FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01

K992256 · Intercontinental New Technologies, Inc. · BWF · Jan 11, 2000 · Anesthesiology

Device Facts

• Record ID: K992256
• Device Name: FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
• Applicant: Intercontinental New Technologies, Inc.
• Product Code: BWF · Anesthesiology
• Decision Date: Jan 11, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Frolov's Respiration Training Device (FRTD-01) is a mechanical breathing trainer consisting of an inner chamber, outer chamber, breathing tube, and perforated bottom cap. Operation involves placing 20 ml (four teaspoons) of water into the outer chamber; patient breathes in and out through the tube. Water provides resistance, creating positive expiratory pressure and inspiratory muscle training effect. Used by patients for respiratory training. Device is non-electronic and purely mechanical.

Clinical Evidence

Bench and user testing performed. No clinical trial data provided. Results indicate safety and effectiveness comparable to the predicate device.

Technological Characteristics

Mechanical breathing trainer; components include inner chamber, outer chamber, breathing tube, and perforated bottom cap. Operates via water-based resistance (20 ml water). No electronic components, software, or external energy source.

Indications for Use

Indicated for adults and children requiring positive expiratory pressure (PEP) therapy and inspiratory muscle training (IMT). Single patient use only.

Regulatory Classification

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.

Predicate Devices

• Mini-Ciser (K974848)

Submission Summary (Full Text)

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K992256

EXHIBIT 2 Intercontinental New Technologies, Inc. 1389 Bristol Lane Buffalo Grove, IL 60089 Tel. [phone] Fax [phone] 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.

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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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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## 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