(174 days)
The intended use of the GoodKnight 418 is to provide Continuous Positive Airway Pressure (CPAP) between 4 and 18 cmH,O to spontaneously breathing patients over 30 kg for the treatment of Obstructive Sleep Apnea in a homecare environment.
The GoodKnight 418 CPAP System is indicated for use in treating obstructive sleep apnea patients weighing over 30 kg within a homecare environment.
The GoodKnight 418 CPAP System is a device used to provide Continuous Positive Airway Pressure between 4 and 18 cmH2O.
The device is powered by AC Mains from 96 to 138 VAC, 60 Hz. The blower motor nominal voltage is 160 VDC, which is obtained by rectifying and filtering the nominal mains power voltage of 120 VAC. The device is double-insulated so that grounding is not required.
The device is set up for use by the homecare dealer using the Set-up Instructions provided with the device. It is operated by following directions in the Patient Guide. Pocket Cards are also provided for both the patient and the homecare dealer as a convenience.
The pressure is set to the prescription with the use of a patient circuit, with the pressure being measured at the patient end of the circuit. By using this method, losses associated with the patient circuit are compensated for and, thus, the device does not require a pressure transducer.
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 418 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
The accessories, i.e., the patient tubing, patient masks and headgear are the same ones used with the GoodKnight 318.
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.
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 CAN/CSA C22.2 No. 601.1-M90 (1994).
The provided document, a 510(k) summary for the Nellcor Puritan Bennett GoodKnight 418 CPAP System, outlines the device's characteristics and its claim of substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the methodology (like sample sizes, expert qualifications, or ground truth establishment) typically associated with such studies.
The document states that no clinical studies were required for the substantial equivalence determination. Instead, performance testing was conducted based on published guidance documents.
Here's an attempt to answer your questions based only on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Device Performance
The document does not explicitly list specific numerical acceptance criteria (e.g., "pressure must be within X% of target"). Instead, it generally states that the device "passed all tests" related to its stated performance specifications and compliance with guidance documents.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Meets stated performance specifications | Device passed all tests. |
| Complies with Nov 1993 draft "Reviewer Guidance for Premarket Notification Submissions" (ARDB) | Device passed all tests. |
| Complies with Aug 1991 "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review" | Device passed all tests. |
| Operates safely in its intended environment | Concluded that it will operate safely. |
| Effective in fulfilling its intended use | Concluded that it will be effective. |
Additional Information on the Study:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "functional testing" and "software testing" but does not specify sample sizes for these tests or the nature of the data/conditions used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. Since no clinical studies were required or reported, there's no mention of expert-established ground truth for a test set. The testing performed was technical/functional validation against internal specifications and regulatory guidance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/None mentioned. Given the nature of the testing (functional and software compliance), an adjudication method as described (typically for clinical outcome evaluation) is not relevant or reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. The device is a CPAP system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The "algorithm" here refers to the embedded software controlling the CPAP device, not an AI for diagnosis or interpretation. The performance discussed is the device operating according to its design, which is inherently "standalone" in its mechanical/electronic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in terms of "ground truth" for a clinical study. The "ground truth" for the device's technical performance would be its design specifications and the requirements outlined in the referenced regulatory guidance documents. The device's operation was compared against these predefined functional expectations.
8. The sample size for the training set
- Not applicable/Not provided. This device is a CPAP system based on established technology, not a machine learning or AI system that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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Jul 2 2 1998
510(k) SUMMARY
NELLCOR PURITAN BENNETT GoodKnight 418 CPAP System
1.0 Submitter Information
Nellcor Puritan Bennett Inc. 2800 Northwest Blvd. Minneapolis, MN 55441
| Submitter's Name: | Stephen Theissen |
|---|---|
| Phone: | (612) 694-3819 |
| Fax Number: | (612) 694-3600 |
| Preparation Date: | January 05, 1998 |
2.0 Device Name
GoodKnight 418 CPAP System (GK418) Proprietary Name:
CPAP Machine Common Name:
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 318, cleared for commercial distribution per K960518.
4.0 Device Description
The GoodKnight 418 CPAP System is a device used to provide Continuous Positive Airway Pressure between 4 and 18 cmH2O.
The device is powered by AC Mains from 96 to 138 VAC, 60 Hz. The blower motor nominal voltage is 160 VDC, which is obtained by rectifying and filtering the nominal mains power voltage of 120 VAC. 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 Set-up Instructions provided with the device. It is operated by following directions in the Patient Guide. Pocket Cards are also provided for both the patient and the homecare dealer as a convenience.
The pressure is set to the prescription with the use of a patient circuit, with the pressure being measured at the patient end of the circuit. By using this method, losses associated with the patient circuit are compensated for and, thus, the device does not require a pressure transducer.
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 418 has the following functions:
-
On/Off
な -
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
The accessories, i.e., the patient tubing, patient masks and headgear are the same ones used with the GoodKnight 318.
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.
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 CAN/CSA C22.2 No. 601.1-M90 (1994).
5.0 Intended Use
The intended use of the GoodKnight 418 is to provide Continuous Positive Airway Pressure (CPAP) between 4 and 18 cmH,O to spontaneously breathing patients 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 418 is 120VAC nominal. For the GoodKnight 318 the range is 110-240 VAC nominal. The 418 has a motor voltage of 160 VDC instead of 24 VDC as does the 318. The 418 is double-insulated whereas the 318 requires grounding.
The GoodKnight 418 uses a microprocessor to set the various controls whereas the GoodKnight 318 uses mechanical means such as a potentiometer to set prescription pressure and DIP switches to set the ramp parameters. The GoodKnight 418 has a fixed ramp duration of 15 minutes whereas the GoodKnight 318 has a ramp duration of 5, 10 or 20 minutes depending on the DIP switch settings. Also, the 418 has a variable ramp starting pressure, from 3.9 cmHJO up to the prescription pressure, whereas the 318 has a fixed ramp starting pressure. For both devices, these parameters are within the same range and are thus are not clinically significant.
The GoodKnight 418 has an Altitude Compensation feature whereas the GoodKnight 318 does not. 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 318 the user reads the pressure gage and looks at the DIP switch settings.
The lowest pressure available with the GoodKnight 418 is 1.0 cmH2O higher than with the GoodKnight 318.
The GoodKnight 418 does not have a compliance meter whereas the GoodKnight 318 has one as optional equipment.
The GoodKnight 418 uses a microprocessor to set and read the control settings whereas the GoodKnight 318 uses analog technology to perform these functions.
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7.0 Summary of Performance Testing
7.1 Functional testing was performed to confirm that the GoodKnight 418 is capable of meeting its stated performance specifications. The device passed all tests.
7.2 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.
7.3 All software was tested in accordance with the August 29, 1991 "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k)Review" published by the Office of Device Evaluation. The device passed all tests.
7.4 No clinical studies were required to support a substantial equivalence determination.
8.0 Conclusions
We conclude that the GoodKnight 418 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.
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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes on its wing, representing service, science, and security. 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
JUL 22 1998
Mr. Stephen G. Theissen Nellcor Puritan Bennett, Inc. 2800 Northwest Boulevard Minneapolis, MN 55441-2625
Re: K980365 GoodKnight 418 CPAP System Regulatory Class: II (two) 73 BZD Product Code: April 29, 1998 Dated: Received: May 4, 1998
Dear Mr. Theissen:
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 regulation 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 requlations.
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Page 2 - Mr. Stephen G. Theissen
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) 594-4648. 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,
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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Page 1 of 1
:
510(k) Number: ५१८०३८ ५
Device Name: GoodKnight 418 CPAP System
Indications for Use:
The GoodKnight 418 CPAP System is indicated for use in treating obstructive sleep apnea The Goodlemgin 116 CFFL Byon patients weighing over 30 kg within a homecare environment.
Concurrence of CDRH, Office of Device Evaluation (ODE)
erk Krame
Prescription Use
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number .
Over-The-Counter Use _
§ 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).