(321 days)
Not Found
No
The description focuses on monitoring basic ventilatory parameters using a microprocessor and pressure transducer, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device description explicitly states, "The TDx PRM performs no diagnostic or therapeutic functions; it functions solely as a patient monitor."
No
The device description explicitly states, "The TDx PRM performs no diagnostic or therapeutic functions; it functions solely as a patient monitor."
No
The device description explicitly states it is a "small, portable battery operated device" and utilizes an "electronic pressure transducer," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the TDx PRM is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to monitor ventilatory functions as an accessory to emergency resuscitators. This involves monitoring physiological parameters (pressure, rate, time ratios) directly related to the patient's breathing.
- Device Description: The description explicitly states that the device "performs no diagnostic or therapeutic functions; it functions solely as a patient monitor". IVD devices are used to diagnose diseases or conditions based on in vitro examination of specimens from the human body.
- Lack of Specimen Analysis: The device monitors parameters related to airflow and pressure within the respiratory system. It does not analyze any biological specimens (blood, urine, tissue, etc.).
Therefore, the TDx PRM falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
73 CAP
Device Description
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.
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
accessory to emergency resuscitators
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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.
2
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