The PMP4 Spiro Pro is intended for pulmonary function testing for use in hospital, clinic or home settings. It allows patients to display and transmit their pulmonary function data via a communication device to medical professionals in a remote server.

Device Description

PMP4 Spiro Pro is a portable spirometer designed to accurately measure lung ventilatory functions during the Forced Vital Capacity (FVC) tests. The system records the following: Volume-Time and Flow-Volume curves, FVC, Forced Expiratory Volume: FEV1, FEV3, Peak Expiration Flow (PEF), Forced Expiratory Flow: FEF75%, FEF50%, FEF25%, FEF25/75. PMP4 Spiro Pro operates in two modes: PDA and Stand-alone. In the PDA mode the test data is transmitted through a Bluetooth or infrared link to a PDA. In this mode all necessary calculations are performed by the PDA's software. In the stand-alone mode the Spiro Pro calculates all parameters and displays the results on its LCD. In conjunction with the pulmonary receiving station PMP4 Spiro Pro provides an important tool for monitoring COPD patients.

AI/ML Overview

The provided text describes the PMP4 Spiro Pro, a portable spirometer. However, it does not contain details about a specific study or acceptance criteria with reported device performance metrics. The document is a 510(k) summary for premarket notification to the FDA, focusing on substantial equivalence to predicate devices and adherence to standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets these criteria as the information is not present in the provided text.

Here's what I can extract based on the information given, and indicate what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in the document with quantitative thresholds for performance. The document generally states that the device "meets the requirements of the following Standards, Regulations and Guidances" and that "performance tests according to the Thoracic society standardization were performed and assured the safety and efficacy of the device."
Reported Device Performance: Not provided in the document.

Acceptance Criteria (Quantitative Thresholds)	Reported Device Performance (e.g., FVC Accuracy, FEV1 Precision)
Not specified in document	Not specified in document

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document mentions "laboratory testing," but no specifics about the data used for performance claims.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Adjudication Method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: Not applicable. This device is a spirometer for measuring lung function, not an AI-assisted diagnostic tool that would typically involve human "readers" or AI improvement.
Effect Size of AI Improvement: Not applicable.

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

The PMP4 Spiro Pro operates in two modes:
- Stand-alone mode: "the Spiro Pro calculates all parameters and displays the results on its LCD." This indicates standalone performance of the device's inherent algorithms for calculating spirometry parameters.
- PDA mode: "In this mode all necessary calculations are performed by the PDA's software." This also reflects an algorithmic standalone calculation, albeit on an external device.
However, the document does not provide performance metrics specifically from these standalone calculations, only that they occur. It states "performance tests according to the Thoracic society standardization were performed," which implies a standalone evaluation of the device's accuracy in measuring various respiratory parameters.

7. The type of ground truth used

The document states "performance tests according to the Thoracic society standardization were performed." The American Thoracic Society (ATS) guidelines for spirometry typically define the gold standard for measurements using calibrated volume-time sources (e.g., syringes) and/or clinically validated reference spirometers.
Therefore, the implied ground truth would be measurements from a calibrated reference standard or another highly accurate spirometer adhering to ATS guidelines.

8. The sample size for the training set

Sample Size for Training Set: Not applicable / Not specified. This device describes a spirometer for direct measurement, not an AI/ML algorithm that typically requires a large training set of data.

9. How the ground truth for the training set was established

Ground Truth for Training Set Establishment: Not applicable / Not specified. As above, this device does not appear to employ AI/ML in a way that would necessitate a "training set" in the conventional sense for a prediction model. Its function is based on direct physical measurement and calculation.

Summary

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MAY - 4 2005

K050853

CARD GUARD

Scientific Survival Ltd.

	PMP4 Spiro Pro
	510(k) Summary of Safety and Effectiveness

Submitter:	Card Guard Scientific Survival Ltd.,
	2 Pekeris St. P.O.B. 527
	Rehovot 76100, Israel
	Tel: 972-8-9484000
	Fax: 972-8-9484044
Contact Person:	Alex Gonorovsky
	RA Manager
	Tel: 972-8-9484000
	E-mail: galex@cardguard.com
Date Prepared:	May 2, 2005

Definition 1.

PMP4 Spiro Pro is a portable spirometer designed to accurately measure lung ventilatory functions during the Forced Vital Capacity (FVC) tests.

The system records the following:

Volume-Time and Flow-Volume curves ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
ﺳ FVC
Forced Expiratory Volume: FEV1, FEV3 -
-Peak Expiration Flow (PEF)
Forced Expiratory Flow: FEF75%, FEF50%, FEF25%, FEF25/75 -

PMP4 Spiro Pro operates in two modes: PDA and Stand-alone.

In the PDA mode the test data is transmitted through a Bluetooth or infrared link to a PDA. In this mode all necessary calculations are performed by the PDA's software. In the stand-alone mode the Spiro Pro calculates all parameters and displays the results on its LCD. In conjunction with the pulmonary receiving station PMP4 Spiro Pro provides an important tool for monitoring COPD patients.

Intended Use 2.

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Image /page/1/Figure/0 description: The image shows the logo for "CARD GUARD" with the tagline "Scientific Survival LTD." underneath. To the right of the text is a graphic that resembles an EKG readout. The EKG graphic has a sharp peak followed by a rounded peak.

Applicable Standards, Regulations, Guidances 3.

PMP4 Spiro Pro meets the requirements of the following Standards, Regulations and Guidances:

ISO 14971:2000 , Medical devices Application of risk management to medical . devices
American Thoracic Society, Standardization of Spirometry, 1994 update. .
IEC 1025: 1990 Fault tree analysis (FTA) .
IEC 801-1, 1984, General Introduction .
IEC 601-1-1, 1996, Safety Requirements for Medical Electrical Systems .
IEC 601-1-2, 2001, Part 2: Electromagnetic compatibility-Requirements and Tests .
IEC 601-1-4, 1996, Part 1-4, Programmable Electrical Medical Systems .
IEC 801-2, 1991, Electrostatic Discharge Requirements' .
IEC 801-3, 1992, Immunity to Radiated Radiofrequency electromagnetic fields .
IEC 801-4, 1988, Electrical Fast Transient Burst Requirements .
CISPR 11 1990 Limits and Methods of Measurement of Electromagnetic . Disturbance Characteristics of Industrial, Scientific and Medical (ISM) Radio frequency Equipment 2nd Edition
Reviewer Guidance for Computer Controlled Medical Devices, FDA Aug 29, 1991 .
ISO 13485 (2003), Medical Devices Quality Management Systems .
ISO 9001:2000, Quality Management Systems Requirements .
ISO 10993:2003, part 5 Biological evaluation of medical devices. Evaluation and testing .
MIL-STD 810E, product environmental testing .
FDA's New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial . equivalence in Premarket Notifications Final Guidance, CDRH, March 20, 1998.
21 CFR part 820 subchapter H -- medical devices , quality system regulations .

Substantial Equivalence 4.

The substantially equivalence to the following predicate devices is claimed:

Card Guard	CG-303 , Spirophone	K934795	Decision Date 04/14/1995
Card Guard	SelfCheck™ ECG	K042254	DecisionDate01/13/2005

The correlation between the comparable parameters and features of the devices, for the purpose of proving their substantial equivalency is herby provided in the comparison table on chapter 7.

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Image /page/2/Figure/0 description: The image shows the text "CARD GUARD" in bold, black letters. Below this text is the phrase "Scientific Survival LTD" in a smaller, lighter font. To the right of the text is a stylized graphic resembling an electrocardiogram (ECG) waveform, suggesting a connection to health or medical monitoring.

Design Controls and Hazard Analysis 5.

The Card Guard's product design procedure, and QA and QC policy, formalize the design and production process and assure that all respective requirements are met. In the framework of the Design Controls and as required by the Risk Analysis, laboratory testing were conducted to verify and validate the PMP4 Spiro Pro compliance with all design specifications. Safety and EMC tests as well as performance tests according to the Thoracic society standardization were performed and assured the safety and efficacy of the device.

The device biocompatibility was evaluated and found to be satisfactory.

The device Level of Concern criteria were evaluated and PMP4 Spiro Pro was characterized as a moderate level of concern system.

The system safety and risk analysis conducted for PMP4 Spiro Pro provided rigorous design and structural evaluation aimed at revealing potential failures or possible system flaws which could directly or indirectly affect the patient.

Conclusions 6.

PMP4 Spiro Pro constitutes a safe and reliable means for pulmonary function testing. Its material composition and operation present no adverse health effect or safety risks to patients when used as intended.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.

MAY - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Alex Gonorovsky Regulatory Affairs Manager Card Guard Scientific Survival Limited 2 Pekeris Street P.O.B 527 Rehovot 76100 ISRAEL

Re: K050853

Trade/Device Name: PMP4 Spiro Pro Regulation Number: 868.1860 Regulation Name: Peak-Flow Meter for Spirometry Regulatory Class: II Product Code: BZH Dated: March 31, 2005 Received: April 4, 2005

Dear Mr. Gonorovsky:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your betermined the device is substantially equivalent (for the relerenced above und have actornelosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersure comments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to do rough act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

ي.

If your device is classified (see above) into either class II (Special Controls) or class III II your device is chassified (See as a difional controls. Existing major regulations affecting (I MA), it may be subject to back as a federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Gonorovsky

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 moan that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal stare requirements, including, but not limited to: registration r ou intist contify war a 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in the quadiation 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) This letter will anow Jourse organization of substantial equivalence of your device to a premarket nothroundine in the rice 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), 11 you desire specific acrise of Compliance at (240) 276-0120. 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 may obtain 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,

Chiu-Lien, Ph.D.

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

510(k) Number: Device name: PMP4 Spiro Pro

The PMP4 Spiro Pro is intended for pulmonary function testing for use in hospital, clinic The I MI + Spiro 110 15 mendor to to display and transmit their pulmonary function data of nome seatings. It in device to medical professionals in a remote server.

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Over-The-Counter Use Prescription Use ど AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mutual Mutual for Ann Graham

, Triston Sign-Off) consion of Anesthesiology, General Hospital, In setion Control, Dental Devices

(k) Number: K050853

Regulation Number and Section

§ 868.1860 Peak-flow meter for spirometry.

(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).