(152 days)
Not Found
No
The summary describes standard ventilator features and performance testing, with no mention of AI or ML capabilities, algorithms, or data sets.
Yes
The device is a ventilator used for respiratory support and mechanical ventilation, which directly treats a medical condition.
No
The device description indicates it is a ventilator providing respiratory support, not a device used to diagnose a medical condition. While it monitors some parameters, these are for managing ventilation, not for diagnostic purposes.
No
The device description clearly outlines numerous hardware components and features, such as an internal flow generator, oxygen blending capabilities, power source options, and optional sensor packages (FIO2, Oximetry). This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing respiratory support and mechanical ventilation to patients. This is a direct therapeutic intervention on the patient's body.
- Device Description: The description details features related to delivering air, controlling pressure and volume, monitoring respiratory parameters, and providing alarms. These are all functions of a respiratory support device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions through in vitro testing, or providing information for diagnosis based on such analysis.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device directly interacts with the patient's respiratory system.
N/A
Intended Use / Indications for Use
PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
Federal law (USA) restricts the sale of this device except by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
The PTV platform provides for the following features:
- . High performance ventilation in a small lightweight package
- A range of maneuvers including Inspiratory and Expiratory hold . and synchronized Nebulization (touch screen models only)
- . Internal flow generator, allowing the PTV to operate without an external compressed gas source
- . Four distinct breath types offering a range of treatment options. CPAP with optional Pressure Support 1, SIMV2, Control, Assist /
Control - Configurable Apnea back-up ventilation .
- NPPV3 ventilation, providing an alarm package suitable for . mask ventilation of patients whose needs do not extend to life support
- Volume Control, Pressure Control and PRVC4 ventilation modes t
- Adjustable alarm settings including High Peak Pressure. Low . Peak Pressure, Low Minute Volume, and Apnea
- Oxygen blending from a high-pressure oxygen source (optional) . or low-pressure oxygen bleed-in
- Lockable front panel controls .
- A wide range of monitors including Breath Rate (f), I:E Ratio . (Measured), MAP, Exhaled Minute Volume (VE), PEEP, PIP and Tidal Volume (Vte)
- Dynamic waveform and loop displays .
- . Graphic trending histogram display
- Real-time patient circuit pressure display .
- . Variable termination options for Pressure Support breaths, including maximum inspiratory time and percentage of peak flow
- . Selectable Percentage of Peak Flow termination for Pressure Control breaths
- Leak Compensation to improve patient triggering when a circuit . leak is present
- . Operation from a variety of power sources including AC power. removable battery and external DC power sources
- . Optional FIO2 sensor package.
- . Optional Oximetry module
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
PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations. Homecare, hospital and transport environments.
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)
Performance testing (Bench testing) verified that the Palmtop Models PTV 8/10 meet specified performance requirements and that the devices are substantially equivalent to the predicate devices listed below.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K060647, K981371, K984056, K021981, K032451
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY
SUBMITTER
Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341
AUG - I 2007
| Contact Person: | Robert C. Samec | Telephone |
|---|---|---|
| (763) 398-8305 | ||
| (763) 398-8400 | Facsimile |
DEVICE / TRADE NAME
| Trade Name: | PALMTop PTV Models 8/10 |
|---|---|
| Common Name: | Ventilator |
| Classification Name: | Ventilator, Continuous (Respirator) 868.5895 |
SUBMISSION DATE
Submission Date: August 1, 2007
DESCRIPTION
The PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
The PTV platform provides for the following features:
- . High performance ventilation in a small lightweight package
- A range of maneuvers including Inspiratory and Expiratory hold . and synchronized Nebulization (touch screen models only)
- . Internal flow generator, allowing the PTV to operate without an external compressed gas source
- . Four distinct breath types offering a range of treatment options. CPAP with optional Pressure Support 1, SIMV2, Control, Assist /
1
Control
- Configurable Apnea back-up ventilation .
- NPPV3 ventilation, providing an alarm package suitable for . mask ventilation of patients whose needs do not extend to life support
- Volume Control, Pressure Control and PRVC4 ventilation modes t
- Adjustable alarm settings including High Peak Pressure. Low . Peak Pressure, Low Minute Volume, and Apnea
- Oxygen blending from a high-pressure oxygen source (optional) . or low-pressure oxygen bleed-in
- Lockable front panel controls .
- A wide range of monitors including Breath Rate (f), I:E Ratio . (Measured), MAP, Exhaled Minute Volume (VE), PEEP, PIP and Tidal Volume (Vte)
- Dynamic waveform and loop displays .
- . Graphic trending histogram display
- Real-time patient circuit pressure display .
- . Variable termination options for Pressure Support breaths, including maximum inspiratory time and percentage of peak flow
- . Selectable Percentage of Peak Flow termination for Pressure Control breaths
- Leak Compensation to improve patient triggering when a circuit . leak is present
- . Operation from a variety of power sources including AC power. removable battery and external DC power sources
- . Optional FIO2 sensor package.
- . Optional Oximetry module
INTENDED USE
PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). They are suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
1 Continuous Positive Pressure Ventilation
2 Synchronized Intermittent Mandatory Ventilation
3 Non-invasive Positive Pressure Ventilation
4 Pressure Regulated, Volume Controlled
2
PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
Federal law (USA) restricts the sale of this device except by or on the order of a physician.
Summary of Testing and Validation
Performance testing (Bench testing) verified that the Palmtop Models PTV 8/10 meet specified performance requirements and that the devices are substantially equivalent to the predicate devices listed below.
| Predicate Device | 510(k) Clearance | Manufacturer |
|---|---|---|
| LTV 1200 | ||
| Ventilator | K060647 | VIASYS |
| Healthcare/Pulmonetic | ||
| Systems, Inc. | ||
| 17400 Medina Road. | ||
| Suite 100 | ||
| Minneapolis, MN 55447 | ||
| LTV 1000 | ||
| Ventilator | K981371 | |
| K984056 | VIASYS | |
| Healthcare/Pulmonetic | ||
| Systems, Inc. | ||
| 17400 Medina Road, | ||
| Suite 100 | ||
| Minneapolis, MN 55447 | ||
| iVent 201 | ||
| Portable | ||
| Ventilator with | ||
| Pulse Oximeter | K021981 | Versamed Corporation |
| 2 Blue Hill Plaza | ||
| Pearl River, NY 10965 | ||
| TBird VELA | ||
| Ventilator | K032451 | VIASYS Healthcare/Bird |
| Products Corporation | ||
| 1100 Bird Center Drive | ||
| Palm Springs, CA 92262 |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2007
Pulmonetic Systems, Incorporated C/O Mr. Robert C. Samec Vice President- Quality Assurance/Regulatory Affairs Division of VIASYS Healthcare 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341
Re: K070594
Trade/Device Name: PALMTop PTV Models 8/10 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 26, 2007 Received: July 27, 2007
Dear Mr. Samec:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Samec
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clues
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K070594 510(k) Number (if known):
Device Name: PALMTop PTV Models 8/10
Indications For Use:
Indications for Use
PALMTop PTV Models 8/10 are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in homecare, hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively.
PALMTop Ventilators are restricted medical devices intended for operation by trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
Federal law (USA) restricts the sale of this device except by or on the order of a physician.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ch (Division Sign-Off)
(acting B.C.) Division of Anesthesinlogy, General Hospital Infection Control, Dental Devices
510(k) Number: K070594
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