(193 days)
Not Found
No
The device description and performance studies focus on mechanical properties and materials, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for soft tissue to bone fixation for various repairs and reconstructions across multiple anatomical sites (e.g., shoulder, knee, hip), which are therapeutic indications.
No
The device is described as a "knotless system for the fixation of soft tissue to bone," indicating it is for surgical repair rather than for diagnosing medical conditions.
No
The device description explicitly lists hardware components including a suture-button implant assembly, an implantable two-holed plate, and instrumentation (drills and drivers).
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 system for soft tissue to bone fixation during surgical procedures (arthroscopy). This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The device components are implants (suture-button assembly, plate) and surgical instruments (drills, drivers). These are used in vivo (within the body) during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.) or providing information for diagnosis. IVDs are designed to perform tests on such samples to provide diagnostic information.
Therefore, the Responsive Arthroscopy Thunderbolt System is a surgical device used for fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Responsive Arthroscopy Thunderbolt System is intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis
Foot and Ankle: Medial/lateral repair and reconstruction, Mid-and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures
Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCL repair/reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement. Joint capsule closure
Hand and Wrist. Collateral ligament repair. Scapholunate ligament reconstruction. Tendon transfers in phalanx. Volar plate reconstruction
Hip: Acetabular labral repair
Product codes (comma separated list FDA assigned to the subject device)
MBI, JDR
Device Description
The Responsive Arthroscopy Thunderbolt System is a knotless system for the fixation of soft tissue to bone. The system includes a suture-button implant assembly made of Ti-6Al-4V ELI per ASTM F136 and ultra high molecular weight polyethylene, an implantable two holed plate made of Ti-6Al-4V EU per ASTM F136, and instrumentation including drills and drivers. The implants and single-use instruments are provided sterile, and the reusable instruments are non-sterile and are to be sterilized by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical testing was performed on the Responsive Arthroscopy Thunderbolt System:
- . Static Pullout Force Testing
- . Cyclic Pullout Force Testing
- Suture Characterization (previously cleared device reference)
- Biocompatibility Risk Analysis
- Sterility
- Packaging
- Shelf-Life
- Pyrogenicity
In summary, mechanical testing of the Responsive Arthroscopy Thunderbolt System indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
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.
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
§ 888.3040 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
April 27, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Responsive Arthroscopy LLC % Benjamin Arnold Cor Medical Ventures, Inc. 2010 Jimmy Durante Boulevard, Suite 200 Del Mar, California 92014
Re: K203121
Trade/Device Name: Responsive Arthroscopy Thunderbolt System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, JDR Dated: October 15, 2020 Received: October 16, 2020
Dear Benjamin Arnold:
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 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
1
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,
for
Laura C. Rose, Ph.D. Assistant 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
Indications for Use
510(k) Number (if known) K203121
R205121
Device Name Responsive Arthroscopy Thunderbolt System
Indications for Use (Describe)
The Responsive Arthroscopy Thunderbolt System is intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis
Foot and Ankle: Medial/lateral repair and reconstruction, Mid-and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures
Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCL repair/reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement. Joint capsule closure
Hand and Wrist. Collateral ligament repair. Scapholunate ligament reconstruction. Tendon transfers in phalanx. Volar plate reconstruction
Hip: Acetabular labral repair
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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."
3
510(K) SUMMARY
SUBMITTER:
Submitted By:
| Company Name:
Address: | Responsive Arthroscopy LLC
701 N. 3rd Street, Suite 208
Minneapolis, MN 55401 |
|---------------------------|------------------------------------------------------------------------------------------------------------------|
| Telephone: | 858-720-1847 |
| CONTACT PERSON: | Benjamin Arnold |
| DATE PREPARED: | March 24, 2021 |
| TRADE NAME: | Responsive Arthroscopy Thunderbolt System |
| COMMON NAME: | Suture-Button Implant |
| CLASSIFICATION NAMES: | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
Staple, Fixation, Bone (21 CFR 888.3030) |
| PRODUCT CODES: | MBI and JDR |
SUBSTANTIAL EQUIVALENCE:
The Responsive Arthroscopy Thunderbolt System is substantially equivalent to the predicate devices in all facets including: function, design, performance, material, and intended use.
Biomet ToggleLocTM System (K130033) Primary Predicate Device:
Arthrex TightRope™ (K043248) Additional Predicate Devices:
DEVICE DESCRIPTION:
The Responsive Arthroscopy Thunderbolt System is a knotless system for the fixation of soft tissue to bone. The system includes a suture-button implant assembly made of Ti-6Al-4V ELI per ASTM F136 and ultra high molecular weight polyethylene, an implantable two holed plate made of Ti-6Al-4V EU per ASTM F136, and instrumentation including drills and drivers. The implants and single-use instruments are provided sterile, and the reusable instruments are non-sterile and are to be sterilized by the end user.
4
INDICATIONS FOR USE:
The Responsive Arthroscopy Thunderbolt System is intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repair, SLAP lesion repairs, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff tear repair, Biceps Tenodesis
Foot and Ankle: Medial/lateral reconstruction, Mid-and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair, Ankle Syndesmosis fixation (Syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures
Elbow: Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee: ACL/PCL repair/ reconstruction, ACL/PCL patellar bone-tendon-bone grafts, Double-Tunnel ACL reconstruction, Extracapsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair
PERFORMANCE TESTING:
The following non-clinical testing was performed on the Responsive Arthroscopy Thunderbolt System:
- . Static Pullout Force Testing
- . Cyclic Pullout Force Testing
- Suture Characterization (previously cleared device reference)
- Biocompatibility Risk Analysis
- Sterility
- Packaging
- Shelf-Life
- Pyrogenicity
In summary, mechanical testing of the Responsive Arthroscopy Thunderbolt System indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
5
CONCLUSIONS:
The Responsive Arthroscopy Thunderbolt System has shown to be substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing, and comparison to predicate devices.