CRITERION 40 OR PM 40

{0}------------------------------------------------ PROMEDIC INC K992101 JAN - 6 2000 Criterion 40 Premarket Notification 510(k) Section 2 - Certification and Summaries **Reset** 1 1 1 1 1 2 1 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 ## Non-Confidential Summary of Safety and Effectiveness page 1 of 4 January 4, 2000 | Caradyne, Ltd. | | |------------------------|-------------------| | Parkmore Business Park | | | Parkmore West | | | Galway, Ireland | | | Tel. | 011-353-91-709010 | | Fax | 011-353-91-758929 | | Official Contact: | John O'Dea, Ph.D. - General Manager | |----------------------------|----------------------------------------------------------| | Proprietary or Trade Name: | Criterion 40 | | Common/Usual Name: | Airway Pressure Monitor | | Classification Name: | Airway Pressure Monitor (includes gauges and / or alarm) | | Device: | Criterion 40 | | Predicate Devices: | Monaghan, Ltd. CM 5000 Airway Pressure Monitor - K871083 | Contraction of the program of the comments of the comments of the comments of the comments of the comments of . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Criterion 40 is a microprocessor controlled device that measures and monitor patient airway pressure. produces continuous positive airway pressure. It measures low and high pressures and advises the user if the pressure fall outside the user-set ranges. It operates on AC / DC power and provides digital and graphically readouts of the pressure - real-time and peak pressures. It connects into the patient circuit with the use of a pressure tubing with integral in-line filter and a connector. | Indicated Use -- | Is intended to measure airway pressure when used with positive<br>pressure devices. The device alarms when the airway pressure falls<br>outside of the user selected high and low alarm limits and displays<br>peak pressure and real-time airway pressures. It may be used with<br>positive pressure devices which do not include pressure<br>measurement capabilities, e.g. resuscitation bags or basic ventilators,<br>or as an independent backup pressure monitor for devices with<br>pressure measurement capability. The device has been designed for<br>stationary and intra-institution transport only. | |------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {1}------------------------------------------------ ## Premarket Notification 510(k) ## Criterion 40 ## Section 2 - Certification and Summaries ## Non-Confidential Summary of Safety and Effectiveness page 2 of 4 January 4, 2000 Environment of Use -- Hospital, sub-acute institutions, home care Comments of the Claim Childers and Andrew Home of the September of Childers of Childers of Children | | For use with positive pressure devices<br>as a standalone or backup device to<br>measure and monitor high and low<br>airway pressures | Standalone accessory to supplement<br>patient monitoring during ventilation<br>(positive) to notify of undesirably low<br>and / or high pressures. | |----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Yes | Yes | | | Any patient utilizing positive<br>pressure devices and the clinician<br>desires to have pressure monitoring.<br>Hospital, Sub-acute Institutions,<br>Home Care | Any patient utilizing positive<br>pressure devices and the clinician<br>desires to have pressure monitoring.<br>Hospital, Sub-acute Institutions,<br>Home Care | | | Limited to stationary and intra-<br>institution transport only | Limited to stationary and intra-<br>institution transport only | | Weights (lb.) | approx. 2 lb. | approx. 1 lb. | | Size (W x H x D) | 6.5" x 3.4" x 5" | 7.5" x 6" x 4" | | Controls | Microprocessor controlled, solid-state<br>pressure transducer, AC / DC<br>adaptable | Solid-state pressure transducer, DC<br>adaptable | | Power specifications | 120 V AC, 60 Hz, 20 W or 230 V<br>AC, 50 Hz, 60 mA, 12 V DC | 9 V DC | | Output | Digital readout of pressures | Analog readout of pressures | | Materials which<br>interface with patient | PVC, K-resin for the pressure tubing<br>and airway connector tee | PVC, K-resin for the pressure tubing<br>and airway connector tee | | Patient interface | Airway adapter placed in the circuit<br>or connection to a face mask | Airway adapter placed in the circuit<br>or connection to a face mask | | Display of<br>information | Low pressure alarm setting<br>High pressure alarm setting<br>Status of alarm silence and time<br>remaining<br>Peak pressure<br>Real-time pressure<br>Power source and status<br>Audible and visual alarm | Low pressure alarm setting<br>High pressure alarm setting<br>Inadvertent off - audible<br>Pressure gauge shows values (peak<br>and real-time read upon visual<br>observation)<br>Power status alarm<br>Audible alarm | | Low pressure alarm<br>range | 1 - 20 cm H2O<br>1 cm H2O resolution | 2 - 50 cm H2O<br>resolution not specified | | | | | | High pressure alarm<br>range | 5 - 99 cm H2O<br>1 cm H2O resolution | 2 - 100 cm H2O<br>resolution not specified | | Peak pressure | Displayed as value | Determined by visual observation | | Real-time pressure | Displayed as bar graph | Determined by visual observation only | | Alarm delay | Yes - 1 - 20 seconds | Yes - 2 - 60 seconds | | AC / DC operation | 120 V AC / 230 V AC and 12 V DC | 9 V DC no AC capabilities | | Accuracy of pressure<br>alarm | +/- (1 + 3% of reading) rounded up to<br>nearest cm H2O | +/- 3 cm H2O | | Accuracy of display -<br>Peak and Pressure bar<br>graph | +/- (1 + 3% of reading) rounded up to<br>nearest 0.5 cm H2O | Not specified | | Alarms | Low pressure<br>High pressure<br>Loss of power<br>Low battery | Low pressure<br>High pressure<br>Inadvertent off<br>Low battery | | Operating temperature<br>/ humidity | 5 °C to 45 °C, 15 - 95% RH | 16 °C - 34 °C, 20 - 90% RH | | Storage temperatures | -40 °C to 60 °C @ 95% RH | not specified | | Battery life | up to 24 hours for backup and<br>transport use but primary power<br>supply is AC | up to 2 months | | Zero calibration | Yes | Yes | | Pressure tubing with<br>in-line filter and<br>airway connector | Yes | Yes | | Pole mount | Yes | Yes | | AC power supply | Yes | Not applicable | | IEC 601-1-2 | Yes | CSA C22.2 No. 125 Risk Class 2 | | UL 260 / IEC 601-1 | Yes | Yes | | FDA PMN<br>requirements<br>November, 1993 | Yes | Not Known | | | None | None | | | Comparable | Comparable | {2}------------------------------------------------ # Premarket Notification 510(k) Section 2 - Certification and Summaries Criterion 40 ## Non-Confidential Summary of Safety and Effectiveness page 3 of 4 January 4, 2000 {3}------------------------------------------------ Premarket Notification 510(k) Section 2 - Certification and Summaries Criterion 40 #### Non-Confidential Summary of Safety and Effectiveness page 4 of 4 January 4, 2000 The Criterion 40 Airway Pressure Monitor is viewed as substantially equivalent to the following predicate device - Monaghan CM 5000 Airway Pressure Monitor (APM) cleared under K871083 and other modifications under K873953, K925673, and K931394. The differences between the Criterion 40 and the predicate device are minimal. There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices. They are viewed as substantially equivalent to the predicate devices since they: - 1. Have the same intended uses - 1.1 Intended for the measurement and monitoring patient airway pressure - 1.2 Provide high and low alarms - 2. Have the same environments for use - 2.1 Used in hospitals, sub-acute institutions, home care settings - 2.2 The device has been designed for stationary and intra-institution transport only. - 3. Are similar in design - 3.1 Utilize the same design and functional features - 4. They employ the same technology - 4.1 Utilize a pressure transducer - 4.2 Utilized tubing to interface with patient circuit - 5. Are made of identical materials - 5.1 Utilize similar materials for the monitor and accessories {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 6 2000 Caradyne, Ltd. c/o Mr. Paul E. Dryden ProMedic, Inc. 6329 W. Waterview Court McCordsville, IN 46055-9501 Re: K992101 Criterion 40 - Airway Pressure Monitor Regulatory Class: II (two) Product Code: 73 CAP Dated: October 8, 1999 Received: October 12, 1999 Dear Mr. Dryden: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. {5}------------------------------------------------ #### Page 2 - Mr. Paul E. Dryden This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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, Jean H Westenberg Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Premarket Notification 510(k) Section 2 - Certifications and Summaries Criterion 40 中特中一篇:中国新闻网 : 除:: (be Page 1 of 1 Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request. | 510(k) Number: | K992101 (To be assigned) | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Criterion 40 Airway Pressure Monitor | | Intended Use : | Is intended to measure airway pressure when used with positive pressure devices. The device alarms when the airway pressure falls outside of the user selected high and low alarm limits and displays peak pressure and real-time airway pressures. It may be used with positive pressure devices which do not include pressure measurement capabilities, e.g. resuscitation bags or basic ventilators, or as an independent backup pressure monitor for devices with | ors, or cies with pressure measurement capability. Environment of use is hospital, home, and sub-acute institutions. The device has been designed for stationary and intra-institution transport only. Concurrence of CDRH, Office of Device Evaluation (ODE) be the best that you can be. (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number Prescription Use V (Per CFR 801.109) or Over-the-counter use