Remington Medical, Inc. 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

Device Description

VascuChek™ 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. 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 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

Here's a summary of the acceptance criteria and study information for the VascuChek™ device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing acceptance criteria with numerical performance targets and reported values. Instead, it describes a series of non-clinical and in vivo tests performed. The "reported device performance" is essentially that the device passed these tests and was found to be "substantially equivalent" to the predicate.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Software/Firmware Performance	Functionality as designed, no critical errors.	Passed. Result demonstrated proper performance.
Mechanical Performance	Device maintains structural integrity and functions correctly under specified conditions.	Passed. Result demonstrated proper performance.
Integrity of Sterile Barrier	Sterility of the probe maintained.	Passed. Result demonstrated proper performance.
Biocompatibility	Materials are safe for patient contact.	Passed. Result demonstrated proper performance.
Pyrogenicity	Absence of pyrogenic substances.	Passed. Result demonstrated proper performance.
Shelf Life / Aging	Device functions as intended for its specified shelf life.	Passed. Result demonstrated proper performance.
Device Lifecycle	Device functions as intended throughout its expected operational life.	Passed. Result demonstrated proper performance.
Sterility Assurance	Sterilization process effectively renders the probe sterile.	Passed. Result demonstrated proper performance.
Reprocessing Manual Cleaning and Intermediate-Level Disinfection	Reusable components can be effectively cleaned and disinfected without degradation inhibiting performance.	Passed. Result demonstrated proper performance.
Distribution Simulation	Device integrity maintained during shipping and handling.	Passed. Result demonstrated proper performance.
Electrical Safety	Meets relevant electrical safety standards.	Passed. Result demonstrated proper performance.
EMC	Electromagnetic compatibility maintained, avoiding interference with other devices and proper function in an electromagnetic environment.	Passed. Result demonstrated proper performance.
Viral Permeability	Not explicitly stated what aspect was tested but implies testing related to fluid ingress or barrier integrity.	Passed. Result demonstrated proper performance.
Environmental Performance Testing	Device performs adequately under various environmental conditions (e.g., temperature, humidity).	Passed. Result demonstrated proper performance.
Simulated Use (In Vivo)	Audio quality in measuring blood flow velocity is comparable to the predicate device at different vessel depths/sizes. Subject device performs equivalently.	Performed using the subject device and predicate device. The performance data demonstrated substantial equivalence. This is the closest to a performance acceptance criteria, implying a qualitative or semi-quantitative comparison of audio quality and blood flow measurement capability.

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

Sample Size: Not explicitly stated for each test beyond "the subject device and predicate device" for the in vivo test. It implies a sufficient number of units or test scenarios were used to generate data for each performance test.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be non-clinical (laboratory/engineering) and in vivo (likely animal or simulated human models for the blood flow assessment, although this is not explicitly stated). The report does not mention human clinical trials. All studies are presumably prospective as they were conducted to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For the in vivo simulated use test comparing audio quality, it would typically involve trained personnel for evaluation, but their number and qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (engineering, biocompatibility, in vivo simulation), formal adjudication methods like 2+1 or 3+1 typically used in image interpretation studies are unlikely to be directly applicable. The test results would be assessed against pre-defined engineering or biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was required." The in vivo test was a "simulated use" assessment comparing the subject device to the predicate in terms of audio quality for blood flow measurement, not a clinical study involving human readers/interpreters.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not directly applicable in the context of the VascuChek™ device. This device is a cardiovascular blood flowmeter that produces an audible tone based on the Doppler effect. Its performance is evaluated on its ability to generate an accurate audible signal representing blood flow, which is inherently designed for human interpretation (listening to the audio). There is no "algorithm only" component that would operate without human input in its intended use.

7. The Type of Ground Truth Used

The ground truth for the various non-clinical tests would be established by:

Engineering Standards/Specifications: For mechanical, electrical, EMC, and software performance.
Regulatory Standards/Guidelines: For biocompatibility (e.g., ISO 10993), pyrogenicity, sterility, and reprocessing.
Predicate Device Performance: For the in vivo simulated use test, the performance of the predicate device serves as the comparative "ground truth" or benchmark, implying that the subject device should produce similar (substantially equivalent) audio quality and blood flow detection capabilities.

8. The Sample Size for the Training Set

This information is not applicable as the VascuChek™ device, as described, does not appear to be an AI/machine learning device that requires a "training set." It is a hardware device based on the Doppler effect for real-time blood flow detection.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8; there is no "training set" for this type of device.

Summary

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October 13, 2022

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

Re: K211589

Trade/Device Name: VascuChek™ Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulatory Class: Class II Product Code: DPW

Dear Matt Brown:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter cleared on January 27, 2022. Specifically, FDA is updating this SE Letter due to a typo in the clearance data, which was incorrectly dated as January 27, 2021.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LCDR Stephen Browning, OHT2: Office of Cardiovascular Devices, 240-402-5241, stephen.browning@fda.hhs.gov.

Sincerely.

Stephen C. Browning -S

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

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January 27, 2021

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

Re: K211589

Trade/Device Name: VascuChek TM Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: December 27, 2021 Received: December 28, 2021

Dear 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 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

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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).

Sincerelv.

Stephen C. Browning -S

Enclosure

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Indications for Use

510(k) Number (if known)

K211589

Device Name VascuChekTM

Indications for Use (Describe)

Remington Medical, Inc. 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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510(k) Summary

Preparation Date	December 22, 2021
Applicant	Remington Medical, Inc.6830 Meadowridge Court,Alpharetta, GA, USA 30005Registration Number: 1056553Owner/Operator Number: 9006473
Contact Person	C. Matt Brown, MS, CQE, RACVP of Quality and Regulatory Affairs470-719-1121mattb@remmed.com
Trade ProprietaryName(s)	Remington Medical, Inc. VascuChek™
Common Name (s)	Flowmeter, Blood, Cardiovascular
Classification Name	21 CFR 870.2100 Cardiovascular blood flowmeterProduct Code: DPW
Device Class:	II

Predicate Device:

Vascular Technology Incorporated (VTI) Surgical Doppler (K082870)

Description of the Device:

The VascuChek™ device follows Track 1.

Intended Use/Indications for Use

Remington Medical, Inc. VascuChek™ device is intended for the intraoperative and transcutaneous evaluation of blood flow in the following clinical applications:

. Intraoperative (Microvascular and Vascular)

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Intraoperative Neurological .
Transrectal and Peripheral Vascular .

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™	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™ is intended for the intraoperative and transcutaneous evaluation of blood flow.	The Vascular Technology Incorporated (VTI) Intraoperative Doppler Systems are intended for the intraoperative and transcutaneous evaluation of blood flow.
Indications for Use Statement	Remington Medical, Inc. 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	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	Adults Only
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 UseTransceiver Yes, Cleaning/Low Level Disinfection	Probe No, Single UseTransceiver Yes, Cleaning

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Sterilization Method	Probe	ETO	Probe	ETO
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 against harmful ingress of liquid (IPX rating)	ProbeTransceiverCharger	1	ProbeTransceiver	70
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 protection against 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 lowbatteries, one indicates activechannel
Calibration Required	No		No
Maintenance	No		No

Performance Data:

To demonstrate that the subject device, Remington Medical Inc. VascuChek™, 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 .
Integrity of the Sterile Barrier ●
Biocompatibility
Pyrogenicity ●
Shelf Life / Aging ●
Device Lifecycle ●
Sterility Assurance
Reprocessing Manual Cleaning and Intermediate-Level Disinfection ●
Distribution Simulation ●
Electrical Safety ●
EMC ●
Viral Permeability ●
Environmental Performance Testing ●

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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™, 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).