VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger

K211589 · Remington Medical, Inc. · DPW · Jan 27, 2022 · Cardiovascular

Device Facts

• Record ID: K211589
• Device Name: VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger
• Applicant: Remington Medical, Inc.
• Product Code: DPW · Cardiovascular
• Decision Date: Jan 27, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended 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) - Intraoperative Neurological - Transrectal and Peripheral Vascular

Device Story

VascuChek™ is a cardiovascular blood flowmeter used intraoperatively or transcutaneously to evaluate blood flow velocity. The system consists of a sterile, single-use surgical probe and a reusable, non-sterile transceiver encapsulated by a sheath. Operation relies on the Doppler effect: a transmitter in the transceiver drives an ultrasonic crystal in the probe tip, emitting a narrow beam into tissue; reflected ultrasonic waves are received, converted via the piezoelectric effect into high-frequency electronic signals, amplified, and processed into baseband audio Doppler-shifted signals. These signals are filtered and converted to audible tones via a speaker. Physicians use the device in hospitals or outpatient surgery centers to assess blood flow, aiding clinical decision-making during vascular or neurological procedures. The device is handheld and battery-operated.

Clinical Evidence

No clinical testing was required. Substantial equivalence was demonstrated through non-clinical bench testing, including software/firmware performance, mechanical integrity, sterile barrier integrity, biocompatibility, pyrogenicity, shelf life, electrical safety, EMC, and simulated use testing to assess audio quality in measuring blood flow velocity at various vessel depths/sizes compared to the predicate.

Technological Characteristics

Handheld cardiovascular blood flowmeter; 9 MHz ultrasonic frequency; Continuous Wave Doppler mode. Components: sterile single-use probe, reusable transceiver. Power: 6.4 VDC LiFePO4 rechargeable battery. Connectivity: standalone. Sterilization: ETO for probe. Type CF applied part. IPX1 rating. Materials/specs verified via biocompatibility and mechanical testing.

Indications for Use

Indicated for intraoperative and transcutaneous blood flow evaluation in adult patients for microvascular, vascular, neurological, transrectal, and peripheral vascular applications.

Regulatory Classification

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.

Predicate Devices

• Vascular Technology Incorporated (VTI) Surgical Doppler (K082870)

Submission Summary (Full Text)

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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, [e-mail].

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 [phone] or 301-796-7100).

Sincerelv.

# 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

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.<br>6830 Meadowridge Court,<br>Alpharetta, GA, USA 30005<br><br>Registration Number: 1056553<br>Owner/Operator Number: 9006473 |
| Contact Person | C. Matt Brown, MS, CQE, RAC<br>VP of Quality and Regulatory Affairs<br>470-719-1121<br>[e-mail] |
| Trade Proprietary<br>Name(s) | Remington Medical, Inc. VascuChek™ |
| Common Name (s) | Flowmeter, Blood, Cardiovascular |
| Classification Name | 21 CFR 870.2100 Cardiovascular blood flowmeter<br>Product Code: DPW |
| Device Class: | II |

### Predicate Device:

Vascular Technology Incorporated (VTI) Surgical Doppler (K082870)

### Description of the Device:

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.

### 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:<br>Remington Medical, Inc.<br>VascuChek™ | Predicate Device:<br>Vascular Technology<br>Incorporated (VTI) Surgical<br>Doppler (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:<br>• Intraoperative (Microvascular and Vascular)<br>• Intraoperative Neurological<br>• 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:<br>• Intraoperative (Microvascular and Vascular),<br>• Intraoperative Neurological<br>• 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)<br>359.7 mW/cm² | < 94 mW/cm² |
| Mode of Operation | Ultrasonic Doppler/Continuous Wave | Ultrasonic Doppler/ Pulsed Wave |
| Reusable | Probe No, Single Use<br>Transceiver Yes, Cleaning/Low Level Disinfection | Probe No, Single Use<br>Transceiver Yes, Cleaning |

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| Sterilization Method | Probe | ETO | Probe | ETO |
|-------------------------------------------------------------------------|--------------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------|---------|
| Dimensions | 221x 33 x 31 mm<br>(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) | Probe<br>Transceiver<br>Charger | 1 | Probe<br>Transceiver | 7<br>0 |
| Power Supply | Rechargeable battery assembly with<br>AC to DC Charger | | Batteries or External Power Source<br>(AC to DC) | |
| Battery Operating Voltage | 6.4 VDC | | 12 VDC | |
| Battery Chemistry | 1 - LiFePO4 rechargeable battery<br>assembly | | 8 AA (LR6) alkaline batteries | |
| The degree of protection against electric shock | Probe | Type CF | Probe<br>Transceiver | Type CF |
| Buttons | Three - Power, Volume Up, and<br>Volume Down | | Five - Power, Volume Up, Volume<br>Down, Channel A, Channel B | |
| Status LED | One: Power and Battery Indicator | | Six: Four indicate power on and<br>volume, one indicates low<br>batteries, one indicates active<br>channel | |
| 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.