(160 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and degradation of a bioabsorbable suture anchor, with no mention of AI or ML capabilities.
Yes
The device is intended for the reattachment of soft tissue to bone to improve specific medical conditions, which falls under the definition of a therapeutic device designed to treat or alleviate a disease or injury.
No
The device is described as an absorbable suture anchor intended for reattaching soft tissue to bone, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a bioabsorbable suture anchor provided with sutures and an insertion device, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is a "bioabsorbable suture anchor" intended for the "reattachment of soft tissue to bone" in various anatomical locations (Shoulder, Knee, Foot & Ankle, Elbow). This is a surgical implant used directly within the body during a procedure.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic purposes, or laboratory use, which are hallmarks of IVDs.
The Smith & Nephew HEALICOIL Absorbable Suture Anchor is a surgical implant/device used for orthopedic procedures.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
MAI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Knee, Foot & Ankle, Elbow
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 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.
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.
K113294, K101459, K032197, K070925, K042778
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
§ 888.3030 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.
0
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.
120
:
్ శిశు వ్యోగా
,在
Predicate Devices
| Manufacturer | Description | Submission
Number | Clearance
Date |
|-------------------------|----------------------------------------|----------------------|-------------------|
| Smith & Nephew,
Inc. | HEALICOIL PK Suture
Anchor | K113294 | 1/20/12 |
| Smith & Nephew,
Inc. | Osteoraptor OS Suture
Anchor | K101459 | 1/27/11 |
| Smith & Nephew,
Inc. | TwinFix AB Anchor | K032197 | 8/8/03 |
| DePuy Mitek | Bioknotless Anchor
Lupine BR Anchor | K070925 | 5/2/07 |
| Linvatec Corp. | Bioanchor | K042778 | 11/4/04 |
1
1
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
2
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
ូរ
ប្រជាជនជាតិ .***
3
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
4
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 repairs | |
| Slap lesion repairs | |
| Capsular shift or capsulolabral | |
| reconstructions | |
| Acromioclavicular separation repairs | |
| Deltoid repairs | |
| Rotator cuff tear repairs | |
| Biceps tenodesis | 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: | Elbow: |
| Hallux valgus repairs | |
| Medial or lateral instability | |
| repairs/reconstructions | |
| Achilles tendon repairs/reconstruction | Ulnar or radial collateral ligament reconstructions |
| Lateral epicondylitis repair | |
| Biceps 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 |