The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

Device Description

VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver.

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. The received electronic signal is amplified and detected. The result is a base 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.

AI/ML Overview

The provided document is a 510(k) summary for the Remington Medical, Inc. VascuChek™ Clinical Device. The product is a cardiovascular blood flowmeter intended for non-invasive transcutaneous evaluation of blood flow in peripheral vasculature. The submission demonstrates substantial equivalence to the predicate device, Vascular Technology Incorporated (VTI) Surgical Doppler (K082870).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" for performance metrics in a quantitative manner (e.g., minimum sensitivity or specificity). Instead, the performance evaluation is based on demonstrating substantial equivalence to a predicate device through various non-clinical and an in vivo simulated use test. The criteria for acceptance are implied by the successful completion of these tests and a conclusion of substantial equivalence.

Acceptance Criteria Category (Implied)	Reported Device Performance	Study Type
Software/Firmware Performance	Tests performed and met.	Non-clinical
Mechanical Performance	Tests performed and met.	Non-clinical
Biocompatibility	Tests performed and met.	Non-clinical
Device Lifecycle	Tests performed and met.	Non-clinical
Reprocessing (Cleaning and Low-Level Disinfection)	Tests performed and met.	Non-clinical
Distribution Simulation	Tests performed and met.	Non-clinical
Electrical Safety	Tests performed and met.	Non-clinical
EMC (Electromagnetic Compatibility)	Tests performed and met.	Non-clinical
Environmental Performance Testing	Tests performed and met.	Non-clinical
Audio Quality in Blood Flow Velocity Measurement	Assessed and compared performance of the new device to its predicate at different vessel depths/sizes. The results contributed to the conclusion of substantial equivalence.	In vivo Simulated Use

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions an "in vivo Simulated Use" test. However, it does not specify the sample size used for this test (e.g., number of subjects, number of measurements). It also does not provide details about the data provenance beyond stating it was an in vivo test. Therefore, information regarding country of origin of the data or whether it was retrospective or prospective is not available in the provided text.

3. Number of Experts Used to Establish the Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth for any test set. The in vivo simulated use test focused on assessing audio quality and comparing performance to the predicate device, implying that the predicate's output or a direct measurement was used as a reference rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set:

Since the document does not describe the use of multiple experts or a diagnostic task requiring consensus, there is no mention of an adjudication method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The study focused on demonstrating substantial equivalence of the device's technical characteristics and performance to a predicate device, not on how human readers' performance might improve with or without AI assistance. The device itself is a blood flowmeter, not an AI-assisted diagnostic tool for interpretation by human readers in the traditional sense of an MRMC study.

6. Standalone Performance:

The primary focus of the performance data section is on the standalone performance of the VascuChek™ Clinical Device, both through non-clinical bench testing and the in vivo simulated use test. The purpose was to show that the device itself performs comparably to the predicate device.

7. Type of Ground Truth Used:

For the in vivo simulated use test, the ground truth appears to be established by comparison to the predicate device in terms of measuring the velocity of blood flow. The phrasing "compare performance of the new device to its predicate" suggests the predicate's output served as the reference for evaluating the subject device's audio quality in measuring blood flow velocity. There is no indication of pathology, outcomes data, or expert consensus being used as ground truth for this device's specific function.

8. Sample Size for the Training Set:

The document does not mention a training set because the VascuChek™ Clinical Device is a cardiovascular blood flowmeter, not a device that employs machine learning or artificial intelligence requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set, there is no information on how its ground truth might have been established.

Summary

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October 7, 2021

Remington Medical, Inc. C. Matt Brown VP of Quality and Regulatory Affairs 6830 Meadowridge Court Alpharetta, Georgia 30005

Re: K212065

Trade/Device Name: VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: September 10, 2021 Received: September 13, 2021

Dear C. Matt Brown:

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

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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 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,

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices 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) K212065

Device Name VascuChek™ Clinical Device

Indications for Use (Describe)

The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

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/1 description: The image contains the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" on the right. The word "Remington" is in a larger, bolder font than the word "MEDICAL", which is stacked below it.

Preparation Date	July 1, 2021 – revised on September 8, 2021
Applicant	Remington Medical, Inc.6830 Meadowridge Court,Alpharetta, GA, USA 30005Registration Number:Owner/Operator Number:	10565539006473
Contact Person	C. Matt Brown, MS, CQE, RACVP of Quality and Regulatory Affairs470-719-1121mattb@remmed.com
Trade ProprietaryName(s)	Remington Medical, Inc. VascuChek™ Clinical Device
Common Name (s)	Flowmeter, Blood, Cardiovascular
Classification Name	21 CFR 870.2100 Cardiovascular blood flowmeterProduct Code: DPW
Device Class:	II

Section 5 - 510(k) Summary

Predicate Device:

Vascular Technology Incorporated (VTI) Surgical Doppler (K082870)

Description of the Device:

VascuChek™ is a cardiovascular blood flowmeter comprised of two components: a nonsterile, single-use VascuChek™ Clinical Probe which connects to the reusable, nonsterile VascuChek™ Transceiver.

The VascuChek™ device follows Track 1.

Intended Use/Indications for Use

The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the noninvasive transcutaneous evaluation of blood flow in Peripheral Vasculature.

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Image /page/4/Picture/1 description: The image shows the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" on the right. The word "Remington" is in a larger font than the word "MEDICAL". The geometric shape is a stylized cross or plus sign.

Comparison to Predicate Device:

The technological characteristics (design, specifications, materials, and performance) of the subject device and the predicate device are substantially equivalent.

	Subject Device:Remington Medical, Inc.VascuChek™ Clinical Device	Predicate Device:Vascular TechnologyIncorporated (VTI) SurgicalDoppler (K082870)
Device Class	Class II	Class II
FDA Product Code	DPW	DPW
Regulation	21 CFR 870.2100 (Flowmeter, Blood, Cardiovascular)	21 CFR 870.2100 (Flowmeter, Blood, Cardiovascular)
Intended Use	The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.	The Vascular Technology Incorporated (VTI) Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.
Indications for Use Statement	The Remington Medical, Inc. VascuChek™ Clinical Device is intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature.	The VTI Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow for the following clinical applications:• Intraoperative (Microvascular and Vascular),• Intraoperative Neurological Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular
Type of Use	Prescription Use	Prescription Use
Use Environment	Hospital, Outpatient Surgery Center	Hospital, Outpatient Surgery Center
Patient Population	Adults Only	Vascular Patients
Installation and Use	Hand-Held (Transceiver and Probe)	Hand Held (Probe)
Theory of Operation	Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature.	Use of the Doppler effect to evaluate the flow velocity of blood in peripheral vasculature.
Frequency	9 MHz	8 MHz and 20 MHz
Global Maximum Outputs / Worst Case Setting	ISPTA 3 (mW/cm²)359.7 mW/cm²	< 94 mW/cm²
Mode of Operation	Ultrasonic Doppler/Continuous Wave	Ultrasonic Doppler/ Pulsed Wave
Reusable	Probe No, Single Use	Probe No, Single Use
	Transceiver Yes, Cleaning/Low Level Disinfection	Transceiver Yes, Cleaning
Sterilization Method	Not Applicable - Transceiver and Probe are nonsterile.	Probe ETO

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Image /page/5/Picture/1 description: The image shows the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" in blue on the right. The word "Remington" is in a larger font than the word "MEDICAL", and it is placed above the word "MEDICAL".

Dimensions	221x 33 x 31 mm(8.7 in x 1.29 in x 1.22 in.)		6.5 in. D x 10 in. W x 4 in. H
Weight	90 grams (0.198 lb)		2.6 lb, nom
The degree of protection	Probe			Probe
against harmful ingress ofliquid (IPX rating)	TransceiverCharger	1		Transceiver	0
Power Supply	Rechargeable battery assembly withAC to DC Charger		Batteries or External Power Source(AC to DC)
Battery Operating Voltage	6.4 VDC		12 VDC
Battery Chemistry	1 - LiFePO4 rechargeable batteryassembly		8 AA (LR6) alkaline batteries
The degree of protectionagainst electric shock	Probe	Type CF	ProbeTransceiver	Type CF
Buttons	Three - Power, Volume Up, andVolume Down		Five – Power, Volume Up, VolumeDown, Channel A, Channel B
Status LED	One: Power and Battery Indicator		Six: Four indicate power on andvolume, one indicates low batteries,one indicates active channel
Calibration Required	No		No
Maintenance	No		No

Performance Data:

To demonstrate that the subject device, Remington Medical Inc. VascuChek™ Clinical Device, is as safe and as effective as the predicate device, Vascular Technology Incorporated (VTI) Surgical Doppler, technological characteristics and performance criteria were evaluated. The following tests were performed on the subject device:

Software/Firmware Performance ●
Mechanical Performance ●
Biocompatibility
Device Lifecycle ●
Reprocessing Manual Cleaning and Low Level Disinfection ●
Distribution Simulation ●
Electrical Safety ●
EMC
Environmental Performance Testing

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Image /page/6/Picture/1 description: The image shows the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" on the right. The word "Remington" is in a larger font than the word "MEDICAL". The geometric shape is made up of several blue triangles that form a cross.

In addition, the following in vivo tests were performed on the subject device and predicate device:

. Simulated Use – assess audio quality in measuring the velocity of blood flow at different vessel depths/sizes and compare performance of the new device to its predicate
The performance data (design, specifications, materials, and performance) of the Subject Device and the Predicate Device are substantially equivalent.

Clinical testing:

No clinical testing was required.

Conclusion:

The results of the non-clinical testing demonstrated that the subject device, Remington Medical Inc. VascuChek™ Clinical Device, is substantially equivalent to the predicate device, Vascular Technology Incorporated (VTI) Surgical Doppler, with respect to intended use, design, materials, and technological characteristics.

Regulation Number and Section

§ 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).