PMP4 SPIROPRO

K050853 · Card Guard Scientific Survival , Ltd. · BZH · May 4, 2005 · Anesthesiology

Device Facts

• Record ID: K050853
• Device Name: PMP4 SPIROPRO
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: BZH · Anesthesiology
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1860
• Device Class: Class 2

Intended Use

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 Story

PMP4 Spiro Pro is a portable spirometer for measuring lung ventilatory functions during Forced Vital Capacity (FVC) tests. Input: patient respiratory effort; device measures Volume-Time and Flow-Volume curves, FVC, FEV1, FEV3, PEF, and FEF parameters. Operation: two modes; PDA mode transmits data via Bluetooth/infrared to PDA for calculation; stand-alone mode performs calculations internally and displays on LCD. Used in hospital, clinic, or home settings by patients or clinicians. Output: pulmonary function data transmitted to remote server for medical professional review. Benefits: enables remote monitoring of pulmonary function, particularly for COPD patients.

Clinical Evidence

Bench testing only. Performance verified against American Thoracic Society (ATS) standardization for spirometry (1994 update). Biocompatibility evaluated per ISO 10993:2003. Safety and EMC testing performed per IEC standards.

Technological Characteristics

Portable spirometer; LCD display; Bluetooth/infrared connectivity. Operates in PDA or stand-alone modes. Complies with IEC 601-1-1 (safety), IEC 601-1-2 (EMC), and ISO 10993 (biocompatibility). Programmable electrical medical system.

Indications for Use

Indicated for pulmonary function testing in hospital, clinic, or home settings for patients requiring monitoring of lung ventilatory functions, including COPD patients.

Regulatory Classification

Identification

A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.

Predicate Devices

• CG-303, Spirophone (K934795)
• SelfCheck™ ECG (K042254)

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone] |
| | Fax: [phone] |
| Contact Person: | Alex Gonorovsky |
| | RA Manager |
| | Tel: [phone] |
| | E-mail: [e-mail] |
| 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.

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.

| This document contains proprietary information of<br>CARD GUARD Scientific Survival Ltd. | Document No. | Rev. | Page | of |
|------------------------------------------------------------------------------------------|--------------|------|------|----|
| --- | | 01 | 1 | 3 |

{1}------------------------------------------------

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 | Decision<br>Date01/13/2005 |

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.

| This document contains proprietary information of<br>CARD GUARD Scientific Survival Ltd. | Document No. | Rev. | Page | of |
|------------------------------------------------------------------------------------------|--------------|------|------|----|
| | --- | 01 | 2 | 3 |

{2}------------------------------------------------

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.

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>This document contains proprietary information of | Document No. | Rev. | Page - | ol |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------|--------|----|
| CARD GUARD Scientific Survival Ltd.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1500V | | | | |

{3}------------------------------------------------

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.

{4}------------------------------------------------

# 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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# 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.

ﺒﻲ

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