(50 days)
No
The device description and performance studies focus on the physical characteristics and functional equivalence of a blood pressure cuff, with no mention of AI or ML.
No.
The device is used for measuring blood pressure, which is a diagnostic function, not a therapeutic intervention.
No
The device is a blood pressure cuff used to measure blood pressure, which is a vital sign, but it does not diagnose a medical condition itself. It's a component of a non-invasive blood pressure measurement system.
No
The device description explicitly states it is a blood pressure cuff, which is a physical hardware component.
Based on the provided information, the TYTAN blood pressure cuff 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.
- TYTAN Blood Pressure Cuff Function: The TYTAN blood pressure cuff is a mechanical device used externally on the body (specifically the upper arm) to measure blood pressure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "measuring one's blood pressure" in conjunction with non-invasive blood pressure measurement systems. This is a physical measurement, not an in vitro diagnostic test.
The information provided aligns with a medical device used for physiological measurement, not an IVD.
N/A
Intended Use / 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.
Product codes
DXQ
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.
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
NEWBORN – LARGE ADULT
Intended User / Care Setting
Not Found
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 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.
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
§ 870.1120 Blood pressure cuff.
(a)
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.(b)
Classification. Class II (performance standards).
0
tan
ition
Tytan Medical Corp. 6F-4. No.11. Wu-Chun 1Rd. Hsin Chuang, Taipei, 24892, Taiwan, R. O. C. Fax : 886-2-2298-9578 Tel : 886-2-2298-9574 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: 886-2-22979579 FAX: 886-2-22989578
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: 886-3-5208829 FAX:886-3-5209783 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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$\overrightarrow{PS}$
1
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 : 886-2-2298-9578 Tel : 886-2-2298-9574 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. | |
| TYTAN BLOOD PRESSURE | ||
| CUFF | YA HORNG Electronic Co., Ltd. | |
| TRICOT BLOOD PRESSURE | ||
| CUFF (K051539) | ||
| INTENDED USE | INDIRECT MEASUREMENT | |
| OF BLOOD PRESSURE | INDIRECT MEASUREMENT | |
| OF BLOOD PRESSURE | ||
| ANATOMICAL | ||
| SITES OF USE | UPPER ARM | WRIST |
| INTENDED | ||
| POPULATION | NEWBORN – LARGE ADULT | CHILD- LARGE ADULT |
| LABELING | SEE SECTION 6 | SEE SECTION 5 |
| OUTER | ||
| MATERIAL | NYLON FABRIC OR | |
| POLYESTER | NYLON FABRIC OR COTTON | |
| BLADDER | ||
| MATERIAL | LATEX | LATEX |
| CUFF CLOSURE | VELCRO | VELCRO |
| PRESSURE | ||
| LIMITS | 0 -300 mmHg | 0 -300 mmHg |
| USABLE LIFE | 10,000 INFLATION | 10,000 INFLATION |
| NUMBER OF | ||
| 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.
Page 2 of 3
2
Tytan
Medical
Tytan Medical Corp. 6F-4. No.11. Wu-Chun 1Rd. Hsin Chuang, Taipei, 24892, Taiwan, R. O. C. Tel:886-2-2298-9574 Fax : 886-2-2298-9578 E-mail : SERVICES@TYTAN.COM 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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3
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.
4
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 (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/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
5
Tytan Medical Corp.
6F-4. No.11. Wu-Chun 1Rd. Hsin Chuang, Taipei, 24892, Taiwan, R. O. C. Fax : 886-2-2298-9578 Tel:886-2-2298-9574 E-mail : SERVICES@TYTAN.COM 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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