K SERIES CPAP SYSTEMS

{0}------------------------------------------------ JAN 1 3 2014 # Section 5. 510(k) Summary # 510(k) SUMMARY ` A 510(k) summary has been prepared in accordance with the requirements of 21 CFR 807.92. | Submitter: | Curative Medical Inc.<br>3227 Kifer Road<br>Santa Clara, CA 95051<br>Establishment Number: 3008361782 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Contact Person: | Cuong Tran, R/D Director<br>Phone: (408) 414-2188<br>Fax: (408) 413-3000<br>Email: ctran@curativemedical.com | | Submission Correspondent: | Amy McKinney, Regulatory Affairs Consultant<br>Address: 6518 Tamarind Sky Ln., Fulshear, TX 77441<br>Phone: (979) 236-1622<br>Email: amckinney29@att.net | | Device Name: | Curasa AUTO CPAP with Heated Humidifier System | | Device Classification Name: | Non-continuous ventilator (BZD)<br>21 CFR 868.5905 | | Predicate Devices: | Respironics Remstar Auto CPAP (K012554)<br>Curasa CPAP SD (K123897) | | Preparation Date: | March 25, 2013<br>Revised December 20, 2013<br>Revised December 29, 2013 | #### Device Description: The Curasa AUTO CPAP System with heated humidifier is used on adult patients for treatment of obstructive sleep apnea (OSA). The Auto CPAP system provides a stable continuous positive airway pressure (CPAP). The Auto mode detects breathing phenomena (e.g. snore, hypopnea) and automatically adjusts the delivered pressure. The humidifier provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The Curasa AUTO CPAP system includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. All of the accessories provided with the Curasa AUTO CPAP are identical to those provided with the predicate Curasa CPAP SD (K123897). The Auto CPAP system has been modified based Curasa CPAP SD (K123897) hardware and software. The design of the humidifier and humidifier interface is identical to the referenced predicate device (Curasa CPAP SD, K123897). The basic function and performance characteristics of Curasa AUTO CPAP are similar to the referenced predicate device (Curasa {1}------------------------------------------------ ## Curative Medical Inc. CPAP SD K123897). The Auto mode of operation is similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554). The Curasa AUTO CPAP with heated humidifier system has the following similarities to the previous cleared predicate devices: - Same intended use . - . Same operating principle - Similar technologies . - Same patient contacting materials . | Parameter | Respironics<br>Remstar Pro Auto<br>CPAP system<br>(K012554) | Curative Medical Inc.<br>Curasa CPAP SD<br>(K123897) | Curative Medical Inc.<br>Curasa AUTO CPAP<br>(Proposed Device) | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CPAP Device: | | | | | Device Size (cm) | 24 x 17 x 12 | 17 x 11.8 x 9.7 | 17 x 11.8 x 9.7 | | Weight (kg) | <1.8 | 1.4 | 1.4 | | Mode of Operation | CPAP and Auto | CPAP | CPAP and Auto | | Indication for Use | The Respironics<br>REMstar Auto<br>System is a CPAP<br>(continuous<br>Positive Airway<br>Pressure) device<br>designed for the<br>treatment of adult<br>Obstructive Sleep<br>Apnea (OSA) only. | The Curasa CPAP SD<br>is designed for the<br>treatment of<br>Obstructive Sleep<br>Apnea only in<br>spontaneously<br>breathing patients<br>weighing >30 kg.<br>It is intended to be<br>used in the home or<br>hospital/institutional<br>environment. | The Curasa AUTO<br>CPAP with Heated<br>Humidifier System is<br>designed for the<br>treatment of<br>Obstructive Sleep<br>Apnea only in<br>spontaneously<br>breathing patients<br>weighing >30 kg.<br>It is intended to be used<br>in the home or<br>hospital/institutional<br>environment. | | Product Use,<br>Transport, Storage | | | | | Operation (°C) | 5 to 35 | 5 to 35 | 5 to 35 | | Transport & Storage<br>(°C) | -20 to 60 | -20 to 60 | -20 to 60 | | Atmosphere Pressure<br>(Operation) | 83 to 102 kPa | 70 to 106 kPa | 70 to 106 kPa | | Mode of Operation | Continuous | Continuous | Continuous | | Type of Protection<br>Against Electric Shock | Class II Equipment | Class II Equipment | Class II Equipment | | Degree of Protection<br>Against Electric Shock | Type BF Applied<br>Part | Type B Applied Part | Type BF Applied Part | {2}------------------------------------------------ #### Curative Medical Inc. | Parameter | Respironics<br>Remstar Pro Auto<br>CPAP system<br>(K012554) | Curative Medical Inc.<br>Curasa CPAP SD<br>(K123897) | Curative Medical Inc.<br>Curasa AUTO CPAP<br>(Proposed Device) | |------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------| | Degree of Protection<br>Against Ingress of<br>Water | IPX1 | IPX1 | IPX1 | | Pressure Range (cm<br>H2O) | 4 - 20 | 4 - 20 | 4 - 20 | | Pressure Stability<br>(cm H2O), as<br>measured by ISO<br>17510-1 | 4-20 cm H2O, +/-<br>1.0 cm H2O | 4-20 cm H20 +/- 2.0<br>cm H20<br>ISO17510 compliant | 4-20 cm H20 +/- 2.0 cm<br>H20<br>ISO17510 compliant | | Maximum Flow (LPM),<br>as measured by ISO<br>17510-1 | 35 | 35 | 35 | | Humidifier | | | | | Water reservoir | 415 ml | 240 ml | 240 ml | | Weight | 2.2 lbs | < 0.9 lbs | < 0.9 lbs | | Power Consumption | | | | | Electrical shock<br>protection: | Class II | Class II | Class II | | Drip Proof Equipment | IPX1 | IPX1 | IPX1 | | Heater Setting | 1 - 5 | continuous | continuous | ## Intended Use: The Curasa AUTO CPAP (Continuous Positive Airway Pressure) with heated humidifier system is intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is for use in the home or hospital linstitutional environment. Contraindications: - . Bullous Lung Disease - Pathologically Low Blood Pressure . - Bypassed Upper Airway . - . Pneumothorax - Pneumocephalus has been reported in a patient using nasal Continuous Positive Airway . Pressure. Caution should be used when prescribing CPAP for susceptible patients such as those with: cerebral spinal fluid (CSF) leaks, abnormalities of the cribriform plate, prior history of head trauma, and/or pneumocephalus. - The use of positive airway pressure therapy may be temporarily contraindicated if you . exhibit signs of sinus or middle ear infection. Not for use with patients whose upper airways are by-passed. {3}------------------------------------------------ ## Summary of Performance Data and Substantial Equivalence: The Curasa AUTO CPAP with heated humidifier system was designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. Curative Medical Inc. has determined that the Curasa AUTO CPAP is substantially equivalent to the predicate Respironics Remstar Auto CPAP for treatment of OSA in adults. The Curasa AUTO CPAP with heated humidifier system has been tested and shown to be compliant with the following standards documents: - 1. IEC 60601-1-1:1988 + A1:1991 + A2:1995 Medical Electrical equipment Part 1: General requirement for Safety - 2. IEC 60601-1-2:2007 Medical Electrical equipment Part 1-2: General requirement for Safety - Collateral Standard: Electromagnetic compatibility - Requirements and tests - 3. EN ISO 8185:2007 Respiratory Tract humidifiers for medical use Particular requirements for respiratory humidifier systems - 4. EN ISO 17510:2007 Sleep Apnoea Breathing therapy Part 1: Sleep apnoea breathing therapy equipment - 5. ISO 10993-3:2003 Biological Evaluation of Medical Devices Part 3. Genotoxicity, Carcinogenicity and Reproductive Toxicity - 6. ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro cvtotoxicity - 7. ISO 10993-6:2007 Biological Evaluation of Medical Devices Part 6: Test for local effect after implantation - 8. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization - 9. ISO 10993-12:2007 Biological Evaluation of medical devices Part 12: Sample Preparation and reference materials - 10. IEC 62304:2006 Medical Device Software Software Life Cycle Process - 11. IEC 60068-2-6:2007 Environmental Testing -- Test FC: Vibration (sinusoidal) - 12. IEC 60068-2-34:1973 Environmental Testing Test FC: Vibration (Random) - 13. IEC 60068-2-27:2008 Basic Environmental Testing Procedure: Test Ea and guidance: Shock The following testing was conducted to demonstrate the performance of Curasa AUTO CPAP, is substantially equivalent to its predicate devices in its intended environment: | Design Verification Test | Result | |-----------------------------------|--------| | Sound Testing | Pass | | VOC and PM2.5 Testing | Pass | | Shock and Vibration Testing | Pass | | Predicate Comparison Testing | Pass | | System and User Interface Testing | Pass | | IFU Validation Testing | Pass | | ESD / EMC / EMI | Pass | | Safety Testing (IPX1 / ESD) | Pass | | Software Verification Testing | Pass | Test data leveraged from the predicate device, Curasa CPAP SD (K123897) includes the following: {4}------------------------------------------------ - Reliability Test . - Packaging Test . - Humidity ISO 8185 Test . - Biocompatibility Tests . This 510(k) submission presents the results of the testing and detailed descriptions to demonstrate that Curasa AUTO CPAP with heated humidifier system is substantially equivalent to the Respironics Remstar Auto CPAP System (K012554) and Cursasa CPAP SD (K123897). #### Clinical Data: Curative Medical conducted a clinical study at two (2) hospitals in China enrolling sixty (60) adult patients diagnosed with Obstructive Sleep Apnea (OSA) to evaluate the Curasa AUTO CPAP system compared to the predicate Respironics Auto CPAP. Selected OSA patients all underwent 3 nights of study with the PSG (polysomngram); the 1st night of PSG diagnosing; then randomly entered either the trial group or the 2nd night; following the 3rd night to complete the alternate group study. Each patient was evaluated by AHI (Apnealhypopnea Index); minimum SpO2 (Pulse Oximeter Oxygen Saturation) and average SpO2 recorded by PSG throughout the 3-night study. P-values were calculated using the t-test for before and after treatment groups and for trial and control groups. Results showed that the Curasa AUTO CPAP is effective and that there is no statistical difference between the Curasa AUTO CPAP and the predicate Respironics Auto CPAP device. #### Conclusion: The minor differences between the Curasa AUTO CPAP and its predicate devices outlined in the tables above do not raise new questions of safety and effectiveness. The information and data provided in this 510(k) notification establishes that the Curasa AUTO CPAP with heated humidifier system is substantially equivalent to the legally marketed predicate devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 13, 2014 Curative Medical, Inc. c/o Ms. Amy E. McKinney Regulatory Affairs Consultant 6518 Tamarind Sky Ln Fulshear, TX 77441 Re: K130828 Trade/Device Name: Curasa AUTO CPAP with Heated Humidifier System Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous ventilator Regulatory Class: II Product Code: BZD Dated: December 20, 2013 Received: December 23, 2013 Dear Ms. McKinney: 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. Please note: CDRH 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. {6}------------------------------------------------ Page 2 - Ms. Amy McKinney 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/McdicalDevices/Safety/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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, Image /page/6/Picture/8 description: The image contains a logo with some text. The text reads "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director". There is also the word "DAGRID" in the image. The word "FOR" is at the bottom right of the image. Erin Keith M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K130828 #### Device Name Curasa AUTO CPAP with Heated Humidifier System #### Indications for Use (Describe) The Curasa AUTO CPAP (Continuous Positive Airway Pressure) with heated humidifier system is intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing >30 kg. It is for use in the home or hospital /institutional environment. Type of Use (Select one or both, as applicable) 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. 11 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 1 1 1 1 1 1 1 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/7/Picture/13 description: The image shows a logo with the letters FDA. The letters are stylized with a triple-line effect, giving them a bold and somewhat retro appearance. The logo is black and white, with the letters standing out against a white background. 2014.01.10 12:38:55 -05'00' FORM FDA 3881 (9/13) ﮧ ﮧﮧ Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. {8}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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