AbStats Gateway

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 14, 2015 GI Logic Inc % Albert Rego Regulatory Consultant Albert Rego. Phd 27001 La Paz Road Suite 312/314 Mission Viejo, California 92691 Re: K150782 Trade/Device Name: Abstats Gateway Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: November 4, 2015 Received: November 9, 2015 Dear Albert Rego: 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. 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 {1}------------------------------------------------ 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (21 CFR 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, Mitchell Stein for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K150782 Device Name Abstats Gateway ### Indications for Use (Describe) The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (stethoscope) that in conjunction with external sensors constitutes the AbStats system external sensors are placed on the abdomen and identify the vibratory signals associated with digestive processes. This device should be used under the direction of a licensed healthcare when it is required to determine this patient digestive state. The device has not been tested for and it is not intended for pediatric use. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <span style="font-size: 100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K150782 Page 1 of 8 909 East Green Street T 626.993.2772 F 626.796.7314 www.qi-logic.com Pasadena, California 91106-2996 Image /page/3/Picture/1 description: The image shows the logo for GI Logic INC. The logo consists of the letters "GI" in blue, followed by a gray rectangle. To the right of the gray rectangle is the word "logic" in orange, stacked vertically, with the letters "INC" in gray below it. 510(k) Summary (As required by 21 CFR 807.92) | Submitted By: | GI Logic®, Inc.<br>909 East Green Street<br>Pasadena, CA 91106-2996<br>USA | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Albert Rego Ph.D., Inc.<br>27001 La Paz Road, Suite 312<br>Mission Viejo, CA 92691<br>Contact: Albert Rego<br>Phone: (949) 770-8710 | | Date Prepared: | March, 2015 | | Trade Name: | AbStats® Gateway | | Common Name: | Electronic Stethoscope | | Classification Name: | Electronic Stethoscope (21 CFR 870.1875) | | Regulatory Class: | Class II | | Product Code: | DQD | | Predicate Device: | RNK PCP-USB Stethoscope (K132560) | ## Device Description: The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (stethoscope) that in conjunction with external sensors constitutes the AbStats system. The Ab-Stats system external sensors are placed on the abdomen and identify the vibratory signals associated with digestive processes. The AbStats Gateway system is a compact, rapidly deployable unit that is comfortable for subjects and convenient in application. The AbStats Gateway sensor includes a standard microelectronic microphone for measurement of vibration acoustic signals. The components in patient contact are disposable, avoiding the need for cleaning and disinfection. The only material in direct contact with the subject is standard, FDA-approved 3M Tegaderm wound bandage adhesive material. The AbStats Gateway sensor includes a system that provides usage assurance of proper application to the patient. The AbStats Gateway sensor includes both an electret microphone and a compact vibration source (based on the principle of standard signaling vibration sources in consumer pager and {4}------------------------------------------------ Image /page/4/Picture/1 description: The image is a logo for GI Logic INC. The logo consists of the letters "GI" in a large, bold, dark blue font, followed by a gray rectangle. To the right of the rectangle, the word "LOGIC" is written vertically in an orange font, with the letters stacked on top of each other. Below the word "LOGIC", the letters "INC" are written in a smaller, gray font. 909 East Green Street Pasadena, California 91106-2996 626.993.2772 626.796.7314 www.qi-logic.com smartphone systems). This small electronic vibration device emits a short duration (50 millisecond length) signal each 2 minutes during usage and alternately from each sensor. This low amplitude and low frequency (less than 1 kHz) vibration signal is not detectable by the subject. lt propagates between the two AbStats sensors where it is detected by the AbStats device and provides direct assurance of proper application of the two sensors. The AbStats Gateway sensor includes fine, flexible cables that connect to the AbStats Gateway. The AbStats Gateway is a low voltage device that is similar in size to a tablet computer. The AbStats Gateway monitors the AbStats sensor signals and provides a measurement of intestinal motility with a Motility Rate. The rate is calculated based on rate of arrival of acoustic events detected by AbStats sensors. ## Indications for Use: The AbStats Gateway is a compact device with integrated sensor interfaces and embedded computing system (stethoscope) that in conjunction with external sensors constitutes the AbStats system. The Ab-Stats system external sensors are placed on the abdomen and identify the vibratory signals associated with digestive processes. This device should be used under the direction of a licensed healthcare practitioner when it is required to determine this patient digestive state. The device has not been tested for and it is not intended for pediatric use. ## IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICE The predicate device used for direct comparison of and the determination of substantial equivalence is: PCP-USB Stethoscope (K132560) The identification of this predicate device is in accordance with ensuring the Agency that this premarket notification is consistent with the currently approved (predicate) device, and meets all expectations of form, fit, function, and safety. ## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The comparison of features and operation principles between AbStats Gateway from GI Logic, Inc., and PCP-USB Stethoscope (K132560) from RNK Products is listed as follows: {5}------------------------------------------------ ### K150782 Page 3 of 8 Image /page/5/Picture/1 description: The image shows the logo for GII Logic Inc. The logo consists of the letters "GII" in blue and gray, followed by the word "LOGIC" in orange, stacked vertically. Below "LOGIC" is the word "INC" in a smaller font, also in orange. 909 East Green Street Pasadena, California 91106-2996 T 626.993.2772 F 626.796.7314 www.gi-logic.com | Parameter | AbStats Gateway | PCP-USB Stethoscope<br>K132560 | Comparison | |----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Indications for Use | The AbStats Gateway is a compact<br>device with integrated sensor inter-<br>faces and embedded computing sys-<br>tem (stethoscope) that in conjunc-<br>tion with external sensors constitutes<br>the AbStats system. The AbStats<br>system external sensors are placed<br>on the abdomen and identify the<br>vibratory signals associated with<br>digestive processes. This device<br>should be used under the direction of<br>a licensed healthcare practitioner<br>when it is required to determine this<br>patient digestive state. The device<br>has not been tested for and it is not<br>intended for pediatric use. | The PCP-USB Stethoscope<br>is intended to transmit<br>auscultation sound data,<br>whereby a clinician at one<br>location on an IP network<br>can listen to the ausculta-<br>tion sounds of a patient at<br>a different location on the<br>IP network with the signal<br>carried on an IP connection<br>between the two locations. | Substantially<br>Equivalent | | Parameter | AbStats Gateway | PCP-USB Stethoscope<br>K132560 | Comparison | | Number of<br>Sensors | 2 | 1 | Different Num-<br>ber - Substantial-<br>ly Equivalent<br>Functionality | | Sensor size (mm)<br>Active Area | 30 mm x 20 mm<br>400 mm² | Approximately 30 mm x<br>20mm<br>400 mm² | Substantially<br>Equivalent | | Sensor Technology | Standard Electrical Micro-<br>phone | Standard Electrical Micro-<br>phone | Substantially<br>Equivalent | | System Technology | Sensor data signal processing<br>and computing | Sensor data signal pro-<br>cessing and computing | Substantially<br>Equivalent | | Interface to PC | None required (no PC Inter-<br>face) | USB Interface | Interface is dif-<br>ferent but each<br>unit provides<br>Substantially<br>Equivalent Func-<br>tionality | | Data Box Connection to<br>PC | None required (no PC Inter-<br>face) | USB Interface | Interface is dif-<br>ferent but each<br>unit provides<br>Substantially<br>Equivalent Func-<br>tionality | | Power Supply | 5V USB Power Source | 5V USB Power Source | Substantially<br>Equivalent | | Sensor Cable Length (m) | 2.0 m | Approximately 0.5 m | Cable Length is<br>different - each<br>unit provides<br>Substantially<br>Equivalent Func-<br>tionality | | IEC6060 1-1:2005 3rd<br>Edition Medical Electri-<br>cal Equipment Part 1:<br>General Requirement<br>for<br>Safety and to EN60601-<br>1-2, 2007/03, | Conformance | Conformance | Equivalent | | Parameter | AbStats Gateway | PCP-USB Stethoscope<br>K132560 | Comparison | | EMC<br>Requirements for Safe-<br>ty, 2. Collateral Stand-<br>ard - Electromagnetic<br>Compatibility Require-<br>ments and Tests. | Conformance | Conformance | Equivalent | | Immunity Requirements<br>for Medical Electrical<br>Equipment Part 1: Gen-<br>eral | Conformance | Conformance | Equivalent | | Software | The AbStats software process-<br>es audio signals for display<br>and presentation to the user. | The PCP-USB Stethoscope soft-<br>ware processes audio signals for<br>display and presentation to the<br>user.<br>The PCP-USB Stethoscope soft-<br>ware provides additional data<br>transport capability to remote<br>users. | Substantially<br>Equivalent | | Biocompatibility | Device use the same materials<br>the predicate that a patient or<br>clinician might touch, the bio-<br>compatibility analysis is the<br>same. | Devices use the same ma-<br>terials that a patient or<br>clinician might touch, the<br>biocompatibility analysis is<br>the same. | Substantially<br>Equivalent | | Auscultation Perfor-<br>mance Tests: Bench<br>Testing and<br>Clinicians | Passed/Conformance | Passed/Conformance | Equivalent | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for GI Logic INC. The logo consists of the letters "GI" in a large, bold, dark blue font, followed by a solid gray rectangle. To the right of the rectangle is the word "LOGIC" stacked vertically in an orange sans-serif font, with "INC" in a smaller gray font below it. T 626.993.2772 F 626.796.7314 www.gi-logic.com {7}------------------------------------------------ Image /page/7/Picture/1 description: The image is a logo for GI Logic INC. The logo consists of the letters "GI" in a large, bold, dark blue font, followed by a gray rectangle. To the right of the rectangle, the word "LOGIC" is written vertically in an orange font, with the letters "INC" in a smaller, gray font below it. T 626.993.2772 F 626.796.7314 www.gi-logic.com Biocompatibility Testing: There is no biocompatibility testing for the AbStats device or sensors, in that there is not direct patient contact except through the use of commercially available dermal adhesive dressings. Electrical Safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the AbStats device, consisting of the device with sensors. The system complies with 1EC6060 1-1:2005 3rd Edition Medical Electrical Equipment Part 1: General Requirement for Safety and to EN60601-1-2, 2007/03, EMC Requirements for Safety, {8}------------------------------------------------ a, California 91106-2996 ww.ai-loaic.com Image /page/8/Picture/1 description: The image is a logo for "GI Logic INC". The logo consists of the letters "GI" in a large, bold, dark blue font. To the right of the letters is a gray rectangle. To the right of the rectangle is the word "LOGIC" in an orange, sans-serif font, stacked vertically, with the letters "INC" in a smaller, gray font at the bottom. 2. Collateral Standard - Electromagnetic Compatibility Requirements and Tests. Immunity Requirements for Medical Electrical Equipment Part 1: General. Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software contained in Medical Devices. The software is considered as " moderate" level of concern. ## Animal Study: The AbStats Gateway was determined not to require animal performance testing due to clinical trial results (proof of function studies). ## Clinical Study: The AbStats Gateway was determined not to need Clinical Evaluations due to clinical trial results (proof of function studies). The IRB Approved Clinical Trial results are given in the following public domain reference: Brennan M R Spiegel, Marc Kaneshiro, Marcia M Russell, Anne Lin, Anish Patel, Vartan C Tashjian,Vincent Zegarski, Digvijay Singh, Samuel E Cohen, Mark W Reid, Cynthia B Whitman, Jennifer Talley, Bibiana M Martinez, William Kaiser, "Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus", J Gastrointest Surg 2014 Oct 5;18(10):1795-803 ## Functional Study (Proof of Function): The results indicated that the AbStats Gateway successfully met all design requirements. | Title of Test Report | Report Number | |-------------------------------|---------------| | AbStats Operation Test Report | TR-001 | {9}------------------------------------------------ Image /page/9/Picture/1 description: The image is a logo for GI Logic Inc. The logo features the letters "GI" in a large, bold, dark blue font. To the right of the letters is a gray rectangle. To the right of the rectangle is the word "LOGIC" in an orange, sans-serif font, stacked vertically, with the letters "INC" in a smaller font below. T 626.993.2772 F 626.796.7314 www.gi-logic.com A summary of the final report is provided below: | Test<br>Step | Test Description | Observed System Response | Test Pass<br>(P) or Fail<br>(F) | |--------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | 1 | System Boot after<br>application of sys-<br>tem power. | System Boot observed with proper screen annunciator<br>Welcome Message displayed. | P | | 2 | Test of Time Zone<br>Setting | Time Zone Setting Message appeared correctly. | P | | 3 | Test of Time Zone<br>Continue State | Time Zone Accepted and Displayed followed by contin-<br>uation to next state. | P | | 4 | Test of Time Zone<br>Setting State | Time Zone Entry Accepted and Displayed followed by<br>continuation to next state. Multiple tests confirm op-<br>eration for all Time Zones. | P | | 5 | Start of New or Con-<br>tinued Study Choice<br>Display | Start of New or Continued Study Choice was displayed<br>correctly. | P | | 6 | Sensor Search Se-<br>quence Test with<br>Sensor Disconnect<br>State | Sensors are disconnected from Simulator. AbStats Sys-<br>tem continues to indicate search for sensors at display<br>correctly. | P | | 7 | Sensor Search Se-<br>quence Test with<br>Sensor Connect<br>State | Sensors are Connected at Simulator. AbStats System<br>indicates proper detection of sensors at display cor-<br>rectly. | P | | 8 | Sensor Recording<br>Cycle Test. | AbStats system enters Recording Cycle correctly after<br>Sensor Search State. | P | | 9 | Sensor Recording<br>Start with Sensor<br>Disconnect | AbStats System detects Sensor Disconnect state cor-<br>rectly. | P | | 10 | Sensor Recording<br>Start with Sensor<br>Disconnect | AbStats System Display Message Indicating Sensor Dis-<br>connect state correctly. Acquired data removed cor-<br>rectly. | P | | 11 | Sensor Recording<br>Start with Sensor<br>Disconnect with Us-<br>age Assurance Test<br>(UAT) Loop. | AbStats System Display Message Indicating Sensor Dis-<br>connect state correctly. Acquired data removed cor-<br>rectly. AbStats System remains in Usage Assurance Test<br>(UAT) recording loop correctly. | P | | 12 | Sensor Recording<br>Start with Sensor<br>Connect | AbStats System acquires signals from Simulator, com-<br>putes signal count by Analysis, and displays signal<br>count with correct signal count value | P | {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for GII Logic INC. The logo consists of the letters "GI" in a large, bold, dark blue font. To the right of the letters is a gray rectangle, and to the right of that is the word "LOGIC" in an orange, sans-serif font, stacked vertically, with the letters "INC" in a smaller font at the bottom. T 626.993.2772 F 626.796.7314 www.qi-logic.com ### Conclusions: Since the comparison of bench testing to clinical outcomes is still not well understood for this type of device, clinical testing was required to support substantial equivalence in the form of functional evaluation and proof of function. The non-clinical data support the safety and effectiveness of the device and the hardware and software verification and validation demonstrate that the AbStats Gateway device should perform as intended in the specified use conditions. The clinical data demonstrate that the AbStats Gateway device functions in a manner comparable to the predicate device that is currently marketed for the same intended use. The AbStats Gateway device utilizes the same technologies as the predicate device and is considered to be substantially equivalent to the predicate device in form, fit, function, safety and efficacy.