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.

Device Description

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 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.

AI/ML Overview

The provided text describes the AbStats Gateway, an electronic stethoscope, and its substantial equivalence to a predicate device (RNK PCP-USB Stethoscope K132560). The document focuses on regulatory approval rather than detailed performance metrics. Therefore, some information, such as precise acceptance criteria, specific device performance numbers, and statistical study details, is not explicitly provided.

However, based on the information available, here's a structured summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific numerical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) that the AbStats Gateway needed to meet. Instead, the "acceptance criteria" are implied by the documented functional tests and the finding of "conformance" or "Pass" for each. The overall acceptance criterion appears to be that the device "performs as intended in the specified use conditions" and "functions in a manner comparable to the predicate device."

Acceptance Criteria (Implied)	Reported Device Performance
System Boot after application of system power.	System Boot observed with proper screen annunciator "Welcome Message" displayed. (P)
Test of Time Zone Setting.	Time Zone Setting Message appeared correctly. (P)
Test of Time Zone Continue State.	Time Zone Accepted and Displayed followed by continuation to next state. (P)
Test of Time Zone Setting State (for all time zones).	Time Zone Entry Accepted and Displayed followed by continuation to next state. Multiple tests confirm operation for all Time Zones. (P)
Start of New or Continued Study Choice Display.	Start of New or Continued Study Choice was displayed correctly. (P)
Sensor Search Sequence Test with Sensor Disconnect State.	AbStats System continues to indicate search for sensors at display correctly. (P)
Sensor Search Sequence Test with Sensor Connect State.	AbStats System indicates proper detection of sensors at display correctly. (P)
Sensor Recording Cycle Test.	AbStats system enters Recording Cycle correctly after Sensor Search State. (P)
Sensor Recording Start with Sensor Disconnect (System behavior).	AbStats System detects Sensor Disconnect state correctly. (P)
Sensor Recording Start with Sensor Disconnect (Display and data removal).	AbStats System Display Message Indicating Sensor Disconnect state correctly. Acquired data removed correctly. (P)
Sensor Recording Start with Sensor Disconnect with Usage Assurance Test (UAT) Loop.	AbStats System Display Message Indicating Sensor Disconnect state correctly. Acquired data removed correctly. AbStats System remains in Usage Assurance Test (UAT) recording loop correctly. (P)
Sensor Recording Start with Sensor Connect (Signal acquisition and display).	AbStats System acquires signals from Simulator, computes signal count by Analysis, and displays signal count with correct signal count value. (P)
Electrical Safety and EMC Compliance (IEC60601-1, EN60601-1-2).	Conformance.
Software Verification and Validation.	Documentation provided and testing conducted as recommended by FDA. Software considered "moderate" level of concern.
Biocompatibility.	Device uses same materials as predicate; no direct patient contact with AbStats device itself (only with disposable dressings).
Auscultation Performance Tests.	Passed/Conformance.
Functional evaluation and proof of function (clinical).	The device functions as intended and is comparable to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Functional/Bench Testing): Not explicitly stated. The "Functional Study (Proof of Function)" section refers to "AbStats Operation Test Report (TR-001)" which lists 12 test steps, all of which "Passed." This appears to be a bench testing and software validation test rather than a clinical sensitivity/specificity study.
Test Set (Clinical): The document references an "IRB Approved Clinical Trial results" in the 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.
- Data Provenance: The k-number refers to the US Food and Drug Administration, implying the clinical trial would likely be conducted in the US, but the country of origin of the data is not specified in the provided text. The study is cited as "postoperative ileus validation," suggesting it is a prospective clinical trial.
- Sample Size: The sample size for this specific clinical study is not mentioned in the provided FDA submission document. One would need to consult the referenced publication.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not available in the provided document. The clinical study referenced is for "Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus." It is likely that ground truth for postoperative ileus would involve clinical diagnosis, potentially with imaging or other clinical parameters, but the number and qualifications of experts involved in establishing this ground truth for the test set (if any specific "experts" were used for ground truth rather than standard clinical diagnosis) are not detailed here.

4. Adjudication Method for the Test Set

Not specified within the provided text. For the clinical study, the adjudication method for diagnosing postoperative ileus (which would serve as ground truth) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not explicitly mentioned or described. The document states that the device (AbStats Gateway) functions "comparable to the predicate device" and that 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." This comparison is at the device level, not an MRMC study assessing human reader improvement with or without AI assistance. The AbStats Gateway itself is described as a stethoscope system identifying vibratory signals, calculating a "Motility Rate," and providing a measurement of intestinal motility; it's not described as an AI-assisted diagnostic tool for human readers in the traditional MRMC sense.

6. Standalone (Algorithm Only) Performance Study

Yes, in essence, a standalone functional study was done. The "Functional Study (Proof of Function)" and "AbStats Operation Test Report" describe the device's (algorithm's) ability to boot, set time zones, detect and record sensor data, and compute signal counts. These are tests of the algorithm's direct output and operational integrity.
The system monitors 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." This implies a standalone algorithmic output. The clinical trial then validates this output's correlation with postoperative ileus.

7. Type of Ground Truth Used

Functional/Bench Testing: The ground truth for the functional tests was internal verification against expected system responses and design requirements (e.g., "Welcome Message displayed," "Time Zone Entry Accepted").
Clinical Study: For the clinical study on postoperative ileus, the ground truth would be the established clinical diagnosis of postoperative ileus as determined by standard medical practice, which the device's "Motility Rate" is validated against. The specific gold standard used in the referenced paper would need to be consulted, but it would typically be based on clinical signs, symptoms, and potentially imaging.

8. Sample Size for the Training Set

Not specified. The document does not provide details on model training or a training set sample size. Given that the device is described as calculating a "Motility Rate" based on the "rate of arrival of acoustic events," the underlying algorithm may involve signal processing and event detection rather than a complex machine learning model requiring a large labeled training set in the modern AI sense. If machine learning was used for event detection, the training set size is not disclosed.

9. How the Ground Truth for the Training Set Was Established

Not specified. As the document doesn't detail a training set, the method for establishing its ground truth is also not mentioned.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K150782

Device Name Abstats Gateway

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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.909 East Green StreetPasadena, CA 91106-2996USA
Contact Person:	Albert Rego Ph.D., Inc.27001 La Paz Road, Suite 312Mission Viejo, CA 92691Contact: Albert RegoPhone: (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:

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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.

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:

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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 StethoscopeK132560	Comparison
Indications for Use	The AbStats Gateway is a compactdevice with integrated sensor inter-faces and embedded computing sys-tem (stethoscope) that in conjunc-tion with external sensors constitutesthe AbStats system. The AbStatssystem external sensors are placedon the abdomen and identify thevibratory signals associated withdigestive processes. This deviceshould be used under the direction ofa licensed healthcare practitionerwhen it is required to determine thispatient digestive state. The devicehas not been tested for and it is notintended for pediatric use.	The PCP-USB Stethoscopeis intended to transmitauscultation sound data,whereby a clinician at onelocation on an IP networkcan listen to the ausculta-tion sounds of a patient ata different location on theIP network with the signalcarried on an IP connectionbetween the two locations.	SubstantiallyEquivalent
Parameter	AbStats Gateway	PCP-USB StethoscopeK132560	Comparison
Number ofSensors	2	1	Different Num-ber - Substantial-ly EquivalentFunctionality
Sensor size (mm)Active Area	30 mm x 20 mm400 mm²	Approximately 30 mm x20mm400 mm²	SubstantiallyEquivalent
Sensor Technology	Standard Electrical Micro-phone	Standard Electrical Micro-phone	SubstantiallyEquivalent
System Technology	Sensor data signal processingand computing	Sensor data signal pro-cessing and computing	SubstantiallyEquivalent
Interface to PC	None required (no PC Inter-face)	USB Interface	Interface is dif-ferent but eachunit providesSubstantiallyEquivalent Func-tionality
Data Box Connection toPC	None required (no PC Inter-face)	USB Interface	Interface is dif-ferent but eachunit providesSubstantiallyEquivalent Func-tionality
Power Supply	5V USB Power Source	5V USB Power Source	SubstantiallyEquivalent
Sensor Cable Length (m)	2.0 m	Approximately 0.5 m	Cable Length isdifferent - eachunit providesSubstantiallyEquivalent Func-tionality
IEC6060 1-1:2005 3rdEdition Medical Electri-cal Equipment Part 1:General RequirementforSafety and to EN60601-1-2, 2007/03,	Conformance	Conformance	Equivalent
Parameter	AbStats Gateway	PCP-USB StethoscopeK132560	Comparison
EMCRequirements for Safe-ty, 2. Collateral Stand-ard - ElectromagneticCompatibility Require-ments and Tests.	Conformance	Conformance	Equivalent
Immunity Requirementsfor Medical ElectricalEquipment Part 1: Gen-eral	Conformance	Conformance	Equivalent
Software	The AbStats software process-es audio signals for displayand presentation to the user.	The PCP-USB Stethoscope soft-ware processes audio signals fordisplay and presentation to theuser.The PCP-USB Stethoscope soft-ware provides additional datatransport capability to remoteusers.	SubstantiallyEquivalent
Biocompatibility	Device use the same materialsthe predicate that a patient orclinician might touch, the bio-compatibility analysis is thesame.	Devices use the same ma-terials that a patient orclinician might touch, thebiocompatibility analysis isthe same.	SubstantiallyEquivalent
Auscultation Perfor-mance Tests: BenchTesting andClinicians	Passed/Conformance	Passed/Conformance	Equivalent

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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

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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,

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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.

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

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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:

TestStep	Test Description	Observed System Response	Test Pass(P) or Fail(F)
1	System Boot afterapplication of sys-tem power.	System Boot observed with proper screen annunciatorWelcome Message displayed.	P
2	Test of Time ZoneSetting	Time Zone Setting Message appeared correctly.	P
3	Test of Time ZoneContinue State	Time Zone Accepted and Displayed followed by contin-uation to next state.	P
4	Test of Time ZoneSetting State	Time Zone Entry Accepted and Displayed followed bycontinuation to next state. Multiple tests confirm op-eration for all Time Zones.	P
5	Start of New or Con-tinued Study ChoiceDisplay	Start of New or Continued Study Choice was displayedcorrectly.	P
6	Sensor Search Se-quence Test withSensor DisconnectState	Sensors are disconnected from Simulator. AbStats Sys-tem continues to indicate search for sensors at displaycorrectly.	P
7	Sensor Search Se-quence Test withSensor ConnectState	Sensors are Connected at Simulator. AbStats Systemindicates proper detection of sensors at display cor-rectly.	P
8	Sensor RecordingCycle Test.	AbStats system enters Recording Cycle correctly afterSensor Search State.	P
9	Sensor RecordingStart with SensorDisconnect	AbStats System detects Sensor Disconnect state cor-rectly.	P
10	Sensor RecordingStart with SensorDisconnect	AbStats System Display Message Indicating Sensor Dis-connect state correctly. Acquired data removed cor-rectly.	P
11	Sensor RecordingStart with SensorDisconnect with Us-age Assurance Test(UAT) Loop.	AbStats System Display Message Indicating Sensor Dis-connect state correctly. Acquired data removed cor-rectly. AbStats System remains in Usage Assurance Test(UAT) recording loop correctly.	P
12	Sensor RecordingStart with SensorConnect	AbStats System acquires signals from Simulator, com-putes signal count by Analysis, and displays signalcount with correct signal count value	P

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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.

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.