(270 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and basic software functions like recording, audio reproduction, graphic display, and automated identification, without mentioning any learning or adaptive capabilities.
No.
The device is intended for the recording, reproduction, display, and identification of lung sounds, which are diagnostic functions, not therapeutic.
Yes
Explanation: The device is intended for "automated identification of lung sounds," which implies it is used to identify conditions or characteristics of the lungs, fitting the definition of a diagnostic device.
No
The device description explicitly lists multiple hardware components including a chest pad with electronic stethoscopes, back pad, pre-amplifier, connection hub, PC computer, printer, cart, speakers, and headphones.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Device Function: The Stethographics STG Multichannel Lung Sound Analysis system records, reproduces, displays, and identifies lung sounds. This is a non-invasive process that involves listening to sounds produced by the body, not analyzing biological specimens.
- Intended Use: The intended use is focused on the analysis of lung sounds, which are physiological signals, not the analysis of in vitro samples.
Therefore, the device falls under the category of a non-invasive diagnostic device that analyzes physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZM
Device Description
The Stethographic STG Monitor Multichannel Lung Sound Analysis System Comprises Chest pad with electronic stethoscopes, back pad, pre-amplifier, connection hub, and a PC computer. The system also includes a printer, a cart, speakers, headphones, re-writable CDs for data storage and custom software. The system is non-invasive with patient contact disposable cotton cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Stethographic STG Monitor Multichannel Lung Sound Analysis System is same as the predicate device.
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.
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
§ 868.1900 Diagnostic pulmonary-function interpretation calculator.
(a)
Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.(b)
Classification. Class II (performance standards).
0
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.
Stethographics, Inc.
1153 Centre Street, Suite 4990
Boston, MA 02130 USA
617-983-7258
617-522-4156 fax |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission
Correspondent: | J. Harvey Knauss
Delphi Consulting Group
11874 South Evelyn Circle
Houston, Texas 77071-3404
713-723-4080
713-723-4080 fax
harvey@delphiconsulting.com |
| Device Name: | STG Monitor Multichannel Lung Sound Analysis System |
| Common Name: | Pulmonary Function Interpretator |
| Classification: | The classification name, 21 CFR Part and Paragraph Number,
product code, classification and tier categorization follows: |
| | Classification
Name | 21 CFR
Section | Product
Code | Class | Tier |
|--|-------------------------------------------------------------------|-------------------|-----------------|-------|------|
| | Calculator,
Pulmonary Function
Interpretation
calculator | 868.1900 | BZM | II | 2 |
| Predicate Devices: | The Stethographic STG Monitor Multichannel Lung Sound
Analysis System is substantially equivalent to the following
released to market device: |
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Device | Manufacturer | 510(k) # | |
|---|---|---|---|
| Pulmotrack, Model 1010 | Karmel Medical Acoustic | ||
| Technologies, Ltd. | K980978 |
| Device Description: | The Stethographic STG Monitor Multichannel Lung Sound
Analysis System Comprises Chest pad with electronic |
| --------------------- | -------------------------------------------------------------------------------------------------------------- |
|---|
1
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.
Stethographics, Inc.
1153 Centre Street, Suite 4990
Boston, MA 02130 USA
617-983-7258
617-522-4156 fax |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission
Correspondent: | J. Harvey Knauss
Delphi Consulting Group
11874 South Evelyn Circle
Houston, Texas 77071-3404
713-723-4080
713-723-4080 fax
harvey@delphiconsulting.com |
| Device Name: | STG Monitor Multichannel Lung Sound Analysis System |
| Common Name: | Pulmonary Function Interpretator |
| Classification: | The classification name, 21 CFR Part and Paragraph Number,
product code, classification and tier categorization follows: |
| Classification
Name | 21 CFR
Section | Product
Code | Class | Tier |
|-------------------------------------------------------------------|-------------------|-----------------|-------|------|
| Calculator,
Pulmonary Function
Interpretation
calculator | 868.1900 | BZM | II | 2 |
| Predicate Devices: | The Stethographic STG Monitor Multichannel Lung Sound
Analysis System is substantially equivalent to the following
released to market device: |
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Device | Manufacturer | 510(k) # |
|---|---|---|
| Pulmotrack, Model 1010 | Karmel Medical Acoustic | |
| Technologies, Ltd. | K980978 |
| Device Description: | The Stethographic STG Monitor Multichannel Lung Sound
Analysis System Comprises Chest pad with electronic |
| --------------------- | -------------------------------------------------------------------------------------------------------------- |
|---|
2
| | stethoscopes, back pad, pre-amplifier, connection hub, and a PC
computer. The system also includes a printer, a cart, speakers,
headphones, re-writable CDs for data storage and custom
software. The system is non-invasive with patient contact
disposable cotton cover. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications: | 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 channels. |
| Technological
Characteristics: | The Stethographic STG Monitor Multichannel Lung Sound System
Analysis device is virtually the same as the Pulmotrack, Model
1010. |
| Performance: | Bench and laboratory testing was conducted to demonstrate
performance (safety and effectiveness) of the Stethographic STG
Monitor Multichannel Lung Sound Analysis System is same as the
predicate device. |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and
21 CFR Part 807, and based on the information provided in the
premarket notification, Stethographics, Inc., concludes that the
Stethographic STG Monitor Multichannel Lung Sound Analysis
System is safe and effective and substantially equivalent to the
predicate devices as described herein. |
| Other: | Stethographics, Inc., will update and include in this summary any
other information deemed reasonably necessary by the FDA. |
3
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.
4
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
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.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED) ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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)