(279 days)
LOCKDOWN™ Acromioclavicular (AC) device (K091207)
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical scaffold, with no mention of AI or ML technologies.
Yes
Explanation: The device is indicated to "provide fixation during the healing process," which directly contributes to the treatment and recovery from an injury, thus serving a therapeutic purpose.
No
The device is described as a surgical scaffold used for fixation during the healing process, not for diagnosing a condition.
No
The device description clearly states it is a knitted surgical scaffold made from poly(ethylene terephthalate) (PET), which is a physical material, not software.
Based on the provided information, the LARS® AC Band device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide fixation during the healing process following a syndesmotic trauma, specifically acromioclavicular separations. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device is a surgical scaffold made of PET, designed to be implanted and secured with sutures. This is a medical device used for structural support and fixation within the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The LARS® AC Band device is a therapeutic device used for surgical repair and support.
N/A
Intended Use / Indications for Use
The LARS® AC Band device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
The LARS® AC Band device is intended for single use only.
Product codes
HTN, MBI
Device Description
The LARS® AC Band device is a knitted surgical scaffold manufactured from poly(ethylene terephthalate) (PET) which is non-biodegradable. The LARS® AC Band device is available in 1 size which is 6mm wide by 400mm in length with a loop at one end and is secured by sutures. The use of high strength #2, non-resorbable single use sterile sutures is recommended. The construct permits the mesh to be cut into any desired size without unraveling. The device is supplied sterile, for singlepatient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
syndesmotic trauma, acromioclavicular separations
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
Non-clinical testing and analysis was conducted on the LARS® AC Band device, including testing for tensile strength, tear strength, burst strength and biocompatibility testing. Review and analysis of published clinical data and test reports was conducted on the LARS® AC Band device, including wear of the surrounding bone and bone fracture, wear of the device, particulates and inflammatory/biologic response at the site of surgical placement.
Key Metrics
Not Found
Predicate Device(s)
LOCKDOWN™ Acromioclavicular (AC) device (K091207)
Reference Device(s)
Surgicraft Surgical Mesh System (K072370)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
Corin USA Lucinda Gerber Global Regulatory Affairs Manager 12750 Citrus Park Lane, Suite 120 Tampa, Florida 33625
Re: K190143
Trade/Device Name: LARS® AC Band Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN, MBI Dated: October 1, 2019 Received: October 2, 2019
Dear Lucinda Gerber:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190143
Device Name LARS® AC Band Device
Indications for Use (Describe)
The LARS® AC Band device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
The LARS® AC Band device is intended for single use only.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740
3
3. 510(K) SUMMARY
| 1. Applicant/Sponsor:
Distributor | Corin USA
12750 Citrus Park Lane
Suite 120
Tampa, Florida 33625
Establishment Registration No .: 1056629 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Manufacturer: | LARS SA
5 Rue De La Fontaine
21560 Arc-Sur-Tille
France
Establishment Registration No: None |
| 3. Contact Person: | Lucinda Gerber
Global Regulatory Affairs Manager
Corin USA
1 (772) 321-2478
Lucinda.Gerber@coringroup.com |
| 4. Date: | January 28, 2019 |
| 5. Proprietary Name: | LARS® AC Band device |
| 6. Common Name: | Fastener, Fixation, Nondegradable, Soft Tissue |
| 7. Product Code(s): | MBI, HTN |
| 8. Classification Name: | 888.3040 - Fastener, fixation, nondegradable, soft tissue
888.3030 - Single/multiple component metallic bone fixation
appliances and accessories |
9. Legally Marketed Devices to which Substantial Equivalence is claimed:
- LOCKDOWN™ Acromioclavicular (AC) device (K091207) .
10. Legally Marketed Reference Devices
- Surgicraft Surgical Mesh System (K072370) ●
11. Device Description:
The LARS® AC Band device is a knitted surgical scaffold manufactured from poly(ethylene terephthalate) (PET) which is non-biodegradable. The LARS® AC Band device is available in 1 size which is 6mm wide by 400mm in length with a loop at one end and is secured by sutures. The use of high strength #2, non-resorbable single use sterile sutures is recommended. The construct permits the mesh to be cut into any desired size without unraveling. The device is supplied sterile, for singlepatient use.
4
12. Intended Use / Indications:
The LARS® AC Band device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
The LARS® AC Band device is intended for single use only.
13. Summary of Technologies/Substantial Equivalence:
The LARS® AC Band device in terms of material is the same as the reference device Surgicraft Surgical Mesh System (K072370). The LARS® AC Band device is identical to the predicate LOCKDOWN™ Acromioclavicular (AC) device (K091207) in indications and material and is similar in design. Based on these similarities, Corin believes that the LARS® AC Band device is substantially equivalent to the predicate device.
14. Non-Clinical Testing:
Non-clinical testing and analysis was conducted on the LARS® AC Band device, including testing for tensile strength, tear strength, burst strength and biocompatibility testing.
15. Clinical Testing:
Review and analysis of published clinical data and test reports was conducted on the LARS® AC Band device, including wear of the surrounding bone and bone fracture, wear of the device, particulates and inflammatory/biologic response at the site of surgical placement.