The Puritan Bennett GoodKnight 425ST is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

Device Description

The GoodKnight 425ST 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 425ST 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 doubleinsulated so that grounding is not required. The GoodKnight 425ST 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 425ST 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 4253T is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system. The GoodKaight 425ST uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 425. The GoodKnight 425ST tubing is equivalent to that of the GoodKnight 425. The GoodKnight 425ST 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 425ST 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 425ST is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use. The GoodKnight 425ST is for use by prescription only and display the appropriate labeling. The GoodKnight 425ST is for use in a hospital and homecare environment. The GoodKnight 425ST 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 425ST is not part of a kit. The GoodKnight 425ST uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.

AI/ML Overview

The provided document, K050072 for the PURITAN BENNETT GoodKnight 425ST, largely focuses on establishing substantial equivalence to a predicate device (GoodKnight 425) and does not detail a study proving specific acceptance criteria in the manner of an AI/ML medical device submission.

Instead, the submission for this conventional medical device relies on:

Functional testing: To confirm the device meets its stated performance specifications.
Compliance with guidance documents and standards: Specifically, the November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" and international standards like IEC 60601-1 and EN ISO 17510-1.
Comparison to a predicate device: Demonstrating that the technological characteristics and performance are sufficiently similar to a device already cleared for market.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this 2005 510(k) submission for a CPAP system.

Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Meets stated performance specifications	"The GoodKnight 425ST is capable of meeting its stated performance specifications. The device passed all tests."
Complies with November 1993 draft "Reviewer Guidance for Premarket Notification Submissions" (Division of Cardiovascular, Respiratory, and Neurological Devices)	"The device passed all tests."
Complies with IEC 60601-1 (Medical electrical equipment)	"The GoodKnight 425ST complies with... IEC 60601-1"
Complies with EN ISO 17510-1 (Sleep apnoea breathing therapy equipment)	"The GoodKnight 425ST complies with... EN ISO 17510-1."
Delivers Positive Airway Pressure in specified ranges	"Delivers 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)." (This is a specification rather than a test result, but implicitly confirmed by functional testing.)
Functions in Bi-level and C-PAP modes with specified settings	The device lists detailed functions for both modes, implying these are functional and perform as designed.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified. This type of submission for a conventional device typically involves bench testing on a limited number of manufactured units, rather than a "test set" of patient data as would be used for an AI/ML device.
Data Provenance: Not applicable in the context of patient data. The testing is bench testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. Ground truth, in the context of device performance verification, is established by measurement against known standards and specifications, not by expert consensus on clinical data.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. Functional tests typically have clear pass/fail criteria based on objective measurements and specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

MRMC Study: No, this type of study was not done. MRMC studies are typically used to assess the impact of an AI algorithm on human reader performance, which is not relevant for this device.

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 AI algorithm's performance. The device itself has software, but its performance is measured as part of the integrated system (e.g., pressure delivery accuracy, adherence to settings), not as a standalone "algorithm."

7. The type of ground truth used

Type of Ground Truth: The "ground truth" for this device's performance validation is its engineering specifications and established regulatory standards (e.g., IEC 60601-1, EN ISO 17510-1, FDA guidance documents). Functional testing verifies that the device operates within these predefined parameters.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not use machine learning in a way that requires a "training set" of data to learn patterns or make predictions. The software controls predefined functions.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable for the same reason as above.

Summary

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K050072

JUN 1 3 2005

510(k) SUMMARY

PURITAN BENNETT GoodKnight 425ST

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	: January 2005

2.0 - Device Name

Proprietary Name	: GoodKnight 425ST
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 425 CPAP system, cleared for commercial distribution as per K041819.

4.0 - Device Description

The GoodKnight 425ST 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 425ST 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 doubleinsulated so that grounding is not required.

The GoodKnight 425ST 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.

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The GoodKnight 425ST 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 4253T is regulated by a pressure sensor which monitors both ambient and output pressure and provides feedback to the control system.

The GoodKaight 425ST uses the same pass over humidifier and interfaces as those approved for use with the GoodKnight 425. The GoodKnight 425ST tubing is equivalent to that of the GoodKnight 425.

The GoodKnight 425ST 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 425ST 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 425ST is for multiple use. Accessories such as the patient circuit and nasal masks are for single patient use.

The GoodKnight 425ST is for use by prescription only and display the appropriate labeling.

The GoodKnight 425ST is for use in a hospital and homecare environment.

The GoodKnight 425ST 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 425ST is not part of a kit.

The GoodKnight 425ST uses software to set the various device parameters such as the prescription pressure and the ramp starting pressure.

The GoodKnight 425ST 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 I/E ratio .
Set backup frequency ◆
. Set inspiratory sensitivity
Set expiratory sensitivity .

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

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. Set rise time between EPAP and IPAP
. 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

5.0 - Intended Use

The Puritan Bennett GoodKnight 425ST 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 425 and GoodKnight 425ST 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).

The global architecture of the GoodKnight 425 and the GoodKnight 425ST is similar. The voltage range for the GoodKnight 425ST is 100 VAC to 240 VAC or 12 VDC as for the GoodKnight 425. The motor voltage of the GoodKnight 425ST is 13 VDC as is the GoodKnight 425 and the GoodKnight 425ST are all double-insulated.

As with the GoodKnight 425, the GoodKnight 425 uses a microprocessor to set the various controls.

The user interface of the GoodKnight 425 and the GoodKnight 425ST is similar. Both devices use an LCD screen with a four button keypad to access and view various device settings. Available settings on the GoodKnight 425ST depend upon the mode of operation.

A pressure sensor, common to both GoodKnight 425 and GoodKnight 425ST, monitors the output and ambient pressure at the mask providing the patient with the right pressure whatever the altitude.

The GoodKnight 425 and the GoodKnight 425ST have the common feature of compliance and hour meters.

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7.0 - Summary of Performance Testing

1. Functional testing was performed to confirm that the GoodKnight 425ST is capable of meeting its stated performance specifications. The device passed all tests.
1. Testing was performed to confirm that the GoodKnight 425ST 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 425ST 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three curved lines, which is a common symbol associated with the department.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 3 2005

Mr. James Bonds Senior Director, Regulatory Affairs Nellcor Puritan Bennett, Inc. 4280 Hacienda Drive Pleasanton, CA 94588-2719

Re: K050072

Trade/Device Name: GoodKnight 425ST Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: BZD Dated: May 31, 2005 Received: June 1, 2005

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.

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Page 2 -- Mr. James 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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Jenette y. Michaitons.

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

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Indications for Use

510(k) Number (if known):

Device Name: Puritan Bennett GoodKnight 425ST

Indications for Use:

The Puritan Bennett GoodKnight 425ST is indicated for use in treating obstructive sleep apnea (OSA) in spontaneously breathing patients weighing over 30 kg within a homecare and hospital environment.

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)

Auy melion

(Division Sign-Off) Division of Anesthestology, General Hospital, Infection Control, Dental Devi-

510(k) Number

050072

Page 1 of 1

Regulation Number and Section

§ 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).