(266 days)
Not Found
No
The summary describes a device that automates standard clinical calculations (ABI, PWV) based on measured physiological parameters. There is no mention of AI, ML, or any learning-based algorithms. The performance studies focus on standard device validation (biocompatibility, safety, clinical tests) rather than AI/ML model performance metrics.
No.
The device is described as a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the VP-2000/1000 is a "non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases." The "Device Description" also reinforces this by stating it is "designed to assist in the detection of peripheral vascular diseases."
No
The device description explicitly states it is a "monitor" and describes its capability of "measuring" various physiological parameters (blood pressure, ECG, pulse waveforms, heart sounds), which requires hardware components like sensors and transducers. The performance studies also include "Electrical safety tests" and "EMC tests," further indicating the presence of hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the VP-2000/1000 is a non-invasive diagnostic system. It measures physiological parameters directly from the patient's body (blood pressure, heart rate, pulse wave, heart sound) and calculates indices based on these measurements. It does not analyze samples taken from the body.
Therefore, while it is a diagnostic device, it falls under the category of in vivo (performed on a living organism) rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
VP-2000/1000 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 wave, and heart sound. It also has a capability of calculating ABI (Ankle Brachial Index), Pulse Wave Velocity and Augmentation Index. The instrument is used in a vascular laboratory, clinic, hospital, doctor's office, and other medical facilities where the non-invasive peripheral vascular test is conducted. It is used an adult patients only.
Product codes
DXN
Device Description
The BP-203 RPE II Series VP-1000 and VP-2000 monitor is a prescriptive device intended for use only by health care professionals. The monitors are designed to assist in the detection of peripheral vascular diseases and have been designed and tested to automate published clinical diagnostic test methods. The device is capable of measuring noninvasive blood pressure (NIBP), ECG (lead I), non-invasive pulse waveforms, and heart sounds. In addition, the monitors are also capable of calculating specific clinically recognized indices such as ABI (Ankle-Brachial Index) and PWV (Pulse Wave Velocity).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients only.
Intended User / Care Setting
prescriptive device intended for use only by health care professionals. The instrument is used in a vascular laboratory, clinic, hospital, doctor's office, and other medical facilities where the non-invasive peripheral vascular test is conducted.
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)
Biocompatibility test, Environmental Tests including Electrical safety tests, EMC tests and Clinical tests were performed and confirmed the performance of VP-2000/1000 met the product requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 921048, K973637, K973562, K922668, K990809
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 9 2002
KO 13434
510(k) Summary for VP-2000/1000
Sponsor 1.
Colin Corporation 2007-1 Hayashi Komaki, 485 Japan
Contact Person: Mark Rison, Sr. Director, QA/RA Colin Medical Instruments Corporation 5850 Farinon Dr. San Antonio, TX. 78249
210-690-6200 Telephone:
Date Prepared: October 13, 2001
2. Device Name
Proprietary Name: VP-2000/1000 Common/Usual Name: Non-invasive blood pressure measurement and vascular profiling system Classification Name: The following devices classifications apply to this device. Class CFR Names 870.1130 Non-invasive blood pressure monitor II 870.2390 Phonocardiograph I Heart sound transducer II 870.2860 870.2300 Heart rate monitor II
All of these devices were reviewed by the Cardiovascular Devices Panel.
3. Predicate Devices
Press-Mate BP8800 (510k # K 921048) Press-Mate Advantage (510k # K973637) IMEXLAB 9100 (510k # K973562) PILOT 9200 (510k # K922668) CADIscope (510k # K990809)
Device Description 4.
The BP-203 RPE II Series VP-1000 and VP-2000 monitor is a prescriptive device intended for use only by health care professionals. The monitors are designed to assist in the detection of peripheral vascular diseases and have been designed and tested to automate published clinical diagnostic test methods. The device is capable of measuring noninvasive blood pressure (NIBP), ECG (lead I), non-invasive pulse waveforms, and heart sounds. In addition, the monitors are also capable of calculating specific clinically recognized indices such as ABI (Ankle-Brachial Index) and PWV (Pulse Wave Velocity).
1
5. Intended Use
VP-2000/1000 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 wave, and heart sound.
It also has a capability of calculating ABI (Ankle Brachial Index), Pulse Wave Velocity and Augmentation Index.
The instrument is used in a vascular laboratory, clinic, hospital, doctor's office, and other medical facilities where the non-invasive peripheral vascular test is conducted.
It is used an adult patients only.
6. Technological Characteristics and Substantial Equivalence
VP-2000/1000 is substantial equivalent to the legally marketed devices listed in the body of this document.
7. Performance Testing
Biocompatibility test, Environmental Tests including Electrical safety tests, EMC tests and Clinical tests were performed and confirmed the performance of VP-2000/1000 met the product requirements.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 9 2002
Colin Instrument Corp. c/o Mr. Mark Rison Sr. Director, Regulatory Affairs / Quality Assurance 5850 Farinon Drive University Technology Park San Antonio, TX 78249
Re: K013434
Device Name: Models VP-1000 and VP-2000 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II Product Code: DXN Dated: April 15, 2002 Received: April 16, 2002
Dear Mr. Rison:
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 such 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
3
Page 2 - Mr. Mark Rison
CFR Part 807); labeling (21 CFR Part 801); 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,
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Robertin
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number 013434
Device Name: VP-2000/1000
Indications For Use:
VP-2000/1000 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 wave, and heart sound
It also has a capability of calculating ABI (Ankle Brachial Index), Pulse Wave Velocity, and Augmentation Index.
The instrument is used in a vascular laboratory, clinic, hospital, doctor's office, and other medical facilities where the non-invasive peripheral vascular test is conducted.
It is used on adult patients only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dak Tule
(Division Sign-Off)
Division of Cardiovascular
and Respiratory Devices
510(k) Number K013434
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use