The NeoCoil ECG CT Gating Device (ECGD) is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The ECGD product includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 3.), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.

The System is compatible with Toshiba Aquilion ONE and Aquilion PRIME CT scanners.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "ECG CT Gating Device," based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Test	Pass/Fail Criteria	Reported Device Performance
Technology Comparison (Heart rate range)	Predicate: 10 to 300 BPM (Adult) ±1% ±1 BPM	30 to 200 BPM +/-2 BPM
Technology Comparison (Arrhythmias)	Identical to Predicate: 1. Normal Sinus Rhythm 2. Sinus Arrhythmia (heart rate variability) 3. Atrial Fibrillation (AFib) 4. Paroxysmal Supraventricular Tachycardia (PSVT) 5. Bradycardia 6. Second-Degree Atrioventricular block	Identical
Technology Comparison (Trigger Output)	Identical to Predicate: 0V baseline, with +5V trigger, 100ms pulse width	Identical
Technology Comparison (Performance Index)	Provides trigger pulses to the scanner, corresponding with R wave peaks, with an accuracy (performance index) of ≥ 98%.	≥ 98%
ECG CT Gating Device Compatibility Testing	Gating Device is Compatible with Toshiba Aquilon CT scanners.	Pass
ECG CT Gating Waveforms and Triggers	Device accurately produces waveforms and triggers through specified range and arrhythmias.	Pass
ECG CT Gating Device Interference Testing	Potentially interfering devices in the CT environment do not interfere with the ECG CT Gating Device.	Pass
ECG CT Gating Device Quality of Service	The ECG Gating Device provides a safe and effective wireless quality of service in the CT environment.	Pass
Clinical Performance (No adverse events)	No adverse events were reported during clinical performance testing.	No adverse events
Clinical Performance (Adequate performance for Indications for Use)	The ECG CT Gating Device demonstrated performance adequate to support the Indications for Use.	Demonstrated adequate performance

Note on Performance Index: The device claims an accuracy of ≥ 98%, which is considered equivalent to the predicate, as the predicate did not make a specific claim for this metric. The document notes that in the rare case of a mistrigger, manual adjustment by the CT scanner operator can be done, similar to the predicate device.

2. Sample Size and Data Provenance for the Test Set

The document mentions "Clinical testing" and "clinical performance testing" but does not specify the sample size for these tests. It also does not explicitly state the country of origin for the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted with human readers or AI assistance. The device is an ECG CT Gating Device, which is an accessory to a CT scanner, not an AI-powered diagnostic tool for interpretation.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance assessment was effectively conducted. The "Performance Index" of ≥ 98% for trigger pulse accuracy is a direct measure of the device's algorithmic performance in identifying R wave peaks and generating triggers. The "ECG CT Gating Waveforms and Triggers" test also assesses the device's standalone capability to accurately produce waveforms and triggers.

7. Type of Ground Truth Used

The type of ground truth used for performance assessment appears to be based on:

Engineering/Technical Specifications: For criteria like heart rate range, trigger output, and accuracy of waveforms/triggers.
Clinical Observation: For confirming the absence of adverse events and adequate performance for its intended use in generating cross-sectional cardiac images.

For the Performance Index, the ground truth would likely be established by comparing the device's generated trigger pulses against a "true" R-wave peak derived from a precise, independent ECG measurement or a known simulated ECG waveform.

8. Sample Size for the Training Set

The document does not provide information on a training set sample size. This device is not described as an AI/machine learning device that would typically have a distinct training set. Its functionality appears to be based on established physiological signal processing, rather than learned patterns.

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

As there is no mention of a training set, there is no information on how its ground truth might have been established.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 16, 2016

Neocoil, LLC Michael Leigh Director, Regulatory/Ouality N27 W23910a Paul Rd. Pewaukee, Wisconsin 53072

Re: K160350

Trade/Device Name: ECG CT Gating Device Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 2, 2016 Received: February 8, 2016

Dear Michael Leigh:

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 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 (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.

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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,

Michael D'Hara

For

Robert A. Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name ECG CT Gating Device

Indications for Use (Describe)

To be used in conjunction with a CT scanner to acquire gated cardiac images. The product is an aid to the acquisition of CT cardiac scans.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:

Image /page/3/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue. The "N" and "eo" are in a larger font size than the "Coil".

5. Traditional 510(k) Summary

5.1. Applicant NeoCoil, LLC N27 W23910A Paul Rd Pewaukee, WI 53072 USA
5.2. Contact Michael Leigh Director, Requlatory/Quality 262-522-6127 (direct) 261-347-1251 (fax) Mike.leigh@neocoil.com
5.3. Preparation Date 01/28/2016
5.4. Name of Device
- Proprietary Name: ●
- Common Name: ●
- Classification: .

ECG CT Gating Device Computed tomography x-ray system (accessory)

21 CFR 892.1750, Product Code JAK
5.5. Model Numbers

NeoCoil Model Number	NeoCoil Model Name
NC065000	Physiologic Acquisition Module (PAM)
NC080000	Receive Interface Module (RIM)
NC065601	ECG lead wires

5.6. Device Description

The System is compatible with Toshiba Aquilion ONE and Aquilion PRIME CT scanners.

5.7. Predicate Device

ECG-Gating System for Aquilion CT Scanner, TSX-101A, K991766 as cleared on 08/10/1999.

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:

Image /page/4/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with a white swirl inside, and the word "NeoCoil" in blue and black text. The "Neo" part of the word is in blue, while the "Coil" part is in black.

5.8. Comparison to Predicate

The NeoCoil ECG CT Gating Device is similar in physical, performance, design and material characteristics to the legally marketed device, ECG-Gating System for Aquillion CT Scanner, TSX-101A, K991766 as cleared on 08/10/1999.

The NeoCoil ECG CT Gating Device is an accessory to the Toshiba Aquilion CT Scanner that allows scans to be triggered by ECG-gating signals. The Toshiba ECG-Gating System is an upgrade to previously cleared Aquilion CT Scanner, TSX-101A. This upgrade will allow scans to be triggered by ECG-gating signals.

The Indications for Use are consistent with the capabilities of the predicate device, ECG-Gating System for Aquilion CT Scanner, TSX-101A, K991766 as cleared on 08/10/1999.

The following table provides a comparison of technology and performance.

Technology
Configuration	ECG leads provide wiredconnection to monitorconnected to scannerinterface	ECG leads provide wirelessconnection to receiverconnected to scannerinterface	Equivalent.
Source of gating signal	Third party monitors (e.g.Ivy Biomedical model7600 - K110987)	NeoCoil ECG CT GatingDevice	Equivalent.
Number of lead wires	Four	Four	Identical
Method	Amplitude	Vector	Equivalent performance
Pacer pulse rejection	Width: 0.1 to 2 ms at ±2 to±700 mV	Width: 0.1 to 2ms at+/-2mv to +/-700mv	Identical
Gating Indications	Lead OffCheck Lead	Lead OffWireless ConnectionBattery Status	NeoCoil use is limited to gatingonly; not monitoring. NeoCoilincludes additional indicatorsfor wireless and battery status.
Defibrillator Protection	IEC 60601-2-27: Edition3.0 compliant	IEC 60601-2-27: Edition 3.0compliant	Identical
Performance
Heart rate range	10 to 300 BPM (Adult)±1% ±1 BPM	30 to 200 BPM+/-2 BPM	NeoCoil use is limited to gatingonly; not monitoring. Range islimited based on clinicalrelevance to gated scans.

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: (262) 347-1250 (262) 347-1251 Fax:

Image /page/5/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape with an arrow pointing to the right, followed by the word "NeoCoil" in blue and black. The "Neo" part of the word is in blue, while the "Coil" part is in black.

Arrhythmias	1. Normal Sinus Rhythm2. Sinus Arrhythmia(heart rate variability)3. Atrial Fibrillation (AFib)4. ParoxysmalSupraventricularTachycardia (PSVT)5. Bradycardia6. Second-DegreeAtrioventricular block	1. Normal Sinus Rhythm2. Sinus Arrhythmia (heartrate variability)3. Atrial Fibrillation (AFib)4. ParoxysmalSupraventricularTachycardia (PSVT)5. Bradycardia6. Second-DegreeAtrioventricular block	Identical
Trigger Output	0V baseline, with +5Vtrigger, 100ms pulse width	0V baseline, with +5Vtrigger, 100ms pulse width	Identical, as required byToshiba scanner
Performance Index1	No claims	Provides trigger pulses tothe scanner, correspondingwith R wave peaks, with anaccuracy (performanceindex) of ≥ 98%.	Equivalent. The performanceindex is 98%. In the rare caseof a mistrigger during imageacquisition, the operator of theCT scanner can manuallyadjust the identification of theQRS complex and then initiateimage reconstruction. Thesame manual editingprocedure is used for bothdevices.

Clinical testing demonstrates that the differences in the devices do not affect the safety and/or the effectiveness of the device when used as labeled.

5.9. Indications for Use
To be used in conjunction with a CT scanner to acquire gated cardiac images. The product is an aid to the acquisition of CT cardiac scans.
5.10. Intended Use
The ECG CT Gating Device is intended to be used in conjunction with a CT scanner to acquire cardiac images.
5.11. Testing
The following data has been submitted, referenced or relied on to demonstrate that the NeoCoil ECG CT Gating Device is safe and effective. The devices' performance meets the requirements of pre-defined acceptance criteria and intended uses.

Test	Pass/Fail Criteria	Result
ECG CT GatingDevice CompatibilityTesting	Gating Device is Compatible with ToshibaAquilon CT scanners.	Pass
ECG CT GatingWaveforms andTriggers	Device accurately produces waveforms andtriggers through specified range andarrhythmias.	Pass
ECG CT GatingDevice InterferenceTesting	Potentially interfering devices in the CTenvironment do not interfere with the ECG CTGating Device.	Pass

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Image /page/6/Picture/1 description: The image shows the logo for NeoCoil. The logo consists of a black circular shape on the left and the word "NeoCoil" on the right. The word "Neo" is in blue, while the word "Coil" is in black.

Test	Pass/Fail Criteria	Result
ECG CT GatingDevice Quality ofService	The ECG Gating Device provides a safe andeffective wireless quality of service in the CTenvironment.	Pass

Published Standards testing:

Standard	Purpose
IEC 60601-1	Electromechanical safety
IEC 60601-1-2	Electromagnetic compatibility
IEC60601-1-6	Usability
IEC 60601-2-44	Electromechanical safety
ISO 10993-1	Biocompatibility

Performance testing - Clinical:

The clinical data represent the indicated use of the device. The cross-sectional images generated demonstrate the expected cardiac anatomy.

No adverse events were reported during clinical performance testing; the ECG CT Gating Device demonstrated performance adequate to support the Indications for Use.

5.12. Conclusion

This submission demonstrates that the Indications for Use are in line with the predicate device to be used in conjunction with a CT scanner to acquire gated cardiac images. The product is an aid to the acquisition of CT cardiac scans. As such, the NeoCoil ECG CT Gating Device is equivalent to their predicate, ECG-Gating System for Aquilion CT Scanner, TSX-101A, K991766 as cleared on 08/10/1999.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.