(189 days)
Not Found
No
The device description and performance studies focus on mechanical principles (water pressure) and traditional testing methods, with no mention of AI/ML terms or data-driven performance metrics.
Yes
The device is described as both a Positive Expiratory Pressure (PEP) device and an Inspiratory Muscle Trainer (IMT), which are used for therapeutic purposes such as improving lung function and strengthening respiratory muscles. Additionally, its comparison to a predicate device for safety and effectiveness aligns with the regulatory pathway for therapeutic devices.
No
Explanation: The "Intended Use / Indications for Use" section describes the device as a "Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT)," which are therapeutic or training devices, not diagnostic ones. There is no mention of it being used to detect, monitor, or identify a disease or condition.
No
The device description clearly outlines physical components (inner chamber, outer chamber, breathing tube, cap) and a mechanism involving water, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a breathing trainer used for Positive Expiratory Pressure (PEP) and Inspiratory Muscle Training (IMT). It works by adding pressure to the patient's breath using water.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. It directly interacts with the patient's respiratory system.
Therefore, this device falls under the category of a therapeutic or training device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is for use as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device, for use by adults and children. The device is for single patient use, not for use on multiple patients.
Product codes
73BWF
Device Description
The breathing trainer includes an inner chamber, an outer chamber, a breathing tube, and a perforated bottom cap to the inner chamber. Four teaspoons of water (20 ml.) are placed in the outer chamber and the patient breaths in and out of the breathing tube. The training effect is caused by the added pressure of the water. US Patent Number 5,755,640.
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
adults and children
Intended User / Care Setting
Not Found
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 results of bench and user testing indicates that the new device is as safe and effective as the predicate device.
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
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).
0
EXHIBIT 2 Intercontinental New Technologies, Inc. 1389 Bristol Lane Buffalo Grove, IL 60089 Tel. 847-955-0311 Fax 847-955-0311 Contact: Aleksey Shlyakhta, President June 30, 1999
510(k) Summary of Safety and Effectiveness
- a) Identification of the Device: Proprietary-Trade Name: Frolov's Respiration Training Device, FRTD-01 Classification Name: 73BWF Common/Usual Name: Breathing training device
- b) Equivalent legally marketed devices This product is similar in design and function to the Mini-Ciser, K974848
- c) Indications for Use (intended use) The device is for use as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device.
- d) Description of the Device: The breathing trainer includes an inner chamber, an outer chamber, a breathing tube, and a perforated bottom cap to the inner chamber. Four teaspoons of water (20 ml.) are placed in the outer chamber and the patient breaths in and out of the breathing tube. The training effect is caused by the added pressure of the water. US Patent Number 5,755,640.
- e) Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the new device is as safe and effective as the predicate device.
- f) Conclusion. After analyzing both bench and user testing data, it is the conclusion of Intercontinental New Technologies, Inc. that the Frolov's Respiration Training Device, FRTD-01 is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
1
Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 11 2000
Mr. Daniel Kamm Intercontinental New Technologies, Inc. c/o Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K992256 Frolov's Respiration Training Device, FRTD-01 Regulatory Class: II (two) Product Code: 73 BWF October 13, 1999 Dated: October 14, 1999 Received:
Dear Mr. Kamm:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Daniel Kamm
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Joanne A. Wintershaven
Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
j) Indications for Use
510(k) Number K992256
Device Name: Frolov's Respiration Training Device, FRTD-01
Indications for Use: The device is for use as a Positive Expiratory Pressure (PEP) device and Inspiratory Muscle Trainer (IMT) in one device, for use by adults and children. The device is for single patient use, not for use on multiple patients.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over the Counter Use (Per 21 CFR 801.109)
J.A. Westman
OR
Division Sign-Off) ivision of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number