(155 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and standard compliance of a blood pressure cuff, with no mention of AI or ML algorithms for data processing or analysis.
No
A therapeutic device is one that treats or prevents a disease. This device is used for measurement, not treatment.
No
The device description clearly states it is a "Blood Pressure Cuff" which is a component of a non-invasive blood pressure monitoring system. It works by inflating and deflating to assist in the measurement of blood parameters, but it does not independently perform the diagnosis. It needs to be connected to a "Non Invasive Blood Pressure Monitor to complete the function".
No
The device description clearly states it is a "rectangle soft inelastic sleeve reusable with a bladder" and a "single-tube connected to the bladder," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to measure blood parameters on adults. This describes a device used externally on the body to facilitate a physiological measurement, not a test performed in vitro (outside of the living body) on biological samples.
- Device Description: The description details a physical cuff that inflates and deflates, connecting to a blood pressure monitor. This is consistent with a mechanical device used for external measurement.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This blood pressure cuff does not perform such a function.
N/A
Intended Use / Indications for Use
Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.
Product codes (comma separated list FDA assigned to the subject device)
DXQ
Device Description
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve reusable with a bladder. There is a single-tube connected to the bladder and the Non Invasive Blood Pressure Monitor for inflating and deflating. The device should connected to a Non Invasive Blood Pressure Monitor to complete the function. There is various sizes for different arm range as follows:
| Model | Arm range |
|---|---|
| KD-525-P31 | 20cm-34cm |
| KD-525-P32 | 30cm-44cm |
| KD-525-P33 | 40cm-48cm |
| KD-525-P34 | 15cm-24cm |
| KD-5917-P42 | 22cm-42cm |
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
adults
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)
Non-clinical Tests have been done as follows:
a. Safety and performance characteristics of the test according to IEC 80601-2-30
b. Biocompatibility test has been performed according to ISO 10993-5 and ISO 10993-10
None of the test demonstrates that the Blood Pressure Cuffs bring new questions of safety and effectiveness.
Clinical Test Concerning the Compliance of ANSI/AAMI SP10
Clinical test has been done in accordance with IEC 80601-2-30-Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, and the test result shows, the device met all applicable requirements of the standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
f
510(k) Summary
K133117 page 1 of 3
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Street Ya An Road, Nankai District, Tianjin, |
| P.R. China | |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: 09/25/2013 | |
2.0 Device information
Trade name: Andon Blood Pressure Cuff Blood Pressure Cuff Device name: Classification name: Blood pressure Cuff
3.0 Classification
Production code: DXQ Regulation number: 870.1120 Classification: II Panel: Cardiovascular
4.0 Predicate device information
| 1 | Manufacturer: | APK Technology Co, Ltd |
|---|---|---|
| Device: | Blood Pressure Cuff | |
| 510(k) number: | K102825 |
1
5.0 Intended use
Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.
6.0 Device description
The proposed device, Blood Pressure Cuff, is a rectangle soft inelastic sleeve reusable with a bladder. There is a single-tube connected to the bladder and the Non Invasive Blood Pressure Monitor for inflating and deflating. The device should connected to a Non Invasive Blood Pressure Monitor to complete the function. There is various sizes for different arm range as follows:
| Model | Arm range |
|---|---|
| KD-525-P31 | 20cm-34cm |
| KD-525-P32 | 30cm-44cm |
| KD-525-P33 | 40cm-48cm |
| KD-525-P34 | 15cm-24cm |
| KD-5917-P42 | 22cm-42cm |
7.0 Summary comparing technological characteristics with predicate device
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Identical |
| Function | Identical |
8.0 Discussion of non-clinical and clinical test performed
Non-clinical Tests have been done as follows:
a. Safety and performance characteristics of the test according to IEC 80601-2-30
b. Biocompatibility test has been performed according to ISO 10993-5 and ISO 10993-10
None of the test demonstrates that the Blood Pressure Cuffs bring new questions of safety and effectiveness.
2
Clinical Test Concerning the Compliance of ANSI/AAMI SP10
Clinical test has been done in accordance with IEC 80601-2-30-Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers, and the test result shows, the device met all applicable requirements of the standard.
9.0 Performance summary
The new cuffs conform to the following standards:
- · IEC 80601-2-30: Particular requirements for the basic safety and performance of of of automated non-invasive essential sphygmomanometers
- · ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk manangement process
- · ISO 10993-5: Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytoto xicity.
- · ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
10.0 Comparison to the predicate device and the conclusion
Compared to the predicate device, the new cuffs are very similar in the intended use, the design principle, the material, the performance and the applicable standards.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
So we claims the proposed cuffs to be Substantially Equivalent (SE) to the predicate devices Blood Pressure Cuff(K102825).
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
[Image of the Department of Health and Human Services logo]
March 4, 2014
Andon Health Co., Ltd Liu Yi No. 3 Jinping Street, Ya An Road, Nankai District Tianjin, 300190 CN
Re: K133117
Trade/Device Name: Andon Blood Pressure Cuff (Model: KD-525-P31, KD-525-P32, KD-525-P33, KD-525-P34, KD-5917-P42) Regulation Number: 21 CFR 870.1120 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXQ Dated: January 2, 2014 Received: January 6, 2014
Dear Liu Yi,
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems
4
Page 2 - Liu Yi
(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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Andon Blood Pressure Cuff FDA 510(k) Files
Statement of Indications for Use
K133117 510(k) Number :
Andon Blood Pressure Cuff (Model: KD-525-P31, Device name: KD-525-P33, KD-525-P34, KD-525-P32, KD-5917-P42)
Indications for use:
Blood Pressure Cuffs are intended to be wrapped on the upper arm and used with a non-invasive blood pressure monitor system to complete the measurement of blood parameters on adults.
AND/OR Over-The-Counter Use YES Prescription use (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Date:
FDA 2024.03.04
14:44:16 -05'00'
for Bram Zuckerman
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