(68 days)
Not Found
No
The description focuses on standard oscillometric blood pressure measurement technology, memory functions, and irregular heartbeat detection. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies summary.
No.
The device is intended to measure blood pressure and pulse rate, which are diagnostic measurements, not therapeutic interventions.
Yes.
The device is intended to measure blood pressure and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosing conditions like hypertension.
No
The device description explicitly mentions hardware components such as an inflatable cuff, LCD, electronic interface module, and silicon integrate pressure sensor technology.
Based on the provided information, this device 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.
- Device Function: The KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor measures blood pressure and pulse rate by using a cuff wrapped around the upper arm. This is a non-invasive measurement taken directly from the body, not from a sample in vitro (in glass/outside the body).
- Intended Use: The intended use clearly states it's a "non-invasive blood pressure measurement system."
Therefore, this device falls under the category of a non-invasive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
It is designed and manufactured according to ANSI/AAMI SP10--manual, electronic or automated sphygmomanometers.
The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module; the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-3909 is 2×60 times, the memory capability of KD-3917 is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-3909 also has the function of averaging the last three measurements.
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
adult individual
Intended User / Care Setting
medical professionals or at home
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)
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004, Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- AAMI SP10:2002. Manual, electronic or automated sphygmomanometers.
- AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
- AAMI / ANSI SP10:2002/A2:2006 -. Amendment 2 to ANSI/AAMI . SP10:2002 Manual, electronic, or automated sphygmomanometers.
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
510(k) Summary
K091739
P 1/4
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
AUG 1 8 2009
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 31, Changjiang 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: | 05/27/2009 |
2.0 Device information
Semi Automatic Electronic Blood Pressure Monitor Trade name: Noninvasive blood pressure measurement system Common name: Noninvasive blood pressure measurement system Classification name:
3.0 Classification
Production code: DXN- Noninvasive blood pressure measurement system. Regulation number: 870.1130 Classification: II Panel: Cardiovascular
4.0 Predict device information
Andon Health Co., Ltd. Manufacturer: KD-391 Semi Automatic Electronic Blood Pressure Monitor Device: K080326 510(k) number:
5.0 Device description
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
1
It is designed and manufactured according to ANSI/AAMI SP10--manual, P2/4 electronic or automated sphygmanometers.
The operational principle is based on oscillometric and silicon integrate pressure sensor technology, the result will be shown on a LCD with an electronic interface module; the result can also be classified and displayed by the function of blood pressure classification indicator, the memory capability of KD-3909 is 2×60 times, the memory capability of KD-3917 is 60 times. If any irregular heartbeat is detected, it can be shown on the LCD. KD-3909 also has the function of averaging the last three measurements.
6.0 Intended use
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
The intended use and the indication for use of KD-3917 and KD-3909, as described in their labelings are the same as the predict device KD-391.
| Technological Characteristics | Comparison result |
|---|---|
| Design principle | Identical |
| Appearance | Similar |
| Patients contact Materials | Identical |
| Performance | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Identical |
| Energy source | Identical |
| Standards met | Identical |
| Electrical safety | Identical |
| EMC | Identical |
| Function | Similar |
7.0 Summary comparing technological characteristics with predicate device
2
8.0 Performance summary
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor conforms to the following standards:
- · IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995.
- · IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004, Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
- · AAMI SP10:2002. Manual, electronic or automated sphygmomanometers.
- · AAMI / ANSI SP10:2002/A1:2003 --, Amendment 1 to ANSI/AAMI SP10:2002 Manual, electronic, or automated sphygmomanometers.
- AAMI / ANSI SP10:2002/A2:2006 -. Amendment 2 to ANSI/AAMI . SP10:2002 Manual, electronic, or automated sphygmomanometers.
9.0 Comparison to the predict device and the conclusion
Our device KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is substantially equivalent to the Semi Automatic Electronic Blood Pressure Monitor KD-391 whose 510(k) number is K080326.
KD-3917 and KD-391 are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Only their appearance is different. The Environmental parameters is changed, the operational range for humidity ( Trade/Device Name: KD-3917, KD-3909 Semi Automatic Electronic Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: undated Received: July 21, 2009
Dear Mr. 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.
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.
5
Page 2 - Mr. Liu Yi
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Žuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Statement of Indications for Use
| 510(k) Number : | K091739 |
|---|---|
| Device name: | KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor |
Indications for use:
KD-3917 and KD-3909 Semi Automatic Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The cuff circumference is limited to 22cm-48cm.
Prescription use Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of/CDRH, Office of Device Evaluation (ODE)
Hofstetter B Zuckerman
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
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