TSX PRM PULMONARY RESUSCITATION MONITOR

K973347 · Spiracle Technology · CAP · Jul 23, 1998 · Anesthesiology

Device Facts

• Record ID: K973347
• Device Name: TSX PRM PULMONARY RESUSCITATION MONITOR
• Applicant: Spiracle Technology
• Product Code: CAP · Anesthesiology
• Decision Date: Jul 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2600
• Device Class: Class 2

Intended Use

The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor vontilatory functions including peak inspiratory pressure, respiratory rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.

Device Story

TDx PRM is a portable, battery-operated airway pressure monitor; attaches to emergency resuscitators (bag mask, demand valves, transport ventilators) lacking pressure gauges. Device uses electronic pressure transducer to monitor peak inspiratory pressure, breath frequency, I/E time, and PEEP; includes CPR metronome for pacing resuscitation. No direct patient contact; uses standard bacterial filters to prevent pathogen transmission. Used in emergency settings by clinicians; provides real-time monitoring of ventilatory parameters to assist in resuscitation management. Device performs no diagnostic or therapeutic functions; provides no alarms.

Clinical Evidence

Bench testing only. Testing included functional performance, environmental stress (impact/drop, storage temperature), electromagnetic interference, electrostatic discharge, spill resistance, surface temperature, and power supply/battery life testing. No clinical data provided.

Technological Characteristics

Microprocessor-controlled monitor; electronic pressure transducer sensing; battery-powered; portable form factor. Attaches to airway circuits via standard bacterial filters. No direct patient contact. Software-based parameter calculation.

Indications for Use

Indicated for use as an accessory to emergency resuscitators (bag mask, oxygen-powered demand valves, or automatic transport ventilators) to monitor ventilatory parameters including peak inspiratory pressure, respiratory rate, PEEP, and I/E ratio in patients requiring emergency ventilation.

Regulatory Classification

Identification

An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.

Predicate Devices

• Bird Mean Airway Pressure Monitor (K812140)
• Sechrist Industries, Inc., Airway Pressure Monitor Model 400 (K814608)

Submission Summary (Full Text)

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JUL 23 1998

K973347

### Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor 510(k) SUMMARY

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Submitter | Contact Person |
|------------------------------------|---------------------------------|
| Michael Sarné | C. Stephen Lawrence |
| Spiracle Technology | Hogan & Hartson, L.L.P. |
| 16520 Harbor Boulevard, "D" | 4675 MacArthur Court, Suite 670 |
| Fountain Valley, California 92708 | Newport Beach, California 92660 |
| Telephone: [phone] | Telephone: [phone] |
| Facsimile: [phone] | Facsimile: [phone] |

#### Name of Device

| Trade Name: | TDx PRM Pulmonary Resuscitation Monitor |
|----------------------|-----------------------------------------|
| Common Names: | Respiratory Monitor |
| Classification Name: | Airway Pressure Monitor |
| | 21 C.F.R. 868.2600 |

#### Predicate Devices

- (1) Bird Mean Airway Pressure Monitor (K812140)
- (2) Sechrist Industries, Inc., Airway Pressure Monitor Model 400 (K814608)

#### Intended Use

The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor vontilatory functions including peak inspiratory pressure, respiratory rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.

## Technological Characteristics and Substantial Equivalence

The TDx PRM is intended to be used as an accessory to emergency resuscitators to monitor ventilatory functions. It is a small, portable battery operated device that attaches to bag mask resuscitators, oxygen powered demand valve resuscitators or automatic transport ventilators, which may not be equipped with pressure gauges for the purpose of patient airway monitoring. The TDx PRM monitors the following patient parameters: peak inspiratory pressure, breath frequency, inspiratory and expiratory times, positive end expiratory pressure ("PEEP"). The TDx PRM also offers a cardiopulmonary resuscitation metronome to

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assist in the pacing of cardiopulmonary resuscitation efforts. The TDx PRM performs no diagnostic or therapeutic functions; it functions solely as a patient monitor and does not provide any patient alarms. Moreover, the TDx PRM has no direct patient contact; transmission of airborne pathogens is prevented by means of standard bacterial filters such as are routinely used with emergency resuscitation equipment.

The TDx PRM is substantially equivalent to other airway pressure monitors including the Bird Mean Airway Pressure Monitor (K812140) and Sechrist Industries, Inc., Airway Pressure Monitor Model 400 (K814608). These predicate devices, like the TDx PRM are microprocessor-controlled devices that utilize a electronic pressure transducer. Additionally, the predicate devices, like the TDx PRM. calculate and display breath rate, peak inspiratory pressure, inspiratory/expiratory time ratio, and positive end expiratory pressure.

#### Performance Data

Extensive functional testing of the TDx PRM has been performed. In addition, testing of the device has been performed under various environmental conditions, including impact/drop testing, storage temperature testing, electromagnetic interference testing, electrostatic discharge testing, spill resistance testing and surface temperature testing. Power supply testing also was performed: these tests included battery life testing and low power icon testing. The functional, environmental and power supply testing performed on the device demonstrated that it meets its performance objectives and complies with applicable FDA guidelines.

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Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 23 1998

Mr. Guy Gansel Spiracle Technology 16520 Harbor Boulevard, Suite "D" Fountain Valley, CA 92708-1360

Re: K973347 TD2 PRM Regulatory Class: II (two) Product Code: 73 CAP May 8, 1998 Dated: Received: May 11, 1998

Dear Mr. Gansel:

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 qeneral controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with

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Page 2 - Mr. Guy Gansel

the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

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 leqally 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 the 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,

Thomas J. Callista

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor Indications for Use Statement

# 510(k) Reference Number:

This is an initial submission; no number has yet been assigned.

# Statement of Indications for Use:

The TDx PRM is intended to be used as an accessory to emergency Fire TDX I Har is and ventilators to monitor ventilatory functions including peak resulchators and voltators or rate, positive end expiratory pressure, and inspiratory/expiratory time ratio.

Marke Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

. Prescription use