(248 days)
Not Found
No
The device description details standard ultrasonic Doppler technology and signal processing without mentioning any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is described as a blood flowmeter intended for evaluation of blood flow, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the intraoperative and transcutaneous evaluation of blood flow". Evaluation of blood flow is a diagnostic activity.
No
The device description clearly states it is comprised of two hardware components: a surgical probe and a transceiver. It describes the physical interaction of these components with ultrasonic waves and electronic signals.
Based on the provided information, the Remington Medical, Inc. VascuChek™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "intraoperative and transcutaneous evaluation of blood flow." This involves directly interacting with the patient's body (intraoperative and transcutaneous) to measure a physiological parameter (blood flow).
- Device Description: The description details a surgical probe and transceiver that transmit and receive ultrasonic waves through tissue. This is a direct interaction with the patient's body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body. IVDs are specifically designed for testing these types of samples in a laboratory or point-of-care setting.
The VascuChek™ device is a medical device used for real-time physiological measurement in vivo (within the living body), which is distinct from the definition of an In Vitro Diagnostic device.
N/A
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)
- Intraoperative Neurological
- Transrectal and Peripheral Vascular
Product codes (comma separated list FDA assigned to the subject device)
DPW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic Doppler/Continuous Wave
Anatomical Site
Not Found
Indicated Patient Age Range
Adults Only
Intended User / Care Setting
Hospital, Outpatient Surgery Center
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)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
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
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Food and 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
2
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
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
3
Indications for Use
510(k) Number (if known)
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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4
510(k) Summary
| Preparation Date | December 22, 2021 |
|---|---|
| Applicant | Remington Medical, Inc. |
| 6830 Meadowridge Court, | |
| Alpharetta, GA, USA 30005 |
Registration Number: 1056553
Owner/Operator Number: 9006473 |
| Contact Person | C. Matt Brown, MS, CQE, RAC
VP of Quality and Regulatory Affairs
470-719-1121
mattb@remmed.com |
| Trade Proprietary
Name(s) | Remington Medical, Inc. VascuChek™ |
| Common Name (s) | Flowmeter, Blood, Cardiovascular |
| Classification Name | 21 CFR 870.2100 Cardiovascular blood flowmeter
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)
5
- 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 Technology
Incorporated (VTI) Surgical
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:
• 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 |