TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700

K033025 · Tytan Medical Corp. · DXN · Dec 10, 2003 · Cardiovascular

Device Facts

• Record ID: K033025
• Device Name: TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
• Applicant: Tytan Medical Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: Dec 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult.

Device Story

Tytan Professional/Economy Series Sphygmomanometer (No 700/710) is a manual non-invasive blood pressure measurement system. Device consists of an inflatable cuff, pressure gauge, and inflation bulb. Operated by user or clinician at home or clinical settings. Principle of operation involves wrapping cuff around patient arm, inflating to occlude artery, and monitoring pressure release to determine systolic and diastolic values via auscultation or visual gauge observation. Provides blood pressure readings to assist in monitoring cardiovascular health. No electronic processing or automated algorithms involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual sphygmomanometer; includes inflatable cuff, pressure gauge, and inflation bulb. Cuff sizes range from 3.5" to 19.5" circumference. Non-electronic, mechanical operation. No software or energy source.

Indications for Use

Indicated for non-invasive systolic and diastolic blood pressure measurement in newborns, infants, children, and adults.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

DEC 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tytan Medical Corp. c/o Mr. William Hsieh 1-3 F, No.2, 1 Lane, Juang Shing Road, Sec.1, WU GU 248, Taipei Hsien, R.O.C. CHINA (TAIWAN) 248

Re: K033025

Trade Name: TYTAN Professional/Economy Series Sphygmomanometer, No 700/710 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 20, 2003 Received: September 26, 2003

Dear Mr. Hsieh:

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, isting 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.

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Page 2 - Mr. William Hsieh

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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dna Heuxhur for
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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## 3. Indications for use statement

Applicant: TYTAN Medical Corp.

510(k) Number ( if known):

Device Name: Tytan Professional series No. 710 / Economy series No. 700

● Indications for use:

The device is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures at home by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. The cuff circumference ranges are 3 1/2" to 5 1/4", 3 3/4" to 7 1/2", 7" to 10 3/4", 10 3/4" to 15 3/4", and 13 1/3" to 19 1/2". The patient population targets are newborn, infant, child, adult.

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Concurrence of CDRH, office of Device Evaluation (ODE )

| (Division Sign-Off) |
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Division of Cardiovascular Devices

| 510(k) Number | R033025 |
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Prescription Use OR Over - The - Counter - Use_

( Per 21 CFR 801.109 )

( Optional Format 1-2-96 )