(160 days)
The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
Shoulder:
Bankart lesion repairs
Slap lesion repairs
Capsular shift or capsulolabral reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Knee:
Extra-capsular repairs:
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs:
Vastus medialis obliquous advancement
Iliotibial band tenodesis.
Foot & Ankle:
Hallux valgus repairs
Medial or lateral instability repairs/reconstructions
Achilles tendon repairs/reconstruction
Midfoot reconstructions
Metatarsal ligament/tendon repairs/reconstructions
Elbow:
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment
The HEALICOIL Absorbable Suture Anchor is a bioabsorbable suture anchor provided with up to three strands of non-absorbable sutures, pre-loaded on an insertion device and is available in two sizes, 4.75mm and 5.5mm.
Here's a summary of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for the K123393 submission for the HEALICOIL Absorbable Suture Anchor does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it uses the concept of "substantial equivalence" to predicate devices.
| Acceptance Criteria (Stated as Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Insertion Strength substantially equivalent to predicate devices | Demonstrated substantially equivalent to predicate devices |
| Pull-out Strength substantially equivalent to predicate devices | Demonstrated substantially equivalent to predicate devices |
| In vitro degradation substantially equivalent to predicate devices | Demonstrated substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set in the performance studies. It mentions that "performance testing was conducted," but no details on the number of samples for insertion strength, pull-out strength, or in vitro degradation are provided.
The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, given they are performance tests specifically conducted for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to the type of device and study described. This device is a physical medical implant, and its performance is evaluated through biomechanical testing (insertion strength, pull-out strength, degradation), not through subjective interpretation by human experts to establish ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the studies described are biomechanical performance tests, not studies requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret data, often with and without AI assistance, to assess the AI's impact on human performance. This submission is for a physical orthopedic implant.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
No, a standalone algorithm-only study was not done because this device is a physical orthopedic implant, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for the performance studies would be the objective measurements obtained from the biomechanical tests themselves. For example:
- Insertion Strength: The force required to insert the anchor, measured by a load cell.
- Pull-out Strength: The force required to pull the anchor out, measured by a load cell.
- In vitro Degradation: Measurements of material properties or mass loss over time in a controlled environment.
This is objective, quantifiable data from physical experiments, not expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device ground truth.
8. Sample Size for the Training Set
This information is not applicable. This device is a physical medical implant, not an AI/machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this device.
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K123393
510(k) Summary Smith & Nephew, Inc. HEALICOIL Absorbable Suture Anchor
Prepared: April 3, 2013
| Submitter Information | Contact Information |
|---|---|
| Smith & Nephew, Inc. | Sue Dahlquist |
| 150 Minuteman Road | Manager, Regulatory Affairs |
| Andover, MA 01810 | Phone: (978) 749-1622 |
| Fax: (978) 749-1443 |
| Device Name & Classification | |
|---|---|
| Proprietary Name | HEALICOIL Absorbable Suture Anchor |
| Common Name | Soft Tissue Fixation Device |
| Classification Name | Fastener, fixation, biodegradable, soft tissue |
| Classification Regulation | 21 CFR 888.3030 |
| Class | II |
| Product Code(s) | MAI |
| Panel | Orthopedic |
Device Description - - - -
The HEALICOIL Absorbable Suture Anchor is a bioabsorbable suture anchor provided with up to three strands of non-absorbable sutures, pre-loaded on an insertion device and is available in two sizes, 4.75mm and 5.5mm.
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Predicate Devices
| Manufacturer | Description | SubmissionNumber | ClearanceDate |
|---|---|---|---|
| Smith & Nephew,Inc. | HEALICOIL PK SutureAnchor | K113294 | 1/20/12 |
| Smith & Nephew,Inc. | Osteoraptor OS SutureAnchor | K101459 | 1/27/11 |
| Smith & Nephew,Inc. | TwinFix AB Anchor | K032197 | 8/8/03 |
| DePuy Mitek | Bioknotless AnchorLupine BR Anchor | K070925 | 5/2/07 |
| Linvatec Corp. | Bioanchor | K042778 | 11/4/04 |
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K123393
Technological Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Smith & Nephew HEALICOIL Absorbable 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 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
The performance testing conducted demonstrates that the insertion strength and pull-out strength of the HEALICOIL Absorbable Suture Anchor are substantially equivalent to the Smith & Nephew HEALICOIL PK Suture Anchor and the Osteoraptor OS Suture Anchor. And, the in vitro degradation of the device is substantially equivalent to the predicate devices.
Intended Use # Home # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # #
The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
Knee
Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis.
Foot & Ankle
. ↑
Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions . Metatarsal ligament/tendon repairs/reconstructions
Elbow
Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment
Substantial Equivalence Information Mation Service のです。 このため、 この場合、 に、 出来、 と、 に、 に、 と、 に、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、 と、
The substantial equivalence of the HEALICOIL Absorbable Suture Anchor is based on similarities in indications for use, design features, operational principles, material composition, and performance to the predicate devices listed in the table above. Based on the similarities to the predicates, the HEALICOIL Absorbable Suture Anchor is substantially equivalent to its predicates.
2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2013
Smith & Nephew, Incorporated % Ms. Susan Dahlquist Manager, Regulatory Affairs 150 Minuteman Road Andover, Massachusetts 01810
Re: K123393
Trade/Device Name: Smith & Nephew HEALICOIL Absorbable Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: March 8, 2013 Received: March 13, 2013
Dear Ms. Dahlquist:
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
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Page 2 - Ms. Susan Dahlquist
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/8 description: The image shows the name "Erin I. Keith" in a stylized font. The name is written in black ink and is easily readable. The letters are bold and have a unique design, making the name stand out.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K123393
Device Name: Smith & Nephew HEALICOIL Absorbable Suture Anchor
Indications For Use:
The Smith & Nephew HEALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications:
| Shoulder: | Knee: |
|---|---|
| Bankart lesion repairsSlap lesion repairsCapsular shift or capsulolabralreconstructionsAcromioclavicular separation repairsDeltoid repairsRotator cuff tear repairsBiceps tenodesis | Extra-capsular repairs:Medial collateral ligamentLateral collateral ligamentPosterior oblique ligamentPatellar realignment and tendon repairs:Vastus medialis obliquous advancementIliotibial band tenodesis. |
| Foot & Ankle: | Elbow: |
| Hallux valgus repairsMedial or lateral instabilityrepairs/reconstructionsAchilles tendon repairs/reconstruction | Ulnar or radial collateral ligament reconstructionsLateral epicondylitis repairBiceps tendon reattachment |
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D) Subpart C)
(21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Casey L. Hanley, Ph.D. |
|---|
| Division of Orthopaedic Devices |
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.