(248 days)
Not Found
No
The device description and intended use are purely mechanical, describing a suture anchor for tissue fixation. There is no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is described as an implant used for secure fixation of soft tissue to bone, which is a restorative or supportive function rather than a therapeutic one (i.e., treating a disease or health problem).
No
Explanation: The "Intended Use / Indications for Use" section clearly states that the device is "intended for the secure fixation of soft tissue to bone." This describes a surgical repair function, not a diagnostic one. A diagnostic device would typically identify, monitor, or assess a condition or disease.
No
The device description clearly states it is a physical suture anchor with attached sutures and an insertion device, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "secure fixation of soft tissue to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical implant (suture anchor) and an insertion device. This is a medical device used for treatment or repair within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health, diagnose conditions, or monitor treatment.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (in the living body) for surgical repair.
N/A
Intended Use / Indications for Use
The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)
Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Shoulder, Foot and Ankle, Elbow, Wrist, and Hand, Knee
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)
Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.
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.
Not Found
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.
0
Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA T 978-749-1000 F 978-749-1443 www.smith-nephew.com
- We are smith&nephew
K122059
page 1 of 2
MAR 1 8 2013
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | |
| 150 Minuteman Road | |
| Andover, MA 01810 | Anne-Marie Keefe |
| Senior Regulatory Affairs Specialist | |
| Phone: (508) 261-3713 | |
| Fax: (978) 749-1443 |
| Device Name & Classification | |
|---|---|
| Proprietary Name | SUTUREFIX Ultra Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, nondegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3040 |
| Class | II |
| Product Code(s) | MBI |
| Panel | Orthopedic |
Device Description
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.
Predicate Devices ·
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | BIORAPTOR 2.3 PK Suture Anchor | K121018 | June 22, 2012 |
| Biomet, Inc. | JuggerKnot® Soft Anchors | K110145 | March 4, 2011 |
1
T 978-749-1000 F 978-749-1443 www.smith-nephew.com
K122059 page 2 of 2
Intended Use
The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)
Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis
Technological Characteristics
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the legally marked predicate devices in commercial distribution and raises no new issues of safety and efficacy.
Summary Performance Data
Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2013
Smith & Nephew, Incorporated % Ms. Anne-Marie Keefe Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K122059
Trade/Device Name: SUTUREFIX Ultra Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 7, 2013 Received: February 12, 2013
Dear Ms. Keefe:
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. Iisting 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
3
Page 2 - Ms. Anne-Marie Keefe
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin DKeith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
510(k) Number (if known):K122059
SUTUREFIX Ultra Suture Anchor Device Name:
Indications for Use:
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)
Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotibial band tenodesis
Prescription Use X __ (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet际圈Ærank -S
Division of Orthopedic Devices