(115 days)
No
The device description explicitly states it uses the Auscultatory method and requires a stethoscope to monitor Korotkov sounds, which is a traditional, non-AI/ML approach to blood pressure measurement. There are no mentions of AI, ML, or related concepts in the summary.
No.
The device is a sphygmomanometer, which is used for measuring blood pressure (a diagnostic function), not for treating a condition.
Yes
Explanation: The device is intended to "measure the systolic and diastolic blood pressures," which are diagnostic measurements for assessing a patient's cardiovascular health.
No
The device description clearly outlines physical components like an inflatable cuff and the use of an Auscultatory method requiring a stethoscope, indicating it is a hardware device with potential software components, not a software-only device.
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.
- Device function: The TYTAN Automatic Aneroid Sphygmomanometer and TYTAN Manual Digital LCD Sphygmomanometer measure blood pressure non-invasively by wrapping a cuff around the upper arm. This is a physical measurement taken directly from the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states "noninvasive blood pressure measurement systems".
- Device Description: The description details the use of the Auscultatory method and monitoring Korotkov sounds, which are physical phenomena related to blood flow, not analysis of a biological sample.
Therefore, this device falls under the category of a non-invasive medical device for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
Product codes
DXN
Device Description
TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series use the Auscultatory method to measure the blood pressure. It needs to use the stethoscope as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systelic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or professional 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)
ELECTRIC SAFETY, EMC and FCC test reports, 1.
General safety IEC 60601-1:1988+ A1:1991+ A2:1995 PASS
EN 60601-1:1990+ A1:1993+ A2:1995+ A13:1996 PASS
EMC conformity EN 60601-1-2: 2001+ A1:2006 PASS
WOVEN COTTON SHEETING: (Same as the predicate devices TYTAN 710/700 )
Uses the 510K Blood-Pressure Cuff: TYTAN Blood-Pressure Cuff (K051539).
PERFORMANCE & CLINICAL TEST 3.
AAMI / ANSI SP10:2002
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Tytan Medical Corp.
Tel:886-2-2298-9579 Fax:886-2-2298-9578 E-mall:services@tytan.com.tw Website:www.tytan.com.tw
:
" 510(k) Summary "
IJAN 1 4 2010
K092893
| Submitter's Name: | TYTAN Medical Corp. |
|---|---|
| Address: | 6F-4, No. 11, Wu-Chun 1 Road, Hsin Chuang, Taipei, 24892, Taiwan, ROC |
| Telephone: | 886-2-22989579 |
| FAX: | 886-2-22989578 |
| Contact Person: | Dr. Jen, Ke-Min |
| Date Summary Prepared: | August 30, 2008 |
| Proprietary Name: | TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Manual Digital LCD Sphygmomanometer model A830 |
| Common Name: | BLOOD PRESSURE MONITOR |
| Classification Name: | NON-INVASIVE BLOOD-PRESSURE MEASUREMENT SYSTEM |
| (per 21CFR section 870.1130) | |
| Device Class: | Class II (performance standards) |
| Specialty: | CARDIOVASCULAR |
| Product code: | DXN |
| Legally Marketed (Predicate) Device: | TYTAN Professional / Economy Series Sphygmomanometer 710, 700 (K033025); A & D Medical UM-101 Digital Blood Pressure Monitor(K061456) |
1
K0928a3 'O
1 D
Tytan Medical Corp.
Tel:886-2-2298-9579 Fax:886-2-2298-9578 E-mail:services@tytan.com.tw Website:www.tytan.com.tw
Description of the new device: (Same as the predicate devices)
TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series use the Auscultatory method to measure the blood pressure. It needs to use the stethoscope as in the traditional measuring method, to monitor the Korotkov sound when deciding the systolic or diastolic pressure. Through simple calculation, the reading can reflect the accurate real blood pressure, and the systelic pressure is defined as the pressure when the cuff pressure oscillating amplitude begins to increase and the diastolic pressure as the pressure when the cuff pressure oscillating amplitude stops decreasing.
Technological Characteristics of our new device compared to the predicate device:
The technological characteristics of TYTAN Automatic Aneroid Sphygmomanometer A730 and TYTAN Manual Digital LCD Sphygmomanometer A830 series are substantially equivalent to TYTAN Professional / Economy Series Sphygmomanometer 710, 700 (K033025) and A&D Medical UM-101 Digital Blood Pressure Monitor(K061456). There are the same design specifications, the same form and intended to be used in the same manner that means the new devices are same as the predicate devices.
The mainly different are:
-
- The new devices TYTAN A730 can use the Li-ion battery and AC adapter to recharge the electric power, but the predicate devices TYTAN 710 / 700 (K033025) have not the power capability.
-
- The new devices TYTAN A730 and A830 series can not display the pulse information but the predicate device A&D Medical UM-101 Digital Blood Pressure Monitor (K061456) has numerical pulse display.
Thus there are substantially equivalent.
2
K092893 . ""
Tytan Medical Corp.
Tel:886-2-2298-9579 Fax:886-2-2298-9578
E-mail:services@tytan.com.tw Website:www.tytan.com.tw
Test Summary:
ELECTRIC SAFETY, EMC and FCC test reports, 1.
| General safety | IEC 60601-1:1988+ A1:1991+ A2:1995 | PASS |
|---|---|---|
| EN 60601-1:1990+ A1:1993+ A2:1995+ A13:1996 | PASS | |
| EMC conformity | EN 60601-1-2: 2001+ A1:2006 | PASS |
- WOVEN COTTON SHEETING: (Same as the predicate devices TYTAN 710/700 ) 2.
Uses the 510K Blood-Pressure Cuff: TYTAN Blood-Pressure Cuff (K051539).
PERFORMANCE & CLINICAL TEST 3.
AAMI / ANSI SP10:2002
TYTAN Medical Corp. believes this information and referred document to be sufficient for the FDA to find our proposed device substantially equivalent to the predicate product and other products currently in distribution.
Ke Zister
Dr. Jen, Ke-Min Official Correspondent TYTAN Medical Corp.
E3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three human profiles facing to the right, representing health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Tytan Medical Corp. c/o Dr. Ke-Min Jen ROC Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City CHINA (TAIWAN) 30067
Re: K092893
Trade Name: Tytan Automatic Aneroid Sphygmomanometer, Model A730; and, Tytan Digital LCD Sphygmomanometer, Model A830 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: December 18, 2009 Received: December 28, 2009
Dear Dr. Jen :
This letter corrects our substantially equivalent letter of January 14, 2010.
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 (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.
MAR 2 3 2010
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Page 2 - Dr. Ke-Min Jen
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); 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 continue 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
W.T.A.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Tytan Medical Corp.
Tel:886-2-2298-9579 Fax:886-2-2298-9578
E-mail:services@tytan.com.tw Website:www.tytan:com.tw
Indications for Use
510(k) Number: K092893
Device Name: TYTAN Medical Corp.
TYTAN Automatic Aneroid Sphygmomanometer model A7.30 and TYTAN Manual Digital LCD Sphygmomanometer model A830
● Indications for use:
The TYTAN Automatic Aneroid Sphygmomanometer model A730 and TYTAN Мапиа! Digital LCD Sphygmomanometer model A830 are noninvasive blood pressure measurement systems intended to measure the systolic and diastolic blood pressures, at hospital or professional environment by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm.
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
Prescription 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)
R. Schner
n of Cardiovascular Devices
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