(50 days)
Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation. Optionally it may be used as a temperature sensor to monitor patient temperature. The electrical conductors are YSI 400 or 700 series compatible. They can be provided "clean, non-sterile" or "sterile".
The NovaMed esophageal stethoscopes are long tubes which at the distal end have openings in the side wall and tip end. These openings are covered by a thin non-inflatable cuff to prevent secretions from entering in the distal end. A temperature sensor or electrical conductor can be placed inside the distal end with connecting wires running internally and exiting the proximal end of the stethoscope. The proximal end is fitted with a standard slip fit luer for connection to any standard earpiece or to the Lifesound electronic stethoscope (K844804). The insulated temperature sensor wires are terminated with standard connectors for fitting to standard cables which connect to the temperature monitor. They are available is various lengths, diameters (sizes), with or without temperature, and packaged clean, non-sterile and sterile.
The provided text describes a 510(k) premarket notification for the "Lifesound Esophageal Stethoscope and Temperature Sensor." This document focuses on demonstrating substantial equivalence to previously approved predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with defined quantitative metrics.
Here's a breakdown of the requested information based on the provided text, and where information is not available due to the nature of a 510(k) submission for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided document is a 510(k) premarket notification. For devices like an esophageal stethoscope, often the "acceptance criteria" are demonstrating substantial equivalence to pre-existing, legally marketed devices. There are no explicit quantitative performance criteria or a study designed to measure and report against them in this document. The "performance" section explicitly states "None applicable." The device's performance is assumed to be equivalent to the predicate devices.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Functional Equivalence to Predicate Devices | The device is described as having the same intended use (monitoring heart/breath sounds, optional temperature sensing), similar design (long tube with openings, non-inflatable cuff, electrical conductor/temperature sensor, luer fitting), and similar materials (PVC for air pathway) as the predicate devices. | The core "acceptance" is that it functions similarly to and is as safe and effective as the predicate devices. No specific quantitative performance metrics are provided. |
| Material Composition | Components in air pathway: PVC | This is a descriptive feature, ensuring material compatibility with existing devices. |
| Temperature Sensor Compatibility | Electrical conductors are YSI 400 or 700 series compatible. | This ensures interoperability with standard temperature monitoring equipment. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document does not describe a performance study with a test set of data/patients. The submission relies on a comparison to predicate devices, inferring their established safety and effectiveness.
- Data Provenance: Not applicable. There is no performance data presented in the document itself.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. There is no ground truth established for a test set in this 510(k) submission as no new clinical or performance study data is presented.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is a passive medical instrument (stethoscope/temperature sensor). MRMC studies are typically for diagnostic imaging devices or AI-assisted diagnostic tools where human readers interpret and make decisions. This submission does not involve such a study.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
- Not applicable. This device is a physical instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted or described.
7. Type of Ground Truth Used
- Not applicable. No ground truth is established or used within the context of a performance study for this submission. The "ground truth" for a 510(k) submission like this is essentially that the predicate devices are already deemed safe and effective.
8. Sample Size for the Training Set
- Not applicable. This device is a physical instrument, not an AI/ML algorithm. Therefore, there is no training set involved.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, no ground truth needed to be established for it.
Summary of the Study (or lack thereof) for Device Acceptance:
The "study" that proves the device meets "acceptance criteria" in this context is the 510(k) Substantial Equivalence pathway. The applicant, NovaMed LLC, demonstrates that their "Lifesound Esophageal Stethoscope and Temperature Sensor" is substantially equivalent to two legally marketed predicate devices:
The key arguments for substantial equivalence are:
- Intended Use: Identical (esophageal stethoscope for heart/breath sounds, optional temperature sensing).
- Technological Characteristics: Similar design, materials (PVC for air pathway), and functional principles. The temperature sensor is compatible with standard YSI 400/700 series.
- Performance: The document explicitly states "Performance: None applicable," indicating that for this type of device and submission, no new performance data was required to establish substantial equivalence beyond the design and material comparison. The FDA's letter concurs with the substantial equivalence determination based on the provided information.
Thus, the device meets its "acceptance criteria" not through a new performance study with quantitative results, but by demonstrating that it is as safe and effective as devices already on the market through a detailed comparison of its features and intended use.
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062020
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 29-Aug-06
| NovaMed LLC4 Nursery LaneRye, NY 10580 | Tel - 914-967-3500Fax - 914-967-3209 | SEP - 5 2000 | |
|---|---|---|---|
| Official Contact: | Peter Derrico - President | ||
| Proprietary or Trade Name: | Lifesound esophageal stethoscope and temperature sensor | ||
| Common/Usual Name: | Stethoscope, Esophageal with electrical conductors | ||
| Classification Name: | Stethoscope, Esophageal with electrical connectors | ||
| Device: | Lifesound esophageal stethoscope | ||
| Predicate Devices: | Biomedical Concepts (NovaMed) - K864858Shore Medical – K982193 | ||
| Device Description: |
The NovaMed esophageal stethoscopes are long tubes which at the distal end have openings in the side wall and tip end. These openings are covered by a thin non-inflatable cuff to prevent secretions from entering in the distal end.
.
A temperature sensor or electrical conductor can be placed inside the distal end with connecting wires running internally and exiting the proximal end of the stethoscope. The proximal end is fitted with a standard slip fit luer for connection to any standard earpiece or to the Lifesound electronic stethoscope (K844804). The insulated temperature sensor wires are terminated with standard connectors for fitting to standard cables which connect to the temperature monitor. They are available is various lengths, diameters (sizes), with or without temperature, and packaged clean, non-sterile and sterile.
| Indications for Use: | |
|---|---|
| Indicated Use -- | For use as an esophageal stethoscope to listen to patientheart and breathe sounds while a patient is under anesthesia orsedation. |
| Optionally it may be used as a temperature sensor to monitorpatient temperature. | |
| The electrical conductors are YSI 400 or 700 series compatible. | |
| They can be provided "clean, non-sterile" or "sterile". |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 29-Aug-06
Environment of Use --
Hospital, sub-acute care or any setting requiring the monitoring of breath sounds and / or temperature
Device Attributes:
| NovaMed Esophageal Stethoscope | |
|---|---|
| Attributes | |
| Intended useGeneral | Monitor heart and breathe soundsOptional configuration to monitor temperature |
| Intended useSpecific | Esophageal stethoscopeMonitor patient temperature |
| Environments of use | For patients under anesthesia or sedation.Hospital, sub-acute care or any settings where monitoringof breathe sounds and /or temperature is required |
| Prescription | Yes |
| Design | Inner tube with holes at distal end, covered with non-inflating cuff with proximal end terminating in a luerfitting. Electrical conductor / temperature sensor whichconnects to standard monitors YSI 400 or 700 seriescompatible. |
| Materials | |
| Components in air pathway | PVC |
| Performance | None applicable |
Differences between Other Legally Marketed Predicate Devices 12008 - 1
The NovaMed esophageal stethoscope is viewed as substantially equivalent to the following predicate devices - Biomedical Concepts (NovaMed) esophageal stethoscope -- K864858 and Shore Medical - K982193.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2006
NovaMed, LLC C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court, #102 Bonita Springs, Florida 34134-2015
Re: K062020
Trade/Device Name: Lifesound Esophageal Stethoscope and Temperature Sensor Regulation Number: 21 CFR 868.1920 Regulation Name: Esophageal Stethoscope with Electrical conductors Regulatory Class: II Product Code: BZT Dated: July 14, 2006 Received: July 17, 2006
Dear Mr. Dryden:
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. Dryden
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. or me ret or any 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 and if the (2 as set forth in the quality systems (QS) regulation (21 GFR 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours,
Syrite Y. Michael MD
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
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Indications for Use Statement
Page 1 of 1
510(k) Number:
K062020 (To be assigned)
Device Name:
Lifesound Esophageal Stethoscope and Temperature Sensor
Indications for Use:
Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation.
Optionally it may be used as a temperature sensor to monitor patient temperature.
The electrical conductors are YSI 400 or 700 series compatible.
They can be provided "clean, non-sterile" or "sterile".
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Snette Y. Michie, Omd.
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Anesthesinlogy General Hospita Juon Control, Dental Device
) Number: K 06 2020
§ 868.1920 Esophageal stethoscope with electrical conductors.
(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).