(79 days)
The K-jump's SmartlogiC models KP-6210 and KP-6211 are intended to be used for the measurement of the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff that is wrapped around the wrist. The devices are indicated for use in adults.
The devices are electronic blood pressure monitors with LCD displays. The devices were designed to measure the blood pressure of the systolic, diastolic, and pulse rate by using an inflating cuff.
Here's an analysis of the provided text regarding the acceptance criteria and study for the K-jump's Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Standard | Reported Device Performance |
|---|---|---|
| Measurement Accuracy | Compliance with AAMI/ANSI SP10A-1996 standard | Complies with AAMI/ANSI SP10A-1996 in its entirety. |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2 (1993) | Complies with EN 60601-1-2 (1993) |
| Electromagnetic Interference (EMI) | CISPR11 (1993) Class B | Complies with CISPR11 (1993) Class B |
| Electrostatic Discharge (ESD) Immunity | IEC 801-2 (1991) | Complies with IEC 801-2 (1991) |
| Radiated/Conducted RF Immunity | IEC 801-3 (1984) | Complies with IEC 801-3 (1984) |
2. Sample Size for Test Set and Data Provenance
The provided text does not explicitly state the sample size used for testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). It only states that the devices comply with the AAMI/ANSI SP10A-1996 standard, which itself outlines testing protocols and sample size recommendations for blood pressure monitors.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish ground truth for the test set. For blood pressure devices, the "ground truth" for accuracy is typically derived from comparison with a highly accurate reference method, such as invasive arterial blood pressure measurement or auscultatory measurement by trained observers using a mercury sphygmomanometer, as specified by standards like AAMI/ANSI SP10.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set, as it does not rely on human interpretation of subjective data requiring consensus. For blood pressure monitors, accuracy is objectively measured against a reference standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or mentioned. This type of study is typically relevant for interpretative devices (e.g., imaging devices) where human readers' performance is influenced by the device's output. Blood pressure monitors provide quantitative readings directly.
6. Standalone (Algorithm Only) Performance Study
The information provided indicates that the study performed was a standalone (algorithm only) performance study in the sense that the device's measurements were evaluated directly against recognized standards. There isn't a human-in-the-loop component for the measurement itself, though a human operates the device. The compliance with AAMI/ANSI SP10A-1996 is a direct assessment of the device's accuracy.
7. Type of Ground Truth Used
The ground truth used for verifying the device's performance is compliance with the AAMI/ANSI SP10A-1996 standard. This standard outlines the methodology for clinical validation of automated sphygmomanometers, which typically involves comparing the device's readings against simultaneous auscultatory measurements by trained observers or an invasive reference method. Therefore, the ground truth is based on a reference standard measurement by trained personnel, not expert consensus, pathology, or outcomes data in the usual sense.
8. Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is because the device is not based on a machine learning algorithm that requires a separate training phase to learn patterns from data. It's a deterministic device that measures physical parameters.
9. How Ground Truth for the Training Set Was Established
As there is no explicit training set for a machine learning model, the concept of establishing ground truth for a training set is not applicable in this context. The device's operation is based on established principles of oscillometric blood pressure measurement.
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510(k) Summary
Kozz916
K-JUMP'S MODELS KP-6210 AND KP-6211
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Daniel C.M. Tseng K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan 248 Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
T.T. Lin, Director Contact Person:
September 2, 2002 Date Prepared:
Name of Device and Name/Address of Sponsor
Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211
K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, Taiwan 248 Phone: + 886 2 22991378 Facsimile: + 886 2 22991386
Common or Usual Name
Blood Pressure Monitor
Classification Name
System, Measurement, Blood Pressure, Non-Invasive
Predicate Devices
- I. K-jump Health Co., Ltd. Wristwatch BPM model KP-6120
- II. Rossmax International Co., Ltd. SmartInflate CardioPro model 1000i and model 3000i
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Intended Use
The K-jump's SmartlogiC models KP-6210 and KP-6211 are intended to be used for the measurement of the systolic, diastolic, and pulse rate (heart rate) by using an inflating cuff that is wrapped around the wrist. The devices are indicated for use in adults.
Technological Characteristics
The devices are electronic blood pressure monitors with LCD displays. The devices were designed to measure the blood pressure of the systolic, diastolic, and pulse rate by using an inflating cuff. K-jump's models KP-6210 and KP-6211 have the same intended use and fundamental scientific technology as the previously cleared model KP-6120. The primary changes are: (1) the systolic, diastolic blood pressure, and pulse rate are measured during deflation of the cuff in cleared model KP-6120 and during inflation of the cuff in new models KP-6211 and KP-6210; (2) all of the readings are displayed on subsequent screens of the LCD display in cleared model KP-6120 and on one LCD screen in new models KP-6211 and KP-6210; and (3) small differences in their blood pressure measurement ranges, operational temperature and humidity, storage temperature and humidity, and number of memories.
Performance Data
The Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211 comply with EN 60601-1-2 (1993); CISPR11 (1993) Class B; IEC 801-2 (1991); IEC 801-3 (1984); and the AAMI/ANSI SP10A-1996.
Substantial Equivalence
The devices are substantially equivalent to K-jump's Wristwatch Blood Pressure Monitor model KP-6120 and Rossmax SmartInflate CardioPro model 1000i and model 3000i. The Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211 have the same intended use and similar indications and principles of operation. With the exception of small differences in their blood pressure measurement ranges, operational temperature and humidity, storage temperature and humidity, and number of memories, models KP-6211 and KP-6210 are technologically identical to their predicate devices, K-jump's Wristwatch Blood Pressure Monitor model KP-6120 and Rossmax SmartInflate CardioPro model 1000i and model 3000i. The minor technological differences do not raise any new issues of safety or effectiveness. Models KP-6120, KP-6210, and KP-6211 all share the same intended use and operate using the same fundamental technology.
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Furthermore, the devices comply with the AAMI/ANSI SP10A-1996 standard in its entirety. Thus models KP-6210 and KP-6211 are substantially equivalent.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of three human profiles facing right, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2002
K-jump Health Co., Ltd. c/o Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth St., N.W. Washington, DC 20004-1109
Re: K022916
Trade Name: Blood Pressure Monitor SmartlogiC Models KP-6210 and KP-6211 Regulation Number: 21 CFR 870.1130 Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: October 24, 2002 Received: October 24, 2002
Dear Mr. Kahan:
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 such 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. Jonathan S. Kahan, Esq.
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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L
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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Indications for Use Form
Ko 279 (6 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211
Indications for Use:
The Blood Pressure Monitor SmartlogiC models KP-6210 and KP-6211 are intended to measure the blood pressure of the systolic, diastolic, and pulse rate by using an inflating cuff. The devices are indicated for use in adults.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | 4022916 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 C.F.R. § 801.109) | OR | Over-The-Counter Use. ✓ |
|---|---|---|
| ----------------------------------------------- | ---- | ------------------------------------------------------------------------- |
(Optional Format 1-2-96)
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§ 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).