studies focus on the mechanical properties and biological integration of a physical interference screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interference screw used for the "reattachment of ligament, tendon, soft tissue, or bone-tendon-bone," which are therapeutic medical procedures.
No.
The device is an orthopedic implant (interference screw) used for reattaching ligaments, tendons, soft tissue, or bone. Its descriptions and intended use are purely therapeutic/surgical, with no mention of diagnosing conditions.
No
The device description clearly states it is a physical, non-absorbable interference screw made of PEEK, intended for surgical implantation. It 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 clearly describes a surgical implant used for reattaching ligaments, tendons, soft tissue, or bone-tendon-bone in various anatomical locations. This is a therapeutic and structural function within the body.
- Device Description: The description details a physical screw made of PEEK, designed for mechanical fixation and bone ingrowth. This is a medical device used in surgery, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used directly within the body for structural support and repair.
N/A
Intended Use / Indications for Use
The BIOSURE HEALICOL PK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications:
Knee
ACL repairs, PCL repairs, Extra-capsular repairs, Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquus advancement, Iliotibial band tenodesis
Shoulder
Acromioclavicular separation repairs, Biceps tenodesis
Foot and Ankle
Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Flexor hullucis longus (FHL), Tendon transfers
Elbow, Wrist, and Hand
Bicens tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers, Carpomedicarpal joint arthroplasty
Product codes
MBI
Device Description
Smith & Nephew BIOSURE HEALICOIL PK interference screw is a non-absorbable, sterile, single-use, interference screw composed of Polyetheretherketone (PEEK). It has a fenestrated open design which allows for bone ingrowth. It is provided in size ranging from 6mm to 10 mm diameter. BIOSURE HEALICOIL interference screw minimizes the volume of material implanted into the body while providing equal fixation strength of a standard interference screw. The central channel of the screw can be packed with autologous bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, Shoulder, Foot and Ankle, Elbow, Wrist, and Hand
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
Mechanical testing data for pull out and insertion testing demonstrates the BIOSURE HEALICOIL PK interference screw is substantially equivalent to the currently marketed predicate devices.
The animal study evaluated bone ingrowth into the BIOSURE HEALICOIL PK interference screw (n=11) and control (n=11) via micro computed tomography (µCT) and histology. µCT demonstrated at twelve weeks that there was bone between the fenestrations and within the central cannulations. Histology demonstrated that new bone formed within the BIOSURE HEALICOIL PK interference screw and control in the fenestration between the threads into the central channel in all specimens.
Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having variety of bone quality based on specific disease states such as osteoporosis.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
JUL 2 1 2014
510(k) Summary
Date Prepared: May 23'd, 2014
| SUBMITTERINFORMATION | CONTACT INFORMATION |
|---|---|
| Smith & Nephew, Inc. | Vivek Mukhatyar |
| 150 Minuteman Road | Regulatory Affairs Specialist II |
| Andover, MA 01810 | ' Phone: (978)749-1043 |
| Fax: (978)749-1443 |
| DEVICE NAME (UNMODIFIED) | |
|---|---|
| Trade or proprietary name | BIOSURE HEALICOIL PK Interference Screw |
| Common or usual name | Soft Tissue Fixation Device |
| Classification name | 21 CFR §888.3040 - Smooth or threaded metallic bone fixation |
| fastener | |
| Device Class | Class II |
| Product Code | MBI |
LEGALUY MARKETED PREDICATE DEVICE
The Smith & Nephew BIOSURE HEALICOIL PK interference screw is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
| K083635 | Smith & Nephew BIOSURE PK
(Cleared on January 30, 2009) |
|---------|------------------------------------------------------------|
| K083226 | |
K042552 Biomet Bio-Core (Cleared on December 14, 2004)
DEVICE DESCRIPTION
Smith & Nephew BIOSURE HEALICOIL PK interference screw is a non-absorbable, sterile, single-use, interference screw composed of Polyetheretherketone (PEEK). It has a fenestrated open design which allows for bone ingrowth. It is provided in size ranging from 6mm to 10 mm diameter. BIOSURE HEALICOIL interference screw minimizes the volume of material implanted into the body while providing equal fixation strength of a standard interference screw. The central channel of the screw can be packed with autologous bone.
1
INTEXPED Clase
The BIOSURE HEALICOL PK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications:
Knee
ACL repairs PCL repairs Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medialis obliquus advancement Iliotibial band tenodesis
Shoulder
Acromioclavicular separation repairs Biceps tenodesis
Foot and Ankle
Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Metatarsal ligament/tendon repairs/reconstructions Flexor hullucis longus (FHL) Tendon transfers
Elbow, Wrist, and Hand
Biceps tendon reattachment Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Scapholunate ligament reconstruction Tendon transfers Carpomedicarpal ioint arthroplasty
TECHNOID ACA CHARACTERESTICS *
Smith & Nephew BIOSURE HEALICOIL interference screw is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate devices (Smith and Nephew BIOSURE PK - K083226 & K083635 and BIOMET Bio-Core K042552) and raises no new issues of safety and efficacy. Smith & Nephew BlOSURE HEALICOIL interference screw and the predicate Smith & Nephew BIOSURE PK Interference screws (K083226 & K083635) are manufactured from the same PEEK material. Smith & Nephew BIOSURE HEALICOIL interference screw and the predicate Biomet Bio-core (K042552) have a similar open lattice construction to allow for bone ingrowth through the fenestrations to the central channel of the screws or to be packed with autologous bone.
SUMMARK OF PERFORMANCE DATA
Mechanical testing data for pull out and insertion testing demonstrates the BIOSURE HEALICOIL PK interference screw is substantially equivalent to the currently marketed predicate devices.
The animal study evaluated bone ingrowth into the BIOSURE HEALICOIL PK interference screw (n=11) and control (n=11) via micro computed tomography (µCT) and histology. µCT demonstrated at twelve weeks that there was bone between the fenestrations and within the central cannulations. Histology andwsis
2
demonstrated that new bone formed within the BIOSURE HEALICOIL PK interference screw and control in the fenestration between the threads into the central channel in all specimens.
Note: Animal data is not necessarily indicative of human clinical outcomes. These results have not been demonstrated in humans having variety of bone quality based on specific disease states such as osteoporosis.
| SUBSTANTIAL EQUIVALENCE INFORMATION | |||
|---|---|---|---|
| and the control control control control control controller and the controlled to the contribution of the contribution of the contribution of the contribution of the contribut |
The substantial equivalence of the BIOSURE HEALICOIL PK interference screw is based on similarities in indications for use, design features, operational principles, material composition, and performance to the predicate devices listed above. Based on the similarities to the BIOSURE HEALICOIL PK interference screw is substantially equivalent to its predicates.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three lines representing the feathers.
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
July 21, 2014
Smith & Nephew, Incorporated Vivek Mukhatyar, Ph.D. Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
Re: K140879
Trade/Device Name: BIOSURE HEALICOIL PK 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: May 23, 2014 Received: May 28, 2014
Dear Dr. Mukhatyar:
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
4
Page 2 - Vivek Mukhatyar, Ph.D.
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" (21 CFR 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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
140879
Device Name The BIOSURE HEALICOIL PK Interference Screw
Indications for Use (Describe)
The BIOSURE HEALICOL PK Interference Screw is indicated for the reattachment of ligament, tendon, soft tissue, or bone-tendon-bone for the following indications:
Knee
ACL repairs, PCL repairs, Extra-capsular repairs, Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs, Vastus medialis obliquus advancement, Iliotibial band tenodesis
Shoulder
Acromioclavicular separation repairs, Biceps tenodesis
Foot and Ankle
Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Flexor hullucis longus (FHL), Tendon transfers
Elbow, Wrist, and Hand
Bicens tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon transfers, Carpomedicarpal joint arthroplasty
Type of Use (Select one or both, as applicable)
2 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)
Casey L. Hanley; Ph.D.
Division of Orthopedic Devices
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