(10 days)
Not Found
Unknown
The document mentions an "autoscoring algorithm" in the performance studies section, which could potentially utilize AI/ML, but there is no explicit mention or description of AI/ML technology being used. The focus is on data recording, display, and basic analysis.
No.
The device is strictly for recording, displaying, and printing physiological information for diagnostic review, and it does not provide any treatment or therapeutic intervention.
Yes
The device is described as a "Polysomnography System" intended to "record, display and print physiological information to clinicians/physicians" for "diagnostic review" of "sleep or other physiological disorders." This directly indicates its use in the diagnostic process.
No
The device description explicitly states that the Alice 5 is a "multi-functional recording device" and includes hardware components like a "head box" and "base station (recording unit)" to which electrodes and sensors are connected. While it uses "Alice Sleepware Software" for viewing, printing, summarizing, and analyzing data, the system itself is not software-only.
Based on the provided information, the Alice 5 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Alice 5 System Function: The Alice 5 System records, displays, and prints physiological information directly from the patient (brain, heart, muscle activity, breathing, etc.) using electrodes and sensors connected to the body. It does not examine specimens in vitro.
- Intended Use: The intended use clearly states it records and presents physiological information for diagnostic review, similar to a traditional paper-based polygraph recorder. This is a direct measurement of physiological signals from the patient.
Therefore, the Alice 5 System falls under the category of a physiological monitoring device rather than an IVD.
N/A
Intended Use / Indications for Use
The Alice 5 System is a Polysornography System that is intended to record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.
This device does not provide alarms and, is not intended for use as an automated apnea monitor.
Product codes (comma separated list FDA assigned to the subject device)
OLZ, OLV
Device Description
The Alice 5 is a multi-functional recording device. The system is used for the recording, monitoring, storage and transfer of up to 55 channels of biophysical parameters such as brain, heart and muscle activily, eye movement, blood pressure, breathing, body movements and oximelry. In addition it has 5 auxiliary channels and 2 serial channels for connection of external devices.
Electrodes and sensors from the patient are connected to Alice 5 head box which in turn is connected to the Alice 5 base station (recording unit) for data processing and recording.
Patient studies recorded using the Alice 5 head box and the base station are viewed, printed, summarized, and analyzed using the Alice Sleepware Soltware.
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
Adults or infant patients
Intended User / Care Setting
Clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments.
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)
An extensive collection of tests has been conducted and successfully completed, including safety, performance and comparative tests. Declarations of conformance to the FDA Recognized list of consensus standards, as well as FDA reviewers guidance and Applicable voluntary standards have been provided in support of the safety and effectiveness of the Alice 5 System. This list of performance testing included in the submittal is as follows:
- IEC 60601-1: 1988 + A1: 1991 + A2: 1995, Medical Electrical Equipment Part 1: General . Requirements for Safety - Tab 11A
- . IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and tests - Tab 11B
- . ISO-10993-1: Biological Evaluation of Medical Devices - Evaluation and Testing - Tab 9
- FDA Reviewer's Guidar ce (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISO-. 10993 - Tab 9
- Alice 4R to Alice 5 Bench test comparison report; assesses the event (breath) detection capability . of the Alice 4R vs. Alice 5 and the autoscoring algorithm. For this testing a known set of inpuls (depicting apneas/hypopneas) was simulated as an input to the Alice 4R and the Alice 5.
- Devilbiss Sleep Recorder Pulse Transit Time vs. the Alice 5 PTT waveform recording assessment . to determine equivalence in the PTT measurement between the Alice 5 and the Devilbiss Sleep Recorder.
- Devilbiss Sleep Recorder Snore channel/signal to the Alice 5 Snore recording assessment to . determine equivalence in the data collection and waveform presentation between the Alice 5 and the Devilbiss Sleep Recorder.
- Devilbiss Sleep Recorder Pressure Based Flow channel/signal to the Alice 5 Pressure Based . Flow waveform recording assessment to determine equivalence in the data collection and waveform presentation between the Alice 5 and the Devilbiss Sleep Recorder.
- Alice 4R vs Alice 5 thermistor channel/signal comparison to determine equivalence in the data ◆ collection and waveform presentation between the Alice 4R and the Alice 5 systems.
- Alice 5 System Requirements Test Procedure/Report; assesses the features of the Alice 5 to . ensure compliance with the System level requirements.
- Alice 5 Shock & Vibration Test Report; assesses compliance of the Alice 5 system to the IEC 68-. 2-34. & 2-26 standards.
- Alice 5 Temperature & Humidity Report; assesses compliance of the Alice 5 Head Box and base . Station to the Operational and Storage test conditions stated in the 1993 FDA Reviewers Guidance.
Additional testing has been performed in to ensure safety & effectiveness of the Alice 5 System. This testing involves the unit, module, and functional testing of the device (lirmware) and the Alice Sleepware Software. Since we are able to declare compliance to AAMI: SW68:2001 Medical Device software – Software life cycle processes, these test protocols and reports are not required to be submitted as part of this submittal, but are available upon request.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Respironics Alice 4R (K971867), Masimo SET Oximeter (K990966), Devilbiss Sleep Recorder (K012437)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
K 040595
. .
MAR 1 8 2004
... .. .. .. .. ..
| Date of Submission | 11 February 2004 |
|---|---|
| Official Contact / Address of Manufacturing facility | Zita A. Yurko |
| Manager, Regulatory Affairs | |
| Respironics Inc. | |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| Phone: 724-387-4120 | |
| Fax: 724-387-4216 | |
| Zita.yurko@respironics.com | |
| Proprietary Name | Alice 5 System |
| Common/Usual Name | Electroencephalograph/Polysomnography System |
| Device Classification Name | Electroencephalograph/Polysomnography System |
| Classification Reference | 21 CFR 882.1400 |
| Classification | Class II |
| Appropriate Classification Panel | Neurology |
| Product Code | OLZ, OLV |
| Predicate Devices | Respironics Alice 4R (K971867) |
| Masimo SET Oximeter (K990966) | |
| Devilbiss Sleep Recorder (K012437) | |
| Reason for submission | Modified design |
Substantial Equivalence
This premarket notification submission demonstrates that the Alice 5 system is substantially equivalent to a combination of the Respironics Alice 4R (K971867), Masimo SET Oximeter (K990966), and the Devilbiss Sleep Recorder (K012437).
:
・・・・
1
The design of the Alice 5 was verified through the use of design verification and validation testing. The Hazards Control Measures Traceability Matrix provided in the Risk Analysis assured that all hazards identified by the risk analysis were successfully mitigated.
This submission is seeking to extend the existing claims of the Alice system to include additional channels to process and record physiologic information.
Indications for Use
The Alice 5 System is a Polysornography System that is intended to record, display and print physiological information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.
This device does not provide alarms and, is not intended for use as an automated apnea monitor.
Device Description
The Alice 5 is a multi-functional recording device. The system is used for the recording, monitoring, storage and transfer of up to 55 channels of biophysical parameters such as brain, heart and muscle activily, eye movement, blood pressure, breathing, body movements and oximelry. In addition it has 5 auxiliary channels and 2 serial channels for connection of external devices.
Electrodes and sensors from the patient are connected to Alice 5 head box which in turn is connected to the Alice 5 base station (recording unit) for data processing and recording.
Patient studies recorded using the Alice 5 head box and the base station are viewed, printed, summarized, and analyzed using the Alice Sleepware Soltware.
Technological characteristics, comparison to predicate devices
Like the predicate devices, the Alice 5 system is intended to detect physiological signals from various points on the patient's body, individually or as a signal measured between selected electrodes and to record those signals in accordance with preset parameters (in a montage) for analysis by a clinician.
@2004 Respironics Inc.
2
Abbreviated 510(k)
Tab 10 – 510(K) Summary
| Abbreviated 510(k)
| Tab 10 - 510(K) Summary | |||
|---|---|---|---|
| Characteristic | Alice 4R (K97xx) | Devilbiss Sleep Recorder, | |
| Model RM60 (K012437) | Alice 5 | ||
| Intended Use | The Alice 4 System is a | ||
| polysomnography system that | |||
| is intended to record, display | |||
| and print EEG and other | |||
| physiological information to | |||
| clinicians/physicians. The | |||
| device will be used in | |||
| hospitals, institutions, sleep | |||
| centers or clinics or other test | |||
| environments where adult or | |||
| infant patients require the | |||
| documentation of various | |||
| sleep or other physiological | |||
| disorders. | The Devilbiss Sleep Recorder | ||
| is intended for screening | |||
| patients suspected of or | |||
| exhibiting symptoms of sleep | |||
| disorders. The Devilbiss | |||
| Sleep Recorder can be used | |||
| with an autotitrating CPAP to | |||
| record the results of CPAP | |||
| treatment for adults diagnosed | |||
| with sleep apnea syndrome. | |||
| Patients suffering from | |||
| excessive daytime sleepiness | |||
| should be referred to a sleep | |||
| disorder specialist. The | |||
| results of an unattended | |||
| screening are insufficient to | |||
| identify all possible medical | |||
| disorders that may produce | |||
| these symptoms. This device | |||
| is intended to aid the | |||
| physician in diagnosing adult | |||
| sleep apnea. A qualified | |||
| medical professional should | |||
| score the device's recorded | |||
| signals to determine | |||
| respiratory events. The | |||
| Devilbiss Sleep Recorder or | |||
| any of its components should | |||
| not be used as a life support | |||
| device, life support system, or | |||
| as a critical component of a | |||
| life support device or life | |||
| support system. | The Alice 5 System is a | ||
| Polysomnographic System | |||
| that is intended to record, | |||
| display and print physiological | |||
| information to | |||
| clinicians/physicians. These | |||
| parameters are presented | |||
| graphically on a computer | |||
| screen for diagnostic review, | |||
| similar in application to the | |||
| use of a traditional paper | |||
| based polygraph recorder. | |||
| The device will be used in | |||
| hospitals, institutions, sleep | |||
| centers or clinics, or other test | |||
| environments where adults or | |||
| infant patients require the | |||
| documentation of various | |||
| sleep or other physiological | |||
| disorders. | |||
| This device does not provide | |||
| alarms and, is not intended for | |||
| use as an automated apnea | |||
| monitor. | |||
| Configuration | Desktop | Wearable | Desktop |
| Number of patients can | |||
| monitor simultaneously | 1 per unit | Same | Same |
| Portable Design | Yes | Samo | Same |
| Data Collection | Yes | Yes | Yes |
| Data Analysis | Optional (always present, but | ||
| a clinician may choose to use | |||
| it or not) | Optional | Optional (always present, but | |
| a clinician may choose to use | |||
| it or not) | |||
| Report Generation | Optional (always present, but | ||
| a clinician may choose to use | |||
| it or not) | Optional | Optional (always present, but | |
| a clinician may choose to use | |||
| it or not) | |||
| Capable of Data Transfer for | |||
| Analysis and Report | |||
| Generation | Yes | Yes | Yes |
| Channels | 35 | 9 | 51 |
| Data input types | ECG, Neurological, | ||
| Respiratory | ECG, respiratory | ECG, Neurological, | |
| Respiratory | |||
| Remote Capability to Monitor | Yes | Yes | Yes |
| Lead Quality | |||
| Electrode Impedance check | Yes | Yes | Yes |
| Calibration Check | Yes | Yes | Yes |
| Selectable Montage | |||
| Configuration | Yes | Yes | Yes |
| Annotations on study | Yes | Yes | Yes |
| Raw data storage | Yes, Hard Disk | Yes, Flash | Yes, Hard Disk |
| Study Modes | Polysomnography Recording | ||
| Long term Monitoring, | |||
| Retrieval and Replay | Overnight at-home study | Polysomnography Recording | |
| Long term Monitoring, | |||
| Retrieval and Replay | |||
| Optional equipment | Time Sync Video, Digital | ||
| video, printer | Not Available | Digital video, printer | |
| Radio LAN Capabilities | No | No | Yes |
:
:
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.
3
Abbreviated 510(k)
Tab 10 ~ 510(K) Summary
Performance testing
An extensive collection of tests has been conducted and successfully completed, including safety, performance and comparative tests. Declarations of conformance to the FDA Recognized list of consensus standards, as well as FDA reviewers guidance and Applicable voluntary standards have been provided in support of the safety and effectiveness of the Alice 5 System. This list of performance testing included in the submittal is as follows:
- IEC 60601-1: 1988 + A1: 1991 + A2: 1995, Medical Electrical Equipment Part 1: General . Requirements for Safety - Tab 11A
- . IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic Compatibility - Requirements and tests - Tab 11B
- . ISO-10993-1: Biological Evaluation of Medical Devices - Evaluation and Testing - Tab 9
・・・
4
Tab 10 -- 510(K) Summary
- FDA Reviewer's Guidar ce (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISO-. 10993 - Tab 9
- Alice 4R to Alice 5 Bench test comparison report; assesses the event (breath) detection capability . of the Alice 4R vs. Alice 5 and the autoscoring algorithm. For this testing a known set of inpuls (depicting apneas/hypopneas) was simulated as an input to the Alice 4R and the Alice 5.
- Devilbiss Sleep Recorder Pulse Transit Time vs. the Alice 5 PTT waveform recording assessment . to determine equivalence in the PTT measurement between the Alice 5 and the Devilbiss Sleep Recorder.
- Devilbiss Sleep Recorder Snore channel/signal to the Alice 5 Snore recording assessment to . determine equivalence in the data collection and waveform presentation between the Alice 5 and the Devilbiss Sleep Recorder.
- Devilbiss Sleep Recorder Pressure Based Flow channel/signal to the Alice 5 Pressure Based . Flow waveform recording assessment to determine equivalence in the data collection and waveform presentation between the Alice 5 and the Devilbiss Sleep Recorder.
- Alice 4R vs Alice 5 thermistor channel/signal comparison to determine equivalence in the data ◆ collection and waveform presentation between the Alice 4R and the Alice 5 systems.
- Alice 5 System Requirements Test Procedure/Report; assesses the features of the Alice 5 to . ensure compliance with the System level requirements.
- Alice 5 Shock & Vibration Test Report; assesses compliance of the Alice 5 system to the IEC 68-. 2-34. & 2-26 standards.
- Alice 5 Temperature & Humidity Report; assesses compliance of the Alice 5 Head Box and base . Station to the Operational and Storage test conditions stated in the 1993 FDA Reviewers Guidance.
Additional testing has been performed in to ensure safety & effectiveness of the Alice 5 System. This testing involves the unit, module, and functional testing of the device (lirmware) and the Alice Sleepware Software. Since we are able to declare compliance to AAMI: SW68:2001 Medical Device software – Software life cycle processes, these test protocols and reports are not required to be submitted as part of this submittal, but are available upon request. Additionally the following set of standards and guidance documents have been used in the design of the Alice 5 System. These include:
5
Required Standards – A Declaration of Conformity for each of these standards is provided in the submiltal:
. ...
- ANSI/AAMI SW68: 2001 Medical Device Software Software Life Cycle Processes. ●
- IEC 60601-1: 1988 + A1: 1991 + A2: 1995, Medical Electrical Equipment Part 1: General . Requirements for Safety
- IEC 60601-1-2: 2001 Medical Electrical Equipment Part 1-2: Collateral Standard: Electromagnetic . Compatibility - Requirements and tests
- ISO-10993-1: Biological Evaluation of Medical Devices Evaluation and Testing .
Voluntary Standards - Guidance, when applicable, has been adopted from the following standards.
- IEC 60601-2-25: 1993 + A1: 1999 Medical Electrical Equipment Part 2-25: Particular requirements . for the safety of electrocardiographs.
- IEC 60601-2-26: 2002 Medical Electrical Equipment -- Part 2-26: Particular requirements for the safety . of electroencephalographs.
- IEC 60601-2-40: 1998 Medical Electrical Equipment Part 2-40: Particular requirements for the safety . of electromyographs and evoked response equipment.
- IEC 60601-2-49: 2001 Medical Electrical Equipment Part 2-49: Particular requirements for the salety ● of multifunction patient monitoring equipment.
Reviewers Guidance - Guidance, when applicable, has been adopled from each of the FDA Reviewers Guidance documents
- FDA Guidance Document, Electroencephalograph Devices Guidance for 510(k) Content, Draft ● Document, Version 1.0.
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, ● May 1998
- FDA Reviewer's Guidance (#G95-1, 5/1/95) Biological Evaluation of Medical Devices; Use of ISO-. 10993
- FDA Reviewer's Guidance for Premarket Notification Submissions, Appendix A, November 1993 .
- FDA Reviewer's Guidance General Principles of Software Validation; Final Guidance for Industry and . FDA Staff, January 2002
Conclusion
It is the conclusion of Respirorics that the Alice 5 system is substantially equivalent to devices already on the market (cleared by the 510(k) process) and presents no new concerns about salely and effectiveness.
(End of Tab.)
Alice C
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Respironics, Inc. c/o Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
Re: K040595
Trade/Device Name: Alice 5 System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLZ, OLV Dated (Date on orig SE 1tr): March 3, 2007 Received (Date on orig SE Itr): March 8, 2004
APR - 9 2012
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of March 18, 2004.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
7
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/7/Picture/7 description: The image shows a signature in black ink on a white background. The signature appears to be cursive and stylized, with a prominent loop extending downwards. The signature is simple and concise, suggesting a quick and practiced hand.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): _ K 040 595
Device Name:
Indications for Use:
The Alice 5 System Is a Polysomnography System that is intended to record, display and print physiological Information to clinicians/physicians. These parameters are presented graphically on a computer screen for diagnostic review, similar in application to the use of a traditional paper based polygraph recorder. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adults or infant patients require the documentation of various sleep or other physiological disorders.
This device does not provide alarms and, is not intended for use as an automated apnea monitor.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K 040595