The BC110 Pressure Manifold is intended for use with 'positive pressure' breathing systems for pediatric patients. The device is placed upstream of the gas delivery to the patient in-line with the circuit and contains a pressure relief valve to protect the patient from excessive inspiratory pressure in the event of a downstream occlusion. The device also provides ports to allow the connection of external pressure monitoring devices and air/oxygen analyzers.

The device is intended for use with flow rates of 0-15 L/min. The relief pressure at 8 L/min is 17 cm H2O. The relief pressure at 15 L/min is 24 cm H2O.

The BC110 is disposable, single patient use and is prescription only.

Device Description

The BC110 Pressure Manifold is an inline pressure relief device designed to protect pediatric/infant patients from excessive pressure in the event of a downstream occlusion occurring in positive pressure breathing systems. The BC110 pressure manifold also provides ports to allow the connection of external pressure monitoring devices and air/oxygen analyzers. The device consists of a rigid plastic tube, open at both ends, containing side ports and a side mounted pressure relief valve. The valve reacts instantaneously to an occlusion and automatically resets upon release of the occlusion. The inlet port for the gas source consists of a barbed connector, the outlet port for the patient connection is a 22/15 mm female.

The body of the BC110 is molded ABS plastic, the port caps are polyethylene. The overall length of the device is 134 mm, the overall diameter 25 mm and depth/height 58 mm. The inlet connector consists of a standard barbed O2 connector made from of mini: me and is supplied pre-fitted to the manifold. The outlet connector is part of the manifold body and is a dual connector consisting of a 22 mm female or 15 mm female port. The O2 analyzer port is also part of the manifold body and is a dual connector consisting of 22 mm male or 15 mm female port. The pressure ports, also part of the manifold body, consist of a female Luer and a 4 or 6 mm male push on. A flow direction arrow is molded into the side of the manifold body to indicate the correct setup position (this is supplemented by different connector sizes at each end). The ISO symbol for 'Single Use Only' is also molded into the side of the manifold. The pressure relief valve utilizes a stainless steel coil spring. An "anti-tampering" shroud covers the valve to ensure the factory set relief pressure (17 cm H2O at 8 Lpm) is not changed. Pressure relief at the maximum recommended flow rate of 15 Lpm is 24 cm H2O.

AI/ML Overview

The provided document, K040366, is a 510(k) Summary of Safety and Effectiveness for a medical device called the "BC110 Pressure Manifold." This document does not contain information about an AI/ML powered device or a study proving its acceptance criteria in the context of an AI/ML system. Instead, it describes a mechanical device. Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document.

However, I can extract the acceptance criteria and performance of the BC110 Pressure Manifold based on the non-clinical tests described.

Here's the information about the BC110 Pressure Manifold:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Target Specification)	Reported Device Performance
Relief Pressure at 8 Lpm Flow Rate	17 cm H2O (factory set and tested)
Relief Pressure at 15 Lpm Flow Rate (maximum recommended flow rate)	24 cm H2O
Prevent excessive inspiratory pressure in downstream occlusion	The device is designed to react instantaneously to an occlusion and automatically resets upon release. The relief pressure values are stated to be "well within the limits for neonates in all relevant ventilator and resuscitation standards."
Operation with flow rates	Greater than 0 L/min up to, and including, 15 L/min.
Durability / Longevity	Accelerated life testing performed "over and above the time likely required for single use." (Specific duration not quantified in the summary, but implies meeting single-use requirements)
Leak Testing	Performed (Result not explicitly stated as pass/fail, but implied to be acceptable as part of demonstrating safety and effectiveness)
Response Time to an Occlusion	Performed (Result not explicitly stated as pass/fail, but implied to be acceptable as part of demonstrating safety and effectiveness; device "reacts instantaneously")
Performance on Wet Side of Humidification Chamber	Performed (Result not explicitly stated as pass/fail, but implied to be acceptable as part of demonstrating safety and effectiveness)
Calibration Testing of Test Equipment	Performed (Ensures accuracy of testing)
Factory Testing for Correct Operation of Pressure Relief Valve	Each pressure manifold is individually tested at the factory.
Tamper-Proof Pressure Setting	An "anti-tampering" shroud covers the valve to ensure the factory set relief pressure is not changed; "cannot be accidently or deliberately adjusted by the user."
Minimization of User Error	"The design of the valve and manifold minimises the chances of user error." User instructions specify conditions of use.
Single Patient Use and Disposable Labeling	Device is labeled clearly as single patient use and disposable. Also noted for prescription only use.

The study proving the device meets these acceptance criteria involved a series of "Non-Clinical Tests" as described in section (b)(1):

Change in relief pressure with flow rate
Leak testing
Response time to an occlusion
Performance on wet side of humidification chamber
Accelerated life testing
Calibration testing of test equipment

The following points (2-9) are specifically for AI/ML device studies and are NOT applicable to the K040366 document because it describes a mechanical medical device, not an AI/ML powered device.

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

Not applicable as this is a mechanical device, not an AI/ML device with a test set of data.

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. Ground truth in the context of AI/ML data is not relevant for this mechanical device. The "ground truth" here is the physical performance of the device against engineering specifications.

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 a standalone mechanical device, not an AI assistance tool for human readers.

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

Not applicable. This is a mechanical device, not an algorithm. Its performance is inherent to its design and manufacturing.

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

Not applicable for an AI/ML context. For this mechanical device, the "ground truth" corresponds to engineering specifications, physical measurements, and compliance with relevant standards (e.g., ventilator and resuscitation standards for neonates).

8. The sample size for the training set

Not applicable. This is a mechanical device, so there is no "training set" in the AI/ML sense.

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

Not applicable.

Summary

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K040366

MAR - 4 2004

Image /page/0/Picture/4 description: The image shows the logo for Fisher & Paykel Healthcare. The words "Fisher & Paykel" are on the top line in a bold, sans-serif font. Underneath is a horizontal line, and below that is the word "HEALTHCARE" in a similar font, but slightly smaller.

P O Box 14-348, Pa Telephone: +64-9-574 0100 Fac

12 Feb 2004

510(k) Summary of Safety and Effectiveness Information

Model/Name:	BC110 Pressure Manifold
Classification Name:	Non-rebreathing valve-73 CBPAnesthesiology, 21 CFR §868.5870 (Class II)
Predicate Device:	AirLife Inc. Whistler In-line Pressure Release ValveK831246
Classification Name:	Non-rebreathing valve-73 CBPAnesthesiology, 21 CFR §868.5870 (Class II)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

(a)(1) - (a)(3) (refer to information above and concluding this summary)

(a)(4) Description of the Device

(a)(5) Statement of the Intended Use

The BC110 Pressure Manifold is designed to protect pediatric/infant patients from excessive inspiratory pressure in the event of a downstream occlusion occurring in positive pressure breathing systems. The device is intended for use with flow rates greater than 0 L/min up to, and including, 15 L/min. The BC110 is fitted upstream of the patient. The BC110 is for single patient use and is prescription only.

(a)(6) Technological Characteristics Summary

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(b)(1) Discussion of the Non-Clinical Tests

The following tests have been performed: Change in relief pressure with flow rate, leak testing, response time to an occlusion, performance on wet side of humidification chamber, accelerated life testing, calibration testing of test equipment.

Each pressure manifold is individually tested at the factory to ensure correct operation of the pressure relief valve.

(b)(2) Discussion of the Clinical Tests None submitted.

(b)(3) Conclusions Demonstrating Safety, Effectiveness and Performance

The value of the set pressure of the relief valve is based on clinical evidence and is well within the limits for neonates stated in all relevant ventilator and resuscitation standards. Additionally, the pressure relief value is set and tested at manufacture and cannot be accidently or deliberately adjusted by the user.

The design of the valve and manifold minimises the chances of user error. User instructions specify the conditions of use. The device is labeled clearly as single patient use and disposable.

The operational performance of the pressure manifold has been tested under the likely conditions of use. Additionally, accelerated life testing has been performed over and above the time likely required for single use.

The Pressure Manifold is safe and effective for its intended use.

signed:

Robert Petry

Fisher & Paykel Healthcare Ltd

te: 12 Feb 2004

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Image /page/2/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 an abstract symbol that resembles an eagle or a stylized human figure. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 4 2004

Mr. Robert Petry Regulatory Affairs Engineer Fisher & Paykel Healthcare Limited P.O. Box 14-348 Panmure, Auckland New Zealand

Re: K040366

Trade/Device Name: BC110 Pressure Manifold Regulation Number: 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: February 12, 2004 Received: February 13, 2004

Dear Mr. Petry:

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 cither 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. Petry

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. or the For of 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 and insting (21 Creents in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as as 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) rins reter notification. The FDA finding of substantial equivalence of your device to a premaired notified aredicate 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), If you desire specific at 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 may votall other gater gaternational 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,

Clives

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): _Ko40366

Device Name: BC110 Pressure Manifold

Indications for Use:

The BC110 Pressure Manifold is intended for use with 'positive pressure' breathing The BOTTS for pediatric patients. The device is placed upstream of the gas delivery bytonio for pound contains a pressure relief valve to protect the patient patient in-ine with the orrouk and our in the event of a downstream occlusion. The from excessive insprakery to allow the connection of external pressure monitoring devices and air/oxygen analyzers.

The device is intended for use with flow rates of 0-15 L/min. The relief pressure at 8 1/10 as 17 cm H2O. The relief pressure at 15 L/min is 24 cm H2O.

The BC110 is disposable, single patient use and is prescription only.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices	Page ___ of ___
510(k) Number:	K040366

Regulation Number and Section

§ 868.5870 Nonrebreathing valve.

(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).