(50 days)
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.
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.
The acceptance criteria, study details, and ground truth establishment for the Tytan Blood Pressure Cuff are derived from the provided 510(k) summary (K062238).
1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used
The Tytan Blood Pressure Cuff sought substantial equivalence to a predicate device (TRICOT BLOOD PRESSURE CUFF, K0515339) by demonstrating equivalent functional and physical performance characteristics. The primary ground truth for evaluating performance was the ANSI/AAMI SP9:1994 standard.
| Acceptance Criteria (Based on AAMI SP9:1994 Standard) | Reported Device Performance (Tytan Blood Pressure Cuff) |
|---|---|
| Functional Performance - Dimension | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Functional Performance - Pressure Capacity | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Functional Performance - Cuff Closure | Equivalent to predicate device (TRICOT Blood Pressure Cuff) |
| Biocompatibility (for new outer material) | Passed three Biocompatibility tests, considered substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific numerical "sample size" in terms of number of cuffs tested for the performance evaluations. Instead, it states that "The TYTAN blood pressure cuff was compared to the TRICOT blood pressure cuff to confirm its functional and physical performance characteristics were equivalent." This implies a comparative testing methodology was used.
The data provenance is prospective testing conducted by the manufacturer for the purpose of demonstrating substantial equivalence. The country of origin for the device's manufacturer is Taiwan, but the testing details (where, by whom) are not specified beyond the reference to the AAMI standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The ground truth for performance was established by the ANSI/AAMI SP9:1994 standard itself, which is a published consensus standard. The process of developing such a standard typically involves numerous experts in the field, but this document does not detail their involvement in this specific submission. The manufacturer performed tests to show adherence to this standard.
4. Adjudication Method for the Test Set
This information is not provided. Given that the evaluation was based on compliance with a specific engineering standard (AAMI SP9:1994), an "adjudication method" in the sense of expert review committees is unlikely for these technical performance attributes. Compliance would typically be determined by meeting predefined thresholds and specifications outlined in the standard.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is a critical component. For a blood pressure cuff, the performance evaluation focuses on physical and functional characteristics, not human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was implicitly done. The "performance data" section describes the evaluation of the cuff's characteristics (dimension, pressure capacity, cuff closure, biocompatibility) based on the AAMI SP9:1994 standard. This testing focuses solely on the device's intrinsic physical and functional properties, independent of human interaction during the measurement process, beyond proper training of personnel for its use.
8. The Sample Size for the Training Set
This concept is not applicable to this device. Blood pressure cuffs are mechanical devices, not AI/algorithm-driven systems that require "training sets" in the conventional machine learning sense. The "study" for this device involved physical and functional testing against a standard, not training a predictive model.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable (see point 8).
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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
page 1 of 3
$\overrightarrow{PS}$
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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 : 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 PRESSURECUFF | YA HORNG Electronic Co., Ltd.TRICOT BLOOD PRESSURECUFF (K051539) |
| INTENDED USE | INDIRECT MEASUREMENTOF BLOOD PRESSURE | INDIRECT MEASUREMENTOF BLOOD PRESSURE |
| ANATOMICALSITES OF USE | UPPER ARM | WRIST |
| INTENDEDPOPULATION | NEWBORN – LARGE ADULT | CHILD- LARGE ADULT |
| LABELING | SEE SECTION 6 | SEE SECTION 5 |
| OUTERMATERIAL | NYLON FABRIC ORPOLYESTER | NYLON FABRIC OR COTTON |
| BLADDERMATERIAL | LATEX | LATEX |
| CUFF CLOSURE | VELCRO | VELCRO |
| PRESSURELIMITS | 0 -300 mmHg | 0 -300 mmHg |
| USABLE LIFE | 10,000 INFLATION | 10,000 INFLATION |
| NUMBER OFTUBES | 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: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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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 (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
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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
Page 1 of 1
§ 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).