The PB 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:

Positive Pressure ventilation
Assist/Control, SIMV, or CPAP modes of ventilation
Breath types including Volume, Pressure Control and Pressure Support.
The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

Device Description

The PB 540 Ventilator gas delivery system is composed of a flow generator capable of supplying a sufficient range of flows and pressures that is then controlled by a three-way valve enabling piloting of the expiration valve. The flow generator is a low-inertia micro-turbine driven by a brushless electric motor and the valve is a proportional electronically driven valve.
These two actuators are controlled according to specific control algorithms by a microprocessor receiving information from the pressure and flow sensors built into the ventilator.

AI/ML Overview

The provided 510(k) summary for the PB 540 Ventilator does not describe an AI/ML device or a study involving acceptance criteria in the typical sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it's for a traditional medical device (a ventilator) and discusses performance in terms of functional testing and compliance with regulatory guidelines.

Therefore, the requested information elements related to AI device performance evaluation (such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable to this document.

Here's an interpretation based on the information available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from text)	Reported Device Performance
Functional specifications	"The device passed all tests," confirming it meets its stated performance specifications.
Applicable portions of "Draft Reviewer Guidance for Ventilators" (July 1995)	"The device passed all applicable tests," confirming compliance.
"Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005)	"The devices passed all tests," indicating compliance with software guidance.
Safe operation in intended environment	Concluded to "operate safely in its intended environment."
Effectiveness in fulfilling intended use	Concluded to "be effective in fulfilling the intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any "test sets" in the context of diagnostic performance. The testing described is functional and compliance-based for a physical device, not an AI model.

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 as this is not an AI/ML diagnostic device and no "ground truth" in this context was established. Performance was assessed against predefined functional and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm-only device. The "standalone" performance implied refers to the ventilator itself meeting its functional specifications.

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

The concept of "ground truth" as used in AI/ML performance evaluation is not relevant here. The "truth" for this device's performance is its ability to meet engineering specifications, functional requirements, and regulatory standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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KO82966

510(k) SUMMARY

OCT 3 1 2008

PB 540 Ventilator

Submitter Information

Covidien, formerly Nellcor Puritan Bennett Inc. 6135 Gunbarrel Avenue Boulder, CO 80301

Submitter's Name	Tina O'Brien
	Regulatory Affairs Associate II
Telephone	303.305.2382
Fax	303.305.2212
Submission Correspondent	Tina O'Brien
	Regulatory Affairs Associate II
	Covidien, formerly Nellcor Puritan Bennett Inc
	6135 Gunbarrel Ave
	Boulder, CO 80301
Telephone	303-305-2512
Fax	303-305-2212

Device Name

Proprietary Name	PB 540 Ventilator
Common Name	Ventilator, continuous, facility use
Classification Name	CBK, Ventilator, continuous, facility use (21 CFR 868.5895)

Device Information

The PB 540 Ventilator is intended to provide continuous or intermittent mechanical ventilatory support as prescribed for patients weighing at least 5kg. The ventilator provides assist/control, SIMV, and CPAP modes of ventilation, and is intended for use in institutional, home, or transport settings. The PB 540 is not intended for use as an emergency transport ventilator.

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Predicate Device Equivalence

This submission is for a modification to a previously cleared device, the Puritan Bennett Legendair XL2 Ventilator (K070899). The modified device has the following similarities to predicate device:

I has the same indicated use;
t uses the same operating principles;
1 incorporates the same basic design;
1 has the same useful life.

In summary, the PB 540 described in this submission is, in our opinion, substantially equivalent to the predicate device.

The term "Substantial Equivalence" as used in this 510(k) Premarket Notification submission is limited to the definition of Substantial Equivalence found in the Federal Food, Drug, and Cosmetic Act, 21 CFR § 807, Subpart E. A determination of substantial equivalency under this submission is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of, substantial equivalence in this submission shall be construed as an admission against interest under the US Patent Laws or their application by the courts..

Device Description

These two actuators are controlled according to specific control algorithms by a microprocessor receiving information from the pressure and flow sensors built into the ventilator.

Indication for Use

The PB 540 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:

. Positive Pressure ventilation
Assist/Control, SIMV, or CPAP modes of ventilation ◆
Breath types including Volume, Pressure Control and Pressure Support. .

The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

Contraindications

This ventilator is not for use with anesthetic gases, and is not intended for use as an emergency transport ventilator.

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Summary of Performance Testing

1. Functional testing confirms that the PB 540 Ventilator is capable of meeting its stated performance specifications. The device passed all tests.
1. Testing confirms that the PB 540 Ventilator complies with the applicable portions of the July 1995 "Draft Reviewer Guidance for Ventilators" published by the Division of Cardiovascular, Respiratory, and Neurological Devices. The device passed all applicable tests.
1. All software is tested in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 2005. The devices passed all tests.

Conclusions

We conclude that the PB 540 Ventilator meets the stated performance specifications and criteria referenced above and that the device and its accessories will operate safely in its intended environment and will be effective in fulfilling the intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 31 2008

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Ms. Tina O'Brien Regulatory Affairs Associate II Covidien, Formerly Nellcor Puritan Bennett, Incorporated 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K082966

Trade/Device Name: PB 540 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 3, 2008 Received: October 6, 2008

Dear Ms. O'Brien:

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. Cooper

THE COLLECTION CHICAL CONSULTION CONSULTION CONSULTER CONSULTER CONTRAL CONTRACT

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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:

. Ship from the same of the start of the same to the comments

Device Name: PB 540 Ventilator

Indications for Use:

The PB 540 Ventilator is indicated for the continuous or intermittent mechanical ventilatory support of palients weighing at least 5 kg who require mechanical ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients who require the following general types of ventilatory support, as prescribed by an attending physician:

Positive Pressure ventilation .
Assist/Control, SIMV, or CPAP modes of ventilation .
Breath types including Volume, Pressure Control and Pressure Support. .

The ventilator is suitable for use in institutional, home, and transport settings. It is not intended for use as an emergency transport ventilator.

L.M. Hamid.

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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).