(19 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of the interference screws and associated instruments, with no mention of AI or ML.
Yes
The device is described as an "Interference Screw System" intended for "fixation of tissue including ligament, tendon, soft tissue, or bone to bone" in various surgical procedures, which are considered therapeutic interventions.
No
The device description clearly states its purpose as "reattachment and fixation of tissue" and lists surgical procedures, indicating a therapeutic or reconstructive function rather than diagnosis.
No
The device description explicitly states that the system includes physical components such as cannulated interference screws made of PEEK or titanium, drivers, sizers, reamers, taps, and guide wires. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text clearly describes a device used for the surgical fixation of tissue (ligament, tendon, soft tissue, or bone to bone) within the body. It is an implantable device used during surgical procedures.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Responsive Arthroscopy Interference Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondy.itis Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
Product codes (comma separated list FDA assigned to the subject device)
HWC, MBI
Device Description
The Responsive Arthroscopy Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polyether ether ketone (PEEK) per ASTM F2026 and Ti-6Al-4V ELI titanium alloy per ASTM F136, along with drivers, sizers, reamers, taps, and guide wires for screw insertion.
The only design differences in the subject device are regarding interference screw length, cannulation, and driving feature. The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 15-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm.
The RA Interference Screw System implants are provided sterile. The RA Interference Screw System single-use instruments are provided sterile, and the RA Interference Screw System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Interference Screw implants and singleuse instruments are sterilized with ethylene oxide (EO).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee, shoulder, elbow, ankle, foot, and hand/wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 bench testing was performed on the Responsive Arthroscopy Interference Screw System:
Insertion (Driving) Torque
Static Push Out Force
Cyclic Pull Out Force
Bacterial Endotoxin Testing (LAL)
In summary, the performance testing of the Responsive Arthroscopy Interference Screw 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.
Responsive Arthroscopy Interference Screw System (K180573), EZStart Interference Screw (K182955)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below.
September 23, 2020
Responsive Arthroscopy LLC % Kristen Peña Associate Manager, Product Development Operations Cor Medical Ventures 215 S. Highway 101, Suite 200 Solana Beach, California 92075
Re: K202569
Trade/Device Name: Responsive Arthroscopy Interference Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: September 1, 2020 Received: September 4, 2020
Dear Ms. Peña:
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.
1
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 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 (OS) 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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K202569
Device Name
Responsive Arthroscopy Interference Screw System
Indications for Use (Describe)
The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction, Anterior Shoulder Instability
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondy.itis Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
| 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) |
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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: | Kristen Peña |
| DATE PREPARED: | September 1, 2020 |
| TRADE NAME: | Responsive Arthroscopy Interference Screw System |
| COMMON NAME: | Interference Screw System |
| CLASSIFICATION NAME: | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| PRODUCT CODE: | HWC, MBI |
SUBSTANTIAL EQUIVALENCE:
The Responsive Arthroscopy Interference Screw System is substantially equivalent to the predicate device in all facets including: function, design, performance, material, and intended use.
| Primary Predicate Device: | Responsive Arthroscopy Interference Screw System (K180573) |
|---|---|
| Predicate Device: | EZStart Interference Screw (K182955) |
DEVICE DESCRIPTION:
The Responsive Arthroscopy Interference Screw System is a family of interference screws for the reattachment and fixation of tissue including ligament, tendon, soft tissue, or bone to bone. The system includes cannulated interference screws in both polyether ether ketone (PEEK) per ASTM F2026 and Ti-6Al-4V ELI titanium alloy per ASTM F136, along with drivers, sizers, reamers, taps, and guide wires for screw insertion.
The only design differences in the subject device are regarding interference screw length, cannulation, and driving feature. The screws are available in a variety of sizes to accommodate various procedures and patient anatomies. RA PEEK Interference Screws are offered with diameters from 7-12mm and lengths from 15-35mm. RA Titanium Interference Screws are offered with diameters from 7-10mm and lengths from 20-35mm.
The RA Interference Screw System implants are provided sterile. The RA Interference Screw System single-use instruments are provided sterile, and the RA Interference Screw System reusable instruments
4
are non-sterile and are to be sterilized by the end user. All RA Interference Screw implants and singleuse instruments are sterilized with ethylene oxide (EO).
MATERIALS:
The RA PEEK Interference Screws are machined from extruded PEEK per ASTM F2026. The RA Titanium Interference Screws are machined from Ti-6Al-4V ELI titanium alloy per ASTM F136.
INDICATIONS FOR USE:
The Responsive Arthroscopy Interference Screws are intended to be used for fixation of tissue including ligament, tendon, soft tissue, or bone to bone. Interference fixation with PEEK or Titanium Interference Screws is appropriate for surgeries of the knee, shoulder, elbow, ankle, foot, and hand/wrist where the sizes offered are patient appropriate. Specifically, screws are intended for use in the following procedures:
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction, Anterior Shoulder Instability
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfers in the Foot and Ankle, Bunionectomy
Knee: Anterior Cruciate Ligament Repair, Posterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal Joint
PERFORMANCE TESTING:
The following bench testing was performed on the Responsive Arthroscopy Interference Screw System:
Insertion (Driving) Torque Static Push Out Force Cyclic Pull Out Force Bacterial Endotoxin Testing (LAL)
In summary, the performance testing of the Responsive Arthroscopy Interference Screw System indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.
CONCLUSION:
The Responsive Arthroscopy Interference Screw System is substantially equivalent to a legally marketed predicate based on indications for use, technological characteristics, performance testing, and comparison to a predicate device.