(16 days)
Not Found
No
The summary describes a standard CPAP/bi-level device using a microprocessor for control and parameter setting, with no mention of AI or ML technologies.
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 description states it is "indicated for use in treating obstructive sleep apnea (OSA)". It delivers positive airway pressure for treatment, not for diagnosis.
No
The device description clearly outlines hardware components such as a blower motor, pressure sensor, and the ability to be powered by AC mains or a battery, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the Puritan Bennett GoodKnight 425 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to treat obstructive sleep apnea (OSA) by delivering positive airway pressure. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a device that delivers air pressure, monitors signals related to patient breathing, and stores compliance data. It does not mention analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVD devices, such as reagents, assays, or analysis of biological markers.
Therefore, the Puritan Bennett GoodKnight 425 is a therapeutic medical device, specifically a CPAP/bi-level device, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Puritan Bennett GoodKnight 425 is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.
Product codes
BZD
Device Description
The GoodKnight 425 is designed to deliver Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O).
The GoodKnight 425 can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 425 is double-insulated so that grounding is not required.
The GoodKnight 425 is set up for use by the homecare dealer using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.
The GoodKnight 425 rely on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the treatment of various signals from the devices including signals relating to patient cycle detection.
Pressure delivery for the GoodKnight 425 is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.
The GoodKnight 425 uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 420S. The GoodKnight 425 tubing is equivalent to that of the GoodKnight 420S.
The GoodKnight 425 can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the SilverLining™ software which is required for downloading and displaying compliance data stored in the device memory.
The GoodKnight 425 is not for use in life-supporting or life-sustaining situations. The devices and/or their accessories are not intended for sterile use.
The GoodKnight 425 is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.
The GoodKnight 425 is for use by prescription only and display the appropriate labeling.
The GoodKnight 425 is for use in a hospital and homecare environment.
The GoodKnight 425 does not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen.
The GoodKnight 425 is not part of a kit.
The GoodKnight 425 uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.
The GoodKnight 425 complies with the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993), IEC 60601-1 and EN ISO 17510-1.
The following functions are available on the GoodKnight 425:
Bi-level Mode
- On/Off .
- Set IPAP pressure .
- . Set EPAP pressure
- Set inspiratory sensitivity .
- . Set expiratory sensitivity
- Set rise time between EPAP and IPAP .
- . Set ramp time
C-PAP Mode
- On/Off ●
- . Set Prescription Pressure
- Set Ramp Time .
- Set Ramp Starting Pressure ● (available only if Ramp Time is not set to 0)
- View Hour Meter ●
- . View Compliance Meter
- . View Embedded Software Version
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
patients weighing over 30 kg
Intended User / Care Setting
homecare and hospital environment
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 425 is capable of meeting its stated performance specifications. The device passed all tests.
- Testing was performed to confirm that the GoodKnight 425 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.
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
JUL 22 2004
510(k) SUMMARY
PURITAN BENNETT GoodKnight 425
1.0 - Submitter Information
Mallinckrodt Développement France 10, allée Pelletier Doisy 54601 Villers-lès-Nancy France
| Submitter's Name | : Moustafa Anki |
|---|---|
| Telephone | : +33 383.44.85.00 |
| Fax Number | : +33 383.44.85.01 |
| Preparation Date | : June 2004 |
2.0 - Device Name
| Proprietary Name | : GoodKnight 425 |
|---|---|
| Common Name | : Bi-level CPAP System |
| Device Classification Name | : Noncontinuous Ventilator (73 BZD), per 21 CFR 868.5905 |
3.0 - Predicate Device Equivalence
We are claiming substantial equivalence to the Puritan Bennett GoodKnight 420S CPAP system, cleared for commercial distribution as per K020886.
4.0 - Device Description
The GoodKnight 425 is designed to deliver Positive Airway Pressure between 3 and 20 cmH2O in CPAP mode or between 3 and 25 cmH2O in bi-level mode (EPAP maximum 20 cmH2O).
The GoodKnight 425 can be powered either by AC mains (100 VAC to 240 VAC nominal) or by an external 12 VDC battery. The blower motor nominal voltage is 13 VDC. The GoodKnight 425 is double-insulated so that grounding is not required.
The GoodKnight 425 is set up for use by the homecare dealer using the Clinician Manual provided. The devices are operated according to the instructions contained in the Patient Manual.
1
The GoodKnight 425 rely on a microprocessor for setting and viewing various control parameters and turning features on and off. The microprocessor is also required for the treatment of various signals from the devices including signals relating to patient cycle detection.
Pressure delivery for the GoodKnight 425 is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.
The GoodKnight 425 uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 420S. The GoodKnight 425 tubing is equivalent to that of the GoodKnight 420S.
The GoodKnight 425 can also be connected to a computer via an RS232 serial port. The device can be configured from the computer using the SilverLining™ software which is required for downloading and displaying compliance data stored in the device memory.
The GoodKnight 425 is not for use in life-supporting or life-sustaining situations. The devices and/or their accessories are not intended for sterile use.
The GoodKnight 425 is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.
The GoodKnight 425 is for use by prescription only and display the appropriate labeling.
The GoodKnight 425 is for use in a hospital and homecare environment.
The GoodKnight 425 does not contain any drugs or biological products as components. However, the devices can be used to provide the patient with supplemental oxygen.
The GoodKnight 425 is not part of a kit.
The GoodKnight 425 uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.
The GoodKnight 425 complies with the draft ARDB Reviewer Guidance for Premarket Notification Submissions (Nov 1993), IEC 60601-1 and EN ISO 17510-1.
The following functions are available on the GoodKnight 425:
Bi-level Mode
- On/Off .
- Set IPAP pressure .
- . Set EPAP pressure
- Set inspiratory sensitivity .
- . Set expiratory sensitivity
- Set rise time between EPAP and IPAP .
- . Set ramp time
C-PAP Mode
- On/Off ●
- . Set Prescription Pressure
- Set Ramp Time .
- Set Ramp Starting Pressure ● (available only if Ramp Time is not set to 0)
- View Hour Meter ●
- . View Compliance Meter
- . View Embedded Software Version
2
- Set Ramp Starting Pressure ● (available only if Ramp Time is not set to 0)
- View Hour Meter .
- . View Compliance Meter
- View Embedded Software Version .
5.0 - Intended Use
The Puritan Bennett GoodKnight 425 is intended for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.
6.0 - Comparison of Technological Characteristics
Both the GoodKnight 420S and GoodKnight 425 are CPAP devices which deliver a constant positive air pressure to the patient at a level prescribed by the practitioner between 4 to 20 cmH2O for IPAP in bi-level mode). However, the GoodKnight 425 can also operate in bi-level mode.
The global architecture of the GoodKnight 420S and the GoodKnight 425 is similar. The voltage range for the GoodKnight 425 is 100 VAC to 240 VAC or 12 VDC as for the GoodKnight 420S. The motor voltage of the GoodKnight 425 is 13 VDC as is the GoodKnight 420S device. The GoodKnight 420S and the GoodKnight 425 are all double-insulated.
As with the GoodKnight 420S, the GoodKnight 425 uses a microprocessor to set the various controls. In common with the GoodKnight 420S, the GoodKnight 425 has got a ramp function which, when activated, progressively attains the set reference pressure within a designated time between 0 to 30 minutes.
The user interface of the GoodKnight 420S and the GoodKnight 425 is similar. Both devices use an LCD screen with a four button kevpad to access and view various device settings on the GoodKnight 425 depend upon the device itself and the mode of operation.
A pressure sensor, common to both GoodKnight 420S and GoodKnight 425, monitors the output and ambient pressure at the mask providing the patient with the right pressure whatever the altitude.
The GoodKnight 420S and the GoodKnight 425 have the common feature of compliance and hour meters.
3
7.0 - Summary of Performance Testing
-
- Functional testing was performed to confirm that the GoodKnight 425 is capable of meeting its stated performance specifications. The device passed all tests.
-
- Testing was performed to confirm that the GoodKnight 425 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.
8.0 - Conclusions
We conclude that the GoodKnight 425 meets the stated performance specifications and criteria outlined in the Reviewers Guidance publications referenced above. We conclude that the device and its accessories 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 shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
JUL 2 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mallinckrodt Développement France C/O Mr. James Bonds Nellcor Puritan Bennett 4280 Hacienda Drive Pleasanton, California 94588-2719
Re: K041819
Trade/Device Name: Puritan Bennett Goodknight 425 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 1, 2004 Received: July 6, 2004
Dear Mr. Bonds:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Bonds
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Puritan Bennett GoodKnight 425
Indications For Use:
The Puritan Bennett GoodKnight 425 is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Que Sulom
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number. K041819
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