(43 days)
The Smith & Nephew KINSA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP Lesion Repairs Capsular Shift of capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff Tear repairs Biceps tenodesis
The KINSA Anchor is a suture anchor manufactured from PEEK polymer. The design incorporates a suture knot within the anchor body and a suture loop with a tension suture extending from the top of the anchor. This design allows the surgeon to implant the anchor, pass the suture loop through the tissue and using the tensioning suture, complete the repair without the need for knot tying.
The provided text describes a 510(k) submission for the Smith & Nephew KINSA Suture Anchor, demonstrating its substantial equivalence to a predicate device, the Smith & Nephew BIORAPTOR 2.9 Suture Anchor (K053344). The information provided is primarily focused on regulatory submission and comparison to a predicate device, rather than detailed performance study data against specific, quantitative acceptance criteria. Therefore, several sections of your request cannot be fully populated as the information is not present in the provided document.
Here's an attempt to extract and infer information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Substantial equivalence in design | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in design... to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344." |
| Substantial equivalence in materials | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in... materials... to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344." The KINSA Anchor is manufactured from PEEK polymer. The BIORAPTOR is not explicitly stated to be PEEK in this document, but equivalence in materials is asserted. |
| Substantial equivalence in function | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in... function... to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344." The KINSA design allows suture knot within anchor body, suture loop with tension suture, and completion of repair without knot tying. The functional equivalence to BIORAPTOR 2.9 (K053344) is stated. |
| Substantial equivalence in intended use and indications for use | "The Smith & Nephew KINSA Suture Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the... BIORAPTOR Suture Anchor (K053344)." "The proposed and the predicate devices both have the same intended use, indications for use, suture material." Intended use: "reattachment of soft tissue to bone." Specific indications for use are listed for the shoulder (e.g., Capsular Stabilization, Bankhart Repair, Rotator Cuff Tear repairs, Biceps tenodesis). |
| Performance testing demonstrates substantial equivalence | "The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew BIORAPTOR 2.9 Suture Anchor, cleared in K053344." "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." |
| No new safety or efficacy issues | "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." |
Study Proving Acceptance Criteria:
The document refers to "Summary Performance Data" and "performance testing conducted" which demonstrated substantial equivalence to the predicate device, the Smith & Nephew BIORAPTOR 2.9 Suture Anchor (K053344). However, the specific details of this study, including test methodologies, quantitative results (e.g., pull-out strength, fatigue testing), and the actual acceptance criteria (e.g., "must meet or exceed X N/mm of pull-out strength") are not provided in the excerpt. The document states that the testing demonstrated that "differences in the new device and the predicate device do not raise any new issues of safety and efficacy." This implies that the performance data for KINSA was within acceptable limits when compared to the established performance of BIORAPTOR 2.9.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not specified, but implied to be from internal Smith & Nephew performance testing, likely conducted in a controlled lab environment given the nature of the device (suture anchor). No mention of patient data (retrospective or prospective) from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as the study described is a performance/mechanical testing study comparing a new device to a predicate, not one requiring expert consensus on clinical or image interpretation.
4. Adjudication method for the test set
Not applicable for a performance/mechanical testing study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (suture anchor) for physical implantation, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a physical medical device.
7. The type of ground truth used
For a suture anchor, the "ground truth" for performance testing would typically be objective, quantitative measurements of mechanical properties (e.g., ultimate tensile strength, pull-out strength, fatigue life, suture retention strength) under controlled laboratory conditions, often established through standardized testing methods (e.g., ASTM standards). The document indicates "performance testing" was conducted to demonstrate equivalence, implying these types of objective measurements were the basis for comparison.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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JUN - 8 2006
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 KINSA Suture Anchor
Date Prepared: April 25, 2006
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810
B. Company Contact
Deana Boushell Principle Regulatory Affairs Specialist Phone: (508) 337-4036 FAX: (508) 261-3620
C. Device Name
Trade Name: KINSA Suture Anchor Common Name: Fastener, fixation, non-degradable, soft tissue Classification Name: Fastener, fixation, non-degradable, soft tissue
D. Predicate Devices
The Smith & Nephew KINSA Anchor is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew BIORAPTOR Suture Anchor (K053344).
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E. Description of Device
The KINSA Anchor is a suture anchor manufactured from PEEK polymer. The design incorporates a suture knot within the anchor body and a suture loop with a tension suture extending from the top of the anchor. This design allows the surgeon to implant the anchor, pass the suture loop through the tissue and using the tensioning suture, complete the repair without the need for knot tying.
F. Intended Use
The Smith & Nephew KINSA Anchor is intended for the reattachment of soft tissue to bone.
G. Comparison of Technological Characteristics
The Smith & Nephew KINSA Suture Anchor is substantially equivalent in design, materials, function and intended use to the Smith & Nephew BIORAPTOR 2.9 suture anchor, cleared in K053344. The proposed and the predicate devices both have the same intended use, indications for use, suture material.
H. Summary Performance Data
The performance testing conducted demonstrates substantial equivalence to the Smith & Nephew BIORAPTOR 2.9 Suture Anchor, cleared in K053344 . 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.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a cascading manner. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2006
Smith & Nephew, Inc. % Ms. Deana Boushell Principle Regulatory Affairs Specialist Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810
Re: K061154
Trade/Device Name: Smith & Nephew KINSA Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: MBI Dated: April 25, 2006 Received: April 26, 2006
Dear Ms. Boushell:
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
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Page 2 - Ms. Deana Boushell
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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
elmalli
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KOGII54 510(k) Number (if known):
Device Name: Smith & Nephew KINSA Suture Anchor
Indications For Use:
The Smith & Nephew KINSA Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Capsular Stabilization Bankhart Repair Anterior Shoulder Instability Repair SLAP Lesion Repairs Capsular Shift of capsulolabral reconstructions Acromioclavicular separation repairs Deltoid Repairs Rotator Cuff Tear repairs Biceps tenodesis
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
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 General, Restorative, |
| and Neurological Devices |
510(k) Number_K06(154
ﺮ
§ 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.