(89 days)
No
The device description and intended use are purely mechanical, describing a suture anchor and its application in surgical procedures. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the reattachment of soft tissue to bone for various orthopedic indications, which falls under therapeutic use.
No
The device description indicates it is a "suture anchor with attached non-absorbable suture(s) preassembled to a stainless steel insertion device." This type of device is used for surgical repair, specifically "reattachment of soft tissue to bone," rather than for diagnosing conditions.
No
The device description explicitly states it consists of a non-absorbable suture anchor with attached non-absorbable suture(s) preassembled to a stainless steel insertion device, indicating it is a physical hardware 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 describes a surgical device used for the reattachment of soft tissue to bone in various anatomical locations (shoulder, foot/ankle, elbow, wrist, hand, knee). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device is described as a suture anchor with attached suture and an insertion device. This is consistent with a surgical implant and delivery system.
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples for diagnostic purposes. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
The 2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis.
Foot/Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstruction. Achilles tendon repairs/reconstruction, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/recontructions and Bunionectomy.
Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,
Knee: Extra-capular repairs -Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement and Illoiotibial band tenodesis.
Product codes
MBI, HWC, JDR
Device Description
The 2.0 PK Suture Anchor T and the 2.0 PK Suture Anchor S consist of a non-absorbable suture anchor with attached non-absorbable suture(s) preassembled to a stainless steel insertion device, and is provided sterile, for single use only. Both anchor models achieve fixation via ribbed/threaded design characteristics that are consistent with the repair of soft tissue to bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Elbow, Wrist, Hand, Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 2,0 PK Suture Anchor T and the 2.0 PK Suture Anchor S are substantially equivalent to the Smith & Nephew 2.3 BIORAPTOR and the Arthrex Mini BioSuture TakTM anchors.
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
§ 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
K0815" pyf 'f2
AUG 2 6 2008
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.
2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S
Date Prepared: May 23, 2008
A. Submitter's Name:
SECTION IV
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Janice Haselton Sr. Regulatory Affairs Specialist Phone: 978-749-1494 Fax: 978-749-1443
C. Device Name
| Trade Name: | 2.0 PK Suture Anchor T
2.0 PK Suture Anchor S |
|----------------------|----------------------------------------------------|
| Common Name: | Fastener, fixation, non-degradable, soft tissue |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Product Code: | MBI |
| Regulation Number: | 21 CFR §888.3040 |
D. Predicate Devices
The 2.0 PK Suture Anchor T and the 2.0 PK Suture Anchor S are substantially equivalent to the following legally marketed device in commercial distribution: Smith & Nephew BIORAPTOR 2.3 PK Suture Anchor cleared in K071586 and Arthrex Mini BioSuture Tak™ cleared in K050749/K061863.
Smith & Nephew, INC 2.0 PK Anchors Pg. 25 of 54
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E. Description of Device
The 2.0 PK Suture Anchor T and the 2.0 PK Suture Anchor S consist of a non-absorbable suture anchor with attached non-absorbable suture(s) preassembled to a stainless steel insertion device, and is provided sterile, for single use only. Both anchor models achieve fixation via ribbed/threaded design characteristics that are consistent with the repair of soft tissue to bone.
F. Intended Use
The 2.0 PK Suture Anchor T and 2.0 PK Suture Anchor S is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis.
Foot/Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstruction. Achilles tendon repairs/reconstruction, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/recontructions and Bunionectomy.
Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,
Knee: Extra-capular repairs -Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement and Illoiotibial band tenodesis.
G. Comparison of Technological Characteristics
The performance testing conducted demonstrates substantial equivalence to the Arthrex Mini BioSuture Tak™suture anchor, cleared in K050749/K061863. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy
H. Summary Performance Data
The performance testing conducted demonstrates that the insertion and fixation properties of the 2,0 PK Suture Anchor T and the 2.0 PK Suture Anchor S are substantially equivalent to the Smith & Nephew 2.3 BIORAPTOR and the Arthrex Mini BioSuture TakTM anchors.
Smith & Nephew INC 2.0 PK Anchors Pg. 26 of 54
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2008
Smith & Nephew, Inc. Endoscopy Division % Ms. Janice Haselton Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K081511
Trade/Device Name: 2.0 PK Suture Anchor "S" and 2.0 PK Suture Anchor "T" Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC, JDR Dated: May 28, 2008 Received: May 29, 2008
Dear Ms. Haselton:
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.
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 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); 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.
3
Page 2 - Ms. Janice Haselton.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
K0815-11
Device Name: ____2.0 PK Suture Anchor S and 2.0 PK Suture Anchor T
Indications For Use:
The 2.0 PK Suture Anchor S and 2.0 PK Suture Anchor T is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder: Capsular stabilization- Bankart repair, Anterior shoulder instability, Slap lesion repair, Capsular shift or capsulolabral reconstruction, Acromilavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs and Biceps tenodesis.
Foot/Ankle: Hallux valgus repairs, Medial or lateral instability repairs/reconstruction. Achilles tendon repairs/reconstruction, Mid-foot reconstruction, Metatarsal ligament/tendon repairs/recontructions and Bunionectomy.
Elbow, Wrist, and Hand: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, and Scapholunate ligament reconstruction,
Knee: Extra-capular repairs -Medial collateral ligament, Lateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement and Illoiotibial band tenodesis.
Prescription Use
AND/OR
(Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Brown
Division of Ger and Neurological Devices
510 k) Number_
Smith & Nephew, INC 2.0 PK Anchors Pg. 16 of 54