(112 days)
The REVCON™ Screw System is indicated for fixation of bone surgery involving reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment
- · Akin type osteotomy
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Calcaneus/cuboid arthrodesis
- · Talar/navicular arthrodesis.
The REVCON™ Screw System is not intended for spinal use.
The REVCON™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device, to allow surgeons to perform a bunion osteotomy and fixation of the osteotomy with a minimally surgical technique. The REVCON™ Screw System contains fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) as per ASTM F136 and are provided non-sterile for end user sterilization.
Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) submission for the REVCON™ Screw System:
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Type | Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|---|
| Mechanical Testing | Torsional Testing: Evaluate resistance to twisting forces. | Acceptable |
| Driving Torque: - Insertion Torque - Removal Torque | Acceptable | |
| Axial Pullout Strength: Evaluate resistance to pulling out from bone. | Acceptable | |
| Biocompatibility | Biological safety evaluation as per ISO 10993-1. Material recognized by FDA for implantation. | Determined to be substantially equivalent to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for the mechanical testing (e.g., number of screws tested for each mechanical property). It generally refers to "testing according to the applicable ASTM standards," which would implicitly define sample size requirements.
The data provenance is non-clinical bench testing. The document does not involve human subjects, so there's no country of origin or retrospective/prospective data as commonly understood in clinical trials. It's essentially laboratory-generated data to demonstrate the physical properties and safety of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study described is non-clinical mechanical and biocompatibility testing, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as above. No ground truth was established through expert adjudication. The "ground truth" for mechanical testing is derived from the objective measurements and comparison against established ASTM standards and predicate device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing is not required and therefore not conducted as part of this submission." This indicates that the device's performance was not evaluated through human readers, with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:
No, a standalone performance study was not done. This type of study would be relevant for devices involving algorithms or AI, which is not the case for the REVCON™ Screw System. The performance evaluated here is directly tied to the physical properties of the screw system itself.
7. Type of Ground Truth Used:
The ground truth used for this submission is based on:
- Objective Mechanical Measurements: Performance against established engineering standards (ASTM F543) for torsional strength, driving torque, and axial pullout strength.
- Biocompatibility Standards: Compliance with ISO 10993-1 and the use of FDA-recognized implantable materials (Ti-6Al-4V-ELI titanium alloy per ASTM F136).
- Comparison to Predicate Device: Demonstrating substantial equivalence to the Wright Medical MICA™ Screw System (K162353), implying that the predicate's established safety and effectiveness serve as a benchmark for the "ground truth" of performance.
8. Sample Size for the Training Set:
Not applicable. This device is a physical medical implant (bone screw system) and does not involve AI/machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reasons as above.
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February 28, 2023
Voom Medical Devices, Inc. % Morgan Hill Senior Project Engineer Jalex Medical 27865 Clemens Road Suite 3 Westlake, Ohio 44145
Re: K223392
Trade/Device Name: REVCON™ Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: November 7, 2022 Received: November 8, 2022
Dear Morgan Hill:
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.
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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 (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 mediation-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.
Jesse Muir -S
For: Shumaya Ali, M.P.H. 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
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Indications for Use
510(k) Number (if known)
K223392
Device Name REVCON™ Screw System
Indications for Use (Describe)
The REVCON™ Screw System is indicated for fixation of bone surgery involving reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment
- · Akin type osteotomy
- · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- · Calcaneus/cuboid arthrodesis
- · Talar/navicular arthrodesis.
The REVCON™ Screw System is not intended for spinal use.
| 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)
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Image /page/3/Picture/0 description: The image shows the logo for Voom Medical Devices. The logo consists of the word "voom" in a dark blue sans-serif font, with a purple square made of smaller squares to the left of the word. The letters are connected and stylized, and the letters are followed by the superscript letters "TM". Below the word "voom" are the words "MEDICAL DEVICES" in a smaller, sans-serif font.
K223392 510(k) Submission - REVCON™ Screws
510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the REVCON™ Screw System.
| Submitted By: | Voom Medical Devices, Inc.800A 5th Ave, #403New York, NY 10065 |
|---|---|
| Date: | 28FEB2023 |
| Contact Person: | Morgan Hill, Senior Project Engineer |
| Contact Telephone: | (440) 222-5414 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | REVCONT™ Screw System |
| Common Name: | Screw, Fixation, Bone |
| Device Classification Name: | 21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | HWC |
| Primary Predicate Device: | Wright Medical MICATM Screw System (K162353) |
| Additional Predicates: | N/A |
Device Description:
The REVCON™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device, to allow surgeons to perform a bunion osteotomy and fixation of the osteotomy with a minimally surgical technique. The REVCON™ Screw System contains fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI) as per ASTM F136 and are provided non-sterile for end user sterilization.
Indications for Use:
The REVCON™ Screw System is indicated for fixation of bone surgery involving reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment
- · Akin type osteotomy
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Image /page/4/Picture/1 description: The image shows the logo for Voom Medical Devices. The logo is purple and blue. The word "Voom" is in a stylized font, with the "V" made up of purple squares. Below the logo, the words "MEDICAL DEVICES" are written in a smaller, sans-serif font.
510(k) Submission - REVCONTM Screws
- Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Calcaneus/cuboid arthrodesis
- · Talar/navicular arthrodesis.
The REVCON™ Screw System is not intended for spinal use.
Summary of Technological Characteristics:
The REVCON™ Screw System is fabricated from titanium alloy per ASTM F136, and the design features for the screw system are similar to the MICA™ Screw System predicate device, including dimensions, shape, and sizes.
Performance Data - Nonclinical:
Substantial equivalence is supported by the results of mechanical testing including engineering analysis of torsional strength, driving torque, and axial pullout strength testing as per ASTM F543. Standard Specification and Test Metallic Medical Bone Screws and the FDA Guidance: Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway).
| Verification Method | Results |
|---|---|
| Torsional Testing | Acceptable |
| Driving Torque:-Insertion Torque-Removal Torque | Acceptable |
| Axial Pullout Strength | Acceptable |
Table 6.1. Mechanical Testing Program for REVCON™ Screw System
Testing according to the applicable ASTM standards demonstrated that the REVCON™ Screw System met all performance based requirements and acceptance criteria to support safety and is considered substantially equivalent to the predicate device.
Biocompatibility:
Biocompatibility evaluation was performed as per ISO 10993-1 to evaluate the biological safety of the REVCON™ Screw System according to the FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". The REVCON™ Screw System is categorized as an implanted medical device, principally contacting bone and tissue, with duration of contact exceeding 30 days (long-term contact). The REVCON™ bone screws are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F136, and this material is recognized by the FDA and cleared for implantation. All patient contacting instrumentation for this device is manufactured from medical grade stainless steel and is specified to be cleaned/passivated as per ASTM A967. Based on the materials, manufacturing methods, and cleaning processes used to produce the REVCON™ system, it was determined that the biocompatibility of the subject device was substantially equivalent to the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for Voom Medical Devices. The logo consists of the word "voom" in a stylized font, with a grid of purple squares to the left of the word. Below the word "voom" is the text "MEDICAL DEVICES" in a smaller font. The color scheme is primarily purple and dark blue.
Performance Data - Clinical:
Clinical testing is not required and therefore not conducted as part of this submission.
Substantial Equivalence:
The REVCON™ Screw System has the same intended use and fundamental scientific technology as the Wright Medical MICA™ Screw System (K162353) primary predicate devices compare similarly in:
- Design features and instrumentation
- Intended use and indications for use
- Material composition
- Dimensions ●
- Function
- Sterilization methods
The potential impact on substantial equivalence of each technological difference was addressed through risk analysis and verification and validation testing. Any differences between the REVCON™ Screw System and the predicate device do not raise any questions of safety and effectiveness.
Conclusion:
The REVCON™ Screw System is as safe and effective as its predicate device, as it has similar intended use, indication for use, material composition, design features, manufacturing method, sterilization method, performance requirements and principles of operation as the primary predicate device (K162353). The design differences do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. Non-clinical testing demonstrates that the REVCON™ Screw System is as safe and effective as the predicate, therefore is substantially equivalent.
§ 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.