TYTAN BLOOD PRESSURE CUFF

K062238 · Tytan Medical Corp. · DXQ · Sep 21, 2006 · Cardiovascular

Device Facts

• Record ID: K062238
• Device Name: TYTAN BLOOD PRESSURE CUFF
• Applicant: Tytan Medical Corp.
• Product Code: DXQ · Cardiovascular
• Decision Date: Sep 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes.

Device Story

The Tytan blood pressure cuff is a non-sterile, reusable, multi-patient device designed for indirect blood pressure measurement. It consists of an inflatable latex bladder housed within an inelastic sleeve (nylon or polyester fabric) with a Velcro closure mechanism. The device is used in conjunction with non-invasive blood pressure measurement systems. It is operated by trained personnel to measure blood pressure in patients ranging from newborns to large adults. The cuff is available in various sizes and supports pressure limits up to 300 mmHg. It is designed for a usable life of 10,000 inflation cycles.

Clinical Evidence

Bench testing only. Performance evaluated against AAMI SP9:1994 standards for dimension, pressure capacity, and cuff closure. Biocompatibility testing was performed to address material differences.

Technological Characteristics

Inflatable latex bladder; inelastic nylon or polyester sleeve; Velcro closure; 0-300 mmHg pressure range; 1 or 2 tube configurations; reusable; non-sterile. Complies with ANSI/AAMI SP9-1994.

Indications for Use

Indicated for non-invasive blood pressure measurement in patients ranging from newborn to large adult sizes. Used by trained personnel in conjunction with blood pressure measurement systems.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• TRICOT BLOOD PRESSURE CUFF (K051539)

Submission Summary (Full Text)

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K062238

tan
ition

Tytan Medical Corp. 6F-4. No.11. Wu-Chun 1Rd. Hsin Chuang, Taipei, 24892, Taiwan, R. O. C. Fax : [phone] Tel : [phone] E-mail : SERVICES(aTYTAN.COM Internet : www.tylan.com.tw

SEP 2 1 2006

#### SUMMARY OF SAFETY AND EFFECTIVENESS 3.

( According to 21 CFR 807.92)

DATE OF

SUBMISSION: SUBMITTER:

July 30, 2006 General Manager, Mr. MICHAEL SHIEH TYTAN MEDICAL CORP. 6F-4. No.11. Wu-Chun 1 Rd., Hsin Chuang, Taipei, 24892, Taiwan TEL: [phone] FAX: [phone]

ESTABLISHMENT 9616940 REGISTRATION NO:

OFFICIAL CONTACT:

Dr. JEN, KE-MIN ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY NO 58, FU-CHIUN ST. HSIN-CHU CITY, CHINA (TAIWAN) 30067 TEL: [phone] FAX:[phone] ESMIL: CEIRS. JEN @ MSA, HINET, Com TYTAN BLOOD PRESSURE CUFF

TRADE NAME:

BLOOD PRESSURE CUFF COMMON/USUAL

NAME: CLASSIFICATION NAME:

CUFF, BLOOD PRESSURE (CFR870.1120)

CLASSIFICATION PANEL:

CARDIOVASCULAR

PREDICATED DEVICE: INTENDED USE:

TRICOT BLOOD PRESSURE CUFF ( K051539 )

The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes

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Image /page/1/Picture/1 description: The image shows the logo for Tytan Medical. The logo is stacked, with the word "Tytan" on top of the word "Medical". The font is bold and slightly distressed, giving it a textured appearance. The logo is black against a white background.

Tytan Medical Corp.

6F-4. No.11. Wu-Chun 1Rd. Hsin Chuang, Taipei, 24892, Taiwan, R. O. C. Fax : [phone] Tel : [phone] E-mail : SERVICES@ TYTAN.COM Internet : www.lytan.com.iw

#### DEVICE DESCRIPTION:

The TYTAN blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes. Each cuff will be packaged in a polyethylene bag.

| ITEM | SUBJECT DEVICE | PREDICATE DEVICE |
|----------------------------|-----------------------------------------------------|--------------------------------------------------------------------------|
| NAME | TYTAN Medical Corp.<br>TYTAN BLOOD PRESSURE<br>CUFF | YA HORNG Electronic Co., Ltd.<br>TRICOT BLOOD PRESSURE<br>CUFF (K051539) |
| INTENDED USE | INDIRECT MEASUREMENT<br>OF BLOOD PRESSURE | INDIRECT MEASUREMENT<br>OF BLOOD PRESSURE |
| ANATOMICAL<br>SITES OF USE | UPPER ARM | WRIST |
| INTENDED<br>POPULATION | NEWBORN – LARGE ADULT | CHILD- LARGE ADULT |
| LABELING | SEE SECTION 6 | SEE SECTION 5 |
| OUTER<br>MATERIAL | NYLON FABRIC OR<br>POLYESTER | NYLON FABRIC OR COTTON |
| BLADDER<br>MATERIAL | LATEX | LATEX |
| CUFF CLOSURE | VELCRO | VELCRO |
| PRESSURE<br>LIMITS | 0 -300 mmHg | 0 -300 mmHg |
| USABLE LIFE | 10,000 INFLATION | 10,000 INFLATION |
| NUMBER OF<br>TUBES | 1 and 2 | 1 and 2 |

#### COMPARISON WITH PREDICATE DEVICE:

### PERFORMANCE DATA

The TYTAN blood pressure cuff was compared to the TRICOT blood pressure cuff to confirm its functional and physical performance characteristics were equivalent. The AAMI SP9:1994 standard was used to select the relevant performance attributes to measure. The cuffs were equivalent in performance in regards to DIMENSION, PRESSURE CAPACITY, and CUFF CLOSURE as required under the SP9 standard. Though the outer materials have certain difference, the subject device passes three Biocompatibility tests, and they are substantially equivalent in this respect.

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**Tytan**
Medical

Tytan Medical Corp. 6F-4. No.11. Wu-Chun 1Rd. Hsin Chuang, Taipei, 24892, Taiwan, R. O. C. Tel:[phone] Fax : [phone] E-mail : [e-mail] Internet : www.tylan.com.tw

## CONCLUSION

In accordance with the FDA 21 CFR 807 and based on the information provided in this premarket notification, TYTAN Medical Corp. concludes that the TYTAN Blood Pressure Cuff is safe, effective and substantially equivalent to the TRICOT BLOOD PRESSURE CUFF ( K051539 ) predicate device as described herein and meets the relevant requirements of ANSI/AAMI SP9-1994.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized eagle with three talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 2006

Tytan Medical Corp. c/o Dr. Jen, Ke-Min ROC Chinese-Euorpean Industrial Research Society No. 58 Fu-Chiun St. Hsin-Chu City, 30067 TAIWAN, REPUBLIC OF CHINA

Re: K062238

Trade Name: Tytan Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: August 21, 2006 Received: August 23, 2006

Dear Dr. Jen, Ke-Min:

We have reviewed your Section 510(k) premarket notification of intent to market the device indication we have reviewed your bection 910(s) per is substantially equivalent (for the indications felerenced above and nave determined it and marketed predicate devices marketed in interstate for use stated in the cherosure) to regard to tegans and the Medical Device American be on to commerce prior to May 20, 1976, the enasciance with the provisions of the Federal Food, Drug, devices that have occh reclassified in acceraapproval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval a and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The You may, therefore, market the devices, cooler ments for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (\$60 above) the existences and regulations affecting your device can
may be subject to such additional controls. Existing major and contribution may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Court of Feactar 11.5 miles in the Federal Register.

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#### Page 2 - Dr. Jen, Ke-Min

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 (OS) 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/industry/support/index.html.

Sincerely yours,

Blymmerton 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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# Tytan Medical Corp.

6F-4. No.11. Wu-Chun 1Rd. Hsin Chuang, Taipei, 24892, Taiwan, R. O. C. Fax : [phone] Tel:[phone] E-mail : [e-mail] Internet : www.tylan.com.tw

## Indications for Use

510(k) Number:

K 062238

Device Name:

TYTAN MEDICAL CORP. TYTAN BLOOD-PRESSURE CUFF

Indications for Use:

The TYTAN blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in newborn through large adult sizes.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Bhummer

(Division Sign-Off) Division of Cardlovascular Devices 510(k) Number

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