MADM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. 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 circle is an abstract symbol that resembles a stylized human face or profile. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 5,2015 Thornhill Research Inc. Cliff Ansel President 210 Dundas St. W. Suite 200 Toronto, ON, Canada M5G 2E8 Re: K140264 Trade/Device Name: MADMTM Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ, CCK Dated: December 15, 2015 Received: December 22, 2015 Dear Mr. Ansel: 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. {1}------------------------------------------------ Page 2 - Mr. Ansel 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/Resourcesfor You/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 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, Susan Runyon DDS, MA Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ #### Indications for Use Statement 510(k) Number (if known): K140264 Device Name: MADM™M MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit. MADM™ is also intended to monitor respiratory rate. CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases. #### Target Population The intended patient population is adults who weigh more than 40 kg. Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # 510(k) SUMMARY ## SUBMITTER INFORMATION | Company Name:<br>Company Address: | Thornhill Research Inc.<br>210 Dundas St. W, Suite 200<br>Toronto, ON, Canada M5G 2E8 | |-----------------------------------|---------------------------------------------------------------------------------------| | Company Phone: | (416) 597-1325 | | Company Fax: | (416) 597-1330 | | Contact Person: | Cliff Ansel, President | #### DEVICE IDENTIFICATION | Trade/Proprietary Name: | MADM™ | |-------------------------|-------------------------| | Classification: | II | | Generic Device Name: | Gas-machine, Anesthesia | #### Classification Names | Classification Name | Product Code | Class | Regulation Number | |-----------------------------------------|--------------|-------|-------------------| | Gas Machine for anesthesia or analgesia | BSZ | II | 21 CFR 868.5160 | | Carbon Dioxide Gas Analyzer | CCK | II | 21 CFR 868.1400 | ## DEVICE DESCRIPTION The MADM™ system is a portable vaporizer capable of delivering anesthetic to the inspiratory limb of a breathing circuit. Unlike other in-line vaporizers, MADMTM can be inserted into a circle system where some exhaled anesthetic is rebreathed. The MADM™ system measures the anesthetic concentration of incoming gas and reduces the anesthetic output to ensure the anesthetic concentration of gas delivered to the patient is as set on the dial. MADM™ includes an internal battery backup capable of powering the device for 20 minutes, and an optional external battery base with hot swappable batteries capable of powering the system for over two hours. Anesthetic is stored in custom single agent anesthetic canisters. {4}------------------------------------------------ ## INTENDED USE MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit. MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases. # Intended Use Population The intended patient population is adults who weigh more than 40 kg. # SUBSTANTIAL EQUIVALENCE The MADM™ is of comparable type and is substantially equivalent to the following predicate devices: | Device | 510(k) # | |------------------------------|----------| | PAC Vaporizer | K850648 | | Penlon Sigma Delta Vaporizer | K002343 | | Tec-6 Plus Vaporizer | K000275 | | IRMA | K123043 | ## Comparison to Predicate Device MADM™ and the predicate devices have the same intended use. Namely, each device is intended for the controlled delivery of anesthetic vapor into the patient breathing circuit. MADM™ can operate in both flow-through and circle systems, both inside and outside the breathing circuit. A typical draw-over vaporizer cannot be inserted into a circle system as it would continually add anesthetic to that being inspired eventually leading to a hazard. MADM™ includes an anesthetic sensor at its input which measures the content of the incoming gas, so that the delivered agent is reduced according to what is recirculated. A detailed risk analysis has been conducted to ensure that this configuration can function safely, and several safety features have been included. These include the inclusion of an anesthetic sensor at the mouth which causes automatic cessation of delivery if inhaled anesthetic exceeds a threshold above what is set. A safety interlock is in place which prevents anesthetic from being delivered if either anesthetic sensor is malfunctioning or not present. {5}------------------------------------------------ # Compliance to Standards and Regulations AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-13 ISO 80601-2-55 ## Summary of Performance Testing Safety and Performance Testing was conducted in accordance with all referenced standards and regulations, and to validate all system requirements. Performance testing included: - . Performance testing across the intended environmental operating range. - Battery Longevity testing across the intended environmental operating range. - Anesthetic delivery accuracy across the anticipated clinical range of respiratory ● rates, fresh gas flows, and tidal volumes. - Disturbance analysis including step changes in Respiratory Rate, Fresh Gas Flow, and Tidal Volume. - Anesthetic compatibility evaluation demonstrating that components in contact with ● anesthetic gas were non-reactive to Isoflurane and Sevoflurane. - Biocompatibility Evaluation according to the 510(k) Memorandum - #G95-1 The results of performance testing demonstrate that the characteristics of MADMTM are substantially equivalent to the identified predicates and meet the acceptance criteria of international standards in terms of anesthetic delivery accuracy and gas sensing accuracy as well as all of its system requirements. # Determination of Substantial Equivalence Differences in technological characteristics between MADMTM and the identified predicates do not raise any new concerns of safety and efficacy. The MADMTM has a substantially equivalent intended use to the listed predicate devices. Where differences exist in performance characteristics, these differences do not adversely affect safety and efficacy. In addition, all relevant aspects of recognized consensus performance standards have been met. ## Conclusion The MADM™ is substantially equivalent to the identified predicate devices and does not raise any new concerns about safety and efficacy.