(20 days)
Not Found
No
The device description focuses on mechanical components and physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's primary function is to protect pediatric patients from excessive inspiratory pressure by acting as a pressure relief valve in positive pressure breathing systems, not to directly treat a disease or condition. It facilitates the safe delivery of gas but does not directly modify physiological function for therapeutic benefit.
No
Explanation: The device is primarily a pressure relief device designed to protect patients from excessive inspiratory pressure. While it provides ports for external pressure monitoring devices and air/oxygen analyzers, its core function is not to diagnose a condition but to manage pressure within a breathing system. The monitoring ports facilitate the collection of data that could be used for diagnostic purposes by external devices, but the device itself does not perform any diagnostic function.
No
The device description clearly details physical components made of plastic and stainless steel, indicating it is a hardware device, not software-only.
Based on the provided text, the BC110 Pressure Manifold is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for use with "positive pressure breathing systems for pediatric patients" and its primary function is to "protect the patient from excessive inspiratory pressure" and provide ports for "external pressure monitoring devices and air/oxygen analyzers." This describes a device used in vivo (on a living patient) to manage breathing parameters and provide access for monitoring, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a mechanical device with a pressure relief valve, connectors for breathing circuits and monitoring equipment, and physical dimensions. There is no mention of reagents, assays, or analysis of biological samples, which are characteristic of IVD devices.
- Lack of IVD Characteristics: The text does not mention any of the typical elements associated with IVD devices, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Diagnostic purposes (identifying diseases, conditions, etc.)
- Reagents or assays
- Calibration with reference materials
The BC110 Pressure Manifold is a medical device used in the delivery of respiratory support to patients. Its function is related to patient safety and monitoring during breathing assistance, not to performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for 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.
The BC110 Pressure Manifold is intended for use with 'positive pressure' breathing systems for pediatric patients. The device is placed upstream of 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 manifold also contains 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.
Product codes
CBP
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 H,O.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric/infant patients
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 CBP |
| Anesthesiology, 21 CFR §868.5870 (Class II) | |
| Predicate Device: | AirLife Inc. Whistler In-line Pressure Release Valve |
| K831246 | |
| Classification Name: | Non-rebreathing valve-73 CBP |
| Anesthesiology, 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
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.
(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
1
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 H,O.
(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
2
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.
3
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
4
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 |