ECG CT Gating Device

K160350 · Neocoil, LLC · JAK · Jun 16, 2016 · Radiology

Device Facts

• Record ID: K160350
• Device Name: ECG CT Gating Device
• Applicant: Neocoil, LLC
• Product Code: JAK · Radiology
• Decision Date: Jun 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The ECG CT Gating Device is intended to be used in conjunction with a CT scanner to acquire cardiac images.

Device Story

Device acquires patient ECG data to provide triggering pulses for CT cardiac scanning. System consists of Physiologic Acquisition Module (PAM) connected to patient via four ECG lead wires; PAM processes ECG data and transmits wirelessly to Receive Interface Module (RIM). RIM creates analog ECG waveform and trigger pulses, interfacing with Toshiba Aquilion CT scanner console. Used in clinical CT environment; operated by radiology staff. Output allows scanner to synchronize image acquisition with cardiac cycle (R-wave peaks). Benefits include improved cardiac image quality by gating scans to specific heart phases. Manual adjustment of QRS complex identification available on scanner console if mistriggering occurs.

Clinical Evidence

Clinical performance testing demonstrated the device generates cross-sectional images showing expected cardiac anatomy. No adverse events reported. Performance index for trigger pulse accuracy is ≥ 98%. Testing included compatibility with Toshiba Aquilion CT scanners, waveform/trigger accuracy across specified heart rates and arrhythmias, and interference testing in the CT environment.

Technological Characteristics

System includes PAM and RIM modules. Uses four ECG lead wires. Wireless data transmission between modules. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-44, and IEC 60601-2-27 (defibrillator protection). Biocompatibility per ISO 10993-1. Trigger output: 0V baseline, +5V pulse, 100ms width. Heart rate range: 30-200 BPM.

Indications for Use

Indicated for use in conjunction with a CT scanner to acquire gated cardiac images as an aid to the acquisition of CT cardiac scans.

Regulatory Classification

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.

Predicate Devices

• ECG-Gating System for Aquilion CT Scanner, TSX-101A (K991766)

Reference Devices

• Ivy Biomedical model 7600 (K110987)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: [phone] [phone] 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) [e-mail]
- 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 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.

### 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: [phone] [phone] 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 wired<br>connection to monitor<br>connected to scanner<br>interface | ECG leads provide wireless<br>connection to receiver<br>connected to scanner<br>interface | Equivalent. |
| Source of gating signal | Third party monitors (e.g.<br>Ivy Biomedical model<br>7600 - K110987) | NeoCoil ECG CT Gating<br>Device | 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<br>±700 mV | Width: 0.1 to 2ms at<br>+/-2mv to +/-700mv | Identical |
| Gating Indications | Lead Off<br>Check Lead | Lead Off<br>Wireless Connection<br>Battery Status | NeoCoil use is limited to gating<br>only; not monitoring. NeoCoil<br>includes additional indicators<br>for wireless and battery status. |
| Defibrillator Protection | IEC 60601-2-27: Edition<br>3.0 compliant | IEC 60601-2-27: Edition 3.0<br>compliant | Identical |
| Performance | | | |
| Heart rate range | 10 to 300 BPM (Adult)<br>±1% ±1 BPM | 30 to 200 BPM<br>+/-2 BPM | NeoCoil use is limited to gating<br>only; not monitoring. Range is<br>limited based on clinical<br>relevance to gated scans. |

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N27 W23910A Paul Rd Pewaukee, WI 53072 USA Direct: [phone] [phone] 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 Rhythm<br>2. Sinus Arrhythmia<br>(heart rate variability)<br>3. Atrial Fibrillation (AFib)<br>4. Paroxysmal<br>Supraventricular<br>Tachycardia (PSVT)<br>5. Bradycardia<br>6. Second-Degree<br>Atrioventricular block | 1. Normal Sinus Rhythm<br>2. Sinus Arrhythmia (heart<br>rate variability)<br>3. Atrial Fibrillation (AFib)<br>4. Paroxysmal<br>Supraventricular<br>Tachycardia (PSVT)<br>5. Bradycardia<br>6. Second-Degree<br>Atrioventricular block | Identical |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trigger Output | 0V baseline, with +5V<br>trigger, 100ms pulse width | 0V baseline, with +5V<br>trigger, 100ms pulse width | Identical, as required by<br>Toshiba scanner |
| Performance Index1 | No claims | Provides trigger pulses to<br>the scanner, corresponding<br>with R wave peaks, with an<br>accuracy (performance<br>index) of ≥ 98%. | Equivalent. The performance<br>index is 98%. In the rare case<br>of a mistrigger during image<br>acquisition, the operator of the<br>CT scanner can manually<br>adjust the identification of the<br>QRS complex and then initiate<br>image reconstruction. The<br>same manual editing<br>procedure is used for both<br>devices. |

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 Gating<br>Device Compatibility<br>Testing | Gating Device is Compatible with Toshiba<br>Aquilon CT scanners. | Pass |
| ECG CT Gating<br>Waveforms and<br>Triggers | Device accurately produces waveforms and<br>triggers through specified range and<br>arrhythmias. | Pass |
| ECG CT Gating<br>Device Interference<br>Testing | Potentially interfering devices in the CT<br>environment do not interfere with the ECG CT<br>Gating 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 Gating<br>Device Quality of<br>Service | The ECG Gating Device provides a safe and<br>effective wireless quality of service in the CT<br>environment. | 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.

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