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.

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.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PALMTop PTV Models 8/10 ventilator, formatted to answer your questions:

Acceptance Criteria and Study Analysis for PALMTop PTV Models 8/10

The provided 510(k) summary for the PALMTop PTV Models 8/10 describes the device and its intended use, and states that performance testing (Bench testing) was conducted to verify that the device meets specified performance requirements and is substantially equivalent to predicate devices.

However, the document does not explicitly provide a table of acceptance criteria with numerical thresholds, nor does it detail a specific clinical study with human subjects, ground truth establishment, or expert adjudication that would typically be associated with AI/ML-driven medical devices. The testing described appears to be traditional engineering performance verification against specifications, rather than a statistical study comparing device output to expert-established ground truth in a diagnostic or predictive context.

Based on the provided information, I can fill in what is available and clarify what is not.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific numerical acceptance criteria (e.g., accuracy > X%, sensitivity > Y%, etc.) or corresponding reported device performance metrics in a quantitative manner. Instead, it broadly states that "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."

Therefore, no direct table can be generated from the given text.

2. Sample Size Used for the Test Set and Data Provenance

The document describes "Performance testing (Bench testing)", which implies laboratory or engineering testing of the device's functionality rather than a test set of patient data. As such:

Sample Size for Test Set: Not applicable or not specified in terms of patient data. The testing involved the device in a benchtop environment.
Data Provenance: Not applicable, as there is no patient data described as part of the performance verification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided. Given that the testing involved "Bench testing," it's likely that ground truth was established by engineering specifications, calibration standards, and established medical device performance parameters, rather than expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. Since there's no mention of a test set involving human data or interpretations, an adjudication method like 2+1 or 3+1 would not be relevant.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, there is no indication that an MRMC comparative effectiveness study was done. The device is a ventilator, a life-support system, and the "Bench testing" described focuses on its mechanical and functional performance, not on interpretation of medical images or signals by human readers assisted by AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The device, a ventilator, is a therapeutic and monitoring device, not an AI algorithm. Its performance is inherent in its operation (e.g., delivering specified pressures or volumes). The "Bench testing" would assess this standalone functional performance. However, there's no "algorithm only" performance reported in the context of diagnostic AI.

7. The Type of Ground Truth Used

The ground truth for the "Bench testing" would have been based on:

Engineering Specifications: The pre-defined parameters and operational ranges the ventilator is designed to achieve.
Calibration Standards: Reference measurements to ensure the device's sensors and outputs (e.g., pressure, flow, volume) are accurate.
Predicate Device Performance: Comparison to the established performance of the legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The PALMTop PTV Models 8/10 is a traditional medical device (a ventilator), not a machine learning or AI-driven system that would require a "training set" of data in the common sense of AI development.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of an AI/ML device described for this product.

In summary: The provided document describes the regulatory submission for a ventilator, a traditional medical device. The "performance testing" mentioned refers to engineering validation and verification (bench testing) against predefined device specifications and predicate device performance, not a clinical study involving human data, expert adjudication, or AI algorithm training/testing. Therefore, many of the questions related to AI/ML device evaluation criteria are not applicable to this submission.

Summary

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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 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 /

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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

1 Continuous Positive Pressure Ventilation

2 Synchronized Intermittent Mandatory Ventilation

3 Non-invasive Positive Pressure Ventilation

4 Pressure Regulated, Volume Controlled

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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 1200Ventilator	K060647	VIASYSHealthcare/PulmoneticSystems, Inc.17400 Medina Road.Suite 100Minneapolis, MN 55447
LTV 1000Ventilator	K981371 K984056	VIASYSHealthcare/PulmoneticSystems, Inc.17400 Medina Road,Suite 100Minneapolis, MN 55447
iVent 201PortableVentilator withPulse Oximeter	K021981	Versamed Corporation2 Blue Hill PlazaPearl River, NY 10965
TBird VELAVentilator	K032451	VIASYS Healthcare/BirdProducts Corporation1100 Bird Center DrivePalm Springs, CA 92262

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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.

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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

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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

Page 1 of 1

Regulation Number and Section

§ 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).