(88 days)
Not Found
No
The device description focuses on standard ultrasonic Doppler technology and signal processing, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is intended for "evaluation of blood flow," which is a diagnostic purpose, not a therapeutic one. It analyzes, rather than treats, the condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for the non-invasive transcutaneous evaluation of blood flow in Peripheral Vasculature" and "for the intraoperative and transcutaneous evaluation of blood flow". Evaluation of blood flow for clinical applications constitutes a diagnostic purpose.
No
The device description explicitly details hardware components such as a transceiver, probes, and a charger, and mentions electrical safety and EMC testing, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "non-invasive transcutaneous evaluation of blood flow" and "intraoperative and transcutaneous evaluation of blood flow". This involves directly interacting with the patient's body to measure a physiological parameter (blood flow).
- Device Description: The description details a "cardiovascular blood flowmeter" that uses ultrasonic waves to measure blood flow. This is a diagnostic tool used on the patient, not a test performed on a sample taken from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests in vitro (outside the body). The device directly interacts with the patient's vasculature.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the living body).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DPW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
Anatomical Site
Peripheral Vasculature; Intraoperative (Microvascular and Vascular); Intraoperative Neurological; Transrectal and Peripheral Vascular.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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
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.
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
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 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"
1
(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.
2
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
3
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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4
K241583
| Date Prepared | August 30, 2024 |
|---|---|
| Sponsor | Remington Medical, Inc. |
| 6830 Meadowridge Court | |
| Alpharetta, GA 30005 | |
| 470-719-1084 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Justin Gracyalny, MSE | |
| Linda Braddon, Ph.D. | |
| 7828 Hickory Flat Highway, Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | VascuChek® Clinical and VascuChek® Surgical |
| Common Name | Flowmeter, Blood, Cardiovascular |
| Classification | |
| Name | 21 CFR §870.2100 Cardiovascular blood flowmeter |
| Product Code: DPW | |
| Device Class | II |
| Predicate | |
| Devices | 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 | |
| Device | |
| Description | 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. |
| Indications for
Use Statement | 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. |
5
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.
6
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.