(329 days)
The Kenz Cardico 1211 is indicated for routine ECG acquisition and ECG signal analysis. It is equipped with an auto-analysis function and is not intended to replace the physician's reading of ECGs. Instead, it is intended to assist physicians and supplement their readings by: providing preliminary interpretations of ECG records which need to be confirmed or edited by the physician, who integrates ECG findings with other relevant clinical data; providing auto-analysed measurements of many ECG parameters, which need to be confirmed by the physician. The device is applicable only to adults (age > 19 years).
Applications: Cardico 1211 is intended to be used as part of health examination of general population, and as part of laboratory tests and clinical examination to diagnose various cardiac abnormalities including myocardial ischemia/infarction, ventricular hypertrophy, cardiac arrhythmias, and atrioventricular (AV) block.
Locations: Hospitals.
Caution: US Federal law restricts this device to sale by or on the order of a physician.
Kenz Cardico 1211 is an electrocardiograph with the following functions and capabilities.
· Simultaneous acquisition of the 12-Lead electrocardiogram (ECG).
· The sampling frequency of P-QRS-T deflections is 1 kHz.
- · The sampling frequency of the pacemaker pulse detection is 10 kHz.
- · 5.7 inch LCD display providing the following information.
- a) ECG waveform
- b) Patient's demographic data
- c) ECG diagnostic interpretation
- d) Summary of Internal Memory data
- · Thermal printer that will print ECG waveforms and analysis reports.
- · Digital filters to minimize AC interference, baseline drift and electromyogram interference.
- · Built-in memory and external memory (Compact Flash card) for 1,000 12-Lead ECG data.
- · As a measure against cybersecurity, in order to secure the integrity of the data in the external memory, only the CF card specially formatted by Suzuken Co., Ltd. can be used with Kenz Cardico 1211.
- · Built-in power supply unit (AC 110-240 V).
- · Built-in battery, after charged for 8 hours, supports one hour operation during emergency.
- · ECG interpretation software providing the following information.
- a) Summary of measured values of ECG waveform in each Lead
- b) Rhythm analysis statements
- c) Morphology analysis statements
- d) Pacemaker pulse detection and Pacemaker rhythm diagnosis
- e) Provide multiple diagnostic outputs for a single ECG, if it contains multiple diagnostic findings
- · Patient cable with D-sub 15 pin connector and 4.0 mm plugs is used for recording 12-Lead resting ECG with the device.
- · ECG electrodes are not provided with the device (Kenz Cardico 1211). Disposable chest/limb electrodes connected to the ECG Adaptor Clips of the plug size 4.0 mm are compatible with the Kenz Cardico 1211.
Here's a breakdown of the acceptance criteria and study details for the Kenz Cardico 1211, based on the provided document:
Acceptance Criteria and Device Performance
The core acceptance criterion is to demonstrate that the diagnostic performance of the Kenz Cardico 1211 (including its updated ECG interpretation software) is non-inferior to its predicate device, the Kenz Cardico 1201.
Table of Acceptance Criteria and Reported Device Performance
| Criterion Category | Specific Acceptance Criterion | Kenz Cardico 1211 Performance | Kenz Cardico 1201 Performance (Predicate) | Meets Criterion? |
|---|---|---|---|---|
| Diagnostic Performance (Type A Statements - Overall Agreement) | Non-inferiority to predicate for total agreement with Cardiologist Consensus. | 93.1% Total Agreement | 76.1% Total Agreement | Yes (demonstrated superiority) |
| Diagnostic Performance (Type A Statements - Sensitivity) | Higher sensitivity than predicate for most individual Type A statements. | Higher for most | Lower for most | Yes |
| Diagnostic Performance (Type A Statements - Specificity) | Similar specificity to predicate for most individual Type A statements. | Similar | Similar | Yes |
| Diagnostic Performance (Type B Statements - Sensitivity) | Higher sensitivity than predicate for most individual Type B statements. | Higher for most | Lower for most | Yes |
| Diagnostic Performance (Type B Statements - Specificity) | Similar specificity to predicate for most individual Type B statements. | Similar | Similar | Yes |
| Diagnostic Performance (Type C Statements - Sensitivity) | Higher sensitivity than predicate for most individual Type C statements. | Higher for most | Lower for most | Yes |
| Diagnostic Performance (Type C Statements - Specificity) | Similar specificity to predicate for most individual Type C statements. | Similar | Similar | Yes |
| Electrical Safety & EMC | Full compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, ANSI/AAMI EC11, ANSI/AAMI EC53. | Fully compliant (testing reports indicated) | N/A (Standard regulatory compliance) | Yes |
Study Details
2. Sample Sizes and Data Provenance
- Test Set Sample Size: A total of 2,451 ECGs from 2,451 subjects were used for diagnostic performance testing.
- Data Provenance: The data came from two sources:
- CSE Database (Common Standards for Electrocardiography): Used for Type A statements and contributing to Type B and C statements. The country of origin for the CSE database is not explicitly stated in this document but is generally a well-known international standard database.
- Suzuken Databases (Suzuken Database-1, Suzuken Database-2, Suzuken Database-3 (Pacemaker rhythm), Acute MI database): Used to supplement the CSE database for various statement types. This implies the data likely originated from Japan, given Suzuken Co., Ltd. is based there.
- Retrospective/Prospective: The document does not explicitly state whether the data was retrospective or prospective, but the use of established databases (CSE and Suzuken's own) suggests a retrospective approach.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: The document refers to "Cardiologist Consensus" as the reference of truth, but it does not specify the number of cardiologists involved in establishing this consensus.
- Qualifications of Experts: The experts are described as "Cardiologist(s)". No further details about their years of experience or specific sub-specialties are provided in this document.
4. Adjudication Method (Test Set)
The adjudication method is described as "Cardiologist Consensus" for all Type B and Type C statements, and for Type A statements when "Cardiologist Consensus" was available (otherwise "Clinical Truth" was used for Type A). The document states that the "Creation of Cardiologist Consensus is described in detail in Att. 18-1," suggesting a formal process, but the details of that process (e.g., how disagreements were resolved, majority vote, etc.) are not included in these provided pages.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A comparative effectiveness study was done by comparing the Kenz Cardico 1211's performance directly against the predicate device, Kenz Cardico 1201. However, this was a device-to-device comparison for standalone performance, not a human reader improvement study.
- Effect Size of Human Readers Improvement with/without AI: This study did not involve human readers in a comparative effectiveness study with and without AI assistance. It focused on the algorithm's performance compared to another algorithm. The device's function is to assist physicians, but this study did not quantify that assistance.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The entire "Diagnostic performance testing" section (Section 10-2) describes the comparison of the Kenz Cardico 1211's auto-analysis function against established ground truth, and against the auto-analysis function of the Kenz Cardico 1201. This is a direct assessment of the algorithm's performance without human intervention in the evaluation process.
7. Type of Ground Truth Used
- Expert Consensus: The primary ground truth for Type A, B, and C statements was "Cardiologist Consensus."
- Clinical Truth: For some Type A statements, "Clinical Truth" was also used (specifically mentioned for the "Acute MI" database). This would typically refer to definitive clinical diagnoses based on a broader range of patient data (e.g., lab results, imaging, follow-up, pathology, not just the ECG).
8. Sample Size for the Training Set
The document does not explicitly state the sample size for the training set used to develop the ECG interpretation software of the Kenz Cardico 1211. It mentions that the software "reflects the results of many ECG clinical studies published after the development of the ECG interpretation software of Kenz Cardico 1201," implying a significant body of data, but not a specific training set size.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established. It only refers to the software "reflecting the results of many ECG clinical studies published." This suggests that the algorithm was likely developed and refined using a large corpus of previously interpreted ECG data from these clinical studies, where the diagnoses would have been established by medical experts (likely cardiologists) in those respective studies.
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Image /page/0/Picture/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services - USA logo. The second logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has the letters FDA in a blue square, followed by the words "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line, both in blue.
June 1, 2018
Suzuken Co., Ltd. % Rhona Shanker President Z&B Enterprises, Inc. 12154 Darnestown Rd. #236 Gaithersburg, Maryland 20878
Re: K172068
Trade/Device Name: Kenz Cardico 1211 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: May 3, 2018 Received: May 3, 2018
Dear Rhona Shanker:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Rhona Shanker
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
M.A. Hilleman
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172068
Device Name Kenz Cardico 1211
Indications for Use (Describe)
The Kenz Cardico 1211 is indicated for routine ECG acquisition and ysis. It is equipped with an auto-analysis function and is not intended to replace the physician's reading of ECGs. Instead, it is intended to assist physicians and supplement their readings by: providing preliminary interpretations of ECG records which need to be confirmed or edited by the physician, who integrates ECG findings with other relevant clinical data; providing auto-analysed measurements of many ECG parameters, which need to be confirmed by the physician. The device is applicable only to adults (19 years or older age).
Applications: Cardico 1211 is intended to be used as part of health examination of general population, and as part of laboratory tests and clinical examination to diagnose various cardiac abnormalities including myocardial ischemia/ infarction, ventricular hypertrophy, cardiac arrhythmias, and atrioventricular (AV) block.
Locations: Hospitals.
Caution: US Federal law restricts this device to sale by or on the order of a physician.
Type of Use (Select one or both, as applicable)
X 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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Section 5. 510(k) Summary
1. Date of Submission
July 1, 2017
2. Submitter
| Name: | Suzuken Co., Ltd. |
|---|---|
| Address: | 8 Higashikataha-machi, |
| Higashi-ku, | |
| Nagoya, Aichi 461-0015, Japan | |
| Contact person: | Eiji Yamaguchi |
| Phone: | +81-52-950-6327 |
| FAX: | +81-52-962-7440 |
| E-mail: | e.yamaguchi@suzuken.co.jp |
3. Application Correspondent
| Name: | Z&B Enterprises, Inc. |
|---|---|
| Address: | 12154 Darnestown Road. #236Gaithersburg, Maryland 20878 |
| Contact Person: | Rhona Shanker |
| Phone: | 301-251-9570 |
| E-mail: | rhonashanker07@verizon.net |
4. Device Name
Trade Name: Kenz Cardico 1211 Common Name: Electrocardiograph
5. Device Classification
| Device Classification: | Class II |
|---|---|
| Regulation: | 21 CFR 870.2340 |
| Panel: | Cardiovascular |
| Product Code: | DPS |
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6. Predicate Device
Trade Name: Kenz Cardico 1201 Manufacturer: Suzuken Co., Ltd 510(k) Number: K870443
7. Device Description
Kenz Cardico 1211 is an electrocardiograph with the following functions and capabilities.
· Simultaneous acquisition of the 12-Lead electrocardiogram (ECG).
· The sampling frequency of P-QRS-T deflections is 1 kHz.
- · The sampling frequency of the pacemaker pulse detection is 10 kHz.
- · 5.7 inch LCD display providing the following information.
- a) ECG waveform
- b) Patient's demographic data
- c) ECG diagnostic interpretation
- d) Summary of Internal Memory data
- · Thermal printer that will print ECG waveforms and analysis reports.
- · Digital filters to minimize AC interference, baseline drift and electromyogram interference.
- · Built-in memory and external memory (Compact Flash card) for 1,000 12-Lead ECG data.
- · As a measure against cybersecurity, in order to secure the integrity of the data in the external memory, only the CF card specially formatted by Suzuken Co., Ltd. can be used with Kenz Cardico 1211.
- · Built-in power supply unit (AC 110-240 V).
- · Built-in battery, after charged for 8 hours, supports one hour operation during emergency.
- · ECG interpretation software providing the following information.
- a) Summary of measured values of ECG waveform in each Lead
- b) Rhythm analysis statements
- c) Morphology analysis statements
- d) Pacemaker pulse detection and Pacemaker rhythm diagnosis
- e) Provide multiple diagnostic outputs for a single ECG, if it contains multiple diagnostic findings
- · Patient cable with D-sub 15 pin connector and 4.0 mm plugs is used for recording 12-Lead resting ECG with the device.
- · ECG electrodes are not provided with the device (Kenz Cardico 1211). Disposable chest/limb electrodes connected to the ECG Adaptor Clips of the plug size 4.0 mm are compatible with the Kenz Cardico 1211.
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K172068
8. Indications for Use
The Kenz Cardico 1211 is indicated for routine ECG acquisition and ECG signal analysis. It is equipped with an auto-analysis function and is not intended to replace the physician's reading of ECGs. Instead, it is intended to assist physicians and supplement their readings by: providing preliminary interpretations of ECG records which need to be confirmed or edited by the physician, who integrates ECG findings with other relevant clinical data; providing auto-analysed measurements of many ECG parameters, which need to be confirmed by the physician. The device is applicable only to adults (age > 19 years).
- Applications: Cardico 1211 is intended to be used as part of health examination of general population, and as part of laboratory tests and clinical examination to diagnose various cardiac abnormalities including myocardial ischemia/infarction, ventricular hypertrophy, cardiac arrhythmias, and atrioventricular (AV) block.
Locations: Hospitals.
Caution: US Federal law restricts this device to sale by or on the order of a physician.
| Parameter | Kenz Cardico1211 | Kenz Cardico1201(K870443) | Remark about KenzCardico 1211compared to KenzCardico 1201 | |
|---|---|---|---|---|
| 1 | Indicationsfor use | The Kenz Cardico 1211 isindicated for routine ECGacquisition and ECG signalanalysis. It is equipped withan auto-analysis function andis not intended to replace thephysician's reading of ECGs.Instead, it is intended toassist physicians andsupplement their readings by:providing preliminaryinterpretations of ECGrecords which need to beconfirmed or edited by thephysician, who integratesECG findings with otherrelevant clinical data;providing auto-analysedmeasurements of many ECGparameters, which need to beconfirmed by the physician.The device is applicable only | The Kenz Cardico 1201 is used asdiagnostic aid. However, thesystem is not intended to replacethe doctor's expert review.For routine adult or pediatric ECGanalysis, particularly when acardiologist is not immediatelyavailable, and to aid in referringpatients for immediate follow up,Kenz Cardico 1201 can assiststrongly physician for promptdiagnosis. Also, Kenz Cardico1201 can be used for pre-op ECGinterpretations, especially when ananalysis needed quickly. Thesystem and its thoroughlyevaluated programs help to savephysicians time by providing aroutine ECG report for physicianreview, with patient information,trace measurement and analysison the report. The exclusion of the | ECG interpretation ofKenz Cardico 1211 isapplicable only toadults. |
9. Summary Table of Comparisons
The table below compares the Kenz Cardico 1211 to its predicate device. Kenz Cardico 1201
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| 2 | Leads | 12-Lead | 12-Lead | Identical |
|---|---|---|---|---|
| 3 | Frequencyresponsebandwidth | 0.05-150 Hz | 0.05-100 Hz | Wider frequencyrange |
| 4 | Inputimpedance | Over 10 M ohm | Over 50 M ohm | Improved noisehandling |
| 5 | Input signal | Both analog and digitalsignal | Analog signal | Digital input added. |
| 6 | Commonmoderejectionratio | Over 100 db | Over 90 db | Higher noisereduction range |
| 7 | Timeconstant | Over 3.2 sec | Over 3.2 sec | Identical |
| 8 | A/Dconversion | 13 bit | 12 bit | Higher resolution |
| 9 | Samplingrate | 1,000 samples/sec | 500 samples/sec | Doubled samplingrate |
| 10 | Pacemakerpulsedetection | 10,000 samples/sec | None | Pacemaker pulsedetection function isadded (Att. 13-2). |
| 11 | Signalamplituderesolution | 2.44 µV | 4.88 µV | Higher resolution |
| 12 | Paper speed | 10, 12.5, 25, 50 mm/sec | 5, 12.5, 25, 50 mm/sec | The paper speed of 5mm/sec available forKenz Cardico 1201 isdeleted. Instead, thepaper speed of 10mm/sec is added forKenz Cardico 1211. |
| 13 | Recordingsensitivity | 2.5, 5, 10, 20 mm/mV | 5, 10, 20 mm/mV | The recordingsensitivity 2.5mm/mV is added. |
| 14 | Writing system | Thermal head (8 dots/mm) | Thermal head (8 dots/mm) | Identical |
| 15 | Power source | AC 110-240 V | AC 100-110, 220-240 V | Equivalent |
| 16 | Mode of operation | AutoManualLong-time | AutomaticManualLong-term | Equivalent |
| 17 | Battery operation | Nickel hydride battery, DC 12 V 3,700 mAh | None | The battery-drive mode is added for more versatility. |
| 18 | Internal memory | 1,000 ECG data storage | None | The memory data function is added. |
| 19 | ECG interpretation software | Equipped with software, reflecting the results of many ECG clinical studies published after the development of the ECG interpretation software of Kenz Cardico 1201. | Equipped with ECG interpretation software which was developed and completed by 1987. | Diagnostic performance of Kenz Cardico 1211 is non-inferior to the Kenz Cardico 1201 (Att. 18-1). |
| 20 | Patient cable | Yes | Yes | Both devices require a Patient Cable |
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The main difference between the two devices is that the subject device (Kenz Cardico 1211) has ECG interpretive software that reflects many ECG clinical studies published after the development of the ECG interpretation software of the Kenz Cardico 1201. However, Kenz Cardico 1211 does not introduce a new scientific technology. Performance testing demonstrates that the automated diagnostic performance of Kenz Cardico 1211 is non-inferior to the predicate device, Kenz Cardico 1201.
10. Summary of Device Testing
10-1. Electrical safety and electromagnetic compatibility
Testing reports on the electrical safety and electromagnetic compatibility of Kenz Cardico 1211 device indicated its full compliance with the following standards.
-
- IEC 60601-1: 2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
- IEC 60601-1-2: 2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
-
- IEC 60601-2-25: 2011, Medical electrical equipment Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs
-
- ANSI/AAMI EC11: 2007, Diagnostic electrocardiograph devices
-
- ANSI/AAMI EC53: 2013, ECG trunk cables and patient lead wires
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K172068
10-2. Diagnostic performance testing
Diagnostic performance of Kenz Cardico 1211 (Cardico 1211 hereafter) and its predicate device, Kenz Cardico 1201 (Cardico 1201 hereafter) in ECG interpretation was tested in a total of 2,451 ECGs recorded from 2,451 subjects. Interpretive statements were classified as Type A, B and C according to the Tenth Bethesda Conference Report, 1978 (Att. 18-1).
Statistical analysis was carried out separately in Type A, B and C statements (see a Table below). Reference of truth employed in the performance evaluation was "Cardiologist Consensus" or "Clinical Truth" for the Type A statements, and "Cardiologist Consensus" for all the Type B and Type C statements. Creation of Cardiologist Consensus is described in detail in Att. 18-1.
| Statement | Database | Analysis | Reference |
|---|---|---|---|
| Type A | CSE Database | Total Agreement (Non-inferiority test)Sensitivity/Specificity (95% CI) | Cardiologist Consensus |
| Suzuken Database-2 | Sensitivity/Specificity (95% CI) | Cardiologist Consensus | |
| (Acute MI) | Sensitivity/Specificity (95% CI) | Clinical Truth | |
| Type B | CSE Database +Suzuken Database-1 | Sensitivity/Specificity (95% CI) | Cardiologist Consensus |
| Suzuken Database-3(Pacemaker rhythm) | Sensitivity/Specificity (95% CI)* | Cardiologist Consensus | |
| Type C | CSE Database +Suzuken Database-1 | Sensitivity/Specificity (95% CI) | Cardiologist Consensus |
CSE: Common Standards for Electrocardiography
*Not applicable to Cardico 1201, which is not equipped with pacemaker pulse detection circuit.
The ECGs from the CSE Database were used to test the statistical hypothesis that Cardico 1211 is non-inferior to Cardico 1201 in the performance of diagnosis for Type A statements. Total agreement of Cardico 1211 with Cardiologist Consensus was greater than that of Cardico 1201, giving rise to an overall sensitivity of 93.1% for Cardico 1211 vs. 76.1% for Cardico 1201. In addition, the Cardico 1211 had a higher sensitivity than did the Cardico 1201 for most individual statement of Type A, B and C, while the specificities of the two devices tended to be similar. The results demonstrate substantial equivalence of the Cardico 1211 to the Cardico 1201 in diagnostic performance.
11. Conclusions
Based on the statistical results derived from the study conducted by Suzuken Co., Ltd. we conclude that the Kenz Cardico 1211 is substantially equivalent to the predicate device, Kenz Cardico 1201.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).