DISPOSABLE PRESSURE MANOMETER

{0}------------------------------------------------ K02240 2 ## Non-Confidential 510(k) Summary of Safety and Effectiveness July 19, 2002 | | July 17, 2012 | |---------------------------------------------------------|-------------------------------------------------------------------| | Vital Signs, Inc.<br>20 Campus Road<br>Totowa, NJ 07512 | Telephone: (973) 790-1330<br>Fax: (973) 790-7587 | | Official Contact: | David L. Najjar - Manager of Quality | | Proprietary or Trade Name: | Disposable Manometer | | Common/Usual Name: | Pressure Manometer | | Classification Name: | Airway Pressure Monitor (Per CFR 868.2600) | | Device: | Disposable Manometer | | Predicate Device: | Engineered Medical System, Inc. - Pressure Manometer -<br>K003497 | ## Device Description: The VSI disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: A flexible nipple for attachment to a sampling/pressure port, Clear polycarbonate (PC) housing with a printed pressure scale, PC float with indication and a double ended stainless steel spring. ## Intended Use: ## Indicated 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. ### Environment of Use: Home, Physician Office, Outdoor Environments, Hospital, Sub-acute Institutions, Emergency Services, anywhere airway pressure is measured. {1}------------------------------------------------ Section 2 Page 2 # Comparison to Predicate Device: | Attribute | Proposed Device | Engineered Medical<br>System, Inc. K003497 | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | Intended Use | To provide visual<br>indication of a patient's<br>airway pressure during<br>ventilation. It may be<br>attached to the<br>manometer port or<br>proximal port on<br>ventilation devices such<br>as resuscitation bags,<br>hyperinflation bags,<br>CPAP Mask, or CPAP<br>Circuits. | Same | | Intended for Single<br>Patient, Multi-Use | Yes | Yes | | Prescription | Yes. Labeling will<br>carry: Caution U.S.<br>Federal Law restricts<br>this device to sale by<br>or on the order of a<br>physician. | Yes | | Intended Population | Any patient requiring<br>airway pressure<br>measurement. | Same | | Intended<br>Environment of Use | Home, Hospital,<br>Physician Office, Sub-<br>Acute Institutions,<br>Emergency Services,<br>anywhere airway<br>pressure is measured. | Same | | Design Features | | | | Range of Pressures<br>Measured | 0-60 cm H2O | 0-60 cm H2O | | Can be used on<br>different ventilation<br>devices | It may be attached to<br>the manometer port or<br>proximal port on<br>ventilation devices such<br>as resuscitation bags,<br>hyperinflation bags,<br>CPAP Mask, or CPAP<br>Circuits. | Same | | Materials<br>Polycarbonate, PC | Polycarbonate to be<br>used for manometer<br>body and float. | Same | | Contains Latex | No | No | | Performance<br>Accuracy cm H2O<br>over the range | VSI | Engineered Medical<br>System, Inc. | | | +/- 1 cm H2O / 0-10 | +/- 1 cm H2O / 0-10 | | | +/- 2 cm H2O / 10-40<br>+/- 3 cm H2O / > 40 | +/- 2 cm H2O / 10-40<br>+/- 3 cm H2O / > 40 | {2}------------------------------------------------ Section 2 page 3 # Device Equivalency: The VSI Disposable Pressure Manometer is viewed as substantially equivalent to the Engineered Medical System, Inc., DPM™, which has been cleared to market under 510(k) K003497. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # AUG 2 2 2002 Mr. David L. Najjar Manager of Quality Vital Signs, Incorporated 20 Campus Road Totowa, New Jersey 07512 Re: K022402 Trade/Device Name: Disposable Pressure Manometer Regulation Number: 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: July 19, 2002 Received: July 23, 2002 Dear Mr. Najjar: 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. 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. {4}------------------------------------------------ Page 2 - Mr. Najjar 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 (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. 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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. Latuca Cicecite/for. Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Section 4 Page 1 ## INDICATION FOR USE STATEMENT 510(k) Number: K022402 ### Device Name: Disposable Pressure Manometer Indications for Use: The Disposable Pressure Manometer will be used 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. Concurrence of CDRH, Office of Device Evaluation (ODE) or Over-the-counter use ________________ Prescription Use V (Per CFR 801.109) foAuluthesn Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KOZZOB 510(k) Number_