(8 days)
Not Found
No
The description details a microprocessor controlling basic functions and pressure regulation through motor speed control, without mentioning any AI/ML algorithms for data analysis, prediction, or adaptive control beyond simple parameter setting and monitoring.
Yes
The device is indicated for use in treating obstructive sleep apnea (OSA), which is a medical condition, making it a therapeutic device.
No
Explanation: The device is indicated for treatment (providing continuous positive airway pressure) of obstructive sleep apnea, not for diagnosing it. Its functions are related to setting and controlling pressure, monitoring compliance and hours of use, and compensating for altitude.
No
The device description clearly states it is a physical device with a blower motor, power supply, and other hardware components, even though it utilizes software for control and parameter setting.
Based on the provided information, the Nellcor Puritan Bennett GoodKnight 418G is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The GoodKnight 418G is a device that provides positive airway pressure to treat sleep apnea. It interacts directly with the patient's airway and does not analyze biological specimens.
- The intended use and device description clearly state its function is to deliver air pressure for treating obstructive sleep apnea. There is no mention of analyzing any biological samples.
Therefore, the GoodKnight 418G falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Nellcor Puritan Bennett GoodKnight 418G is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare environment.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
The GoodKnight 418G is a device used to provide Continuous Positive Airway Pressure between 4 and 18 cmH2O.
The device is powered either by AC mains (115 VAC or 230 VAC nominal) or by an external 24 VDC battery. The blower motor nominal voltage is 24 VDC, which is obtained directly from the external battery or by rectifying and filtering the nominal mains power. The device is double-insulated so that grounding is not required.
The device is set up for use by the homecare dealer using the Clinician Manual provided with the device. It is operated by following the directions in the Patient Manual.
The device uses a microprocessor to set the various control parameters, turn features on and off and view the set parameters.
Pressure regulation is accomplished by maintaining a constant motor speed. This is done by the microprocessor counting the motor RPM pulses and then changing the motor speed voltage supplied to the motor drive circuit as required to maintain constant speed.
The GoodKnight 418G has the following functions :
- On/Off
- Calibration
- Set Prescription Pressure
- Check Prescription Pressure
- Enable/Disable Ramp Feature
- Set Ramp Starting Pressure
- Start Ramp Feature
- Enable/Disable Altitude Compensation Feature
- Compensating for Changes in Altitude
- Check Compliance Meter
- -- Reset Compliance Meter
- Check Hour Meter
The accessories, i.e. the patient tubing, patient masks and headgear are the same ones used with the GoodKnight 418 CPAP System.
The device is not for use in life-supporting or life-sustaining situations.
Neither the device nor its accessories are sterile.
The device itself and the air filter are for multiple use. The other accessories, i.e. the patient circuit and nasal masks are for single patient use.
The device is for prescription use and contains appropriate labeling.
The device is for use in a homecare environment.
The device does not contain a drug or biological product as a component. However, it can be used to provide the patient with supplemental oxygen.
The device is not part of a kit.
Software is used to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to enable/disable the ramp and altitude compensation features. Software is also used to increase the hour meter and the compliance meter.
The device is electrically operated.
The device complies with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC 601-1.
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
patients weighing over 30 kg
Intended User / Care Setting
Homecare environment. The device is set up for use by the homecare dealer.
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)
- Functional testing was performed to confirm that the GoodKnight 418G is capable of meeting its stated performance specifications. The device passed all tests.
- Testing was performed to confirm that the GoodKnight 418 complies with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The device passed all tests.
- All software was tested in accordance with the May 29, 1998 "Guidance for the Content of Premarket submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. The device passed all tests.
- No clinical studies were required to support a substantial equivalence determination.
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.
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
§ 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).
0
APR 14 - 39
510(k) SUMMARY
NELLCOR PURITAN BENNETT GoodKnight 418G
1.0 - Submitter Information
Nellcor Puritan Bennett France Développement 10, Allée Pelletier Doisy 54601 Villers-lès-Nancy France
| Submitter's Name | : Moustafa Anki |
|---|---|
| Phone | : +33 383.44.85.00 |
| Fax Number | : +33 383.44.85.01 |
| Preparation Date | : March 31, 1999 |
2.0 - Device Name
| Proprietary Name | : GoodKnight 418G |
|---|---|
| Common Name | : CPAP Machine |
| Classification Name | : Noncontinuous Ventilator (73 BZD), per 21 CFR 868.5905 |
3.0 - Predicate Device Equivalence
We are claiming substantial equivalence to the Nellcor Puritan Bennett GoodKnight 418 CPAP System, cleared for commercial distribution per K980365.
4.0 - Device Description
The GoodKnight 418G is a device used to provide Continuous Positive Airway Pressure between 4 and 18 cmH2O.
The device is powered either by AC mains (115 VAC or 230 VAC nominal) or by an external 24 VDC battery. The blower motor nominal voltage is 24 VDC, which is obtained directly from the external battery or by rectifying and filtering the nominal mains power. The device is double-insulated so that grounding is not required.
1
The device is set up for use by the homecare dealer using the Clinician Manual provided with the device. It is operated by following the directions in the Patient Manual.
The device uses a microprocessor to set the various control parameters, turn features on and off and view the set parameters.
Pressure regulation is accomplished by maintaining a constant motor speed. This is done by the microprocessor counting the motor RPM pulses and then changing the motor speed voltage supplied to the motor drive circuit as required to maintain constant speed.
The GoodKnight 418G has the following functions :
- On/Off
- Calibration
- Set Prescription Pressure
- Check Prescription Pressure
- Enable/Disable Ramp Feature
- Set Ramp Starting Pressure
- Start Ramp Feature
- Enable/Disable Altitude Compensation Feature
- Compensating for Changes in Altitude
- Check Compliance Meter
- -- Reset Compliance Meter
- Check Hour Meter
The accessories, i.e. the patient tubing, patient masks and headgear are the same ones used with the GoodKnight 418 CPAP System.
The device is not for use in life-supporting or life-sustaining situations.
Neither the device nor its accessories are sterile.
The device itself and the air filter are for multiple use. The other accessories, i.e. the patient circuit and nasal masks are for single patient use.
The device is for prescription use and contains appropriate labeling.
The device is for use in a homecare environment.
The device does not contain a drug or biological product as a component. However, it can be used to provide the patient with supplemental oxygen.
The device is not part of a kit.
2
Software is used to set the various device parameters such as the prescription pressure and the ramp starting pressure, and to enable/disable the ramp and altitude compensation features. Software is also used to increase the hour meter and the compliance meter.
The device is electrically operated.
The device complies with certain voluntary standards, specifically the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993) and IEC 601-1.
5.0 - Intended Use
The intended use of the GoodKnight 418G is to provide Continuous Positive Airway Pressure (CPAP) between 4 and 18 cmH2O to spontaneously breathing patient over 30 kg for the treatment of Obstructive Sleep Apnea in a homecare environment.
6.0 - Comparison of Technological Characteristics
The voltage range for the GoodKnight 418G is 115 VAC nominal, 230 VAC nominal or 24 VDC. For the GoodKnight 418 CPAP system the voltage is only 115 VAC nominal. The 418G has a motor voltage of 24 VDC instead of 160 VDC as does the 418 CPAP System. Both the 418 CPAP System are doubleinsulated.
Both the 418G and the 418 CPAP System use a microprocessor to set the various controls. The GoodKnight 418 CPAP System has a fixed ramp duration of 15 minutes whereas the GoodKnight 418G has a ramp duration that can be chosen within the following values of 5, 10, 15, 20, 25 or 30 minutes. For both devices, the ramp starting pressure can be set from 4 cmH2O up to the prescription pressure.
Both the 418G and the 418 CPAP System have an Altitude Compensation Feature.
To read the control settings on the GoodKnight 418 CPAP System, the user presses various buttons and counts the number of times the indicator lamp flashes, whereas with the GoodKnight 418G, the user presses various buttons and reads the control settings on an LCD screen.
Both the 418G and the 418 CPAP System have a pressure range of 4 to 18 cmH2O.
The GoodKnight 418 CPAP System does not have a compliance meter whereas the GoodKnight 418G has a compliance meter and an hour meter.
3
7.0 - Summary of Performance Testing
-
- Functional testing was performed to confirm that the GoodKnight 418G is capable of meeting its stated performance specifications. The device passed all tests.
-
- Testing was performed to confirm that the GoodKnight 418 complies with the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The device passed all tests.
-
- All software was tested in accordance with the May 29, 1998 "Guidance for the Content of Premarket submissions for Software Contained in Medical Devices" published by the Office of Device Evaluation. The device passed all tests.
-
- No clinical studies were required to support a substantial equivalence determination.
8.0 - Conclusions
We conclude that the GoodKnight 418G meets its stated performance specifications and criteria outlined in the Reviewers Guidance publications referenced above. We conclude that the device will operate safely in its intended environment and will be effective in fulfilling its intended use.
4
Image /page/4/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 caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1999
Mr. Moustafa Anki Nellcor Puritan Bennett France Développement 10, allée Pelletier Doisy F-54601 Villers-lès-Nancy celex FRANCE
Re: K991150 Nellcor Puritan Bennett GoodKnight 418G CPAP Device Requlatory Class: II (two) Product Code: 73 BZD Dated: March 31, 1999 Received: April 6, 1999
Dear Mr. Anki:
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 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 requlations 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. requlatory 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.
5
Page 2 - Mr. Moustafa Anki
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 regulation (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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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
6
Statement of Intended Use
Device Name :
Nellcor Puritan Bennett, GoodKnight 418G
Intended Use :
The Nellcor Puritan Bennett GoodKnight 418G is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare environment.
Concurence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
510(k) number: 1991158
At. A. Ciachowsh.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number