(112 days)
Not Found
No
The summary describes automated calculations of standard indices (ABI, TBI, pulse wave velocity) and measurements (blood pressure, heart rate, pulse volume, heart sounds). There is no mention of AI, ML, or any learning algorithms used for diagnosis or interpretation. The device automates established clinical methods.
No
The device is described as a "non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases." Its capabilities are measuring and calculating various physiological parameters, which are all diagnostic in nature, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases."
No
The device description explicitly states it is a "non-invasive diagnostic system" capable of measuring blood pressures, heart rate, pulse volume recordings, and heart sounds, which requires physical hardware components like cuffs, sensors, and a processing unit.
Based on the provided information, the Fukuda Denshi VaSera model VS-1500AU is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the VaSera VS-1500AU clearly states it is a non-invasive diagnostic system that measures parameters directly from the patient's body (blood pressure, heart rate, pulse volume, heart sounds). It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use and device description focus on direct physiological measurements and calculations based on those measurements. This is characteristic of in vivo diagnostic devices, not in vitro ones.
Therefore, the Fukuda Denshi VaSera model VS-1500AU falls under the category of in vivo diagnostic devices.
N/A
Intended Use / Indications for Use
The Fukuda Denshi VaSera model VS-1500AU is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measing non-invasive blood pressures, heart rate, pulse volume recordings and heart sounds.
The device also has the capability of calculating ABI (Ankle Brachial Index), TBI (Toe Brachial Index), and pulse wave velocity measurements.
The device is intended to be used under the order of a physician, in hospitals, doctor's offices, clinics or other medical facilities where non-invasive peripheral vascular tests are performed.
The device is intended to be used on adult population only.
The device is not intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQC, JOO
Device Description
The Fukuda Denshi VaSera model VS-1500AU is a prescriptive device intended for use by health care professionals. It is designed to be used to assist the clinician in the detection of peripheral vascular diseases and has been designed and tested to automate published clinical diagnostic test methods. The device is capable of measuring non-invasive blood pressures, non-invasive pulse volume recordings and heart sounds. In addition, the device is capable of calculating specific clinically recognized indices such as ABI (Ankle Brachial Index), TBI (Toe Brachial Index) and pulse wave velocity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vascular system
Indicated Patient Age Range
Adult population only.
Intended User / Care Setting
Used under the order of a physician, in hospitals, doctor's offices, clinics or other medical facilities where non-invasive peripheral vascular tests are performed.
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)
Final testing for the device included various performance tests, including clinical validation using the predicate device, to insure that all functional and performance specifications were met.
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.
Colin Medical VP-1000/2000 (K013434), Fukuda Denshi DS-5300 Patient Monitor (K964187)
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Section 6 510(k) Summary Fukuda Denshi VaSera VS-1500AU
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 870.92.
The assigned 510(k) number is: K / 252
-
- Submitter:
Fukuda Denshi U.S.A. INC. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 425-881-7737 Fax: 425-869-2018
- Submitter:
Contact Person: ●
Doug Blakely Director- Regulatory Affairs Fukuda Denshi U.S.A. INC. 17725 NE 65th St. Building C Redmond WA, 98052 Tel: 425-881-7737 Fax: 425-869-2018 Email: DBlakely@fukuda.com
. Date Prepared: August 15, 2011
-
- Device Name:
- Proprietary Name: ● Fukuda Denshi VaSera Model VS-1500AU
- Noninvasive blood pressure measurement system and Common Name . Vascular profiling system
- DXN Noninvasive blood pressure measurement system Classification ● DQC Phonocardiograph Heart Sound Transducer 100
The following device classifications apply to this device: Names: Class: CFR: Non-invasive Blood Pressure Monitor II 870.1130 Phonocardiograph I 870.2390 Heart sound Transducer II 870.2860
All of these devices are reviewed by the Cardiovascular Devices Panel
Fukuda Denshi VaSera Model VS-1500AU 510K Submission
Page 1 OF 3
1
510(k) Summary Fukuda Denshi VaSera VS-1500AU
Legally Marketed Predicate Devices:
Colin Medical VP-1000/2000 (K013434) Fukuda Denshi DS-5300 Patient Monitor (K964187)
Description:
The Fukuda Denshi VaSera model VS-1500AU is a prescriptive device intended for use by health care professionals. It is designed to be used to assist the clinician in the detection of peripheral vascular diseases and has been designed and tested to automate published clinical diagnostic test methods. The device is capable of measuring non-invasive blood pressures, non-invasive pulse volume recordings and heart sounds. In addition, the device is capable of calculating specific clinically recognized indices such as ABI (Ankle Brachial Index), TBI (Toe Brachial Index) and pulse wave velocity.
Statement of Intended Use:
The Fukuda Denshi VaSera model VS-1500AU is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measuring non-invasive blood pressures, heart rate, pulse volume recordings and heart sounds.
The device also has the capability of calculating ABI (Ankle Brachial Index), TBI (Toe Brachial Index), and pulse wave velocity measurements.
The device is intended to be used under the order of a physician, in hospitals, doctor's offices, clinics or other medical facilities where non-invasive peripheral vascular tests are performed.
The device is intended to be used on adult population only.
The device is not intended for home use.
Fukuda Denshi VaSera Model VS-1500AU 510K Submission
Page 2 of 3
2
Technological Characteristics and Substantial Equivalence:
The Fukuda Denshi Vasera Model 1500AU incorporates similar noninvasive technology as the predicate devices. The device uses the same technology as the Colin Medical VP-1000/2000 (K013434) for assessing lower extremity peripheral pressures and calculated indices such as Ankle-Brachial Index, Toe-Brachial Index and PWV values. The device also uses the same standard NIBP module as the Fukuda Denshi DS-5300 Patient Monitor (K964187) for assessing upper brachial blood pressures.
The device provides a means for interfacing with the patient, collecting specific physiological data, processing the data and generating a report of specific standard vascular indices to assist the clinician in the detection of peripheral vascular diseases.
The technological characteristics of the Vasera Model 1500AU do not affect the safety or efficacy of the device. Any safety issued raised by this software controlled medical device are wither the same issues already addressed by the predicate devices or are addressed by the Risk Management Report (See Exhibit 4.1) or in the system validation.
Testing:
ార్లు భారత్యశ
The Fukuda Denshi VaSera model VS-1500AU has been subjected to extensive safety, environmental and performance testing. Final testing for the device included various performance tests, including clinical validation using the predicate device, to insure that all functional and performance specifications were met.
The Fukuda Denshi VaSera model VS-1500AU has also been tested to assure compliance to the requirement of various published standards including the following:
UL60601-1; 2006, IEC 60601-1 :1988+A1+A2 IEC 60601-1-1 Ed. 2.0 :2000 IEC 60601-1-1 Ed. 2.0 :2001+Am1 :2004 IEC 60601-1-4 Ed. 1.1 :2000
Conclusion:
In conclusion, drawing from laboratory testing, validation and risk Analysis, the Fukuda Denshi VaSera model VS-1500AU demonstrates that this device is as safe and effective and performs as well as the legally marketed predicate devices, the Colin Medical VP-1000/2000 (K013434) and the Fukuda Denshi DS-5300 Patient Monitor (K964187).
Fukuda Denshi VaSera Model VS-1500AU 510K Submission
Page 3 of 3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 2 1 2011
Fukuda Denshi USA, Inc. c/o Mr. Doug Blakely Director, Regulatory Affairs 17725 NE 65th Street, Building C Redmond, WA 98052-4911
Re: K112521
Trade/Device Name: Fukuda Denshi Vasera Model VS-1500AU Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II (two) Product Codes: DXN, DQC, JOO Dated: November 29, 2011 Received: December 2, 2011
Dear Mr. Blakely:
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. 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.
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
4
Page 2 - Mr. Doug Blakely
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Math Filmore fo.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K112521
Device Name:__Fukuda Denshi Vasera Model 1500AU
Indications For Use:
The Fukuda Denshi VaSera model VS-1500AU is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. It has a capability of measing non-invasive blood pressures, heart rate, pulse volume recordings and heart sounds.
The device also has the capability of calculating ABI (Ankle Brachial Index), TBI (Toe Brachial Index), and pulse wave velocity measurements.
The device is intended to be used under the order of a physician, in hospitals, doctor's offices, clinics or other medical facilities where non-invasive peripheral vascular tests are performed.
The device is intended to be used on adult population only.
The device is not intended for home use.
Prescription Use × Over-The-Counter Use (Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Miller for Brian Tucker
Page 1 of
(Division Sign-Off) Date:
Division of Cardiovascular Devices
510(k) Number K112521