(207 days)
The PulmoTrack TM 2020 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack TM 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The PulmoTrack TM 2020 is indicated for patient population above two years old
The PulmoTrackTM 2020 is a computer based electronic stethoscope that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays, printed reports and automated identification of lung sounds. The data transfer may be done via Bluetooth wireless communication.
The PulmoTrack™ 2020 is a computer-based electronic stethoscope that acquires, amplifies, filters, records, and analyzes pulmonary sounds. Its intended use is for the analysis, interpretation, and documentation of lung sounds, specifically quantifying the presence of wheezing during pulmonary function testing, provocation tests, bronchodilator administration, or physical examinations. It is indicated for patients above two years old, to be used by or under the supervision of a physician.
This device did not undergo a clinical study as it claimed substantial equivalence to its predicate device, PulmoTrack™ 2010 (WIM-PC™) (K071955), without raising new safety and/or effectiveness concerns. The only technical modification was the data transfer from A/D to the PC via a Bluetooth wireless channel. Therefore, the performance validation focused on demonstrating that the PulmoTrack™ 2020 performed according to its specifications and as well as the predicate device, particularly concerning biocompatibility and wireless functionality.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device's substantial equivalence) | Reported Device Performance (PulmoTrack™ 2020) |
|---|---|
| Acquisition, amplification, filtering, recording, and analysis of pulmonary sounds from trachea and thorax. | "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Provides high fidelity audio outputs, visual displays, printed reports, and automated identification of lung sounds. | "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Quantification of wheezing. | "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Biocompatibility of materials in contact with the human body. | "Materials of the PulmoTrack™ 2020 that are in contact with the human body are biocompatible in accordance with ISO 10993-1." |
| Wireless data transfer functionality (Bluetooth). | "The Bluetooth is substantial equivalence to HOSPIRA Vital Signs Wireless Monitoring System, cleared in K090610" and "underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance." |
| Compliance with relevant medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, EN ISO 10993-1, ISO 14971). | "The system complies with the following standards: IEC 60601-1:1998, IEC 60601-1-2:2001 and IEC 60601:2005, EN ISO 10993-1:2003, ISO 14971:2007." |
2. Sample Size Used for the Test Set and the Data Provenance
A specific "test set" for a clinical performance study (as would be typical for a novel device) is not explicitly described. Because this was a 510(k) submission based on substantial equivalence to a predicate device with only a minor technological change (Bluetooth), the performance validation was likely focused on technical specifications and functional testing rather than a clinical study with a patient test set. The document states "All testing results demonstrated satisfactory performance," implying internal verification and validation activities. There is no information provided about country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical study involving a test set and expert ground truth establishment is described for the PulmoTrack™ 2020 in this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical study involving a test set and adjudication is described.
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
Not applicable. No MRMC study was conducted or described. The PulmoTrack™ 2020 is an electronic stethoscope that provides analysis and interpretation of lung sounds, but the provided documentation does not detail a study comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is an electronic stethoscope with automated identification of lung sounds. The "Performance Validation" section broadly states that the device "underwent validation testing to ensure performance according to its specifications." This would imply standalone performance testing for its ability to analyze and identify lung sounds as per its design. However, specific details of such standalone testing (e.g., against a known dataset of pre-recorded lung sounds with established ground truth) are not provided in this 510(k) summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for validating the automated identification of lung sounds. For a device like this, ground truth would typically come from:
- Expert auscultation/consensus: A panel of experienced physicians listening to the same lung sounds and agreeing on the presence or absence of wheezing.
- Spirometry/pulmonary function tests: Objective measures of lung function that correlate with the presence of wheezing.
Given the nature of the submission (substantial equivalence with minor changes), it's more likely that the validation focused on ensuring the device accurately captured and processed sounds, and that its automated identification algorithm performed comparably to the predicate device, which would have had its own original validation methods for ground truth.
8. The sample size for the training set
Not applicable. The document does not describe a new training set for an AI/algorithm. The device is claiming substantial equivalence to a predicate, implying it uses the same underlying technology/algorithms as the PulmoTrack™ 2010.
9. How the ground truth for the training set was established
Not applicable. As no new training set is described for the PulmoTrack™ 2020, how its ground truth was established is not part of this submission. It would rely on the original methodologies used to develop and validate the predicate device's technology.
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K102229
ﻬﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
510(K) SUMMARY
MAR - 4 2011
PulmoTrack™ 2020
510(k) Number K
| Preparation Date: | August 3, 2010 | |||
|---|---|---|---|---|
| Applicant's Name: | Karmel Sonix Ltd16 Palyam St.Haifa 33095Tel: (972)4-861-5025Fax: (972)4-866-7702 | |||
| Contact Person: | Yoram Levy, Qsite31 Haavoda St.Binyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com | |||
| Trade Name: | PulmoTrackTM 2020 | |||
| Classification: | Name: Diagnostic pulmonary-function interpretation calculatorProduct Code: BZMRegulation No: 21 CFR 868.1900Class: IIPanel: Anesthesiology |
Device Description:
The PulmoTrackTM 2020 is a computer based electronic stethoscope that utilizes an acoustic contact sensor to acquire, amplify, filter, record and analyze pulmonary sounds from the trachea and thorax and provides high fidelity audio outputs, visual displays, printed reports and automated identification of lung sounds. The data transfer may be done via Bluetooth wireless communication.
Intended Use Statement:
The PulmoTrackTM 2020 is intended for the analysis,
interpretation and documentation of lung sounds.
The PulmoTrack™ 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when
1-3 PulmoTrack™ 2020 - Special 510k Notification
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there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
The PulmoTrack™ 2020 is indicated for patient population above two vears old
Predicate Devices:
Substantial equivalence to the following predicate device is claimed:
| Device Name | 510k No | Clearance Date |
|---|---|---|
| PulmoTrack™ 2010 (WIM-PC™) | K071955 | Nov 01, 2007 |
Performance Standards:
PulmoTrack"151 2020 complies with U.S. Federal Performance Requirements and Standards 21 CFR 801, 21 CFR 820 and FD&C act sections 501, 502, 516, 518, 519, 520.
In addition, the system complies with the following standards:
- . IEC 60601-1:1998 Medical electrical Equipment Part 1: "General requirements for safety" Second addition, 1990 including amendments No.1 (1993) No.2 (1995).
- . IEC 60601-1-2:2001 and IEC 60601:2005 Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral standard: Electromagnetic compatibility - Requirements and tests.
- EN ISO 10993-1:2003 Biological Evaluation of Medical . Devices.
- ISO 14971:2007 Risk management for medical devices . ●
Technical Modifications from Predicate Device:
The PulmoTrack™ 2020 is identical to the PulmoTrack™ 2010 (WIM-PC"1) predicate except for the data transfer from the A/D to the PC which is done via Bluetooth wireless channel, thus contains generic software driver that handles the Bluetooth channel.
Substantial Equivalence:
The PulmoTrack™ 2020:
- Incorporates the same intended use and the same . technology as the PulmoTrackTM 2010 (WIM-PC™), cleared in K071955
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- The Bluetooth is substantial equivalence to HOSPIRA . Vital Signs Wireless Monitoring System, cleared in K090610
Performance Validation:
The PulmoTrack™ 2020 underwent validation testing to ensure performance according to its specifications and as good as the predicate devices. All testing results demonstrated satisfactory performance.
- Materials of the PulmoTrack"]1 2020 that are in contact with the Materials: human body are biocompatible in accordance with ISO 10993-1.
- KarmelSonix Ltd. believes that, based on the information provided Conclusion: in this submission, the PulmoTrack™ 2020 is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Karmelsonix C/O Mr. Yoram Levy Osite 31 Haavoda St. Binyamina, Israel 30500
MAR - 4 2011
Re: K102229
Trade/Device Name: Pulmo Track"" 2020 Regulation Number: 21 CFR 868.1900 Regulation Name: Diagnostic Pulmonary-Function Interpretation Calculator Regulatory Class: II Product Code: BZM Dated: January 28, 2011 Received: February 3, 2011
Dear Mr. Levy:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Levy
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony V. Rao
Anthony D. Watson, B.S., M.S., M.B.A. 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 STATEMENT
510(k) Number (if known): K102229
Device Name:
PulmoTrack™ 2020
| Indications for Use: | The PulmoTrack TM 2020 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack TM 2020 is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds. The PulmoTrack TM 2020 is indicated for patient population above two years old |
|---|---|
| ---------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Prescription Use | X |
|---|---|
| (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K 102229 510(k) Number: _
l - 1 PulmoTrack™ 2020 - Special 510k Notification
§ 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).