(248 days)
Not Found
No
The device description details a sensor technology (hot wire) and electrical feedback loop for measurement, without mentioning any AI/ML algorithms for data processing or interpretation. The performance studies focus on accuracy against standard waveforms, not on learning or adaptive capabilities.
No.
This device is for monitoring and managing chronic respiratory conditions by measuring peak expiratory flow and forced expiratory volumes, not for directly treating or curing a condition.
Yes
The device is described as "intended for monitoring expiratory-breath function...for monitoring and managing of chronic respiratory conditions, especially asthma and COPD," which indicates its use in evaluating a patient's health status related to specific conditions.
No
The device description explicitly details hardware components, including a hot wire, air flow measurement tube, and electrical heating elements, which are integral to its function of measuring airflow. This indicates it is a physical device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The K-jump Health Co, Ltd. Peak Flow Meter, Model KN-9710, measures expiratory breath function by analyzing the flow and volume of air exhaled from the lungs. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for monitoring respiratory function, specifically PEF and FEV1, which are measurements of lung mechanics, not analysis of biological samples.
Therefore, based on the provided information, the KN-9710 Peak Flow Meter is a respiratory monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The KN-9710 is intended for monitoring expiratory-breath function at home under direction of a physician or licensed health care professional. It measures the peak expiratory flow (PEF) and timed forced expiratory volumes for 1 second (FEV1) through its mouthpiece. This device can be used from 6-year-old children to adult patients for monitoring and managing of chronic respiratory conditions, especially asthma and COPD.
Product codes
BZH
Device Description
The Peak Flow Meter, KN-9710, uses hot wire on the thin film inside the air flow measurement tube. The hot wire will electrically heat up to a constant temperature. As air flow passes through the air flow measuring tube, the wires cool off, requiring extra electrical energy to heat up to the the constant temperature. The air flow sensor will instantly feed back a voltage to maintain temperature. And the proper proportion and evaluation of the peak flow rate and volume will be determined. The KN-9710 is a compact, small and light-weight designed portable handheld device that electronically measures the Peak Expiratory Flow (PEF) as will as the Forced Expiratory Volume in the first second of expiration (FEV1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
6-year-old children to adult patients
Intended User / Care Setting
Home under direction of a physician or licensed health care professional.
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)
The KN-9710 electronic peak flow meter was tested at an independent laboratory, LDS Hospital (Salt Lake City, UT), using a precision waveform generator. The peak expiratoy (PEF) and forced expiratory volume in one second (FEV1) measurement from the KN-9710 were compared against the generated values. Both PEF and FEV1 values were well within the required ATS (ATS 1994 update) accuracy specification using the 24 standard waveforms and the 26 flow-time waveforms. Interdevice and intradevice variability testing demonstrated the KN-9710 to comply with all variability requirements. Our evaluation showed the KN-9710 met ATS (ATS 1994 update) monitoring device recommendations for accuracy and precision in the measurement of PEF and FEV1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
0
page 1 of 4
EXHIBIT 1
510(k) SUMMARY
APR - 9 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K092335
1. Submitter's Identification:
K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, 248, Taiwan Tel: +886-2-22991378 Fax: +886-2-22331386
Contact: Mr. Jason Cheng Date Summary Prepared: July 31, 2009
2. Name of Device:
K-jump Health Co., Ltd. Peak Flow Meter, Model KN-9710
3. Common or Usual Name:
Peak Flow Meter [ 21 CFR 868.1860 ]
4. Predicate Device Information:
- K010009, Peak Flow Meter, Model KoKo Peak KP and KP+, PDS Health Products, -Inc., U.S.A
- K040723, Peak Flow Meter with PEF and FEV1, Model PF-100, Microlife Intellectual -Property GmbH, Switzerland
1
5. Device Description:
The Peak Flow Meter, KN-9710, uses hot wire on the thin film inside the air flow measurement tube. The hot wire will electrically heat up to a constant temperature. As air flow passes through the air flow measuring tube, the wires cool off, requiring extra electrical energy to heat up to the the constant temperature. The air flow sensor will instantly feed back a voltage to maintain temperature. And the proper proportion and evaluation of the peak flow rate and volume will be determined. The KN-9710 is a compact, small and light-weight designed portable handheld device that electronically measures the Peak Expiratory Flow (PEF) as will as the Forced Expiratory Volume in the first second of expiration (FEV1).
6. Intend Use:
The KN-9710 is intended for monitoring expiratory-breath function at home under direction of a physician or licensed health care professional. It measures the peak expiratory flow (PEF) and timed forced expiratory volumes for 1 second (FEV1) through its mouthpiece. This device can be used from 6-year-old children to adult patients for monitoring and managing of chronic respiratory conditions, especially asthma and COPD.
7. Comparison to Predicate Devices:
The subject device is substantially equivalent to the predicate devices, K010009, Model KoKo Peak KP and KP+. The substantial equivalence chart is provided as follows:
| Characteristics | K-jump Device
(Subject Device) | KoKo KP+, PDS
Healthcare Product,
USA, K#010009 | PF-100
Microlife
K#040723 |
|-------------------------------|-----------------------------------|-------------------------------------------------------|---------------------------------|
| Model No. | KN-9710 | KoKo KP+ | PF-100 |
| Measurement
method | Hot wire on the thin film | Cantilever beam | Rotating wing wheel |
| Maximum recorded
flow rate | 900 l/min | 999 l/min | 900 l/min |
| Maximum recorded
volume | 9.0 Liter | 9.99 Liter | 9.99 Liter |
| Volume measuring
accuracy | $\pm$ 5% or $\pm$ 0.1 L | $\pm$ 3.5% or $\pm$ 0.1 L | $\pm$ 5% or $\pm$ 0.1 L |
| Flow measuring
accuracy | $\pm$ 10% or $\pm$ 20 l/min | $\pm$ 5% or $\pm$ 20 l/min | $\pm$ 10 or $\pm$ 20 l/min |
| Test duration | 1 to 2 seconds | 1 to 2 seconds | 1 to 2 seconds |
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| Correction Factors | Altitude | None | None |
|---|---|---|---|
| # of Results stored | 240 Tests | 64 Tests | 240 Tests |
| Storage medium | Non-volatile EEPROM | Non-volatile EEPROM | Non-volatile EEPROM |
| Time/Date | Real-time clock | Real-time clock | Real-time clock |
| User warnings | |||
| Low battery | Yes | Yes | Yes |
| Memory low | No | No | No |
| Memory full | No | No | No |
| Alarm type | Yes | Yes | Yes |
| Color zones | 3 zones (green, yellow, red) | 3 zones (green, yellow, red) | Manually recorded in seperative "traffic light scheme" |
| Device configuration | Use device key | Use device display | Use device key |
| Display | LCD display | LCD display | LCD display |
| Power source | Two 1.5V AA batteries | Two 1.5 silver oxide batteries | Two 1.5 AAA batteries |
| Dimension | 144X131X33mm | 120X50X20mm | 144X77X48mm |
| Weight | 198g | 82g | 150g |
| Operating condition | 10°C ~40°C (Altitude 0-1400m) | ||
| 15°C ~25°C (Altitude 1400-3000m) | |||
| 10% ~85% RH, non-condensing | 10℃ ~ 38℃ | ||
| 0% ~100% RH, non-condensing | 10℃~ 40℃ | ||
| 10% ~85% RH, non-condensing | |||
| Storage condition | -5℃ ~ 50℃ | ||
| 10% ~85% RH, non-condensing | -20℃ ~ 60℃ | -5℃ ~ 50℃ | |
| 10% ~ 90% RH, Non-condensing |
8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The following performance testing was conducted:
- The KN-9710 electronic peak flow meter was tested at an independent laboratory, LDS Hospital (Salt Lake City, UT), using a precision waveform generator. The peak expiratoy (PEF) and forced expiratory volume in one second (FEV1) measurement from the KN-9710 were compared against the generated values. Both PEF and FEV1 values were well within the required ATS (ATS 1994 update) accuracy specification using the 24 standard waveforms and the 26 flow-time waveforms. Interdevice and intradevice variability testing demonstrated the KN-9710 to comply with all variability requirements. Our evaluation showed the KN-9710 met ATS (ATS 1994 update) monitoring device Page 3 of 4
3
recommendations for accuracy and precision in the measurement of PEF and FEV1.
- · The recognized consensus standards for safety of medical electrical equipment: IEC 60601-1 for safety and IEC.60601-1-2 for electromagnetic compatibility are complied.
- · The biocompability of KN-9710 is tested according to the guidance #G95-1. The cytotoxicity, skin sensitization and skin irritation test reports showed KN-9710 complied with the biological evaluation standard ISO 10993-1.
9. Discussion of Clinical Tests Performed:
Not Applicable. Determination of substantial equivalence is not based on assessment of clinical data.
10. Conclusions:
K-jump Health Co., Ltd. Peak Flow Meter, Model KN-9710, has the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety by successful completion of testing to the IEC60601-1 standard and electromagnetic standard, IEC 60601-1-2. The device claims to meet the American Thoracic society (ATS 1994 update) recommendations. Performance test at LDS Hospital demonstrates the the KN-9710 meets the ATS (ATS 1994 update) standard recommendations.
From the above information we conclude the the subject device, KN-9710, is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jason Cheng Regulatory Affairs K-jump Health Company, Limited No. 56, Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, 248 TAIWAN
Re: K092335
Trade/Device Name: K-jump Health Co., Ltd. Peak Flow Meter, Model KN-9710 Regulation Number: 21 CFR 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: April 2, 2010 Received: April 2, 2010
APR - 9 2010
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. Please note: CDRF 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.
5
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-fm e number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Cinthen 9,2
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
EXHIBIT B
Indications for Use Statement
page 1 of
510(k) Number (if known):__K092335
Device Name: K-jump Health Co., Ltd. Peak Flow Meter, Model KN-9710
Indications for Use:
K-jump Health Co, Ltd. Peak Flow Meter, Model KN-9710, is intended for monitoring expiratory-breath function at home under direction of a physician or licensed health care professional. It measures the peak expiratory flow (PEF) and timed forced expiratory volumes over 1 second (FEV1). This device can be used from 6-year-old children to adult patients for monitoring and managing of chronic respiratory conditions, especially asthma and COPD.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-The Counter Use (21 CFT 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Division Sign-Off) ിvision of Anesthesiology, General Hearter of CDRH, Office of Device Evaluation (ODE) ifection Control, Dental Devices
-10(k) Number: K092335