The Nellcor Puritan Bennett KnightStar 335 is indicated for use in treating spontaneously breathing adult patients with obstructive sleep apnea or respiratory insufficiency in a homecare, hospital or institutional environment. In addition, when used with a Control Module Type 1 and an airway pressure monitor, it is indicated for use in treating spontaneously breathing adult patients with respiratory failure in a hospital or institutional environment.

Device Description

The KnightStar 335 is a microprocessor-controlled flow generator capable or monitoring and controlling pressure within the patient tubing circuit. Three modes of operation are available: CPAP (continuous positive airway pressure), I/E PAP (inspiratory and expiratory positive airway pressure), A/C (assist with control).

AI/ML Overview

The provided text is a 510(k) summary for the Nellcor Puritan Bennett KnightStar 335 ventilator. It establishes substantial equivalence to a predicate device and describes the device's features and intended use. However, it does not contain specific acceptance criteria or a detailed study proving the device meets such criteria.

The document explicitly states:

"No additional performance testing was done inasmuch as the KnightStar 335 has not been physically changed since the 510(k), K942210 was cleared."
"All applicable tests outlined in the November 1993 'Reviewer Guidance for Premarket Notification Submissions' have been performed on the KnightStar 335, as described in the original 510(k) submission. K942210."
"Clinical studies have been performed, as described in the article 'Evaluation of the Puritan Bennett 335 Portable Pressure Support Ventilator: Comparison with the Respironics BiPAP S/T', included as Attachment 5. Although not an extensive study, it does demonstrate that both devices can be used to treat patients with respiratory failure."

Therefore, I cannot populate the requested table and answer the questions based solely on the provided text, as the detailed information about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication, or MRMC studies for this device is not present in this 510(k) summary. The summary refers to an original 510(k) submission (K942210) and an attachment (Attachment 5) for the details of testing and clinical studies, which are not included here.

Based on the provided text, here is what can be inferred or explicitly stated, with the understanding that key details are missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (If mentioned)	Reported Device Performance (If mentioned)
Not specified in this document	Not specified in this document beyond functional description
Equivalence to predicate device for indications of use	Demonstrated substantial equivalence to Respironics BiPAP S/T-D 30 with Detachable Control Panel 30 (K955324)
Compliance with general controls and GMP	Assumed through FDA's substantial equivalence determination

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

The document mentions a clinical study in "Attachment 5" but does not provide details on the sample size or data provenance (e.g., country of origin, retrospective/prospective). It only states: "Although not an extensive study..."

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

This information is not provided in the document.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

This device is a ventilator, not an AI or imaging device that would typically involve "human readers" or "AI assistance" in the way implied by this question. Therefore, an MRMC study demonstrating human reader improvement with AI is not applicable to this device type based on the provided information.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Similar to point 5, this question pertains to AI/algorithm performance. The KnightStar 335 is a microprocessor-controlled ventilator, and the concept of "standalone algorithm performance without human-in-the-loop" as applied to diagnostic algorithms is not directly relevant to its described function. Performance testing would be against engineering specifications and clinical outcomes, not an AI algorithm's diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The document implies clinical studies demonstrating that "both devices can be used to treat patients with respiratory failure." This suggests clinical outcomes data might have been part of the implicit "ground truth" for demonstrating efficacy, but specific details are not given.

8. The sample size for the training set:

This information is not provided in the document and is not applicable in the context of traditional medical device testing as opposed to AI/machine learning model development.

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

This information is not provided in the document and is not applicable in the context of traditional medical device testing as opposed to AI/machine learning model development.

Summary

{0}------------------------------------------------

JUL 1 6 1998

发973004

Image /page/0/Picture/1 description: The image shows the logo for Puritan Bennett. The logo consists of the letters "PB" in a bold, sans-serif font on the left side. To the right of the letters is the name "PURITAN BENNETT" in a similar font, with the word "PURITAN" stacked above the word "BENNETT". There is a horizontal line separating the two words.

510(k) SUMMARY

NELLCOR PURITAN BENNETT KnightStar 335

August 12, 1997

1.0 Submitter Information

Puritan-Bennett Corporation 9728 Pflumm Road Lenexa, KS 66215

Submitter's Name:	C. Marshall Smith
Phone:	(913) 495-4845
Fax Number:	(913) 894-8764
Summary Preparation Date:	August 12, 1997

2.0 Device Name

Proprietary Name:	Nellcor Puritan Bennett KnightStar 335
Common Name:	Bi-level Pressure Support Ventilator
Classification Name:	73 MNT, Continuous Ventilator, per 21 CFR 868.5895

3.0 Predicate Device Equivalence

We are claiming substantial equivalence to the Respironics BiPAP S/T-D 30 with Detachable Control Panel 30, cleared for commercial distribution per K955324.

4.0 Device Description

The KnightStar 335 is a microprocessor-controlled flow generator capable or monitoring and controlling pressure within the patient tubing circuit. Three modes of operation are available:

CPAP (continuous positive airway pressure
I/E PAP (inspiratory and expiratory positive airway pressure)
A/C (assist with control)

In the CPAP mode the system will deliver a continuous positive regulated airway pressure throughout the breath cycle (a range from 3 to 20 cmH20). In the I/E PAP mode, the system will track patient breathing effort and in response to the patient's inspiratory and expiratory efforts, provide two levels of pressure - a higher level of pressure for inhale (a range from 3 to 35 cmH20) and a lower pressure for exhale (a range from 3 to 20 cmH20). In the A/C mode, the system will deliver the same two levels of pressure as described for the I/E PAP mode with the addition of a guaranteed rate (a range from 3 to 30 breaths per minute) and I:E ratio (a range from 1:1.0 to 1:4.0).

{1}------------------------------------------------

All patient parameters are entered via the Control Module Type I. In addition, the Control Module Type 1 provides analog signal output jacks for estimated nasal pressure, estimated patient flow and estimated tidal volume.

The Monaghan Airway Pressure Monitor is used to monitor the breathing circuit pressure and to alarm if either a preset high or low pressure is encountered.

5.0 Intended Use

The Nellcor Puritan Bennett KnightStar 335, is indicated for use in treating spontaneously breathing adult patients with obstructive sleep apnea or respiratory insufficiency in a homecare, hospital or institutional environment. In addition, when used with a Control Module Type 1 and an airway pressure monitor, it is indicated for use in treating spontaneously breathing adult patients with respiratory failure in a hospital or institutional environment.

6.0 Comparison of Technological Characteristics

Although most of the technological characteristics are the KnightStar 335 is microprocessor-controlled whereas the predicate device is not. Also, the KnightStar 335 uses digital scrolling to set controls and read values, whereas the predicate device uses rotating knobs. However, no new concerns are raised regarding safety and effectiveness as both technologies are well understood.

7.0 Summary of Testing Performed

No revisions have been made to the KnightStar 335 software since the device was cleared for commercial distribution per K942210.

No additional performance testing was done inasmuch as the KnightStar 335 has not been physically changed since the 510(k), K942210 was cleared.

All applicable tests outlined in the November 1993 "Reviewer Guidance for Premarket Notification Submissions" have been performed on the KnightStar 335, as described in the original 510(k) submission. K942210. No additional testing was performed for the present 510(k) submission because no physical changes have been made since that submission was cleared.

Clinical studies have been performed , as described in the article "Evaluation of the Puritan Bennett 335 Portable Pressure Support Ventilator: Comparison with the Respironics BiPAP S/T", included as Attachment 5. Although not an extensive study, it does demonstrate that both devices can be used to treat patients with respiratory failure.

8.0 Conclusions

We have concluded that the KnightStar 335 with a Control Module Type 1 and an airway pressure monitor is substantially equivalent to the Respironics BiPAP S/T-D 30 with Detachable Control Panel 30 and that the KnightStar 335 with a Control Module Type 1 and an airway pressure monitor can be indicated for use in treating spontaneously breathing patients over 30 Kg with respiratory failure in a hospital or institutional environment.

{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 or bird design, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird symbol. The logo is simple and recognizable, representing the department's role in health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ിക്കു

JUL 1 6 1998

Mr. Stephen G. Theissen Puritan-Bennett Corporation 2800 Northwest Boulevard Minneapolis, MN 55441-2625

K973004 Re: Knightstar 335 Regulatory Class: II (two) Product Code: 73 MNT Dated: April 24, 1998 April 29, 1998 Received:

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 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 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 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 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.

{3}------------------------------------------------

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,

Thomas J. Callahan, Ph.D.

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

, :

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Puritan Bennett. The logo consists of the letters "PB" in a bold, blocky font, enclosed in a black square. To the right of the square, the words "PURITAN" and "BENNETT" are stacked on top of each other, with a thick black line running above the word "BENNETT".

LENEXA MEDICAL DIVISION 9728 Pflumm Road P.O. Box 15915 Lenexa, KS 66285-5915 913-495-4800

Device Name:

Nellcor Puritan Bennett KnightStar 335

Indications for Use:

The Nellcor Puritan Bennett KnightStar 335 is indicated for use in treating spontaneously breathing patients over 30 Kg with obstructive sleep apnea or respiratory insufficiency in a homecare, hospital or institutional environment. In addition, when used with a Control Module Type 1 and an airway pressure monitor, it is indicated for use in treating spontaneously breathing patients over 30 Kg with respiratory failure in a hospital or institutional environment.

Kramer

r. > (14) 4 - 1 - 1 - 1 - 1 1 temmas 5 . Ak) Number __

. Prescription Use

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).