(128 days)
The ResScan software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan is used to download and view therapy data, as well as store therapy information and print reports.
The ResScan software with its capabilities of data collection and display of patient information provides an adjunct for patient compliance management. ResScan allows the clinician to download and view data from a ResMed CPAP or Bilevel device. The data displayed will depend on the ventilator used. Parameters displayed may include one or more of the following: usage (hrs: min); respiratory rate (breaths/min); tidal volume (L/min); leak (L/min); minute ventilation (L/min); apnea and hypopnea index including apnea index (AI), hypopnea index (HI) and AHI (events/hr); oxygen saturation SpO2 (%); pulse rate (bpm);. The software allows the creation of reports on patient details, and downloaded treatment data. ResScan displays data as retrieved. Data processing in ResScan is limited to computing the statistics (e.g., median) on retrieved data. The software operates under Windows 98SE, Windows 2000 SP2, Windows NT4 SP6, Windows XP, and is available on CD-ROM.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the ResScan device:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list quantitative acceptance criteria for the ResScan software. Instead, the performance data section states that the software was tested in accordance with FDA guidance documents and "passed all tests." This implies that the acceptance criteria were met, but the specific metrics are not detailed.
Given the device's function as data download and display software, the implied "performance" likely relates to:
- Accuracy of Data Display: The displayed data (usage, respiratory rate, tidal volume, leak, minute ventilation, AHI, SpO2, pulse rate) should accurately reflect the data downloaded from the ResMed CPAP or Bilevel device.
- Functionality: The software should reliably perform its stated functions: downloading data, viewing data, storing data, and printing reports.
- Compatibility: The software should operate correctly on the specified Windows operating systems and be compatible with ResMed flow generators using their proprietary communication protocol.
- Security/Integrity: Data downloaded and stored should not be corrupted or altered by the software.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accurate display of downloaded therapy data | "The ResScan software passed all tests." |
| Reliable data download from ResMed flow generators | "The ResScan software passed all tests." |
| Correct functionality of viewing, storing, and printing reports | "The ResScan software passed all tests." |
| Compatibility with specified operating systems and devices | "The ResScan software passed all tests." |
| Data integrity during download, display, and storage | "The ResScan software passed all tests." |
| Substantial equivalence to predicate device (AutoScan™ software) | "it is substantially equivalent to the predicate device" |
| Compliance with FDA Software Guidance | "tested in accordance with the recommendations of the FDA |
| Guidance... and the General Principles of Software | |
| Validation." |
2. Sample Size Used for the Test Set and Data Provenance:
The document provides no specific information regarding the sample size used for the test set or the provenance of the data (e.g., country of origin, retrospective/prospective). The statement "The ResScan software passed all tests" is a high-level summary without granular details.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document provides no information on the use of experts or the establishment of ground truth in the context of typical clinical validation studies for diagnostic or AI devices. Given that ResScan is primarily data download and display software, the "ground truth" would likely be the data as logged by the ventilator, and testing would focus on the software's ability to accurately retrieve and present that data, rather than clinical interpretation by experts.
4. Adjudication Method:
The document provides no information on any adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document provides no information on an MRMC comparative effectiveness study, nor would it be expected for this type of device. The device's function is to display data, not to assist human readers in making a diagnosis or interpretation in a way that would require an MRMC study to measure improved effectiveness.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
For the ResScan software, the concept of "standalone" performance is inherent to its function. The software is designed to operate without human intervention during the data download and display process itself. Tests would assess if the software accurately processes and presents the data as designed, without a human "in the loop" for that specific function. However, the document does not describe the methodology or results of such a standalone study in detail, beyond stating that "all tests" were passed and it's substantially equivalent.
7. Type of Ground Truth Used:
The fundamental "ground truth" for this device would be the raw therapy data generated and logged by the ResMed CPAP or Bilevel flow generators. The software's performance is measured against its ability to accurately download, display, and store this pre-existing data. It's not a diagnostic device that interprets signals to establish a medical ground truth (like a pathology report or clinical outcome).
8. Sample Size for the Training Set:
The concept of a "training set" is typically relevant for machine learning or AI-driven devices. The ResScan software, as described, appears to be a rule-based or algorithmic data processing and display tool, not a machine learning model. Therefore, no "training set" information is provided or would be expected.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention or indication of a training set, the question of how ground truth for it was established is not applicable.
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MAY - 5 2004
510(k) SUMMARY—ResScan
| Submitter Name: | ResMed Corp. |
|---|---|
| Submitter Address: | 14040 Danielson Street, Poway CA 92064-6857USA |
| Contact Person: | David D'Cruz, VP Regulatory & Clinical Affairs US |
| Phone Number: | (858) 746 2238 |
| Fax Number: | (858) 746 2900 |
| Date Prepared: | April 30, 2004 |
| Device Trade Name: | ResScan™ |
| Device Common Name/Classification Name: | Data download and display software |
| Predicate Devices: | AutoScan™ software (K024191) |
| Device Description: | The ResScan software with its capabilities of data collectionand display of patient information provides an adjunct forpatient compliance management. ResScan allows the clinicianto download and view data from a ResMed CPAP or Bileveldevice. The data displayed will depend on the ventilator used.Parameters displayed may include one or more of thefollowing: |
| usage (hrs: min);respiratory rate (breaths/min);tidal volume (L/min); |
- . leak (L/min);
- . minute ventilation (L/min);
- apnea and hypopnea index including apnea index . (AI), hypopnea index (HI) and AHI (events/hr);
- . oxygen saturation SpO2 (%);
- pulse rate (bpm); .
The software allows the creation of reports on patient details, and downloaded treatment data. ResScan displays data as retrieved. Data processing in ResScan is limited to computing the statistics (e.g., median) on retrieved data.
The software operates under Windows 98SE, Windows 2000 SP2, Windows NT4 SP6, Windows XP, and is available on CD-ROM.
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Intended Use: The ResScan software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan is used to download and view therapy data, as well as store therapy information and print reports.
The ResScan software cannot be used to set or change ventilator parameters, or to modify the operation/ function of the ventilator.
Device Technological Characteristics and Comparison to Predicate Device(s):
The ResScan software is based on the previously cleared predicate device ResMed's AutoScan software.
The ResScan software is used to download therapy data previously generated or logged by a ResMed ventilator on an IBM compatible computer and to allow the clinician to download, view. and store data, and print reports. The software operates under various Windows operating systems. These features are consistent with and comparable to the predicate device.
Performance Data:
The ResScan software was tested in accordance with the recommendations of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 29, 1998) and the General Principles of Software Validation (January 11, 2002).
The ResScan software passed all tests.
Conclusion:
The ResScan software complies with the requirements for functionality, safety and effectiveness, and it is substantially equivalent to the predicate device AutoScan.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird with three wing-like shapes above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2004
Resmed Limited c/o David D'Cruz Resmed Corporation 14040 Danielson St. Poway, CA 92064-6857
Re: K034033
Trade/Device Name: ResScan Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 6, 2004 Received: April 9, 2004
Dear Mr. D'Cruz;
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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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Page 2 – David D'Cruz
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) 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 (301) 594-4646. 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/dsma/dsmamain.html.
Sincerely vours.
Chis Ls
Lin Liu, Ph.D.
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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Image /page/4/Picture/0 description: The image shows the word "RESMED" in bold, black letters. The letters are capitalized and slightly slanted to the right. To the left of the word is a black square with a white line extending from the bottom right corner of the square to the beginning of the word.
ResMed Ltd ACN 003 765 142 97 Waterloo Road North Ryde NSW 2113 Australia Tel: +61 2 9886 5000 Fax: +61 2 9878 0120
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
. . . .
ResScan
Indications for Use:
The ResScan software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan is used to download and view therapy data, as well as store therapy information and print reports.
Prescription Use Rx only (Part 21 CFR 801 Subpart D)
AND/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)
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital, |
| Infection Control, Dental Devices |
| 510(k) Number: | K034033 |
|---|---|
| ---------------- | --------- |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).