(206 days)
The Audicor® Sensors are a family of dual-function sensors for use on adult patients (≥ 18 years) for acquisition of both heart sounds and ECG electrical signals and to transmit these signals to a compatible Audicor system to allow for the evaluation of patient status, to aid in diagnosis, and to determine effects of treatment on ECG and hemodynamics.
There are disposable and reusable versions of the Audicor Sensor. Both can be used in the collection of resting ECG reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.
The Audicor Sensors are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data, and include a microphone for detection of heart sounds. The devices are intended for use on the chest wall in the V3 and/or V4 positions.
Audicor sensors are available in two versions:
- Single-use disposable sensors, for use up to 48 hours
- Durable reusable sensors
Here's an analysis of the provided text regarding the acceptance criteria and study for the Inovise Medical, Inc. AUDICOR Sensor 2.0 and 3.0:
The provided document is a 510(k) premarket notification summary and approval letter, which primarily focuses on establishing substantial equivalence to a predicate device based on performance standards and technological characteristics. It does not contain information about a clinical study involving a test set, ground truth established by experts, or efficacy measures like sensitivity, specificity, or reader improvement.
The "Test Summary & Conclusion" section refers to compliance with performance standards rather than a clinical performance study measuring diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the provided document (510(k) summary for substantial equivalence), the "acceptance criteria" discussed are primarily related to compliance with recognized standards for safety and basic functionality, rather than specific performance metrics like sensitivity or specificity of a diagnostic algorithm.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC12:2000 - Disposable ECG Electrodes | Shown to comply |
| ISO 10993-1:2003, Biological Evaluation of Medical Devices - Evaluation and testing | Shown to comply |
Note: These are compliance standards, not diagnostic performance metrics or clinical acceptance criteria in the typical sense of AI/CADe device evaluation. The document highlights "substantial equivalence" to the predicate device (Audicor™ COR Sensor, K030316) through technological characteristics.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a clinical study with a test set of patient data to evaluate the device's diagnostic performance. The testing mentioned refers to compliance with electrical and biocompatibility standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical study involving expert-established ground truth is described in the provided material.
4. Adjudication Method for the Test Set
Not applicable. No clinical study with a test set requiring 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. The document does not describe an MRMC study or any study evaluating reader improvement with AI assistance. The device in question is a sensor for acquiring signals, not an AI interpretation system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a sensor, not an algorithm for standalone diagnostic performance. Its function is to acquire and transmit signals to a compatible Audicor system. The compliance testing mentioned is for the sensor itself (electrical safety, biocompatibility) rather than diagnostic accuracy.
7. The Type of Ground Truth Used
Not applicable. As no clinical performance study for diagnostic accuracy is described, no ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned. The "ground truth" for the tests performed would be the specifications outlined in the standards (e.g., impedance values, biocompatibility metrics).
8. The Sample Size for the Training Set
Not applicable. The device is a sensor; it does not involve machine learning or an "algorithm" in the sense of one that requires a training set. The reference to "Audicor-enabled ECG/heart sounds systems" implies that the system may have interpretive capabilities, but the submission is for the sensors only.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no discussion of how ground truth would be established for it.
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SEP 2 5 2008
:
Summary of Safety and Effectiveness
As required by 21 CFR, part 807.92
As required by 21 CFR, part 807.92
| Submitted By: | Inovise Medical, Inc.10565 SW Nimbus Ave, Suite 100Portland, OR 97233-4311Phone 503-431-3849Fax 503-431-3801 |
|---|---|
| Contact: | Kendra RathkeyManager, Quality and Regulatory |
| Date Prepared: | August 26, 2008 |
| ProprietaryName: | AUDICOR Sensor 2.0 and 3.0 |
| Common/ UsualName: | ECG/ Heart Sound Sensor |
| Classification: | 870.2360, DRX, class II, Electrocardiograph electrode870.1875, DQD, class II, Stethoscope, electronic |
| PerformanceStandards: | ANSI/AAMI EC12:2000 |
| Intended Use: | The Audicor® Sensors are a family of dual-function sensors for use on adultpatients (≥ 18 years) for acquisition of both heart sounds and ECG electricalsignals and to transmit these signals to a compatible Audicor system to allow forthe evaluation of patient status, to aid in diagnosis, and to determine effects oftreatment on ECG and hemodynamics.There are disposable and reusable versions of the Audicor Sensor. Both can beused in the collection of resting ECG reports. The disposable Audicor Sensor isalso intended for longer term monitoring applications of up to 48 hours. |
| DeviceDescription: | The Audicor Sensors are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed withconductive patient-contact surfaces to enable capture of ECG data, and include amicrophone for detection of heart sounds. The devices are intended for use on thechest wall in the V3 and/or V4 positions.Audicor sensors are available in two versions:1) Single-use disposable sensors, for use up to 48 hours2) Durable reusable sensors |
| Test Summary& Conclusion: | The Audicor sensors have been tested to the applicable requirements of thefollowing standards, and shown to comply.• ANSI/AAMI EC12:2000 - Disposable ECG Electrodes• ISO 10993-1:2003, Biological Evaluation of Medical Devices - Evaluation andtesting. |
| SubstantialEquivalence: | The Audicor Sensors are substantially equivalent to the Audicor™ COR Sensor(K030316). Modifications include:• Extended contact duration up to 48 hours for single-use sensor• Added reusable sensor to the product line |
| TechnologicalCharacteristics: | The Audicor sensors included in this submission are technologically equivalent tothe predicate in that all are dual function sensors (ECG/heart sounds detection)and all are designed for use with Audicor-enabled ECG/heart sounds systems. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human services.
Public Health Service
SEP 2 5 2008
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Inovise Medical Inc. c/o Ms. Kendra Rathkey Manager, Quality and Regulatory 10565 SW Nimbus Avenue, Suite 100 Portland, OR 97223-4311
Re: K080602
Trade/Device Name: Audicor Sensors 2,0 and 3,0 Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II Product Code: DRX, DQD Dated: September 19, 2008 Received: September 22, 2008
Dear Ms. Rathkey:
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.
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
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Page 2 - Ms. Kendra Rathkey
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality 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) rmoreteet 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dma R. Lachner
1 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080602
Device Name: Audicor Sensor 2.0 and 3.0
Indications For Use:
The Audicor® Sensors are a family of dual-function sensors for use on adult patients (≥ 18 years) for acquisition of both heart sounds and ECG electrical signals and to transmit these signals to a compatible Audicor system to allow for the evaluation of patient status, to aid in diagnosis, and to determine effects of treatment on ECG and hemodynamics.
There are disposable and reusable versions of the Audicor Sensor. Both can be used in the collection of resting ECG reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.
Prescription Use × (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)
Page 1 of 1
R. vchmer
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_Ku8062
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special 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. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.