(321 days)
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.
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 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 a microprocessor-controlled device that utilizes a electronic pressure transducer.
Here's an analysis of the acceptance criteria and study information for the Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor, based on the provided text:
Device: Spiracle Technology TDx PRM Pulmonary Resuscitation Monitor
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for the device's performance parameters (e.g., peak inspiratory pressure accuracy within X mmHg, respiratory rate accuracy within Y breaths/min).
Instead, it broadly states that the device "meets its performance objectives." Without explicit criteria, the "reported device performance" can only be a confirmation that the device functions as intended.
| Performance Characteristic | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Ventilatory function monitoring | Not explicitly stated | "demonstrated that it meets its performance objectives" |
| Peak inspiratory pressure | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Respiratory rate | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Positive end expiratory pressure | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Inspiratory/expiratory time ratio | Not explicitly stated | Functions as intended, part of "performance objectives" |
| Cardiopulmonary resuscitation metronome accuracy | Not explicitly stated | Functions to "assist in the pacing of cardiopulmonary resuscitation efforts" |
| Environmental conditions (impact/drop, storage temp, EMI, ESD, spill resistance, surface temp) | Not explicitly stated | "demonstrated that it meets its performance objectives and complies with applicable FDA guidelines" |
| Power supply (battery life, low power icon) | Not explicitly stated | "demonstrated that it meets its performance objectives" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any of the performance tests. It refers to "Extensive functional testing" and "testing... performed under various environmental conditions."
The data provenance is not explicitly stated, but given the context of a 510(k) submission, it would be internal company testing conducted for regulatory approval.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of external experts to establish ground truth for the device's performance. The testing described appears to be internal validation by the manufacturer.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing ground truth, as no external experts or consensus process is mentioned. The testing relies on the device itself and its ability to monitor specified parameters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a monitor, not a diagnostic imaging tool that would typically involve human readers interpreting results. Its function is to display physiological parameters.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone monitor. Its performance evaluation would inherently be a standalone assessment of its accuracy in measuring the ventilatory functions it's designed to monitor. The phrase "standalone performance" isn't explicitly used, but the testing described (functional, environmental, power supply) is an evaluation of the device's inherent capabilities without human intervention for its primary function of measurement.
7. The Type of Ground Truth Used
The type of ground truth used would be measurement standards or reference devices/methods. For example, to verify the accuracy of peak inspiratory pressure, the TDx PRM's readings would be compared against a calibrated, highly accurate pressure gauge. Similarly, respiratory rate would be validated against precise timing mechanisms. The document doesn't explicitly state what reference methods were used, but rather that the device "meets its performance objectives."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The TDx PRM is a hardware-based monitor with a microprocessor calculating parameters from transducer inputs. It does not use machine learning or AI algorithms that require a training set to learn patterns or make predictions. Its "logic" is programmed, not learned.
9. How the Ground Truth for the Training Set Was Established
As stated above, a "training set" and associated ground truth establishment for such a set are not applicable to this device.
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JUL 23 1998
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: (714) 418-1091 | Telephone: (714) 440-0400 |
| Facsimile: (714) 418-1095 | Facsimile: (714) 833-0976 |
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 (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,
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
§ 868.2600 Airway pressure monitor.
(a)
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.(b)
Classification. Class II (performance standards).