STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM

K012387 · Stethographics, Inc. · BZM · Apr 23, 2002 · Anesthesiology

Device Facts

• Record ID: K012387
• Device Name: STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
• Applicant: Stethographics, Inc.
• Product Code: BZM · Anesthesiology
• Decision Date: Apr 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1900
• Device Class: Class 2

Intended Use

The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel. Prescription Device. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

The STG Monitor is a multichannel lung sound analysis system consisting of electronic stethoscopes, a back pad, pre-amplifier, connection hub, PC, printer, cart, speakers, and headphones. It uses a disposable cotton cover for patient contact. The system records lung sounds from one or more channels, processes the audio signals, and provides graphic displays and automated identification of lung sounds. It is intended for use in clinical settings by healthcare professionals to assist in pulmonary function interpretation. The output allows clinicians to visualize and listen to lung sounds, aiding in clinical decision-making regarding respiratory health.

Clinical Evidence

Bench and laboratory testing only. No clinical data provided. Testing demonstrated that the performance, safety, and effectiveness of the STG Monitor are equivalent to the predicate device.

Technological Characteristics

System includes electronic stethoscopes, back pad, pre-amplifier, connection hub, PC, printer, cart, speakers, and headphones. Non-invasive with disposable cotton patient contact covers. Software-based analysis of lung sounds. Connectivity via PC-based system.

Indications for Use

Indicated for the recording, audio reproduction, graphic display, and automated identification of lung sounds in patients requiring pulmonary assessment. Prescription use only.

Regulatory Classification

Identification

A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

Predicate Devices

• Pulmotrack, Model 1010 (K980978)

Submission Summary (Full Text)

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APR 2 3 2002

510(k) Submission, New, STG Monitor Stethographics, Inc., Boston, MA 02130

## Summary

21 CFR Part 807.92

K012387 K#

Date: January 22, 2002

S....... H

| Contact: | Raymond L. H. Murphy, Jr., M.D.<br>Stethographics, Inc.<br>1153 Centre Street, Suite 4990<br>Boston, MA 02130 USA<br>617-983-7258<br>617-522-4156 fax |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission<br>Correspondent: | J. Harvey Knauss<br>Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, Texas 77071-3404<br>713-723-4080<br>713-723-4080 fax<br>[e-mail] |
| Device Name: | STG Monitor Multichannel Lung Sound Analysis System |
| Common Name: | Pulmonary Function Interpretator |
| Classification: | The classification name, 21 CFR Part and Paragraph Number,<br>product code, classification and tier categorization follows: |

| | Classification<br>Name | 21 CFR<br>Section | Product<br>Code | Class | Tier |
|--|-------------------------------------------------------------------|-------------------|-----------------|-------|------|
| | Calculator,<br>Pulmonary Function<br>Interpretation<br>calculator | 868.1900 | BZM | II | 2 |

| Predicate Devices: | The Stethographic STG Monitor Multichannel Lung Sound<br>Analysis System is substantially equivalent to the following<br>released to market device: |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

| | Device | Manufacturer | 510(k) # |
|--|------------------------|-----------------------------------------------|----------|
| | Pulmotrack, Model 1010 | Karmel Medical Acoustic<br>Technologies, Ltd. | K980978 |

| Device Description: | The Stethographic STG Monitor Multichannel Lung Sound<br>Analysis System Comprises Chest pad with electronic |
|---------------------|--------------------------------------------------------------------------------------------------------------|
|---------------------|--------------------------------------------------------------------------------------------------------------|

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K012387

APR 2 3 2002

510(k) Submission, New, STG Monitor Stethographics, Inc., Boston, MA 02130

# Summary

21 CFR Part 807.92

K# K012387

Date: January 22, 2002

| Contact: | Raymond L. H. Murphy, Jr., M.D.<br>Stethographics, Inc.<br>1153 Centre Street, Suite 4990<br>Boston, MA 02130 USA<br>617-983-7258<br>617-522-4156 fax |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission<br>Correspondent: | J. Harvey Knauss<br>Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, Texas 77071-3404<br>713-723-4080<br>713-723-4080 fax<br>[e-mail] |
| Device Name: | STG Monitor Multichannel Lung Sound Analysis System |
| Common Name: | Pulmonary Function Interpretator |
| Classification: | The classification name, 21 CFR Part and Paragraph Number,<br>product code, classification and tier categorization follows: |

| Classification<br>Name | 21 CFR<br>Section | Product<br>Code | Class | Tier |
|-------------------------------------------------------------------|-------------------|-----------------|-------|------|
| Calculator,<br>Pulmonary Function<br>Interpretation<br>calculator | 868.1900 | BZM | II | 2 |

| Predicate Devices: | The Stethographic STG Monitor Multichannel Lung Sound<br>Analysis System is substantially equivalent to the following<br>released to market device: |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|

| Device | Manufacturer | 510(k) # |
|------------------------|-----------------------------------------------|----------|
| Pulmotrack, Model 1010 | Karmel Medical Acoustic<br>Technologies, Ltd. | K980978 |

| Device Description: | The Stethographic STG Monitor Multichannel Lung Sound<br>Analysis System Comprises Chest pad with electronic |
|---------------------|--------------------------------------------------------------------------------------------------------------|
|---------------------|--------------------------------------------------------------------------------------------------------------|

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| | stethoscopes, back pad, pre-amplifier, connection hub, and a PC<br>computer. The system also includes a printer, a cart, speakers,<br>headphones, re-writable CDs for data storage and custom<br>software. The system is non-invasive with patient contact<br>disposable cotton cover. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications: | The Stethographics STG Multichannel Lung sound Analysis<br>system is intended for the recording, audio reproduction, graphic<br>display and automated identification of lung sounds. It can be<br>configured to record from one or more than one channels. |
| Technological<br>Characteristics: | The Stethographic STG Monitor Multichannel Lung Sound System<br>Analysis device is virtually the same as the Pulmotrack, Model<br>1010. |
| Performance: | Bench and laboratory testing was conducted to demonstrate<br>performance (safety and effectiveness) of the Stethographic STG<br>Monitor Multichannel Lung Sound Analysis System is same as the<br>predicate device. |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and<br>21 CFR Part 807, and based on the information provided in the<br>premarket notification, Stethographics, Inc., concludes that the<br>Stethographic STG Monitor Multichannel Lung Sound Analysis<br>System is safe and effective and substantially equivalent to the<br>predicate devices as described herein. |
| Other: | Stethographics, Inc., will update and include in this summary any<br>other information deemed reasonably necessary by the FDA. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized representation of a human profile with three overlapping faces, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 2002

Mr. Harvey Knauss Stethographics, Inc. c/o Delphi Consulting Group 11874 S. Evelyn Circle Houston, TX 77071

Re: K012387

STG Monitor Multichannel Lung Sound Analysis System Regulation Number: 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: II (two) Product Code: BZM Dated: December 20, 2001 Received: January 24, 2002

Dear Mr. Knauss:

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. Harvey Knauss

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of the 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 or any 1 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 SI it rat 807), its 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) rms leter will and my of the FDA finding of substantial equivalence of your device to a legally premated predicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K012387

STG Monitor Multichannel Lung Sound Analysis System. Device Name:

Indications for use: The Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.

Prescription Device.

Federal Law (US) restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012387

Section 4 Page 2

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)