(123 days)
Not Found
Unknown
The summary describes an "analysis procedure" to identify heart sounds but does not explicitly mention AI or ML, nor does it provide details about the algorithm or training data that would confirm the use of these technologies.
No
The device is intended to provide support to physicians in evaluating heart sounds for diagnosis, not to treat any condition.
Yes
The device aids in the "evaluation of heart sounds," "identif[ies] specific heart sounds," and marks "suspected systolic murmurs," all of which are diagnostic functions. While it states it is "not intended as a sole means of diagnosis," it clearly contributes to the diagnostic process by assisting physicians in evaluating patient data.
No
The device description explicitly states that the complete system consists of an electronic stethoscope and software, and the user must provide a compatible electronic stethoscope. This indicates a hardware component is required for the device to function as intended.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stethographics Heart STG acquires and analyzes acoustic signals of the heart from outside the body using an electronic stethoscope. It does not analyze samples taken from the body.
- Intended Use: The intended use is to provide support to the physician in the evaluation of heart sounds, not to perform a diagnostic test on a biological sample.
Therefore, based on the provided information, the Stethographics Heart STG falls under the category of a medical device that aids in diagnosis through the analysis of physiological signals, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stethographics Heart STG is software intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these The product will acquire and reversity identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs.
The device is indicated for use in the clinical setting, by a physician or by trained The device is indicated for use in the entired physician. It in not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Heart STG System are only significant The microletonio of near with physician over-read as well as consideration of all relevant patient data.
Product codes
DQD
Device Description
The Heart STG is software intended to provide support to medical personnel in the The Freart STO is software mension vare records and analyzes an acoustic signal of the e valuation of near bounds - aids the healthcare provider by marking SI, S2, and suspected systolic murmurs on the waveform.
As a complete system the Heart STG system consists of an electronic stethoscope and As a complete system the rical by on a computer with Windows operating system. The user must provide a compatible electronic stethoscope and a computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Acoustic signals
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or trained personnel acting on the orders of a licensed physician in the clinical setting.
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
Two different sets of cardiac sounds were utilized for evaluation.
- STG data set:
- Sample size: 91 sounds from 91 patients.
- Data source: Recorded by Heart STG from patients scheduled for echocardiography assessment.
- Annotation protocol: Cardiologist over-read for murmur presence/absence, with "positive" defined when 2 out of 3 cardiologists agreed on the presence of murmur.
- Proctor Harvey data set:
- Sample size: 363 sounds from 232 patients (63 sounds from children, 300 from adults).
- Data source: Clinical Auscultation of the Cardiovascular System, by Proctor Harvey and David C. Canfield. Considered a "gold standard" covering a broad range of heart disorders.
- Annotation protocol: All sounds were graded by three experienced cardiologists. Murmur "positive" when 2 out of 3 cardiologists agreed on the presence of murmur.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Standalone performance evaluation against cardiologist over-read ("2 out of 3 cardiologists") and comparison of agreement with inter-cardiologist agreement. Heart Rate (HR) validation.
STG Data Set:
- Sample Size: 91 sounds
- Overall Percent Agreement: 83%
- Agreement with murmur-positive (Sensitivity/PPV against 2/3 cardiologists): 70% (calculated as 100%*(23)/(23+10) = 70%)
- Agreement with murmur-negative (Specificity/NPV against 2/3 cardiologists): 93% (calculated as 100%*(54)/(54+4) = 93%)
Proctor Harvey Data Set:
- Sample Size: 363 sounds
- Overall Percent Agreement: 82%
- Agreement with murmur-positive (Sensitivity/PPV against 2/3 cardiologists): 91% (calculated as 100%*(227)/(227+23) = 91%)
- Agreement with murmur-negative (Specificity/NPV against 2/3 cardiologists): 62% (calculated as 100%*(70)/(70+43) = 62%)
Key Results:
- The STG agreement with 2/3 cardiologists was found to be comparable to that measured among experienced cardiologists (demonstrated by tables 3 and 4 comparing STG agreement with inter-cardiologist agreement).
- Heart Rate (HR) validation showed correlations between the Heart STG calculated HR and an independent ECG/Pulse Ox interpretation: 0.96 for the STG data set and 0.91 for the Proctor Harvey data set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
STG Data Set (compared to 2/3 cardiologists):
- Agreement with murmur-positive: 70%
- Agreement with murmur-negative: 93%
Proctor Harvey Data Set (compared to 2/3 cardiologists):
- Agreement with murmur-positive: 91%
- Agreement with murmur-negative: 62%
Heart Rate (HR) Correlation:
- STG data set: 0.96
- Proctor Harvey data set: 0.91
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
DEC 2 3 2005
115
Stethographics, Heart STG System 510(k) Summary
Company:
Stethographics, Inc 1153 Centre Street Boston, MA
Owner:
Raymond Murphy 1153 Centre St. Boston, MA Phone: (617) 983-7259 Fax: 617-522-4156
Contact:
Rozanne Paciej Stethographics, Inc 1153 Centre Street Boston, MA
Date Prepared:
August 17, 2005
Name of Device:
Stethographics Heart STG System
Common Name of Device:
Electronic Stethoscope
Classification Name:
Heart STG System 21 CFR 870.1870
Predicate Devices:
The Stethographics Heart STG System is substantially equivalent to the Zargis' Acoustic Cardioscan (#K031517).
Stethographics 510(k)
1
Intended Use:
The Stethographics Heart STG is software intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these The product will acquire and reversity identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs.
The device is indicated for use in the clinical setting, by a physician or by trained The device is indicated for use in the entired physician. It in not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Heart STG System are only significant The microletonio of near with physician over-read as well as consideration of all relevant patient data.
Device Description:
The Heart STG is software intended to provide support to medical personnel in the The Freart STO is software mension vare records and analyzes an acoustic signal of the e valuation of near bounds - aids the healthcare provider by marking SI, S2, and suspected systolic murmurs on the waveform.
As a complete system the Heart STG system consists of an electronic stethoscope and As a complete system the rical by on a computer with Windows operating system. The user must provide a compatible electronic stethoscope and a computer.
Technological Characteristics:
The technological characteristics of the new device are compatible to those of the predicate devices.
Performance Data:
Both bench testing and clinical testing were performed to ensure that the device performs Doth ochen testing and chilied tooling in this pre-market notification includes descriptive as intended. The intended supplied in the echnological characteristics.
This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).
2
| Device Specification | |
|---|---|
| Recording frequency range | 20Hz to 2000Hz |
| Sampling frequency | 8,000 Hz |
| Data recording | Standard .wav (PCM) files at resolution of 16 Bit, Mono. |
| Recording time | 20 seconds |
| Acoustic sensor | Electronic stethoscope. Compatible models include Andromed |
| iStethos, Cardionics e-Scope, 3M E-4000. | |
| Number of sensors | 1 |
----------------------------------------------------------------------------------------------------------------Device Snecification
Heart Sound Analysis STG Performance Data
In order to evaluate the Heart STG with both common heart disorders and more rare disorders, two different sets of cardiac sounds were utilized. The first set of cardiac fare disorders, two allerentise of Heart STG to record 91 patients that were scheduled Sounds were obtained of assessment (referred to as the STG data set). The second set was for conocurdio graphy abbeart sounds provided in the Clinical Auscultation of the Cardiovascular System, by Proctor Harvey and David C. Canfield (referred to as the Cardiovasoular Systems of Proctor Harvey course is considered the gold standard for I roctor frai vey tata bething and covers a broad range of heart disorders (363 sounds total), both common and rare. All sounds were graded by three experienced cardiologists. total), both common and fare. In be ositive when 2 out of 3 cardiologists agreed on the presence of murmur.
The STG data set included 91 sounds from 91 patients that were scheduled for th echocardiography assessment. Average age was 61±17 years (range 23 to 94). The cender distribution in this population was 44% male and 56% female. The patients were gender distribution in this peparates recording. The STG recorded 20 second sounds asked to nota then orean ouring stres STG performance to that of the cardiologists. The '+' indicates murmur-positive sounds and '-' indicates murmur-negative sounds.
| Table 1. STG compared to 2 out of 3 cardiologists. STG Data Set. | |||
|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Number of sounds 91 | 2 out of 3 cardiologists + | 2 out of 3 cardiologists - |
|---|---|---|
| Heart STG + | 23 | 4 |
| Heart STG - | 10 | 54 |
The corresponding overall percent agreement = 100%(23 + 54)/91 = 83% The contesponding overall percent adjoonists -positive = 100%(23)(23+10) = 70% Agreement of the STG with 2/3 cardiologists-negative = 100%*(54)/(54+4) = 93%
The Proctor Harvey data set included 363 sounds from 232 patients. Sixty-three sounds were recorded from children, 300 from adults. The Proctor Harvey data set is sounds were recorded from only of common and less common heart pathologies and, represemative of grout namber of be algorithm's performance in both common and less ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Stethographics 510(k)
400253 1 / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /
3
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------common heart conditions. Table 2 compares STG performance to that of the cardiologists.
Table 2. STG compared to 2 out of 3 cardiologists. Proctor Harvey Data Set.
| Number of sounds 363 | 2 out of 3 cardiologists
- | 2 out of 3 cardiologists
- |
|----------------------|-------------------------------|-------------------------------|
| Heart STG + | 227 | 43 |
| Heart STG - | 23 | 70 |
The corresponding overall percent agreement = 100%(227 + 70)/363 = 82% The concesponaing & verair p 2/3 cardiologists-positive = 100%(227)(227+23) = 91% Agreement of the STG with 2/3 cardiologists-negative = 100%*(70)/(70+43) = 62%
The agreement between cardiologists was also calculated, Tables 3 and 4, columns 3 to 8.
Table 3. Agreement between cardiologists. STG Data Set.
| | STG
compared to
2 out of 3
cardiologists | Cardiologist
1 with
cardiologist
2 as a gold
standard | Cardiologist
1 with
cardiologist
3 as a gold
standard | Cardiologist
2 with
cardiologist
1 as a gold
standard | Cardiologist
2 with
cardiologist
3 as a gold
standard | Cardiologist
3 with
cardiologist
1 as a gold
standard | Cardiologist
3 with
cardiologist
2 as a gold
standard |
|------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Agreement
with
murmur-
positive | 70 | 91 | 100 | 72 | 93 | 67 | 79 |
| Agreement
with
murmur-
negative | 93 | 79 | 77 | 94 | 89 | 100 | 96 |
Table 4. Agreement between cardiologists. Proctor Harvey Data Set.
| | STG
compared to
2 out of 3
cardiologists | Cardiologist
1 with
cardiologist
2 as a gold
standard | Cardiologist
1 with
cardiologist
3 as a gold
standard | Cardiologist
2 with
cardiologist
1 as a gold
standard | Cardiologist
2 with
cardiologist
3 as a gold
standard | Cardiologist
3 with
cardiologist
1 as a gold
standard | Cardiologist
3 with
cardiologist
2 as a gold
standard |
|------------------------------------------|---------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Agreement
with
murmur-
positive | 91 | 97 | 97 | 83 | 94 | 82 | 93 |
| Agreement
with | 62 | 61 | 60 | 91 | 86 | 91 | 88 |
4
| =469========================================================================================================================================================================== | ||||
|---|---|---|---|---|
| murmur- | ||||
| negative |
Thus, the STG agreement with 2/3 cardiologists was found to be comparable to that measured among experienced cardiologists.
Heart Rate (HR) was validated by comparing the HR calculated by the STG to that Treat Rale (TIT) was vanuated by contpassion. The correlations between the Heart STG canculated by JN Entimall: 21.000 tlosscope for the STG data set and Proctor Harvey data set are 0.96 and 0.91, respectively.
41,30200 p 5 / 5
5
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle head with three lines forming the head and neck. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle head.
DEC 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stethographics, Inc. c/o Ms. Rozanne Paciej Director, Regulatory Affairs Quality Assurance 1153 Centre Street Boston, MA 02130
Re: K052283
Trade Name: Stethographics Heart STG System Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: November 14, 2005 Received: November 22, 2005
Dear Ms. Paciej:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications referenced above and have determined the actived predicate devices marketed in interstate for use stated in the encrosule) to regally manced promoted in vice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chacance with the provisions of the Federal Food, Drug, devices that have been reculted in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a providions of the Act. The and Cosment Act (Act) that do not require approvate of the general controls of the Act. The You may, therefore, market the device, subject to tits gonto for annual registration, listing of the and general controls provisions of the Free merals required.
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 If your device is classified (SCC above) the entile is a control stars and control device can
may be subject to such additional controls. Existing major regulations EDA mov may be subject to such additional controllar antitudes of the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Poderal Regaring your device in the Federal Register.
7
Page 2 – Ms. Rozanne Paciej
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscription with other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decidination that your de received by other Federal agencies. You musti of any Federal statutes and regulations daminities, but not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: r comply with all the Act s requirements, morams, connective requirements as set CFR Part 807); labeling (21 CFR Part 807); good if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni form in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1 product radiation control provisions (Decions of the as described in your Section 5 (0(k)
This letter will allow you to begin marketing your device as described in your high I his letter will anow you to begin manceing your and equivalence of your device to a legally premarket notification. The PDA multing of substantial equal and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please if you desire specific advice for your ac not one one one not the regulation entitled. comact the Office of Complanes at (210) = 15 = 16 = 16 = 1 = 1 = 1 = 1 = 1 = 1 = 5 = = $ Small Misoraliung by reference to promantovitibilities under the Act from the Division of Small other general information on your responsibilities and its toll-free number (800) 638-204 or btrail Manufacturers, International and October http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
A. Ui Feinter for
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): _ KOS 2283
Device Name: Stethographics Heart STG System
Indications for Use:
The Stethographics Heart STG System, is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected systolic murmurs.
The device is indicated for use in the clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It in not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Heart STG System are only significant when used in conjunction with physician over-read as well as consideration of all relevant patient data.
Prescription Use XXX (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)
A.M. Mcclellan for Brian D. Zuckerman, (MD)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
Page 1 of 1