To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask, or CPAP circuits, For patients that the clinician desires to monitor or measure airway or circuit pressure, including neonates to adults. Home. Physician office, Hospital, Sub-acute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

Device Description

The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: 1. A flexible nipple for attachment to a sampling / pressure port. 2. Clear housing with a printed pressure scale 3. A float with indicator 4. Spring. When positive pressure is present in the ventilation device, the manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range - 0-60 cm H2O. Besmed intends offer three (3) models / styles of their disposable pressure manometer. They are identical in design, function and materials. The differences are: Pressure range. 0 0 60 cm H2O 0 40 cm H2O · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design Note the accuracy and performances are identical . Indicator strip . O All models have the pressure range embossed on the housing o A color strip / indicator may also be included to indicate the pressure. It is a single patient, disposable, packaged non-sterile device.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate)	Reported Device Performance (Besmed Disposable Pressure Manometer)
Accuracy:	Accuracy:
• ± 1 cm H₂O from 0-10 cm H₂O	• ± 1 cm H₂O from 0-10 cm H₂O
• ± 2 cm H₂O from 10-40 cm H₂O	• ± 2 cm H₂O from 10-40 cm H₂O
• ± 3 cm H₂O above 40 cm H₂O	• ± 3 cm H₂O above 40 cm H₂O
(Implied) Durability/Longevity (no specific criteria stated)	Age Testing – 5 years (simulated) (met)
(Implied) Environmental Stability (no specific criteria stated)	Environmental Testing - High / Low and Humidity conditions (MIL-STD-810E) (met)
(Implied) Mechanical Robustness (no specific criteria stated)	Drop test (met)
(Implied) Biocompatibility (no specific criteria stated)	• External Communication (Indirect contact) for all materials not in direct contact • Tissue communicating • Limited duration (<24 hours) • Identical materials to Besmed predicate (met)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific numerical sample size for the test set used for accuracy or other performance testing. It simply refers to "a number of tests."

Data Provenance: The document does not specify the country of origin of the data. It implies the testing was conducted by or for Besmed Health Business Corp., which is located in New Taipei City, Taiwan. The studies were likely prospective as they were conducted to demonstrate the device's performance against defined criteria.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a device like a pressure manometer, the "ground truth" for accuracy testing would typically be established by a highly accurate reference pressure measurement system or calibrated standard, not by human experts.

4. Adjudication Method for the Test Set

This information is not applicable/provided. As the "ground truth" for pressure measurements is established by a reference instrument, an adjudication method involving human experts is not relevant for this type of objective performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a measurement tool, not an interpretive one.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device does not contain an algorithm in the sense of AI. It is a mechanical device. The performance testing described ("Accuracy of pressure across the full pressure range") essentially is a standalone performance evaluation of the device's ability to measure pressure. There is no human-in-the-loop component for the measurement itself, only for the observation and interpretation of the displayed pressure by the clinician.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the accuracy testing, the ground truth was based on a reference pressure standard. The document states, "Accuracy of pressure across the full pressure range to meet the pass / fail criteria." This implies the device's readings were compared against a known, precise pressure source.

8. The Sample Size for the Training Set

This information is not applicable. This device is a mechanical manometer, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for a mechanical device.

Summary

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JUN 1 9 2014

510(k) Summary Page 1 of 4

Date Prepared:	19-Jun-2014
Besmed Health Business Corp.No. 5, Lane 116, Wu-Kong 2nd Rd,Wu-Ku District, New Taipei City, Taiwan	Tel - 011-886-2-2290-3959Fax - 011-886-2-2299-9076
Official Contact:	Winnie ChungRegulatory Affairs Associate
Proprietary or Trade Name:	Disposable Pressure Manometer
Common/Usual Name:	Airway Pressure Monitor
Classification Name:	21CFR 868.2600CAP - Airway Pressure MonitorClass II
Predicate Devices:	K003497 - Engineered Medical Systems - Pressure Monitor

Device Description:

The Besmed disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation.

The device consists of:

1. A flexible nipple for attachment to a sampling / pressure port.
1. Clear housing with a printed pressure scale
1. A float with indicator
1. Spring

When positive pressure is present in the ventilation device, the manometer displays the pressure in the "circuit". The proposed design incorporates a calibrated spring, which has demonstrated reasonable accuracy over the expected clinical pressure range - 0-60 cm H2O.

Besmed intends offer three (3) models / styles of their disposable pressure manometer.

They are identical in design, function and materials. The differences are:

Pressure range .
- 0 0 60 cm H2O
- 0 40 cm H2O
- · Rationale some devices which may use a pressure manometer do not produce as high a pressure and the user often would like a lower limit pressure design
  - Note the accuracy and performances are identical
. Indicator strip

O All models have the pressure range embossed on the housing
o A color strip / indicator may also be included to indicate the pressure

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510(k) Summary Page 2 of 4 19-Jun-2014

It is a single patient, disposable, packaged non-sterile device.

Indications for Use:

Substantial Equivalence Discussion:

Table 1 compares the key features of the proposed Besmed Disposable Pressure Manometer with the identified predicate and demonstrates that the device can be found to be substantially equivalent. In summary one can conclude that substantial equivalence is met based upon the following:

Indications for Use -

The indications for use are identical for the proposed device when compared to the predicate -K003497 - EMS pressure manometer.

Discussion - Each device is indicated for use to measure pressure in a circuit or airway.

Technology and construction -

The design, components, shape, size, etc., are equivalent to the predicate - K003497 - EMS pressure manometer.

Discussion ~ The design is simple housing with a float that sits on a spring that goes up or down based upon the pressure in the device. It has markings to indicate the pressure observed as well as a fixed leak to avoid over pressurization.

Environment of Use -

The environments of use are identical to predicate - K003497 - EMS pressure manometer. Discussion - The environments of use are identical to the predicate - K003497 - EMS pressure manometer.

Patient Population -

The patient population is defined as patient where the clinician wants to measure or monitor circuit or airway pressure. The specific patient population is the same as the device to which it is attached which could be neonates to adults.

Discussion - The patient populations are equivalent to the predicate - K003497 - EMS pressure manometer.

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510(k) Summary

Attribute	Predicate	Proposed
	EMS – K003497 Pressure Manometer	Besmed DPM
Indications for Use	To provide visual indication of apatient's airway pressure duringventilation. It may be attached to themanometer port or proximal port onventilation devices such as resuscitationbags, hyperinflation bags, CPAP mask,or CPAP circuits.	To provide visual indication of apatient's airway pressure duringventilation. It may be attached to themanometer port or proximal port onventilation devices such as resuscitationbags, hyperinflation bags, CPAP mask,or CPAP circuits.
Patient population	Patient that the clinician desires tomonitor or measure pressure, neonates toadults	Patient that the clinician desires tomonitor or measure pressure.
Environments of use	Home, Physician office, Hospital, Sub-acute Institutions, Emergency services oranywhere measurement of airwaypressure is desired.	Home, Physician office, Hospital, Sub-acute Institutions, Emergency services oranywhere measurement of airwaypressure is desired.
Prescriptive	Yes	Yes
Single patient, disposable	Yes	Yes
Connects to a samplingport of any device, i.e.resuscitator, etc.	It may be attached to the manometer portor proximal port on ventilation devicessuch as resuscitation bags, hyperinflationbags, CPAP mask, or CPAP circuits.	It may be attached to the manometer portor proximal port on ventilation devicessuch as resuscitation bags, hyperinflationbags, CPAP mask, or CPAP circuits.
Basic components	HousingFloatSpringPressure markingsFixed leak in the unit	HousingFloatSpringPressure markingsFixed leak in the unit
Pressure range	0 - 50 cm H₂O	0 - 60 cm H₂O
Models	Only one	Three 0-40, 0-60 with indicator stripe0-60 with embossed pressure but noindicated stripe
Performance testing	Accuracy• ± 1 cm H₂O from 0-10 cm H₂O• ± 2 cm H₂O from 10-40 cm H₂O• ± 3 cm H₂O above 40 cm H₂O	Accuracy• ± 1 cm H₂O from 0-10 cm H₂O• ± 2 cm H₂O from 10-40 cm H₂O• ± 3 cm H₂O above 40 cm H₂OAge Testing – 5 yearsPre and post- exposureEnvironmental TestingHigh / Low and Humidity conditionsDrop test
Biocompatibility		• External Communication (Indirectcontact) for all materials not indirect contact• Tissue communicating• Limited duration (<24 hours)• Identical materials to Besmedpredicate

Table 1 - Comparison to Predicates

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510(k) Summary Page 4 of 4 19-Jun-2014

Non-Clinical Testing Summary -

We performed a number of tests including comparative pressure accuracy and the results demonstrated equivalent performance demonstrating the proposed device is equivalent to the -K003497 - EMS pressure manometer.

Testing included:

. Accuracy of pressure across the full pressure range to meet the pass / fail criteria
Comparative accuracy testing showed no statistical difference in accuracy performance . between the proposed device and the predicate, K003497 - EMS
. Age testing simulated to be equivalent to 5 years
. Environmental testing at high and low temperatures (MIL-STD-810E)
Mechanical testing Drop test .

All testing demonstrated that the proposed device is substantially equivalent to the predicate device.

Substantial Equivalence Conclusion:

The proposed device has been found to be substantially equivalent to the predicate. Differences between the proposed device and the predicate do not raise new questions of safety or efficacy.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 19, 2014

Besmed Health Business Corp. c/o Paul Dryden Consultant No. 5. Lane 116. Wu-Kong 2nd Rd. Wu-Ku District, New Taipei City, Taiwan

Re: K140370

Trade/Device Name: Disposable Pressure Manometer (RE-21466, RE-21464 and RE-21460) Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Manometer Regulatory Class: Class II Product Code: CAP Dated: May 10, 2014 Received: May 13, 2014

Dear Mr. Dryden:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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 -- Paul Dryden

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

. . . . Tejashri Purohit-Sheth, M.D. Tejashri Purofit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin J. Keith. MS Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K140370

Device Name Disposable Pressure Manometer

Indications for Use (Describe)

To provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, CPAP mask, or CPAP circuits. For patients that the clinician desires to monitor or measure airway or circuit pressure, including neonates to adults. Home, Physician office, Hospital, Subacute Institutions, Emergency services or anywhere measurement of airway pressure is desired.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Anya C. Harry -S 2014.06.19 09:14:08 -04'00'

FORM FDA 3881 (9/13)

PSC Publishone Scrinces (101) 445-674)

Regulation Number and Section

§ 868.2600 Airway pressure monitor.

(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).