(28 days)
The KP-7770 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff wrapped around the arm. It is indicated for use in adults.
The devices display irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arm Blood Pressure Monitor Model KP-7770:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance regarding blood pressure accuracy (e.g., mean difference and standard deviation compared to a reference method). Instead, it states compliance with recognized consensus standards.
Acceptance Criteria (Implied by Compliance with Standards):
| Criterion | Source / Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Blood Pressure Accuracy | AAMI/ANSI SP10 (2002 / A1:2003) | "The Arm Blood Pressure Monitor Model KP-7770 complies with the following FDA recognized consensus standards..." | Compliance with AAMI/ANSI SP10 implies that the device meets the accuracy requirements outlined in that standard (e.g., mean difference ≤ 5 mmHg and standard deviation ≤ 8 mmHg for both systolic and diastolic blood pressure when compared to a reference standard). However, specific accuracy metrics are not provided in this document. |
| Electrical Safety | IEC 60601-1 (1988) | "The Arm Blood Pressure Monitor Model KP-7770 complies with the following FDA recognized consensus standards..." | The device adheres to general requirements for safety of medical electrical equipment. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (2002) | "The Arm Blood Pressure Monitor Model KP-7770 complies with the following FDA recognized consensus standards..." | The device meets requirements related to electromagnetic emissions and immunity for medical electrical equipment. |
| Electromagnetic Immunity (Specific) | EN61000-4-2 (1995) | "The KP-7770 also complies with the following additional standards-" | Adheres to electrostatic discharge immunity requirements. |
| Electromagnetic Immunity (Specific) | EN61000-4-3 (2002) | "The KP-7770 also complies with the following additional standards-" | Adheres to radiated, radio-frequency, electromagnetic field immunity requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Clinical performance of the modified device is remain unchanged; therefore another clinical trial for this device, KP-7770, is not required."
This indicates that no new clinical test set was used for the KP-7770 model as its clinical performance was deemed unchanged from its predicate. Therefore, information regarding sample size and data provenance for a new test set is not applicable to this specific submission for the KP-7770.
3. Number of Experts and Qualifications for Ground Truth of Test Set
As no new clinical test set was conducted for the KP-7770, this information is not provided. The substantial equivalence argument relies on the predicate device's established performance.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set was conducted for the KP-7770.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. Blood pressure monitors are typically evaluated for accuracy against a reference standard in clinical studies, not through MRMC studies which are more common for diagnostic imaging or interpretation tasks.
6. Standalone Performance (Algorithm Only)
The document focuses on the overall device (Arm Blood Pressure Monitor Model KP-7770), which is an integrated system. "Standalone" performance in the sense of an algorithm separate from human interaction isn't directly applicable for this type of device. Its performance is measured as the device's output (systolic, diastolic BP, pulse rate) against a clinical reference. The document states the device "can use MOMI or fuzzy logic method to measure blood pressure," implying the algorithm is intrinsic to the device's operation, and its performance is assessed via compliance with AAMI/ANSI SP10.
7. Type of Ground Truth Used
For devices complying with standards like AAMI/ANSI SP10, the ground truth is typically established by simultaneous measurements by trained observers using a validated reference method (e.g., auscultation with a mercury sphygmomanometer or another validated oscillometric device) in a clinical setting. While not explicitly stated in this document for the KP-7770, compliance with AAMI/ANSI SP10 implies such a methodology was used for the predicate device(s) that established the "unchanged" clinical performance.
8. Sample Size for the Training Set
The document does not provide information on the training set for the KP-7770's algorithms (MOMI or fuzzy logic) or the predicate devices. This type of detail is often proprietary and generally not included in 510(k) summaries unless a novel algorithm is being introduced that requires specific clinical validation. Given the reliance on predicate devices and established methods (fuzzy logic), it's likely the algorithms were developed and validated internally during product development, possibly using simulated data or internal clinical data, but no specifics are given here.
9. How the Ground Truth for the Training Set was Established
Similar to point 8, this information is not provided in the 510(k) summary. For blood pressure measurement algorithms, ground truth for training would typically involve large datasets of reference blood pressure measurements (e.g., from auscultation or highly accurate invasive methods) paired with the corresponding oscillometric waveforms.
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510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Mr. Daniel C.M. Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
Date Prepared: August 31, 2009
Name of Device
Arm Blood Pressure Monitor Model KP-7770
Name/Address of Sponsor
K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien Taiwan Phone: + 886 2 22991378 Facsimile: + 886 2 22991386 Contact Person: Jason Cheng
Common or Usual Name
Arm Blood Pressure Monitor
Classification Name
Class II § 870.1130; System, Measurement, Blood Pressure, Non-Invasive
Predicate Device
- K jump Health Co., Ltd.'s Arm Blood Pressure Monitor Smartlogic Model KP-7500 and Fuzzylogic Model KP-7500D, K083753.
Intended Use/Indications for Use
OCT = 9 2009
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The device is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff wrapped around the arm. The device is indicated for use with adults.
The device displays irregular pulse detection (IPD) icon on LCD screen when irregular pulse is detected during blood pressure measurement.
Technological Characteristics
The device is an electronic blood pressure monitor. The device consists of an inflating cuff, a LCD display, a bellows sensor, an internal air pump, a leakage valve, an exhaust valve, a battery power resource, and keys for operation.
Performance Data
The Arm Blood Pressure Monitor Model KP-7770 complies with the following FDA recognized consensus standards, to the extent that these standards are applicable to this device:
- . AAMI/ANSI SP10 (2002 / A1:2003);
- IEC 60601-1 (1988); and .
- IEC 60601-1-2 (2002).
The KP-7770 also complies with the following additional standards-
- . EN61000-4-2 (1995); and
- EN61000-4-3 (2002).
pg 2 of 3
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Clinical performance of the modified device is remain unchanged; therefore another clinical trial for this device, KP-7770, is not required.
Substantial Equivalence
The KP-7770 has the same intended use and indications for use as K-Jump's Arm Blood Pressure Monitor Model KP-7500 and KP-7500D.
The KP-7770 has the same technological characteristics as the KP-7500 except that the KP-7770 can use MOMI or fuzzy logic method to measure blood pressure rather than the KP-7500 which can only use smart logic method or the KP-7500D which can only use fuzzy logic method.
Thus, the minor differences between the KP-7770 and the predicate devices are not new technological characteristics for arm blood pressure monitors. Therefore, these minor technological differences do not raise any new questions of safety or effectiveness. Accordingly, the KP-7770 is substantially equivalent to its predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
K-jump Health Co., Ltd. c/o Mr. Jason Cheng Assistant Manager, Product Planning Department No. 56 Wu Kung 5th Road, Wu Ku Industrial Park Taipei Hsien 248 TAIWAN
OCT - 9 2009
Re: K092806
Trade/Device Name: Auto Digital Upper Arm Blood Pressure Monitor, Model KP-7770 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: September 9, 2009 Received: September 11, 2009
Dear Mr. Cheng:
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.
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Page 2 - Mr. Jason Cheng
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 vours.
M. G. Williams
Bram D. Zuckerman, M.D. Ser Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if Known):__K092806
Device Name: Arm Blood Pressure Monitor Model KP-7770 Indication for Use:
The KP-7770 is intended to measure the systolic and diastolic blood pressure and pulse rate (heart rate) by using an inflating cuff wrapped around the arm. It is indicated for use in adults.
The devices display irregular pulse detection (IPD) icon on LCD
screen when irregular pulse is detected during blood pressure measurement.
Prescription Use (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use X (Optional Format 1-2-96)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
. A. Allibenne
(Division Sign-Off) Division of Cardiovascular Devices
K092806 510(k) Number
§ 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).