(177 days)
The Nellcor Puritan Bennett Suzanne is intended for use in collecting physiological data to be used in diagnosing sleep disorders.
A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.
The Suzanne System is composed of a data recorder that contains the electronics and software necessary to capture the physiological information of each sensor and to store this information in a Flash card it to a computer via a serial communication port.
The information that can be recorded by the Suzanne System is :
- · EEG signals
- · ECG signals
- · Pressure signals
- · Thoracic movements
- Abdominal movements .
- · Breath detection (through bucco-nasal thermistor)
- · Flow (through pneumotachometer)
- · Envelope of ambient sound
- · Body position
- · Ambient light detection
The signals are amplified by different amplifiers contained in elements of the system known as headboxes. When used in a home environment, the data is recorded in the flash card and the clinican uses a setup unit to check that the system works correctly and to set the recording starting time.
When used in a clinical environment, the system can be used as described above or data can be recorded to a computer with the use of a PC application software.
The system is powered by an internal battery.
The provided text describes the regulatory clearance for the "Suzanne" Ventilatory Effort Recorder (K990565), not a study with detailed acceptance criteria and performance metrics typically associated with AI/ML devices. Therefore, much of the requested information cannot be extracted directly from this document.
However, based on the limited information available, here's a breakdown of what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Functional Performance | Ability to meet stated functional specifications and produce readable output. | "The Suzanne System passed all tests." |
| Regulatory Compliance | Compliance with the November 1993 draft "Reviewer Guidance for Premarket submissions" (Division of Cardiovascular, Respiratory, and Neurological Devices). | "The Suzanne System passed all tests." |
| Software Validation | Compliance with the May 29, 1998 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Office of Device Evaluation). | "The Suzanne System passed all tests." |
| Basic Signal Generation | Verification of readable, appropriate signals when connected to a healthy person. | Implied as passing, as no further clinical studies were deemed necessary for substantial equivalence. |
| Intended Use Fulfillment | Collect physiological data for diagnosing sleep disorders. | "Nelloor Puritan Bennett concludes that the Suzanne meets its stated specifications, operates safely in its intended environment, and is effective in fulfilling its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated in terms of a formal test set for performance metrics. The document mentions "connecting the device to a healthy person and running the system to verify that readable, appropriate signals were generated." This suggests a very small, qualitative "test" rather than a statistically powered test set.
- Data Provenance: Not specified, but given the nature of the test (connecting to a healthy person), it would be prospective data collection, likely from the manufacturer's location.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not mentioned.
- Qualifications: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not mentioned, as there was no formal expert-adjudicated test set described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was explicitly not done. The text states: "No clinical studies were required to support a substantial equivalence determination, except for connecting the device to a healthy person and running the system to verify that readable, appropriate signals were generated." The device is a data recorder, not an AI for interpretation, so such a study would not typically be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of an "algorithm only" device as described for AI. This device (Suzanne) is a data collection system. Its "performance" refers to its ability to accurately acquire and record physiological signals, not to produce diagnostic interpretations that would typically have a standalone algorithm performance measurement. The functional and software tests described confirm its ability to collect and store data reliably.
7. The Type of Ground Truth Used
- Ground Truth: For the basic signal generation test, the "ground truth" was likely the expected physiological signals (e.g., a visibly clear ECG waveform, consistent respiratory patterns, etc.) that would be generated by a healthy person and observable by an engineer or technician. It was not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a hardware and software system for data acquisition, not a machine learning algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable, as there is no training set for a machine learning model. The "ground truth" for the device's development would be its engineering specifications and the accurate reflection of known physical phenomena.
{0}------------------------------------------------
AUG 1 8 1999
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in compliance with the requirements of the Safe Medical Device Act of 1990 and CFR 807.92.
10.0 - Manufacturer Name Nellcor Puritan Bennett (Mallinckrodt, Inc.) 2800 Northwest Blvd. Minneapolis, MN 55441 612-694-3500
11.0 - Proprietary Name of Device
Suzanne
12.0 - Common name of Device
Ventilatory Effort Recorder
13.0 - Device Classification
Devices of this type have been class II by the Anesthesiology Devices Panel. Devices of this type have a classification code of MNR, Ventilatory Effort Recorder (21 CFR 868.2375).
14.0 - Intended Use
The Nellcor Puritan Bennett Suzanne is intended for use in collecting physiological data to be used in diagnosing sleep disorders.
A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.
{1}------------------------------------------------
15.0 - Device Description
The Suzanne System is composed of a data recorder that contains the electronics and software necessary to capture the physiological information of each sensor and to store this information in a Flash card it to a computer via a serial communication port.
The information that can be recorded by the Suzanne System is :
- · EEG signals
- · ECG signals
- · Pressure signals
- · Thoracic movements
- Abdominal movements .
- · Breath detection (through bucco-nasal thermistor)
- · Flow (through pneumotachometer)
- · Envelope of ambient sound
- · Body position
- · Ambient light detection
The signals are amplified by different amplifiers contained in elements of the system known as headboxes. When used in a home environment, the data is recorded in the flash card and the clinican uses a setup unit to check that the system works correctly and to set the recording starting time.
When used in a clinical environment, the system can be used as described above or data can be recorded to a computer with the use of a PC application software.
The system is powered by an internal battery.
16.0 - Predicate Device Equivalence
The Nellcor Puritan Bennett SleepWizard is the predicate device for the Nellcor Puritan Bennett Suzanne.
17.0 - Performance Testing
performed to confirm that the Suzann is capable of meeting its stated Functional testing v performances specifications and that the device output is readable. The Suzanne System passed all tests.
Testing was performed to confirm that the Suzanne System complies with the November 1993 draft "Reviewer Guidance for Premarket submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The Suzanne System passed all tests.
All software was tested in accordance with the May 29, 1998 "Guidance for the Content of Picmarket Submissions for Software Contained in Medical Devices" published by the Office Evaluation. The Suzanne System passed all tests.
No clinical studies were required to support a substantial equivalence determination, except for connecting the device to a healthy person and running the system to verify that readable, appropriate signals were generated.
18.0 - Conclusion
Nelloor Puritan Bennett concludes that the Suzanne meets its stated specifications, operates safely in its intended environment, and is effective in fulfilling its intended use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
Mr. Darin L. Busch Requlatory Affairs Project Manager Nellcor Puritan Bennett, Inc. Sleep & Ventilation Division 2800 Northwest Blvd. Minneapolis, MN 55441-2625
Re: K990565 Trade Name: Suzanne Regulatory Class: II Product Code: MNR Dated: June 14, 1999 Received: June 16, 1999
Dear Mr. Busch:
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 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 In addition, FDA may publish further announcements concerning action. your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation
{3}------------------------------------------------
Page 2 - Mr. Darin Busch
vou 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.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. 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 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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Statement of Intended Use
Device Name :
Suzanne Portable Polysomnograph System
Intended Use :
The Nellcor Puritan Bennett Suzanne is intended for use in collecting and recording physiological data to be used in diagnosing sleep disorders.
A pediatric through adult patient population is intended for the Suzanne, which can be used in either home or hospital environments.
Concurence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
510(k) number: K990565
V. Qaytell
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990565
§ 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).