(75 days)
Browser is a software program that is used by a HCP (Healthcare Professional) to view, analyze, and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor.
Information that is collected includes patient information, equipment parameters, compliance logs, patient events, equipment events, and waveforms.
The data is downloaded to a PC, either by direct connection to the monitor or by modem. The data can also be retrieved from a computer file or memory disk such as a floppy or card.
The software allows the user to review and manipulate event information, produce reports, save changes, and forward data via e-mail.
Browser is a Windows 95 software program used for reviewing events recorded by a Healthdyne Technologies SmartMonitor. Browser allows the operator to observe the time and duration of physiological events such as apnea, bradycardia, tachycardia and oxygen desaturation. The operator can also observe the waveforms associated with these events. These events and waveforms are downloaded from the monitor using a directly connected cable or via a modem.
The document provided describes a software program named "Browser" (Model 4500E), which is intended to be used by Healthcare Professionals to view, analyze, and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor. It does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics as typically seen for medical devices with diagnostic or treatment functions.
Based on the provided text, here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria. Instead, it focuses on functional equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (Healthdyne Technologies 9500E software): The software should perform the same essential user features as the predicate device. | "Both allow the user to observe physiological events and equipment events and both allow the user to view waveforms associated with events." |
| Functionality, Safety, and Effectiveness: The software should operate as intended, be safe for its intended use, and be effective in fulfilling its purpose. | "The cumulative test results demonstrated the functionality and safety and effectiveness of the Browser software..." |
| Ability to view, analyze, and edit patient data from SmartMonitor® Infant Apnea Monitor. | "Browser is a software program which is used by Intended Use: Healthcare Professionals to view, analyze and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor." |
| Ability to observe time and duration of physiological events (apnea, bradycardia, tachycardia, oxygen desaturation). | "Browser allows the operator to observe the time and duration of physiological events such as apnea, bradycardia, tachycardia and oxygen desaturation." |
| Ability to observe waveforms associated with events. | "The operator can also observe the waveforms associated with these events." |
| Data download capability (direct connection or modem). | "These events and waveforms are downloaded from the monitor using a directly connected cable or via a modem." |
| No change in source code from predicate. | "...Browser is a completely new program that shares no source code with the 9500E." (This is a design choice, not a performance metric, but relevant to its equivalence claim). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "actual patient data" and "simulated patient data" were used for testing. However, it does not specify the number of patient datasets or cases used in the test set.
- Data Provenance: The document does not specify the country of origin of the data. It implies both retrospective (historical patient data) and simulated data were used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for the test set. The comparison was primarily between the output of the new software and the predicate software, using "actual patient data" and "simulated patient data." There is no indication of independent expert review for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method as ground truth was not established by multiple experts in a consensus manner. The comparison was between the output of two software programs.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This device is a software tool for data review, not an AI diagnostic aid that assists human readers in interpreting images or data for making clinical decisions. The comparison was between two software programs.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Yes, a form of standalone performance was assessed. The "Non-Clinical Testing" involved:
- "System level and module/integration level testing to verify all the defined software requirements." This implicitly refers to the algorithm's functional performance.
- A "clinical comparison of actual patient data was performed by comparing reports generated by the predicate 9500E software and the Browser software." This compares the output of the new software with the predicate software, essentially evaluating the algorithm's output without human intervention during the comparison step itself.
7. The Type of Ground Truth Used:
The "ground truth" for the test set was effectively the output of the predicate device (Healthdyne Technologies 9500E software) when processing "actual patient data." The new Browser software's output was compared against the 9500E's output to demonstrate "substantial equivalence." Simulated patient data was also used, where the "ground truth" would be the known parameters of the simulated data.
8. The Sample Size for the Training Set:
Not applicable. This is a software program for viewing and analyzing data, not a machine learning or AI model that requires a training set in the conventional sense. The "Browser" is described as a "completely new program that shares no source code with the 9500E," indicating it was developed through traditional software engineering rather than machine learning.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set in the context of machine learning. The software was developed and tested against its defined requirements and against the functionality of the predicate device.
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5 1898 OCT
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Image /page/0/Picture/1 description: The image shows the logo for Respironics. The logo consists of a stylized human figure inside a triangle, with the word "RESPIRONICS" written below it in a bold, sans-serif font. The human figure appears to be in motion, and the triangle is a simple, geometric shape. The logo is black and white.
1255 Kennestone Circle Marietta, Georgia 30066-6029 USA
ার প্রায়
510(k) SUMMARY
Establishment Registration Number:
1040777
Submitter:
Betsy Cortelloni Respironics, Inc. 1255 Kennestone Circle Marietta, GA 30066 Phone: 770-429-2894 Fax: 770-499-1139
| Date Prepared: | July 20, 1998 |
|---|---|
| Name of Contact: | Betsy Cortelloni, Regulatory Affairs Associate |
| Device Name: | Browser |
| Device Model Number: | 4500E |
| Classification Name: | Breathing Frequency Monitor, 21 CFR 868.2375 |
| Device Classification: | Class II |
| Predicate Devices: | Healthdyne Technologies, Inc. 9500E software.Originally cleared under K892006 (5/23/89), and asubsequent modification K903287 (8/17/90). |
| Device Description: | Browser is a Windows 95 software program used forreviewing events recorded by a HealthdyneTechnologies SmartMonitor. Browser allows theoperator to observe the time and duration ofphysiological events such as apnea, bradycardia,tachycardia and oxygen desaturation. The operatorcan also observe the waveforms associated withthese events. These events and waveforms aredownloaded from the monitor using a directlyconnected cable or via a modem. |
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510(k) Summary. continued:
Browser is a software program which is used by Intended Use: Healthcare Professionals to view, analyze and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor. Comparison of Technological Characteristics: The predecessor to Browser is the Healthdyne Technologies 9500SE software. Since both software packages interface to the SmartMonitor, they both have the same essential user features. Both allow the user to observe physiological events and equipment events and both allow the user to view waveforms associated with events. Browser runs on the Windows 95 platform whereas the 9500E ran on the DOS platform. However, Browser is not a port of the 9500E software to Windows. Browser is a completely new program that shares no source code with the 9500E. The Browser Software Test Plan consisted of system level and module/integration level testing to verify all the defined software requirements. The tests utilized actual patient data as well as simulated patient data. A clinical comparison of actual patient data was
performed by comparing reports generated by the predicate 9500E software and the Browser software.
The cumulative test results demonstrated the functionality and safety and effectiveness of the Browser software, as well as its substantial equivalence to the predicate device.
Non-Clinical Testing:
Conclusion:
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 5 1898
Ms. Betsy Cortelloni Respironics, Inc. 1255 Kennestone Circle Marietta, GA 30066
Re: K982550 Browser (Event Software) Model 4500E Regulatory Class: II (two) Product Code: 73 BZQ Dated: July 21, 1998 Received: July 22, 1998
Dear Ms. Cortelloni:
: 11 0
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Betsy Cortelloni
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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enter for Devices and Radiological Health
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| 510(k) Number (if known): | K982550 |
|---|---|
| Device Name: | BROWSER |
Indications for Use:
Browser is a software program that is used by a HCP (Healthcare Professional) to view, analyze, and edit patient data gathered with a SmartMonitor® Infant Apnea Monitor.
Information that is collected includes patient information, equipment parameters, compliance logs, patient events, equipment events, and waveforms.
The data is downloaded to a PC, either by direct connection to the monitor or by modem. The data can also be retrieved from a computer file or memory disk such as a floppy or card.
The software allows the user to review and manipulate event information, produce reports, save changes, and forward data via e-mail.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _
Prescription Use (Per 21 CFR 801.109)
OR
II II
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).