(54 days)
Not Found
No
The summary describes a software program for analyzing physiological data and identifying apneas, but it does not mention the use of AI or ML algorithms for this analysis. The description focuses on data display, logging, and analysis of breathing patterns and other physiological signals.
No
The device is a software package for analyzing breathing patterns and physiological data, not for directly treating or diagnosing medical conditions. It aids in data analysis and display but does not provide therapy.
Yes
The device aids in identifying and classifying apneas, which is a diagnostic function related to breathing patterns analysis derived from physiological data.
Yes
The device description explicitly states that RespiEvents™ is a "software analysis program running on a personal computer" and its purpose is to "capture full fidelity Respitrace™ data on a continuous basis, and to provide playback and analysis of the captured data." While it processes data from other devices, the device itself is described solely as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device function: RespiEvents™ analyzes physiological signals collected from the body (breathing patterns, heart rate, pulse oximetry, body position, impedance pneumograph). It does not analyze specimens derived from the body.
- Intended Use: The intended use focuses on analyzing breathing patterns, identifying apneas, and displaying physiological signals. This is related to monitoring and analyzing bodily functions, not analyzing biological samples.
Therefore, RespiEvents™ falls under the category of a physiological monitoring and analysis device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
RespiEvents™ is a software package running on a personal computer that is intended to provide analysis of breathing patterns from RespiTrace technology, aid in identifying and classifying apneas, displaying heart rate changes from electrocardiographic waveforms, logging values from pulse oximetry, and displaying signals from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states as well as activities of daily living.
Product codes
74 DQK
Device Description
RespiEvents™ is a software analysis program running on a personal computer. RespiEvents™ presents waveforms collected from RespiTrace™ technology-based and RespiTrace PT™ and is intended to provide analysis of:
- Breathing patterns from Respitrace™ technology,
- Aid in identifying and classifying apneas,
- Displaying heart rate changes from electrocardiographic waveforms,
- Logging values from pulse oximetry, and
- Displaying signals from physiologic recording devices.
The purpose of RespiEvents™ software is to capture full fidelity Respitrace™ data on a continuous basis, and to provide playback and analysis of the captured data.
The system presents the information from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states. The system does not present alarms, alarm functions, or alarm management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The new software has undergone complete verification and validation test scenarios to show that all functions are in compliance with the user requirements, safety standards, and performance specifications. This involved the use of simulated input signals, manual operations and recordings of actual physiological waveforms.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RespiEvents™ software, Version 4.2, K001369
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Non-Invasive Monitoring Systems Inc. The logo features the company name in two lines, with the acronym "Nims" in a bold, stylized font above the full name. The word "Nims" is set against a black background.
Special 510(k) Submission
510(k) Summary APPENDIX G
AUG 2 1 2001
510(k) Summary For Non-Invasive Monitoring Systems, Inc. RespiEvents™ software, Version 5.2
June 24, 2001 DATE THIS SUMMARY WAS PREPARED:
SUBMITTER'S NAME AND ADDRESS:
Non-Invasive Monitoring Systems, Inc. 1840 West Avenue Miami Beach, Florida 33139
CONTACT PERSON:
Allan F. Brack, Chief Executive Officer Telephone: (305) 534-3694 Facsimile: (305) 534-9368
DEVICE NAME:
Proprietary or Trade Name: RespiEvents™ software, Version 5.2 Event data processing software for a PC Common Name: Programmable Diagnostic Computer Classification Name:
PREDICATE DEVICE:
The legally marketed device to which equivalence is claimed is:
RespiEvents™ software, Version 4.2, K001369, cleared on July 26, 2000.
- 74 DQK * Product Code:
- 870.1425 * CFR Section:
DEVICE DESCRIPTION:
RespiEvents™ is a software analysis program running on a personal computer. RespiEvents™ presents waveforms collected from RespiTrace™ technology-based RespiEvelts "prosents wavelorm" and RespiTrace PT™ and is intended to provide analysis of:
1840 West Avenue, Miami Beach, FL 33139, USA Tel: 1 305 534 3694 - Fax: 1 305 534 9368 http://www.nims-inc.com - nims@respitrace.com
Non-Invasive Monitoring Systems, Inc. RespiEvents™ v5.2
June 2001 APPENDIX G, page G01
1
- Breathing patterns from Respitrace™ technology, ● ·
- Aid in identifying and classifying apneas, .
- Displaying heart rate changes from electrocardiographic waveforms, .
- Logging values from pulse oximetry, and .
- Displaying signals from physiologic recording devices .
The purpose of RespiEvents™ software is to capture full fidelity Respitrace™ data on a continuous basis, and to provide playback and analysis of the captured data.
The system presents the information from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states. The system does not present alarms, alarm functions, or alarm management.
INTENDED USE:
RespiEvents™ is a software package running on a personal computer that is intended to provide analysis of breathing patterns from RespiTrace technology, aid in identifying and classifying apneas, displaying heart rate changes from electrocardiographic waveforms, logging values from pulse oximetry, and displaying signals from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states as well as activities of daily living.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
This submission is for modifications to the RespiEvents™ software, version 4.2 that was cleared for marketing under Premarket Notification K001369. The RespiEvents™ software, version 5.2 is a modification to the predicate device which does not change the intended use or the fundamental scientific technology.
The RespiEvents™ software has been modified to operate on PC running Microsoft Windows 95 or 98 and presents the user with an ergonomically acceptable typical Windows User Interface. The software also has several re-named traces for greater user clarity. No modifications were made to the core software, algorithms, or fundamental scientific technology.
NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The new software has undergone complete verification and validation test scenarios to show that all functions are in compliance with the user requirements, safety standards, and performance specifications. This involved the use of simulated input signals, manual operations and recordings of actual physiological waveforms.
CONCLUSIONS FROM NONCLINICAL TESTING:
The testing of the RespiEvents™ software, version 5.2 demonstrates the performance is substantially equivalent to the predicate device. When used in accordance with the directions for use, by qualified personnel, RespiEvents™ software, version 5.2, is safe and effective, as indicated, for its intended use.
Non-Invasive Monitoring Systems, Inc. RespiEvents™ v5.2
June 2001 APPENDIX G, page G02
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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 wavy lines representing its body and wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2001
Mr. Allan F. Brack Chief Executive Officer Non-Invasive Monitoring Systems, Inc. 1840 West Avenue Miami Beach, FL 33139
Re: K012020
Trade Name: RespiEvents™ Software, Version 5.2 Regulation Number: 21 CFR 870.1425 Regulatory Class: II (two) Product Code: 74 DQK Dated: August 3, 2001 Received: August 6, 2001
Dear Mr. Brack:
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 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (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 regulations.
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Page 2 - Mr. Allan F. Brack
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
Dank Mella
Tames E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT APPENDIX B
RespiEvents™ software, version 5.2 Indications for Use
510(k) Number:
Device Name:
RespiEvents™ software, version 5.2
Indications for Use:
RespiEvents™ is a software package running on a personal computer that is intended to provide analysis of breathing patterns from RespiTrace technology, aid in identifying and classifying apneas, displaying heart rate changes from electrocardiographic waveforms, logging values from pulse oximetry, and displaying signals from physiologic recording devices such as a body position sensor and impedance pneumograph, in the wake and sleeping states as well as activities of daily living.
This is the same intended use as most recently cleared for the NIMS RespiEvents DOS software, version 4.2, 510(k): K001369, dated July 26, 2000.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012030