(118 days)
Not Found
No
The summary describes a mechanical and optical device for endoscopic surgery with video visualization, but there is no mention of AI or ML capabilities for image analysis, decision support, or any other function.
Yes
The device is intended for minimally invasive ligament or fascia release surgeries, which are procedures performed to treat medical conditions, thereby qualifying it as a therapeutic device.
No
The device description indicates it is a surgical tool used for minimally invasive ligament or fascia release, not for diagnosis. Its components (surgical knife, camera, light) are for visualization during surgery and cutting tissues, not for identifying or characterizing a medical condition.
No
The device description clearly outlines hardware components including a handpiece with a surgical knife, camera, light, cannula, and a proprietary tablet. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "minimally invasive ligament or fascia release surgeries," specifically carpal tunnel release and cubital tunnel release. This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical tool (handpiece with a knife, camera, and light) used to cut tissue inside the body. It is introduced through incisions and used to visualize and sever ligaments or fascia.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This device is a surgical instrument used during a procedure on the patient, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The VECTR - Video Endoscopic Carpal Tunnel Release System is in minimally invasive ligament or fascia release surgeries, such as:
· Carpal tunnel release in the wrist
· Cubital tunnel release in the elbow
Product codes
HRX, EMF
Device Description
The VECTR – Video Endoscopic Carpal Tunnel Release System is composed of a handpiece (5200-01) and a proprietary tablet (5200-90). The handpiece is an arthroscopic unit with an integrated surgical knife. It is intended for minimally invasive ligament or fascia release in endoscopic carpal tunnel release (ECTR) surgery. The proprietary tablet is a registered class I medical device that is commercially available.
The handpiece is a single-use disposable device that combines the traditional manual surgical knife with an arthroscope all in one. It is fully integrated into a single unit and consists of a functional tip (surgical knife), live-action camera, light, cannula, and cord to connect to the proprietary tablet. The surgical knife can be used to sever tendons, ligaments, or fascia in the joints or limbs and is able to be protracted or retracted via a slide switch on the side of the handpiece.
During procedures, surgeons will introduce the device through incisions made in the patient's wrist. Once inside, the camera and light are used to visualize the surgical environment on the proprietary tablet. Once the surgeon has maneuvered the device into the desired location, the blade can be actuated and the ligament can be cut. Once cut, the surgeon will withdraw the blade and remove the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist, elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Nonclinical tests were used to help validate the substantial equivalence between the VECTR System and the chosen predicate the SMARTRELEASE Endoscopic Soft Tissue Release System (K223406). Specifically, this submission utilizes sterility; package stability; shelf life; biocompatibility; electromagnetic compatibility; electrical, mechanical, and thermal safety; and bench testing.
The sterility nonclinical testing provided in this submission supports an ethylene oxide sterilization method. This nonclinical testing included a combined biological indicator and bioburden approach. Along with sterilization method validation, Rafael Medical Devices completed ethylene oxide and ethylene chlorohydrin residual testing.
Following sterilization testing, package stability testing was completed to determine the ability of the package system to protect the VECTR System from hazards typically associated with the shipping and distribution environment.
After package validation testing, accelerated aging testing for validation of a six month shelf life was completed on the primary packaging of the VECTR System to ensure that seal integrity persisted over the defined shelf life.
For biocompatibility, Rafael Medical Devices provided nonclinical testing to support a tissue contact of "externally-communicating device: tissue/bone/dentin" with a "transient (
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
December 11, 2024
Rafael Medical Devices, LLC % Michael Nilo President, Principal Consultant Nilo Medical Consulting Group, LLC 3706 Butler St, Suite #313 Pittsburgh, Pennsylvania 15201
Re: K242417
Trade/Device Name: VECTR - Video Endoscopic Carpal Tunnel Release System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, EMF Dated: November 15, 2024 Received: November 15, 2024
Dear Michael Nilo:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Robert M. Stefani -S 2024.12.11 13:22:02 -05'00'
For: Jesse Muir, 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
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Indications for Use
510(k) Number (if known) K242417
Device Name
VECTR - Video Endoscopic Carpal Tunnel Release System
Indications for Use (Describe)
The VECTR - Video Endoscopic Carpal Tunnel Release System is in minimally invasive ligament or fascia release surgeries, such as:
· Carpal tunnel release in the wrist
· Cubital tunnel release in the elbow
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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510(k) Summary
| 510(k) # | K242417 |
|---|---|
| Date Prepared | December 6, 2024 |
Contact Details: 21 CFR 807.92(a)(1)
| Applicant Name | Rafael Medical Devices, LLC |
|---|---|
| Applicant Address | 520 Broad Street Newark NJ 07102 United States |
| Applicant Contact Telephone | (973) 381-0411 |
| Applicant Contact | Dr. Gavriel Feuer |
| Applicant Contact Email | gavi.feuer@rafaelmedicaldevices.com |
| Correspondent Name | Nilo Medical Consulting Group, LLC |
|---|---|
| Correspondent Address | 3706 Butler St, Suite #313 Pittsburgh PA 15201 |
| United States | |
| Correspondent Contact Telephone | (717) 421-4369 |
| Correspondent Contact | Mr. Michael Nilo |
| Correspondent Email | Michael.nilo@nilomed.com |
Device Name: 21 CFR 807.92(a)(2)
| Device Trade Name | VECTR – Video Endoscopic Carpal Tunnel Release
System |
|---------------------|----------------------------------------------------------|
| Common Name | Arthroscope |
| Classification Name | Arthroscope |
| Regulation Number | 888.1100 |
| Product Codes | HRX, EMF |
Legally Marketed Predicate Devices: 21 CFR807.92(a)(3)
| Predicate Number | K223406 |
|---|---|
| Predicate Trade Name | SMARTRELEASE Endoscopic Soft Tissue Release |
| System | |
| Product Code | HRX |
| Reference Device | A.M. Surgical Stratos ECTR Device |
|---|---|
| Registration Number | 2437731 |
| Classification | Class-1 |
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Device Description Summary: 21CFR807.92(a)(4)
The VECTR – Video Endoscopic Carpal Tunnel Release System is composed of a handpiece (5200-01) and a proprietary tablet (5200-90). The handpiece is an arthroscopic unit with an integrated surgical knife. It is intended for minimally invasive ligament or fascia release in endoscopic carpal tunnel release (ECTR) surgery. The proprietary tablet is a registered class I medical device that is commercially available.
The handpiece is a single-use disposable device that combines the traditional manual surgical knife with an arthroscope all in one. It is fully integrated into a single unit and consists of a functional tip (surgical knife), live-action camera, light, cannula, and cord to connect to the proprietary tablet. The surgical knife can be used to sever tendons, ligaments, or fascia in the joints or limbs and is able to be protracted or retracted via a slide switch on the side of the handpiece.
During procedures, surgeons will introduce the device through incisions made in the patient's wrist. Once inside, the camera and light are used to visualize the surgical environment on the proprietary tablet. Once the surgeon has maneuvered the device into the desired location, the blade can be actuated and the ligament can be cut. Once cut, the surgeon will withdraw the blade and remove the device.
Intended Use/Indications for Use: 21 CFR 807.92(a)(5)
The VECTR - Video Endoscopic Carpal Tunnel Release System is indicated for use in minimally invasive ligament or fascia release surgeries, such as:
- · Carpal tunnel release in the wrist
- Cubital tunnel release in the elbow
Indications for Use Comparison: 21CFR807.92(a)(5)
The VECTR - Video Endoscopic Carpal Tunnel Release System and the SMARTRELEASE Endoscopic Soft Tissue Release System (K223406) have almost identical indications for use. K223406 also includes indications for trigger finger release in the hand which were granted after two additional 510(k) were submitted to the FDA. The current indications for the VECTR - Video Endoscopic Carpal Tunnel Release System are identical to the original indications for use present in K181819.
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Technological Comparison: 21CFR807.92(a)(6)
There are two technological differences between the predicate and reference devices. First, the reusability of the two devices differs. The SMARTRELEASE® Endoscopic Soft Tissue Release System (K223406) utilizes an endoscope that is inserted into the housing for procedures. Once the surgery is completed, the housing is removed from the endoscope and disposed of while the endoscope is reprocessed for later use. For the VECTR - Video Endoscopic Carpal Tunnel Release System (hereon VECTR System), the housing has an intrinsic CMOS camera that is discarded with the rest of the handpiece, making it a singleuse system. This difference in reusability does not present any additional risks when compared to the predicate device.
The second difference between the predicate and reference device is in the materials used to make the housing. The SMARTRELEASE® Endoscopic Soft Tissue Release System (K223406) is built with aluminum, stainless steel, and Radel polyphenylsulfone. The housing for the VECTR System is made of Makrolon M430-901510.
Non-Clinical and/or Clinical Tests Summary & Conclusions: 21CFR807.92(b)
Brief Discussion of the nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence:
Within this submission. nonclinical tests were used to help validate the substantial equivalence between the VECTR System and the chosen predicate the SMARTRELEASE® Endoscopic Soft Tissue Release System (K223406). Specifically, this submission utilizes sterility; package stability; shelf life; biocompatibility; electromagnetic compatibility; electrical, mechanical, and thermal safety; and bench testing.
The sterility nonclinical testing provided in this submission supports an ethylene oxide sterilization method. This nonclinical testing included a combined biological indicator and bioburden approach. Along with sterilization method validation, Rafael Medical Devices completed ethylene oxide and ethylene chlorohydrin residual testing. The standards referenced by these nonclinical tests include AAMI/ISO 11135:2014/Amendment 1:2018 Sterilization of health care products - Ethylene oxide - Requirements or the development, validation and routine control of a sterilization process for medical devices; ISO 10993-7:2008/AMD 1:2019 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals; ISO 11138-1:2017 Sterilization of healthcare products - Biological indicators - Part 1: General Requirements; ISO 11138-2:2017 Sterilization of healthcare products - Biological indicators - Part 2; Biological indicators for ethylene oxide
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sterilization processes, ISO 11737-1:2018/AMD 1:2021 Sterilization of medical devices -Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1; ISO 11737-2:2019 Sterilization of medical devices -Microbiological methods – Part 2: Tests of sterility performed in the validation of a sterilization process: AAMI TIR 16:2017/R 2020 Microbiological aspects of ethylene oxide sterilization: PRO 24001 Protocol for Full Validation dated January 2024: and RPT 24001 Rev B Report for Full Validation dated July 2024.
Following sterilization testing, package stability testing was completed. This nonclinical testing was provided to determine the ability of the package system to protect the VECTR System from hazards typically associated with the shipping and distribution environment. The standards referenced by this testing include ASTM D5276-19 Standard Test Method for Drop Test of Loaded Containers by Free Fall; ASTM D642-20 Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads; D999-08 Standard Test Methods for Vibration Testing of Shipping Containers; ASTM D4728-17 Standard Test Method for Random Vibration Testing of Shipping Containers; and ASTM D6344-04 Standard Test Method for Concentrated Impacts to Transport Packages.
After package validation testing, the next nonclinical testing referenced in this submission was accelerated aging testing for validation of a six month shelf life. This testing was completed on the primary packaging of the VECTR System to ensure that seal integrity persisted over the defined shelf life. This testing referenced ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices; ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test); and ASTM F88/F88M-23 Standard Test Method for Seal Strength of Flexible Barrier Systems.
For biocompatibility, Rafael Medical Devices provided nonclinical testing to support a tissue contact of "externally-communicating device: tissue/bone/dentin" with a "transient ( Pyrogen Test.
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For Electromagnetic Compatibility (EMC) testing, Rafael Medical Devices conducted appropriate immunity and emitter testing as defined by IEC 60601-1-2:2014/AMD1:2020 Amendment 1 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests. As a part of this nonclinical testing, appropriate immunity testing was conducted including CISPR 11 emission limits: electrostatic discharge immunity: radiated RF electromagnetic field immunity; proximity field immunity; power frequency magnetic field immunity; conducted disturbances generated by RF fields immunity; electrical fast transient/burst immunity; and voltage dips, short interruptions, and voltage variations immunity.
For electrical, mechanical, and thermal safety testing, appropriate nonclinical testing was supplied to support the requirements set forth by ANSI/AAMI ES60601-1:2005/(R)2012/A2:2021 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance - Amendment 2; ISO 14971 Medical Devices -Application of Risk Management to Medical Devices; and IEC 60601-2-18:2009 Medical Electrical Equipment - Part 2-18: Particular Requirements for the Basic Safety and Essential Performance of Endoscopic Equipment.
Lastly nonclinical bench testing was conducted to support the substantial equivalence between the predicate and reference device. This testing included device and tablet continuous working and LED temperature, latency, blade deployment, insertion force, blade height, blade safety lock, blade safety lock force, tablet video output, tablet control, tablet admin control testing, blade sharpness, blade horizontal deflection, and blade vertical deflection testing.
Summary discussion of the clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence:
Not Applicable
Conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified above:
The testing performed demonstrates that the device is sterile, adequately packaged, supports the labeled shelf life, is electromagnetically compatible, and performs the intended functions as designed. The evidence presented demonstrates that the VECTR is substantially equivalent to the predicate device.