(65 days)
Not Found
No
The 510(k) summary describes a mechanical suture anchor and its insertion device, with no mention of AI or ML capabilities. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is described as a 'suture anchor' intended for the 'fixation of soft tissue to bone' in various anatomical locations, all of which fall under the scope of treating medical conditions or injuries.
No
The device is a surgical anchor used for the fixation of soft tissue to bone, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components: a suture anchor, an insertion device, a stay suture, and a suture threader. This indicates it is a hardware medical device, not software-only.
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 the "fixation of soft tissue to bone" in various anatomical locations (Shoulder, Foot and Ankle, Knee). This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "suture anchor" with an insertion device and suture. This is a physical implant used during surgery.
- 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. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, SL is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew, Inc. FOOTPRINT Ultra PK Suture Anchor, SL is intended for use in the fixation of soft tissue to bone for the following indications:
Shoulder
Rotator Cuff repair, Bankart repair, Slap lesion repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or capsulolabral reconstruction
Foot and Ankle
Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair
Knee
Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, SL consists of four assembled components; a non-absorbable suture anchor, a suture anchor insertion device, a stay suture, and a suture threader. The FOOTPRINT Ultra PK Suture Anchor is not preloaded with suture, but rather preassembled to an insertion device and held in place with a stay suture. The anchor accommodates up to four (4) strands of ULTRABRAID #2 suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, 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)
Mechanical insertion test data demonstrates the device has met the performance specifications 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
Smith & Nephew, Inc. FOOTPRINT Ultra PK 4.5mm and 5.5mm Suture Anchor, SL Special 510(k) Premarket Notification (K123579)
510(k) Summary Date prepared: January 11, 2013
JAN 2 3 2013
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Catherine Kilshaw |
| 150 Minuteman Road | Senior Regulatory Affairs Specialist |
| Andover, MA 01810 | Phone: (508) 337-4104 |
| Fax: (978) 749-1443 |
| Device Name (Unmodified) | |
|---|---|
| Trade or proprietary name | FOOTPRINT Ultra PK Suture Anchor 4.5 mm, SL |
| FOOTPRINT Ultra PK Suture Anchor 5.5mm, SL | |
| Common or usual name | Soft Tissue Fixation Device (MBI) |
| Classification name | 21 CFR §888.3040 Fastener, fixation, nondegradable, soft tissue |
Legally Marketed Predicate Device
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, SL is substantially equivalent in intended use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution:
| K113274 | FOOTPRINT Ultra PK Suture Anchor
(cleared March 6, 2012) |
|---------|----------------------------------------------------------------------------|
| K093897 | SMITH & NEPHEW FOOTPRINT Ultra PK Suture Anchor
(cleared March 4, 2010) |
Device Description
The Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, SL consists of four assembled components; a non-absorbable suture anchor, a suture anchor insertion device, a stay suture, and a suture threader. The FOOTPRINT Ultra PK Suture Anchor is not preloaded with suture, but rather preassembled to an insertion device and held in place with a stay suture. The anchor accommodates up to four (4) strands of ULTRABRAID #2 suture.
Indications for Use
The Smith & Nephew, Inc. FOOTPRINT Ultra PK Suture Anchor, SL is intended for use in the fixation of soft tissue to bone for the following indications:
Shoulder
Rotator Cuff repair, Bankart repair, Slap lesion repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or capsulolabral reconstruction
Foot and Ankle
1
Smith & Nephew, Inc. FOOTPRINT Ultra PK 4.5mm and 5.5mm Suture Anchor, Special 510(k) Premarket Notification (K123579)
Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair
Knee
Medial collateral ligament repair, Lateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, Iliotibial band tenodesis
Technological Characteristics
The Smith & Nephew FOOTPRINT Ultra PK 4.5mm and 5.5mm Suture Anchor, SL is substantially equivalent in design and fundamental scientific technology to the defined predicate devices and raise no new issues of safety and efficacy.
Performance Data
Mechanical insertion test data demonstrates the device has met the performance specifications and therefore, is considered substantially equivalent to the currently marketed predicate devices.
2
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of several curved lines. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 23, 2013
Smith & Nephew. Incorporated % Ms. Catherine Kilshaw Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K123579
Trade/Device Name: FOOTPRINT Ultra PK Suture Anchor, SL Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 21, 2012 Received: December 26, 2012
Dear Ms. Kilshaw:
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 -- Ms. Catherine Kilshaw
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/ReportalProblem/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.
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Smith & Nephew, Inc. FOOTPRINT Ultra PK 4.5mm and 5.5mm Suture Anchor, SL Special 510(k) Premarket Notification (K123579)
- Indications for Use Statement
510(k) Number (if known): K123579
FOOTPRINT Ultra PK Suture Anchor, SL Device Name:
Indications for Use:
The Smith & Nephew, Inc. FOOTPRINT Ultra PK Suture Anchor, SL is intended for use in the fixation of soft tissue to bone for the following indications:
Shoulder
Rotator Cuff repair, Bankart repair, Slap lesion repair, Biceps Tenodesis, Acromio-Clavicular separation, Deltoid repair, and Capsular shift or capsulolabral reconstruction
Foot and Ankle
Lateral stabilization, Medial stabilization, Achilles tendon repair, Hallux valgus reconstruction, Mid-foot reconstruction, Metatarsal ligament repair
Knee
Medial collateral ligament repair, Lateral collateral ligament repair, Patellar tendon repair, Posterior oblique ligament repair, fliotibial band tenodesis
Prescription Use _ × (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)
2013.01.18 14:08:47 Anton E. Dmitriev, PhD Division of Orthopedic Devices =05'00'