(156 days)
Not Found
No
The device is a simple, disposable blood pressure cuff accessory and the description focuses on its physical components and materials. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No.
The device is an accessory for noninvasive blood pressure measurement systems, used for diagnostic purposes (measuring blood pressure), not for treating a disease or condition.
No
This device is an accessory (blood pressure cuff) used with noninvasive blood pressure measurement systems, not a diagnostic device itself. Its function is to facilitate blood pressure measurement, which then provides data for diagnosis.
No
The device description clearly states it is a physical blood pressure cuff made of non-woven fabrics and polyvinyl chloride, incorporating an inflatable bladder and air hose. It is a hardware accessory.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The Tenso TS-101S and TS-101D disposable blood pressure cuff is an accessory used to physically occlude an artery on a patient's limb to allow for the measurement of blood pressure. This is a physical measurement taken on the body (in vivo).
- Intended Use: The intended use is to be used in conjunction with noninvasive blood pressure measurement systems, which are devices that measure blood pressure directly on the patient.
- Device Description: The description details a physical cuff with an inflatable bladder and air hose, designed to be applied to a limb. There is no mention of collecting or analyzing biological specimens.
Therefore, the function and intended use of this blood pressure cuff clearly fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Tenso TS-101S and TS-101D disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in infant, pediatric and adult sizes. They are used in hospital settings.
Product codes (comma separated list FDA assigned to the subject device)
DXO
Device Description
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are an accessory used in conjunction with noninvasive blood pressure measurement systems. They incorporate an inflatable nondistensible bladder, sized to encircle a patient's limb. This allows air to flow in and out of the cuff for inflation and deflation, for the purpose of occlusion of an artery.
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" have a structure which contains Cuff with bladder and Air Hose. Air hose has either single tube or double tubes." The device is secured by hook and loop closure onto the patient limb. It has two variations: TS-101S" is the variant that has single tube structure, while "TS-101D" is the variant that has double-tube structure.
The cuff is made from non-woven fabrics, the air hose and tubes are made from polyvinyl chloride. Therefore, the non-woven fabric (cuff) is the material used to contacting with the patient.
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are single use device and are provided as non-sterile. They are available in infant, pediatric and adult sizes.
"Tenso TS-101S Disposable Blood Pressure Cuffs" (single tube model) have 6 models with different size for different population with different arm size. "TS-101D Disposable Blood Pressure Cuffs" (double tube model) also have 6 models with different size for different population with different arm size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient limb, arm, thigh
Indicated Patient Age Range
infant, pediatric and adult
Intended User / Care Setting
hospital settings.
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- . ISO 81060-1:2007 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
The subject device also conforms to the following FDA guidance:
- . Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final
Specifically, the following table summarizes the mechanical testing results of the subject device:
- Characteristics: Mechanical Strength; Specifications: Able to withstand 300 mm Hg; Test Method: Internal; Results: Meet
- Characteristics: Fatigue Strength; Specifications: Able to withstand inflation (to 300 mm Hg) and deflation for at least 300 times; Test Method: Internal; Results: Meet
- Characteristics: Leakage Rate; Specifications: Leakage rate
§ 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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2016
Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. % Charles Shen Official Correspondent Manton Business And Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K153251
Trade/Device Name: Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: March 8. 2016 Received: March 8, 2016
Dear Charles Shen:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mitchell Stein
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153251
Device Name
TS-101S and TS-101D Disposable Blood Pressure Cuff
Indications for Use (Describe)
The Tenso TS-101S and TS-101D disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in infant, pediatric and adult sizes. They are used in hospital settings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 5: 510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
5.1 Submitter & Foreign Manufacture Identification
Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. 24/F, 238 Zhongshan East Road, Ningbo, China. Zipcode 315010 TEL: (086) 574-87344400 Submitter's FDA Registration Number: N/A
5.2 Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey, USA 07436 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: November 09, 2015 5.3
5.4 Device Name:
| Proprietary Name: | Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff |
|---|---|
| Common Name: | Blood Pressure Cuff |
| Classification Name: | Blood Pressure Cuff |
| Device Classification: | II |
| Classification Regulation: | 21 CFR 870.1120 |
| Panel: | Cardiovascular |
| Product Code: | DXQ |
ર્સ્ડ Predicate Device Information:
- (1) K151290, "Disposable/Reusable Blood Pressure Cuff", manufactured by "Xuzhou Maicuff Technology Co., Ltd." (for arm cuffs)
- (2) K120364, "Unined Disposable Blood Pressure Cuff", manufactured by "Unined Medical supplies Inc." (for thigh cuffs)
5.6 Device Description:
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are an accessory used in conjunction with noninvasive blood pressure measurement systems. They incorporate an inflatable nondistensible bladder, sized to encircle a patient's limb. This allows air to
4
flow in and out of the cuff for inflation and deflation, for the purpose of occlusion of an artery.
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" have a structure which contains Cuff with bladder and Air Hose. Air hose has either single tube or double tubes." The device is secured by hook and loop closure onto the patient limb. It has two variations: TS-101S" is the variant that has single tube structure, while "TS-101D" is the variant that has double-tube structure.
The cuff is made from non-woven fabrics, the air hose and tubes are made from polyvinyl chloride. Therefore, the non-woven fabric (cuff) is the material used to contacting with the patient.
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" are single use device and are provided as non-sterile. They are available in infant, pediatric and adult sizes.
"Tenso TS-101S Disposable Blood Pressure Cuffs" (single tube model) have 6 models with different size for different population with different arm size. "TS-101D Disposable Blood Pressure Cuffs" (double tube model) also have 6 models with different size for different population with different arm size.
5.7 Intended Use:
Tenso TS-101S and TS-101D disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and for single-patient use. It is available in infant, pediatric and adult sizes. They are used in hospital settings.
ર્સ જિ Summary of Device Testing:
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- . ISO 81060-1:2007 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type
The subject device also conforms to the following FDA guidance:
- . Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance Version 1; Final
5
Specifically, the following table summarizes the mechanical testing results of the subject device:
| Characteristics | Specifications | Test Method | Results |
|---|---|---|---|
| Mechanical Strength | Able to withstand 300 mm Hg | Internal | Meet |
| Fatigue Strength | Able to withstand inflation (to 300 mm Hg) and deflation for at least 300 times | Internal | Meet |
| Leakage Rate | Leakage rate 260 mm Hg |
Table 5.2: Comparison of Intended Use, Design, Material, and Processing (Thigh Cuffs)
| Description | Subject Device | Predicate Device (K120364) |
|---|---|---|
| Indication for | ||
| Use | Tenso TS-101S and TS-101D disposable | |
| blood pressure cuff is an accessory used in | ||
| conjunction with noninvasive blood pressure | ||
| measurement systems. The cuff is non-sterile | ||
| and for single-patient use. It is available in | ||
| infant, pediatric and adult sizes. They are | ||
| used in hospital settings. | The Unimed Blood Pressure Cuff is an | |
| accessory used in conjunction with | ||
| noninvasive blood pressure measurement | ||
| systems. The cuff is non-sterile and for | ||
| single-patient use. It is available in neonatal, | ||
| pediatric and adult sizes. The cuff is no | ||
| designed, sold, or intended for use except as | ||
| indicated. | ||
| Patient | ||
| Population | Adults/Pediatrics | Adults/Pediatrics |
| Tube | ||
| Configuration | One or two tube | One or two tube |
| Material | Non-woven, nylon, and PVC | Non-woven, nylon, and PVC |
| Size | Conform to AHA bladder sizes | |
| recommendations | ||
| Thigh (45-66 mm) | Conform to AHA bladder sizes | |
| Recommendations | ||
| Thigh (45-56 mm) | ||
| Single Use | Yes | Yes |
| Sterile | Non-sterile | Non-sterile |
| Pressure | ||
| Range | 0-300 mm Hg | 0-300 mm Hg |
| Measurement | ||
| Range | 0-270 Hg | 0 - >260 mm Hg |
The subject device is essentially identical to the predicate devices in terms of indications for use, design, and material. The minor differences are not related to the safety and efficacy features of the two devices.
7
5.10 Comparison of Performance with Predicate Device
Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of ISO 81060-1, and results met all relevant requirements in the test standard.
The following table shows similarities and differences of the biocompatibility between our device and the predicate devices. Tests were conducted following the recommended procedures outlined in the FDA recognized consensus standard of ISO 10993, and results met all relevant requirements in the test standards, and are comparable to the predicate device.
| Description | Subject Device: | Predicate Device (K151290) |
|---|---|---|
| Cytotoxicity | ||
| (ISO 10993-5:2009) | No cytotoxicity effect | No cytotoxicity effect |
| Irritation | ||
| (ISO 10993-10: 2010) | Not a irritant under the | |
| conditions of the study | Not a irritant under the | |
| conditions of the study | ||
| Sensitization (ISO | ||
| 10993-10: 2010) | Not a sensitizer under the | |
| conditions of the study | Not a sensitizer under the | |
| conditions of the study |
Table 5.2: Comparison of Biocompatibility Testing
Therefore, "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" manufactured by "Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd." meet requirements per ISO 81060-1 and ISO 10993-1. It is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses. The test results are also comparable to the predicate device.
5.11 Substantial Equivalence Conclusion
It has been shown in this 510(k) submission that "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" and their predicate devices have the identical indications for use, similar composition and biocompatibility, and similar performance.
The difference between the "Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs" and their predicate devices do not raise any question regarding its safety and effectiveness.
"Tenso TS-101S and TS-101D Disposable Blood Pressure Cuffs", as designed and manufactured, are as safe and effective as its predicate device, and therefore is substantially equivalent as its predicate device.