(21 days)
No
The device description and intended use are for a physical suture anchor made of PEEK polymer. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on the physical properties and equivalence to a predicate device.
Yes
The device is described as a suture anchor used for the reattachment of soft tissue to bone, which is a therapeutic intervention.
No
This device is a suture anchor used for reattaching soft tissue to bone, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a suture anchor manufactured from PEEK polymer, which is a physical material, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "suture anchor" made of PEEK polymer, intended for "reattachment of soft tissue to bone" in various anatomical locations. This is a surgical implant used within the body to physically repair tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide diagnostic information about a patient's condition. Its function is purely mechanical and surgical.
Therefore, the Smith & Nephew FOOTPRINT RCX PK Suture Anchor falls under the category of a surgical implant or device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment 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/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, Illiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Product codes
MBI
Device Description
The FOOTPRINT RCX PK Suture Anchor is a suture anchor manufactured from PEEK polymer. The screw-in anchor can be loaded with up to four strands of suture and facilitates arthroscopic repair of soft tissue to bone. The design allows the surgeon to adjust the tension on the tissue intraoperatively and secure the repair.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Hand/Wrist, 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)
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew FOOTPRINT RCX PK suture anchor is substantially equivalent to the predicate Smith & Nephew Twinfix PK FP suture anchor, cleared via K073509. The testing also demonstrates the new device does not raise any new issues of safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew FOOTPRINT RCX PK Suture Anchor
Date Prepared: December 18, 2007
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Christina Flores Regulatory Affairs Specialist II (508) 261-3705 Phone: FAX: (508) 261-3620
C. Device Name
Trade Name: FOOTPRINT RCX PK Suture Anchor Common Name: Suture Anchor Classification Name: Fastener, fixation, non-degradable, soft tissue
D. Predicate Devices
The Smith & Nephew FOOTPRINT RCX PK Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew Twinfix PK FP Suture Anchor.
E. Description of Device
The FOOTPRINT RCX PK Suture Anchor is a suture anchor manufactured from PEEK polymer. The screw-in anchor can be loaded with up to four strands of suture and facilitates arthroscopic repair of soft tissue to bone. The design allows
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K093935p.20f 2
the surgeon to adjust the tension on the tissue intraoperatively and secure the repair.
F. Intended Use
The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Rotator cuff repair, Bankart repair. Slap lesion repair, Biceps tenodesis, Acromioclavicular separation, Deltoid repair, and Capsular shift or Capsulolabral reconstruction.
Foot/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, Illiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction
G. Comparison of Technological Characteristics
The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is substantially equivalent in materials, fundamental scientific technology, and intended use and is as safe and effective as its currently marketed predicate device, the Smith & Nephew Twinfix PK FP (K073509).
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the Smith & Nephew FOOTPRINT RCX PK suture anchor is substantially equivalent to the predicate Smith & Nephew Twinfix PK FP suture anchor, cleared via K073509. The testing also demonstrates the new device does not raise any new issues of safety and efficacy.
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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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Christina Flores Regulatory Affairs Specialist II 150 Minuteman Road Andover, Massachusetts 01810
APR - 6 2010
Re: K093935
Trade/Device Name: Smith & Nephew FOOTPRINT RCX PK 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: March 26, 2010 Received: March 29, 2010
Dear Ms. Flores:
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 iddications 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 Amendmants, or to devices that have been reclassified in accordance with the provisions of the Federal Foond, Or re 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 Trich, general controls provisions of the Act include requirements for annual registration, institus of devices, good manufacturing practice, labeling, and prohibitions against misbrandijing and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations after in ground (in the can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, UDA 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. Your 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); good manufacturing practice requirements as set
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Page 2 - Ms. Christina Flores
forth in the quality systems (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
":
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Kod 3935 510(k) Number (if known):
Device Name: Smith & Nephew FOOTPRINT RCX PK Suture Anchor
Indications For Use:
The Smith & Nephew FOOTPRINT RCX PK Suture Anchor is intended for use for the reattachment 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/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, Illiotibial band tenodesis.
Hand/Wrist: Scapholunate ligament reconstruction, Ulnar collateral ligament reconstruction, Radial collateral ligament reconstruction.
Elbow: Biceps Tendon reattachment, Ulnar or radial collateral ligament reconstruction.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | K093935 |
|---|---|
| --------------- | --------- |