DISPOSABLE PRESSURE MANOMETER

{0}------------------------------------------------ # JUN 1 9 2014 # 510(k) Summary Page 1 of 4 | Date Prepared: | 19-Jun-2014 | | |-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--| | Besmed Health Business Corp.<br>No. 5, Lane 116, Wu-Kong 2nd Rd,<br>Wu-Ku District, New Taipei City, Taiwan | Tel - 011-886-2-2290-3959<br>Fax - 011-886-2-2299-9076 | | | Official Contact: | Winnie Chung<br>Regulatory Affairs Associate | | | Proprietary or Trade Name: | Disposable Pressure Manometer | | | Common/Usual Name: | Airway Pressure Monitor | | | Classification Name: | 21CFR 868.2600<br>CAP - Airway Pressure Monitor<br>Class 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. - 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 {1}------------------------------------------------ # 510(k) Summary Page 2 of 4 19-Jun-2014 It is a single patient, disposable, packaged non-sterile device. ### Indications for Use: 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. ### 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. {2}------------------------------------------------ # 510(k) Summary | Attribute | Predicate | Proposed | |--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | EMS – K003497 Pressure Manometer | Besmed DPM | | Indications for Use | To provide visual indication of a<br>patient's airway pressure during<br>ventilation. It may be attached to the<br>manometer port or proximal port on<br>ventilation devices such as resuscitation<br>bags, hyperinflation bags, CPAP mask,<br>or CPAP circuits. | To provide visual indication of a<br>patient's airway pressure during<br>ventilation. It may be attached to the<br>manometer port or proximal port on<br>ventilation devices such as resuscitation<br>bags, hyperinflation bags, CPAP mask,<br>or CPAP circuits. | | Patient population | Patient that the clinician desires to<br>monitor or measure pressure, neonates to<br>adults | Patient that the clinician desires to<br>monitor or measure pressure. | | Environments of use | Home, Physician office, Hospital, Sub-<br>acute Institutions, Emergency services or<br>anywhere measurement of airway<br>pressure is desired. | Home, Physician office, Hospital, Sub-<br>acute Institutions, Emergency services or<br>anywhere measurement of airway<br>pressure is desired. | | Prescriptive | Yes | Yes | | Single patient, disposable | Yes | Yes | | Connects to a sampling<br>port of any device, i.e.<br>resuscitator, etc. | It may be attached to the manometer port<br>or proximal port on ventilation devices<br>such as resuscitation bags, hyperinflation<br>bags, CPAP mask, or CPAP circuits. | It may be attached to the manometer port<br>or proximal port on ventilation devices<br>such as resuscitation bags, hyperinflation<br>bags, CPAP mask, or CPAP circuits. | | Basic components | Housing<br>Float<br>Spring<br>Pressure markings<br>Fixed leak in the unit | Housing<br>Float<br>Spring<br>Pressure markings<br>Fixed leak in the unit | | Pressure range | 0 - 50 cm H₂O | 0 - 60 cm H₂O | | Models | Only one | Three 0-40, 0-60 with indicator stripe<br>0-60 with embossed pressure but no<br>indicated stripe | | Performance testing | Accuracy<br>• ± 1 cm H₂O from 0-10 cm H₂O<br>• ± 2 cm H₂O from 10-40 cm H₂O<br>• ± 3 cm H₂O above 40 cm H₂O | Accuracy<br>• ± 1 cm H₂O from 0-10 cm H₂O<br>• ± 2 cm H₂O from 10-40 cm H₂O<br>• ± 3 cm H₂O above 40 cm H₂O<br>Age Testing – 5 years<br>Pre and post- exposure<br>Environmental Testing<br>High / Low and Humidity conditions<br>Drop test | | Biocompatibility | | • External Communication (Indirect<br>contact) for all materials not in<br>direct contact<br>• Tissue communicating<br>• Limited duration (<24 hours)<br>• Identical materials to Besmed<br>predicate | Table 1 - Comparison to Predicates - · {3}------------------------------------------------ # 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. {4}------------------------------------------------ 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. {5}------------------------------------------------ # 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 {6}------------------------------------------------ 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)