(112 days)
Not Found
No
The description focuses on signal processing techniques (adaptive interference cancellation) and acoustic sensors to measure blood pressure, with no mention of AI or ML terms or concepts.
No.
The device provides data for assessing cardiac health via blood pressure readings, but it does not directly treat or alleviate a medical condition.
Yes
The device provides data for assessing cardiac health via blood pressure readings and explicitly states it is used to provide “preliminary blood pressure data from ambulatory patients.” Although it also states that patient diagnosis is not to be performed solely based on its results, the purpose of providing data for health assessment and preliminary data for non-time critical applications aligns with the definition of a diagnostic device, which aids in the identification of a disease or condition.
No
The device description explicitly mentions hardware components such as an electronic pressure cuff with three acoustic sensors (microphones).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device measures blood pressure and heart rate using acoustic sensors placed on the patient's body (biceps and triceps). It does not analyze any specimens taken from the body.
- Intended Use: The intended use is to provide blood pressure and heart rate data for assessing cardiac health and for preliminary blood pressure data. This is a physiological measurement taken directly from the patient, not an analysis of a biological sample.
Therefore, the PIESOMETER MK-1 Digital Blood Pressure Monitor falls under the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician. Patient diagnosis is not to be performed solely based on the results of this device.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Model PIESOMETER MK-1 Digital Blood Pressure Monitor measures systolic and diastolic blood pressure and heart rate using adaptive interference cancellation (signal processing) technologies. The system employs three acoustic sensors (i.e. microphones) in the electronic pressure cuff. During a blood pressurement, two acoustic sensors are placed in the traditional location on the patient's biceps. This set of sensors, operating much like a conventional stethoscope, senses the Korotkoff sounds. Unique to the PIESOMETER MK-1 is a second set of a sensor placed in the triceps area. This sensor serves to detect any interference signals that would normally compromise the reading. This allows reading to be taken even in noise and vibration intensive environment. This technology functions by identifying signals lying within the audio frequency and filtering out the interference signal. The CANAMET PIESOMETER is protected by U.S. Patent 6,520,918.
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
Not Found
Intended User / Care Setting
qualified medical personnel or trained users, qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician.
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)
The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices.
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.
K031479, K941167, K904318, K855127, K913844
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
K04/169
S1/2
AUG 2 4 2004
EXHIBIT 2 510(k) Summary
CANAMET CANADIAN NATIONAL MEDICAL TECHNOLOGIES INC. 1120 Finch Ave West, Suite 201 Toronto ON M3J-3H7 Phone (416) 916-0469 Ext 333 Fax: (416)-916-0313 Email: Stergios@canamet.com Contact: STERGIOS STERGIOPOULOS Date: July 31, 2004
- Identification of the device 1. Proprietary-Trade Name: PIESOMETER MK-1 Classification Names: DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE, Common/Usual Name: Non-invasive automated blood pressure meter.
2. Equivalent legally marketed devices
This product is similar in function and design to the Spacelabs ABP (Ambulatory Blood Pressure), K031479, K941167, K904318, K855127 and, SunTech Accutracker DX, K913844.
Indications for Use (intended use) 3.
The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician. Patient diagnosis is not to be performed solely based on the results of this device.
4. Description of the Device
The Model PIESOMETER MK-1 Digital Blood Pressure Monitor measures systolic and diastolic blood pressure and heart rate using adaptive interference cancellation (signal processing) technologies. The system employs three acoustic sensors (i.e. microphones) in the electronic pressure cuff. During a blood pressurement, two acoustic sensors are placed in the traditional location on the patient's biceps. This set of sensors, operating much like a conventional stethoscope, senses the Korotkoff sounds. Unique to the PIESOMETER MK-1 is a second set of a sensor placed in the triceps area. This sensor serves to detect any interference signals that would normally compromise the reading. This allows reading to be taken even in noise and vibration intensive environment. This technology functions by identifying signals lying within the audio frequency and filtering out the interference signal. The CANAMET PIESOMETER is protected by U.S. Patent 6,520,918.
1
Safety and Effectiveness, comparison to predicate device 5.
The results of bench and user/clinical testing indicate that the new device is as safe and effective as the predicate devices.
| Designation | Spacelabs ABP (Ambulatory
Blood Pressure), K031479,
K941167, K904318, K855127 | SunTech
Accutracker DX,
K913844. | PIESOMETER MK-1 |
|------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Operating
Principle | Auscultatory Technology
Korotkoff sound technique. | Auscultatory
Technology
Korotkoff sound
technique, Motion
Tolerant | Auscultatory
Technology
Korotkoff sound
technique, Motion
Tolerant |
| Display | 4-digit, 7-segment LCD;
systolic, diastolic and
heart rate information | 32 Character LCD | 32 Character LCD |
| Recording Time | Up to 48 hours | Up to 48 Hours | Up to 48 Hours |
| Power supply | 4 AA alkaline disposable
or rechargeable NiCad
batteries | Four 1.5 (AA) alkaline
batteries | Rechargeable Lithium-
Ion battery (Not user
replaceable)
rechargeable with
supplied charger. |
| External
dimensions | 1.1"x4.5"x3.4" (2.8 cm
x11.4 cm x8.6 cm)
Model 90217:
0.97"x3.94"x2.77" (2.5 cm
x10.0 cm x7.0 cm) | 3.25"W x 5"L x 1.30"D
(8.25cm x 12.7cm x
3.3cm) | 5.28" x 3.74" x 1.73"
(13.4 cm X 9.5cm X
4.4cm) |
| Memory | Not specified | Over 250 samples of
systolic, diastolic, and
heart rate. | 60 records of systolic,
diastolic, and heart rate |
| Weight | 12.2 oz. (347 g) (with
batteries)Model 90217: 9
oz. (255 g) (with
batteries) | 12.6oz. (357.2 grams) | 850 grams |
| Accessories | Not specified | Multiple cuff sizes | Multiple cuff sizes |
Comparison matrix - new ys. Predicate device 6
7. Conclusion
After analyzing both bench and clinical testing data, it is the conclusion of Canamet that that the "PIESOMETER MK-1" Automated Blood Pressure Monitor is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
p (_/%
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2004
Canamet Canadian National Medical Technologies, Inc. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K041169
Trade Name: Piesometer, Model MK-1 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: August 09, 2004 Received: August 10, 2004
Dear Mr. Kamm:
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
3
Page 2 - Mr. Daniel Kamm, P.E.
comply with all the Act's requirements, including, but not limited to: registration and listing (21 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Neil R.P. Ogden for
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):________________K041169
Device Name: PIESOMETER MK-1
The device is used to provide data to qualified medical personnel or trained users for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period. Measurements of systolic, diastolic, and heart rate are made and stored. The device can also be used to provide blood pressure and heart rate data in single measurement mode. The device is also intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only. It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician. It is also intended for home care use by a trained patient with periodic health consultations from his or her physician.
Patient diagnosis is not to be performed solely based on the results of this device.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil H. Golen
for BOZ
| (Division Sign-Off) Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number | K041169 |
Page 1 of 1