(129 days)
Not Found
No
The description focuses on standard ECG signal processing and triggering based on R-wave detection, with no mention of AI or ML techniques.
No
The device aids in acquiring cardiac images and generating ECG data for scanning purposes. It is not used for treating any medical condition or disease.
No
The device acquires ECG data and transmits it to a CT scanner to aid in cardiac imaging by providing trigger pulses for gated scans. It helps in the acquisition of images, but it does not analyze or interpret the images to provide a medical diagnosis on its own.
No
The device description explicitly mentions hardware components like the Physiologic Acquisition Module (PAM) and the Receive Interface Module (RIM), which acquire and transmit ECG data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to acquire ECG data and provide triggering pulses to a CT scanner for cardiac imaging. This is a device used in conjunction with an imaging modality to improve image acquisition, not a device that performs a diagnostic test on a biological sample in vitro.
- Device Description: The description details how the device acquires physiological data (ECG) from the patient and interfaces with the CT scanner. It does not mention analyzing biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: The description and performance information do not align with the typical characteristics of an IVD, which would involve:
- Analyzing a biological sample.
- Providing a result related to a disease, condition, or physiological state based on that analysis.
- Performance metrics like sensitivity, specificity, or accuracy related to the detection or measurement of an analyte in a sample.
The device is clearly focused on facilitating and improving the acquisition of in vivo imaging data (CT scans) by providing physiological gating information.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JAK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- ECG CT Gating Device Compatibility Testing: Gating Device is Compatible with Toshiba Aquilion CT scanners. Result: Pass.
- ECG CT Gating Waveforms and Triggers: Device accurately produces waveforms and triggers through specified range and arrhythmias. Result: Pass.
- ECG CT Gating Device Interference Testing: Potentially interfering devices in the CT environment do not interfere with the ECG CT Gating Device. Result: 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. Result: Pass.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Performance Index: Provides trigger pulses to the scanner, corresponding with R wave peaks, with an accuracy (performance index) of ≥ 98%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ECG-Gating System for Aquilion CT Scanner, TSX-101A, K991766
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring three abstract human profiles connected by flowing lines.
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.
1
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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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 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.
4
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 wired | ||
| connection to monitor | |||
| connected to scanner | |||
| interface | ECG leads provide wireless | ||
| connection to receiver | |||
| connected to scanner | |||
| interface | Equivalent. | ||
| Source of gating signal | Third party monitors (e.g. | ||
| Ivy Biomedical model | |||
| 7600 - K110987) | NeoCoil ECG CT Gating | ||
| 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 | ||
| ±700 mV | Width: 0.1 to 2ms at | ||
| +/-2mv to +/-700mv | Identical | ||
| Gating Indications | Lead Off | ||
| Check Lead | Lead Off | ||
| Wireless Connection | |||
| Battery Status | NeoCoil use is limited to gating | ||
| only; not monitoring. NeoCoil | |||
| includes additional indicators | |||
| for wireless and battery status. | |||
| Defibrillator Protection | IEC 60601-2-27: Edition | ||
| 3.0 compliant | IEC 60601-2-27: Edition 3.0 | ||
| compliant | Identical | ||
| Performance | |||
| Heart rate range | 10 to 300 BPM (Adult) | ||
| ±1% ±1 BPM | 30 to 200 BPM | ||
| +/-2 BPM | NeoCoil use is limited to gating | ||
| only; not monitoring. Range is | |||
| limited based on clinical | |||
| relevance to gated scans. |
5
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 Rhythm
2. Sinus Arrhythmia
(heart rate variability)
3. Atrial Fibrillation (AFib)
4. Paroxysmal
Supraventricular
Tachycardia (PSVT)
5. Bradycardia
6. Second-Degree
Atrioventricular block | 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 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trigger Output | 0V baseline, with +5V
trigger, 100ms pulse width | 0V baseline, with +5V
trigger, 100ms pulse width | Identical, as required by
Toshiba scanner |
| Performance Index1 | No claims | Provides trigger pulses to
the scanner, corresponding
with R wave peaks, with an
accuracy (performance
index) of ≥ 98%. | Equivalent. The performance
index is 98%. In the rare case
of a mistrigger during image
acquisition, the operator of the
CT scanner can manually
adjust the identification of the
QRS complex and then initiate
image reconstruction. The
same manual editing
procedure is used for both
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 | ||
| 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 |
6
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 | ||
| Device Quality of | ||
| Service | The ECG Gating Device provides a safe and | |
| effective wireless quality of service in the CT | ||
| 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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