(88 days)
VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger: The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.
VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger: The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:
- Intraoperative (Microvascular and Vascular)
- Intraoperative Neurological
- Transrectal and Peripheral Vascular.
VascuChek® Surgical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.
VascuChek® Clinical is a cardiovascular blood flowmeter comprised of two components: a sterile VascuChek™ Surgical Probe with sheath which connects to the reusable, nonsterile VascuChek™ Transceiver. The sheath is deployed over, and encapsulates the transceiver, allowing it to be used within the sterile field.
The VascuChek® device follows Track 1.
A transmitter in the transceiver drives the ultrasonic transmitting crystal located at the tip of the probe component. The ultrasonic waves generated by the sensor travel through the tissue just under the probe tip in a narrow beam. The reflected ultrasonic waves are received by the transducer and are converted via the piezoelectric effect into a high frequency electronic signal. band audio Doppler shifted signal which is filtered and converted to audio via a speaker. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the returning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
The provided text is a 510(k) summary for a medical device called VascuChek®. It outlines the device description, indications for use, comparison to predicate devices, and a summary of non-clinical performance testing.
However, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance: While it mentions electrical safety, EMC, firmware verification, and biocompatibility testing, these are general device safety and performance criteria, not specific performance metrics for an AI/ML algorithm (e.g., sensitivity, specificity, AUC).
- Sample size and data provenance for a test set: No information regarding a test set, its size, or where the data came from (country, retrospective/prospective) is provided.
- Number and qualifications of experts for ground truth: There's no mention of experts, how many, or their qualifications, as the device doesn't appear to rely on such ground truth establishment for its performance claims.
- Adjudication method: Not applicable as there's no mention of expert review or ground truth establishment in this context.
- MRMC comparative effectiveness study: There is no indication of such a study being performed or any effect size for human reader improvement with AI assistance.
- Standalone (algorithm only) performance: The device described is a blood flowmeter, a hardware device with firmware, not an AI/ML algorithm that would have standalone performance metrics like sensitivity/specificity.
- Type of ground truth used: Not applicable for a non-AI/ML device that measures physiological parameters.
- Sample size for training set: Not applicable as it's not an AI/ML device.
- How ground truth for training set was established: Not applicable.
Explanation Based on the Provided Document:
The VascuChek® device is a cardiovascular blood flowmeter that uses ultrasonic technology to detect blood flow and convert frequency differences into an audible tone. It's a hardware device with integrated firmware, not an AI/ML-driven diagnostic or assistive tool. The performance studies mentioned are related to:
- Electrical Safety Testing (ANSI AAMI ES60601-1): Ensures the device is electrically safe.
- EMC Testing (IEC 60601-1-2, IEC 60601-2-37): Ensures the device operates correctly in its electromagnetic environment and doesn't interfere with other devices.
- Firmware Verification Testing: Confirms the embedded software functions as intended.
- Biocompatibility information: Addresses the safety of the materials in contact with the patient.
These are standard regulatory requirements for medical devices but are not related to the performance evaluation of an AI/ML algorithm. The document explicitly states that the device employs "identical technology" and "identical firmware requirements and performance" to its predicate devices, indicating that its performance is established through equivalence to existing, cleared devices, rather than through complex AI/ML validation studies.
Conclusion:
The provided 510(k) summary does not contain the information requested regarding acceptance criteria and study details for an AI/ML device because the VascuChek® device is an ultrasonic blood flowmeter and not an AI/ML-based medical device. Therefore, a study demonstrating AI/ML performance metrics (e.g., sensitivity, specificity, reader studies) was not conducted or reported for this submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2024
Remington Medical, Inc. % Justin Gracyalny Regulatory Affairs Manager Secure BioMed Evaluations 7828 Hickory Flat Hwy, Suite 120 Woodstock, Georgia 30188
Re: K241583
Trade/Device Name: VascuChek® Clinical and VascuChek® Surgical Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: June 3, 2024 Received: June 3, 2024
Dear Justin Gracyalny:
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.
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"
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(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 OS 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 Rue"). 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.
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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-regulatory-
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,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular 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) K241583
Device Name VascuChek® Clinical and VascuChek® Surgical
Indications for Use (Describe)
VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe, VascuChek® Charger: The VascuChek® device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.
VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe, VascuChek® Charger:
The VascuChek® device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:
-
Intraoperative (Microvascular and Vascular)
-
Intraoperative Neurological
-
Transrectal and Peripheral Vascular.
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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K241583
| Date Prepared | August 30, 2024 |
|---|---|
| Sponsor | Remington Medical, Inc. |
| 6830 Meadowridge CourtAlpharetta, GA 30005470-719-1084 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Justin Gracyalny, MSE | |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway, Suite 120Woodstock, GA 30188770-837-2681Regulatory@SecureBME.com | |
| Trade Name | VascuChek® Clinical and VascuChek® Surgical |
| Common Name | Flowmeter, Blood, Cardiovascular |
| ClassificationName | 21 CFR §870.2100 Cardiovascular blood flowmeterProduct Code: DPW |
| Device Class | II |
| PredicateDevices | K211589 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver,VascuChek Surgical Probe, VascuChek Charger |
| K212065 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver,VascuChek Clinical Probe, VascuChek Charger | |
| DeviceDescription | VascuChek® Surgical is a cardiovascular blood flowmeter comprised of twocomponents: a sterile VascuChek™ Surgical Probe with sheath whichconnects to the reusable, nonsterile VascuChek™ Transceiver. The sheath isdeployed over, and encapsulates the transceiver, allowing it to be used withinthe sterile field.VascuChek® Clinical is a cardiovascular blood flowmeter comprised of twocomponents: a sterile VascuChek™ Surgical Probe with sheath whichconnects to the reusable, nonsterile VascuChek™ Transceiver. The sheath isdeployed over, and encapsulates the transceiver, allowing it to be used withinthe sterile field.The VascuChek® device follows Track 1.A transmitter in the transceiver drives the ultrasonic transmitting crystallocated at the tip of the probe component. The ultrasonic waves generated bythe sensor travel through the tissue just under the probe tip in a narrow beam.The reflected ultrasonic waves are received by the transducer and areconverted via the piezoelectric effect into a high frequency electronic signal. |
| band audio Doppler shifted signal which is filtered and converted to audio | |
| via a speaker. During the intervals when the unit is not transmitting, thedevice passes any reflected signals that it receives to a receiving circuit. This | |
| circuit amplifies the returning echoes, compares their frequency to that of the | |
| transmitted signal and converts any frequency differences into an audible | |
| tone. | |
| Indications forUse Statement | VascuChek® Kit, VascuChek® Transceiver, VascuChek® Clinical Probe,VascuChek® Charger: |
| The VascuChek® device is intended for the non-invasive transcutaneousevaluation of blood flow in Peripheral Vasculature. | |
| VascuChek® Kit, VascuChek® Transceiver, VascuChek® Surgical Probe,VascuChek® Charger: | |
| The VascuChek® device is intended for the intraoperative andtranscutaneous evaluation of blood flow in the following clinicalapplications: | |
| - Intraoperative (Microvascular and Vascular) | |
| - Intraoperative Neurological | |
| - Transrectal and Peripheral Vascular. |
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Comparison of Technological Characteristics
The subject device is substantially equivalent to its predicate devices (K211589 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger and K212065 Remington Medical, Inc. VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger).
Similarities to Predicate
The subject device has the same intended use and technological characteristics as the identified predicate devices. The system employs identical technology as the identified predicates. The principles of operation and technological characteristics are identical to the predicate devices. The system has similar or identical technological characteristics including:
- . Identical system and kit components including use of single use sterile (for surgical use) and non-sterile (for clinical use) probes and a multi-use transceiver
- Identical patient population
- Identical intended use ●
- Identical principles of operation ●
- . Identical firmware requirements and performance
Differences to Predicate
The only differences between the subject and predicate device relate to minor hardware, firmware, and housing material differences in the subject device transceiver. All differences have been addressed through risk analysis and supporting verification / validation testing.
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Non-Clinical Performance Testing Summary
All necessary testing has been performed to assure substantial equivalence to the predicate devices and to demonstrate the subject device performs as intended. All testing was performed in accordance with relevant performance standards or internal test methods. The following evaluations were conducted:
- Electrical Safety Testing per ANSI AAMI ES60601-1 .
- EMC Testing per IEC 60601-1-2, IEC 60601-2-37 ●
- Firmware Verification Testing ●
- Biocompatibility information was provided in accordance with Attachment G of the FDA ● guidance for biocompatibility to support the transceiver housing material change
Conclusions
Based on the similarities of the intended use / indications for use, technological and functional characteristics, and the results of the non-clinical performance testing, the subject device is substantially equivalent to the legally marketed predicate devices.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).