(38 days)
Not Found
No
The description focuses on standard spirometry measurements and data logging, with no mention of AI or ML algorithms for analysis or interpretation. The device is described as physically, technologically, and logically identical to its predicate, with added features being extensions of existing functionalities.
No.
The device is for monitoring and measuring respiratory functions and does not describe any therapeutic action, treatment, or therapy.
Yes
The device measures, logs, and reports events related to respiration and spirometric values (e.g., PEF, FEV1, FEV6), which are used for monitoring expiratory-breath function under the direction of a physician. This process of measuring physiological parameters to understand a health condition, even for monitoring, is a form of diagnostic activity.
No
The device description explicitly states it is a physical, battery-powered, hand-held instrument with a mouthpiece, custom liquid-crystal display, and infrared data port, indicating it is a hardware device with embedded software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "personal monitoring of expiratory-breath function at home under direction of a physician." This describes a device used to measure physiological parameters directly from the patient's body (specifically, their breath).
- Device Description: The device measures "the rate at which a person blows through them" and calculates spirometric values based on this physical action. It does not analyze biological samples (like blood, urine, or tissue) in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device measures a physical function of the body itself.
N/A
Intended Use / Indications for Use
For personal monitoring of expiratory-breath function at home under direction of a physician. It measures, logs, and reports events related to respiration and the spirometric values of peak expiratory flow (P.EF), zone and percent of PEF compared to a reference value, timed forced expiratory volumes over 1 second (FEV1) and 6 seconds (FEV6), and the ration of FEV1/FEV6.
Product codes (comma separated list FDA assigned to the subject device)
BZH
Device Description
KP+ LFM is a model variation of the KoKo Peak KP and KP+ peak flow meters. The KoKo Peak KP+, complete with data-communication accessory and dedicated PC display software, was cleared for over-the-counter sale in 510(k) notification K010009. The LFM is identical to its predicate device-the KP+-physically, technologically, and logically.
This new variation extends some KP+ features-namely, an additional timed flow measurement and extended electronic features. These variations make the LFM a prescription device, rather than an over-the-counter one, like its predicate.
All KP flow meters are personal, electronic, flow meters for measuring the rate at which a person blows through them. Approximately 5x2x1 inches in size, the devices are batterypowered, hand-held, single-user instruments with a mouthpiece removable for cleaning. The meter has a custom liquid-crystal display, one-button operation, and an infrared data port for communicating to a serial port of a PC through an optional data-communication link.
Selecting between the models is done during manufacture by simply setting appropriate flags in the device's memory. This selection can be done during initial calibration at the factory, only. The model is then designated by packaging and labeling.
LFM features include
- Performing all KoKo Peak KP+ features and functions
- Measuring six-second forced expiratory volume (FEV6) by continuing to integrate the ● breath flow measurement over a 6-s period and displaying the value after a test session
- . Displaying the FEV1/FEV6 ratio on meter's front panel after a test session
- Enabling diary logs to be expanded to up to 16 entries from the 5 entries . preprogrammed into the KP+
- Enabling options for uploading diary ranges, zone ranges, reference PEF, data-clear . command, and alarm-clock settings directly to meter's memory from a PC
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
Not Found
Intended User / Care Setting
personal monitoring of expiratory-breath function at home under direction of a physician.
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)
Since the device is identical to its predicate device and the added features are simply enhancements or extensions of features already available on the predicate device, no clinical testing was necessary or performed.
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
§ 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
Date
510(k) Summary -- KP+ LFM Flow Meter for Spirometry
Submitter:
| Company: | PDS Healthcare Products, Inc.
908 Main Street, Louisville, Colorado 80027
303 666 6340, 303 666 6380 Fax |
|----------|----------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Lewis, Regulatory Associate |
19 October 2001 Prepared:
Device Name:
| Trade: | KP+ LFM |
|---|---|
| Common: | Flow meter for spirometry |
| Classification: | Peakflow meter for spirometry [21 CFR 868.1860] |
Predicate Device:
| Trade Name: | KoKo Peak KP+ |
|---|---|
| 510(k) Number: | K010009 |
| Manufacturer: | PDS Healthcare Products, Inc. |
Description of Device:
KP+ LFM is a model variation of the KoKo Peak KP and KP+ peak flow meters. The KoKo Peak KP+, complete with data-communication accessory and dedicated PC display software, was cleared for over-the-counter sale in 510(k) notification K010009. The LFM is identical to its predicate device-the KP+-physically, technologically, and logically.
This new variation extends some KP+ features-namely, an additional timed flow measurement and extended electronic features. These variations make the LFM a prescription device, rather than an over-the-counter one, like its predicate.
All KP flow meters are personal, electronic, flow meters for measuring the rate at which a person blows through them. Approximately 5x2x1 inches in size, the devices are batterypowered, hand-held, single-user instruments with a mouthpiece removable for cleaning. The meter has a custom liquid-crystal display, one-button operation, and an infrared data port for communicating to a serial port of a PC through an optional data-communication link.
Selecting between the models is done during manufacture by simply setting appropriate flags in the device's memory. This selection can be done during initial calibration at the factory, only. The model is then designated by packaging and labeling.
LFM features include
- Performing all KoKo Peak KP+ features and functions
- Measuring six-second forced expiratory volume (FEV6) by continuing to integrate the ● breath flow measurement over a 6-s period and displaying the value after a test session
- . Displaying the FEV1/FEV6 ratio on meter's front panel after a test session
1
- Enabling diary logs to be expanded to up to 16 entries from the 5 entries . preprogrammed into the KP+
- Enabling options for uploading diary ranges, zone ranges, reference PEF, data-clear . command, and alarm-clock settings directly to meter's memory from a PC
Indications for Use:
For personal monitoring of expiratory-breath function at home under direction of a physician. It measures, logs, and reports events related to respiration and the spirometric values of peak expiratory flow (P.EF), zone and percent of PEF compared to a reference value, timed forced expiratory volumes over 1 second (FEV1) and 6 seconds (FEV6), and the ration of FEV1/FEV6.
Summary of Technological Characteristics:
There are no technological differences between the LFM and its predicate device.
Summary of Non-Clinical Performance Data:
Since LFM and its predicate, KP+, are physically identical, they meet the same standards for safety of medical electrical equipment.
Both KP+ LFM and its predicate device meet or exceed each aspect of American Thoracic Society standard for spirometry' as it relates to monitoring devices. Testing to ATS standard was performed successfully in-house using industry-recognized automatic waveform generator built specifically for that purpose.
Summary of Clinical Performance Data:
Since the device is identical to its predicate device and the added features are simply enhancements or extensions of features already available on the predicate device, no clinical testing was necessary or performed.
Technical Specifications:
Meter
| • Dimensions: | 120 x 70 x 20 mm |
|---|---|
| • Weight: | 85 g |
| • Operating Temperature: | 10 to 38 °C |
| • Operating Humidity: | 0 to 100 %RH, non-condensing |
| • Storage Temperature: | -20 to 60 °C |
| • Display: | Reflective liquid crystal, 21x40 mm |
| • Power: | Two 1.5-volt silver-oxide batteries |
| • Battery Symbol: | Low battery |
| • Battery Life: | 1 year (3 test sessions per day) |
| • Memory Capacity: | 64 test sessions (FIFO overflow) |
| • Data port: | Infrared optical |
1 American Thoracic Society. Standardization of spirometry: 1994 update. Am J Respir Crit Care Med 152:1107-36, 1995.
2
90 x 60 x 40 mm
10 to 38 °C
-40 to 70 °C
Infrared optical
serial port available
1 year
50 g (without batteries)
0 to 100 %RH, non-condensing
Four AAA alkaline batteries
Data cradle
- Dimensions: ●
- Weight: ●
- Operating Temperature: ●
- Operating Humidity: ●
- Storage Temperature: .
- Power: .
- Battery Life: .
- Meter data port: .
- PC data port: .
- Computer requirement: .
PC software
-
Computer requirements: ● Accessories:
Operating system: Memory: Processor speed: Disk capacity: -
Program size: .
-
Physical media: .
SVGA monitor and graphic card, or better, CD-ROM drive Windows 95, 98, or NT 32 MB of RAM Pentium 120 MHz or faster processor 500 MB of available space 33.2 MB CD
3-conductor wire to RS232 9-pin connector
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Àdministration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2001
Mr. Jim Lewis PDS Healthcare Products, Inc. 908 Main Street Louisville, CO 80027
Re: K013489 KP+ LFM Regulation Number: 868.1860 Regulation Name: Peak Flow Meter Regulatory Class: Class II (two) Product Code: BZH Dated: October 19, 2001 Received: October 22, 2001
Dear Mr. Lewis:
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.
4
Page 2 - Mr. Jim Lewis
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 Of It 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,
Salih Tilah
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K013489
KP+ LFM __ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
For personal monitoring of expiratory-breath function at home under direction of a physician. It r or personal monitoring or expiration and the spirometric values of peak measures, flow (PEF), zone and percent of PEF compared to a reference value, timed forced expiratory now (r Lr ); 2010 and person) on the eseconds (FEV6), and the ratio of FEV1/FEV6.
(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 K013489
(Optional Format 3-10-98)
- PRESCRIPTION USE