(210 days)
No
The description focuses on hardware components (LEDs, sensor array) and software for data collection and presentation. There is no mention of AI, ML, or related concepts like algorithms that learn or adapt.
No.
The device is described as a "trending device" and a "monitor" which measures and displays blood pressure trending and pulse rate. Its intended use is for "measuring and display", not for treatment or therapy.
No
The device is described as a "trending device" for blood pressure and pulse rate, providing measurements and displaying data. It does not state that it identifies a disease, condition, or provides a diagnosis based on these measurements.
No
The device description explicitly mentions hardware components such as LEDs, a sensor array, a rechargeable battery, and a physical chamber for the finger. While it utilizes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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. They are performed outside of the body (in vitro).
- Device Function: The TensorTip device measures blood pressure trending and pulse rate by placing a finger into the device. This is a non-invasive measurement performed on the body, not on a sample taken from the body.
- Intended Use: The intended use describes measuring and displaying blood pressure trending and pulse rate directly from the finger.
- Device Description: The description details a finger compartment and sensors that interact directly with the finger tissue.
Therefore, the TensorTip device falls under the category of a non-invasive medical device that measures physiological parameters directly from the body, rather than an in vitro diagnostic device that analyzes samples taken from the body.
N/A
Intended Use / Indications for Use
The TensorTip - Non-invasive Hemodynamic blood pressure monitor trending device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
Product codes
DXN, DSB
Device Description
The TensorTip - Non-invasive Hemodynamic Blood Pressure Monitor measurement chamber is designed to measure spot-check of heartbeat and blood pressure trending levels by simply inserting the finger into the device "chamber".
It contains a dedicated finger compartment having soft gel on the upper compartment lead door suiting the finger to be placed inside. The device incorporates LEDs (Light Emitting Diode); a sensor array enables to sense the spectrum from near UV to near IR and a rechargeable battery for power supply. The device has large display for displaying temporal Pulse Per Minute (PPM) and Systolic and Diastolic Blood Pressure trending. In addition it shows the capillary blood waveform and the blood pressure variation during the measurement period. It is utilizing software that collects and presents the measured data. Body contact materials were evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capillary finger tip tissue (other than the thumb). The ring finger is the recommended site.
Indicated Patient Age Range
above 18 years old
Intended User / Care Setting
any person aged above 18 years old. / home environment.
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)
Cnoga Medical's TensorTip spot-check pulse rate and non-invasive blood pressure trending device has been successfully tested with bench, human and safety testing to support the determination of substantial equivalence with predicate devices. Safety and EMC tests were conducted with accordance to EN 60601-1 and EN/IEC 60601-1-2 standards. Clinical validation has met the requirement of ISO 81060-2 standard.
Tests results are supporting all labeling claims and substantial equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K093981
P1/3
Image /page/0/Picture/1 description: The image shows the text "CNOGA MEDICAL Seeing Beyond Imagination". The text is arranged in three lines, with "CNOGA" on the top line, "MEDICAL" on the second line, and "Seeing Beyond Imagination" on the third line. There is a graphic between the N and G in the first line.
JUL 22 2010
510(K) SUMMARY FOR CNOGA MEDICAL'S TENSORTIP™ - NON-INVASIVE HEMODYNAMIC BLOOD PRESSURE MONITOR
DATE PREPARED: JULY 10, 2010
1. 510(K) OWNER NAME
Cnoga Medical ACAL North Industrial Park, Ha-Ilan 83 St., Or Akiva, Israel Tel: +972 4 6361080, Fax: +972 4 6361321, E mail: yosef@cnoga.com (Mailing address: POB 79, Zichron Yaacov, 30900, Israel).
Contact person name: Dr. Yosef Segman, Cnoga Medical's CEO. Telephone: 972-4-6361080 ext. 105, E-mail: yosef@cnoga.com
Submitter: Ms. Tali Hazan - R.A Consultant Telephone: 972-50-5292304, Fax: 972-151-508963806, E-mail: tali.hazan@012.net.il
DEVICE NAME 2.
Common/Usual Name: Non-Invasive Measurement Chamber. Proprietary/Trade name: TensorTip™ - Non-invasive Hemodynamic Blood Pressure Monitor
Classification: Cnoga Medical's TensorTip- Non-invasive Hemodynamic Blood Pressure Monitor has been classified as Class II devices under the following classification names:
| Classification Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| System, measurement, blood-pressure, non-invasive | DXN | 870.1130 | Cardiovascular |
| Impedance plethysmograph | DSB | 870.2770 | Cardiovascular |
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3. PREDICATE DEVICES
Cnoga Medical's TensorTip device is substantially equivalent to the following Predicates:
- 3.1 A&D Engineering's A&D Medical Ua-767pbt Digital Blood Pressure Monitor (non-invasive), cleared under 510(k) number K043217.
- 3.2 Finapres Medical Systems' Finometer Noninvasive Hemodynamic Monitor, cleared under 510(k) number K023723.
- 3.3 Finapress Medical Systems' Portapress Ambulatory Continuous noninvasive blood pressure monitor, cleared under 510(k) number K023338.
DEVICE DESCRIPTION 4.
The TensorTip - Non-invasive Hemodynamic Blood Pressure Monitor measurement chamber is designed to measure spot-check of heartbeat and blood pressure trending levels by simply inserting the finger into the device "chamber".
It contains a dedicated finger compartment having soft gel on the upper compartment lead door suiting the finger to be placed inside. The device incorporates LEDs (Light Emitting Diode); a sensor array enables to sense the spectrum from near UV to near IR and a rechargeable battery for power supply. The device has large display for displaying temporal Pulse Per Minute (PPM) and Systolic and Diastolic Blood Pressure trending. In addition it shows the capillary blood waveform and the blood pressure variation during the measurement period. It is utilizing software that collects and presents the measured data. Body contact materials were evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing with acceptable results.
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5. INTENDED USE
The TensorTip - Non-invasive blood pressure trending device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory.
p3/3
The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Cnoga Medical's TensorTip-Non-invasive Hemodynamic Blood Pressure Monitor device combines two features (Pulse rate spot-check and blood pressure trending) into one device. Both features are substantially equivalent to the predicate devices already commercially available in the market, as identified in this 510(k) summary, section 3. These predicate devices have the same intended use and share a similar technology as our TensorTip device.
Certain differences in the technology utilized for the TensorTip did not raise new safety and effectiveness questions and found to be substantial equivalence for the device intended use.
7. PERFORMANCE DATA
Cnoga Medical's TensorTip spot-check pulse rate and non-invasive blood pressure trending device has been successfully tested with bench, human and safety testing to support the determination of substantial equivalence with predicate devices. Safety and EMC tests were conducted with accordance to EN 60601-1 and EN/IEC 60601-1-2 standards. Clinical validation has met the requirement of ISO 81060-2 standard.
Tests results are supporting all labeling claims and substantial equivalency.
CONCLUSIONS 8.
The evaluation of our device performances demonstrates that it is as safe and as effective as predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle, with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUL 2-2 2010
Cnoga Medical, Ltd. c/o Ms. Tali Hazan Regulatory Affairs Advisor for Medical Devices Ramot Naftali M.P. Upper Galilee ISRAEL 13830
Re: K093981
Trade/Device Name: TensorTip - Noninvasive Hemodynamic Blood Pressure Monitor Regulatory Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: June 12, 2010 Received: June 16, 2010
Dear Ms. Hazan:
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.
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Page 2 -- Ms. Tali Hazan
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 (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 yours,
W.M.d.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: TensorTip - Non-invasive Hemodynamic Blood Pressure Monitor
Indications for Use:
The TensorTip - Non-invasive Hemodynamic blood pressure monitor trending device is a small, lightweight, handheld, device intended for measuring and display of Blood Pressure trending (systolic and diastolic) and spot-check of Peripheral pulse rate (PPR) and Peripheral pulse wave (PPW). Measurement is performing on capillary finger tip tissue (other than the thumb). The ring finger is the recommended site. The results of each measurement are stored in the system memory. The device is intended for use in the home environment. It is intended to be used by any person aged above 18 years old.
Prescription Use > (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1
(Posted November 13, 2003)
ivision Sian-Off) Division of Cardiovascular Devices
510(k) Number K093981
Cnoga 510(k) AI TensorTip - Non-invasive Hemodynamic Blood Pressure Monitor July 10, 2010 Page 1 of 1