(238 days)
The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
- Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.
Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.
The provided document is a 510(k) summary for the Cardio Q50 and Cardio Q70 ECG Analysis System, which includes both ECG and spirometry functions. The document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner you've requested.
However, based on the information provided, I can infer some aspects related to acceptance criteria and how the device's performance is demonstrated:
1. A table of acceptance criteria and the reported device performance
The document does not provide a direct table of acceptance criteria with reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., for the diagnostic algorithms. Instead, it states that the device complies with certain international standards. Compliance with these standards implicitly serves as the acceptance criteria for various aspects of the device's functionality and performance.
| Acceptance Criteria (Implied from Standards Compliance) | Reported Device Performance (Implied from Compliance Statement) |
|---|---|
| ECG Functionality: | |
| Electrical Safety & Essential Performance (IEC 60601-1 Ed 3.2) | Complies |
| Electromagnetic Compatibility (IEC 60601-1-2 Ed 4.1) | Complies |
| Usability (IEC 60601-1-6 Ed 3.1) | Complies |
| Specific Safety for Electrocardiographs (IEC 60601-2-25: 2011) | Complies |
| Performance for Ambulatory ECG Recorders (ANSI AAMI EC53) | Complies |
| Spirometry Functionality: | |
| Spirometers for Forced Expired Volumes (ISO 26782:2009) | Complies |
| Peak Expiratory Flow Meters (ISO 23747:2009) | Complies |
| Software: | |
| Software Development Process & Validation (FDA Guidance) | Software developed, verified, and validated |
| Cybersecurity Management (FDA Guidance) | Implied compliance by citing guidance |
| Biocompatibility: | |
| Cytotoxicity (EN ISO 10993-5) | Complies by reference to standards used |
| Sensitization (EN ISO 10993-10) | Complies by reference to standards used |
| Intracutaneous Reactivity (ISO 10993-10) | Complies by reference to standards used |
2. Sample size used for the test set and the data provenance
The document does not provide details on sample size, data provenance (e.g., country of origin, retrospective/prospective), or demographic information for any test sets used to validate the performance of the Bionet or Glasgow ECG analysis algorithms. It mentions "Non-Clinical Test Summary" and "Clinical Test Summary" but states "Clinical testing is not required." This implies that the device's performance regarding the ECG interpretation algorithm itself was likely established based on prior validation of the algorithms (Bionet algorithm V 3.26 and Glasgow algorithm V 30.4) outside the scope of this specific 510(k) submission, or that the FDA did not require new clinical data for this particular clearance due to substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document because no specific clinical study data is presented for the ECG analysis algorithm. The document mentions that the interpretive analysis "must be confirmed by a qualified medical professional along with other relevant clinical information." This highlights the human-in-the-loop nature of the device's intended use rather than providing details on ground truth establishment for an algorithm's validation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as no specific clinical study data (including ground truth establishment) is detailed in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not indicate that an MRMC comparative effectiveness study was performed or refer to any such study demonstrating the effect size of human readers improving with AI assistance. The device's clearance is based on substantial equivalence to existing devices and compliance with relevant standards, not on a demonstrated improvement in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the document states that the ECG interpretation algorithm provides analytical information that "must be confirmed by a qualified medical professional," it also includes the algorithm as a feature. The compliance with standards like ANSI AAMI EC53 (Ambulatory ECG Recorders) might implicitly cover some standalone algorithm performance metrics, but no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of the algorithms) are explicitly provided in this 510(k) summary. The document focuses on the safety and essential performance of the electrocardiograph system as a whole, rather than the isolated diagnostic performance of its interpretive algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of ground truth used for the validation of the Bionet or Glasgow ECG analysis algorithms, as details of a specific validation study are not included in this submission. For ECG interpretation algorithms, ground truth is typically established through expert consensus by multiple cardiologists, often aided by correlation with other clinical data and patient outcomes.
8. The sample size for the training set
The document does not provide information on the sample size for the training set of the ECG analysis algorithms.
9. How the ground truth for the training set was established
The document does not describe how the ground truth for the training set was established. This information would typically be part of the algorithm's development and validation, which precedes the 510(k) submission for a device incorporating a previously developed or updated algorithm. The document only states the versions of the Bionet (V 3.26) and Glasgow (V 30.4) algorithms being used, implying their prior establishment and validation.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2023
Bionet Co., Ltd. Kyungeun Park Assistant Manager 5F, 61 Digital-ro 31 gil, Guro-gu Seoul, 08375 Korea. South
Re: K231160
Trade/Device Name: Cardio Q50, Cardio Q70 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, BZG Dated: November 17, 2023 Received: November 17, 2023
Dear Kyungeun Park:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer W. Shih -S
Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231160
Device Name Cardio 050. Cardio 070
Indications for Use (Describe)
The Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
- Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatic patients aged 5 and older in general practice, specialist and hospital settings is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV
| 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)
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Image /page/3/Picture/0 description: The image shows the word "bionet" in a stylized font. The first three letters, "bio", are in a light blue color, while the last three letters, "net", are in black. The font is rounded and sans-serif, giving the word a modern and clean appearance. The letters are closely spaced, creating a compact and unified design.
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
April 14, 2023
Submitter's Information [21 CFR 807.92(a)(1)] 2.
- Name of Manufacturer: Bionet Co., Ltd. ●
- Address: 5F, 61 Digital-ro 31 gil, Guro-gu, Seoul, Republic of Korea 08375 ●
- Contact Name: Kyungeun Park / Assistant Manager ●
- Telephone No.: +82-2-6292-6410 ●
- Fax No.: +82-2-6499-7788
- Email Address: kepark@ebionet.com ●
- Registration No.: 3003681187 ●
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device Name | Cardio Q50, Cardio Q70 |
|---|---|
| K Number | K231160 |
| Common Name | Electrocardiograph & Spirometer |
| Regulation Number | 870.2340 / 868.1840 |
| Regulation Name | Electrocardiograph / Diagnostic spirometer |
| Regulation Class | 2 |
| Product Code | DPS / BZG |
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K231160
4. Identification of Predicate Device(s) [21 CFR 807.92[a)(3)[
The identified predicate devices within this submission are shown as follow;
Primary Predicate device
- 510(k) Number: K220535 ●
- Applicant: Bionet Co., Ltd.
- Trade/Device Name Cardio10 ●
- Regulation Number 870.2340 / 868.1840
- Regulation Name: Electrocardiograph / Diagnostic spirometer
- . Regulation Class: ನ
- Product Code: DPS / BZG .
Reference device
●
●
| ● | 510(k) Number: | K160840 |
|---|---|---|
| ● | Applicant: | Cardioline S.p.A |
| ● | Trade/Device Name | ECG100+, ECG200+ |
| ● | Regulation Number | 870.2340 |
| ● | Regulation Name: | Electrocardiograph |
| ● | Regulation Class: | 2 |
| ● | Product Code: | DPS |
The predicate device and reference device have not been subject to a design-related recall.
5. Description of the Device [21 CFR 807.92(a)(4)]
Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.
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Image /page/5/Picture/0 description: The image shows the word "bionet" in a sans-serif font. The first three letters, "bio", are in a light blue color, while the last three letters, "net", are in black. The letters are all lowercase and connected, giving the impression of a single word.
6. Indications for use [21 CFR 807.92(a)(5)]
The Cardio 050 / Cardio 070 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.
- Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
The system provides 12-lead ECG and interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
Sending and receiving ECG data to and from the Hospital Information System is optional.
The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
In addition. the Cardio 050 / Cardio 070 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.
Determination of Substantial Equivalence 7.
The Cardio Q50, Cardio Q70 is substantially equivalent to legally marketed predicate device and reference device with respect to indications for use and technology characteristics.
| Proposed Device | Predicate Device | Reference device | |
|---|---|---|---|
| Product Name | Cardio Q50, Cardio Q70 | Cardio10 | ECG100+, ECG200+ |
| 510(k)Number | K231160 | K220535 | K160840 |
| Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. | Cardioline S.p.A |
| Product Code | DPS / BZG | DPS / BZG | DPS |
| Device Class | 2 | 2 | 2 |
| Common specification | |||
| Indicationsfor Use | The Cardio Q50 / Cardio Q70ECG Analysis System isintended to acquire, analyze,display and record ECGinformation from adult andpediatric populations.* Bionet Algorithm - 3 yearsor older / Glasgow Algorithm- 0 years or olderThe system provides 12-leadECG and interpretiveanalysis. | The Cardio10 ECG AnalysisSystem is intended toacquire, analyze, display, andrecord electrocardiographicinformation from adult andpediatric populations.Pediatric population isdefined as patients betweenthe ages from 3 and less than16 years.Basic systems deliver 12 leadECG's, interpretive analysis, | ECGxxx(z)(+) is a high-performance, multi-channel, interpretativeresting electrocardiograph.The ECG signal is acquiredwith a 10-wires patientcable and is displayed inreal time on a LCD screenintegrated in the device.The electrocardiographcan analyse and store theECG traces, send them toan external peripheral via |
| K231160 | |||
| Proposed Device | Predicate Device | Reference device | |
| The 12-Lead ECGinterpretation algorithmprovides analyticalinformation about thepatient's heart condition,which must be confirmed bya qualified medicalprofessional along with otherrelevant clinical information.Sending and receiving ECGdata to and from the HospitalInformation System isoptional.The Cardio Q50 / Cardio Q70is intended to be used bypersonnel trained inhospitals or medicalprofessional facilities underthe direct supervision of alicensed healthcarepractitioner.In addition, the Cardio Q50 /Cardio Q70 is intended forprescription use only toperform spirometrydiagnostic tests in adults andpediatric patients aged 5 andolder in general practice,specialist and hospitalsettings. The device isintended to be used whatmeasures patient respiratoryparameters including FVC.FEV1/FEV6, SVC, MVV | and can be upgraded toprovide software analysisoptions such as a highresolution signal averaging ofQRS and P wave portions ofthe electrocardiogram. The12-lead ECG interpretivealgorithm provides acomputer-generated analysisof potential patient cardiacabnormalities, which mustbe confirmed by a physicianwith other relevant clinicalinformation.Transmission and receptionof ECG data to and from acentral ECG cardiovascularinformation system isoptional.The Cardio10 is intended tobe used under the directsupervision of a licensedhealthcare practitioner, bytrained operators in ahospital or medicalprofessional's facility.Cardio10 is intended forprescription use only toconduct diagnosticspirometry testing of adultsand pediatric patients, 5years and older, in generalpractice, specialty physician,and hospital settings. Thedevice is intended to be usedas a spirometer whichmeasures patient respiratoryparameters including FVC,COPD, SVC, MVV. | network or via USB, printthe 12 lead ECG inautomatic or manual modeby means of a thermalprinter. ECGxxx(z)(+) isintended for assessmentand diagnosis of cardiacfunctions. In any case theresults of analysisperformed by theelectrocardiograph mustbe validated by a Physician.ECGxxx(z)(+) is intendedfor use in hospitals, inmedical clinics anddoctor's offices of any size.- The device is indicatedfor use to acquire, analyse,display and printelectrocardiograms. - Thedevice is intended toprovide the physician withan automaticinterpretation of the ECGto be reviewed by aphysician. - The device isindicated for use in aclinical setting, by aphysician or by trainedpersonnel who are actingon the orders of a licensedphysician. It is notintended as a sole means ofdiagnosis. - Theinterpretations of ECGoffered by the device areonly significant when usedin conjunction with aphysician overread as wellas consideration of allother relevant patient data.- The device is indicatedfor use on adult andpediatric populations. -The device is not intendedto be used as a vital signsphysiological monitor. | |
| Proposed Device | Predicate Device | Reference device | |
| Battery | Replaceable andRechargeable Lithium Ion,10.8V, 6500mA | Replaceable andRechargeable Lithium Ion,10.8V, 6500mA | Internal rechargeable battery (NiMH), 12Vdc 2200 mAh |
| 10 hours of normal use orprint 350 ECG (12 channelformat at 25mm/s and10mm/mV) or Spiro pages.Battery recharge to full | 10 hours of normal use orprint 350 ECG(12 channelformat at 25mm/s and10mm/mV) or Spiro pages.Battery recharge to full | ||
| capacity in 3 hours. (Thedevice is turned off) | capacity in 3hours. (Thedevice is turned off) | ||
| Data storage | Internal Storage for 500Data : Built- in Memory | Internal Storage for 500data : Built in memory | Up to 100 ECGs |
| Dimension | 1) Main Body- 286(W) x 350(D) x 140(H)mm (Cardio Q50)- 286(W) x 350(D) x 144(H)mm (Cardio Q70) | 1) Main Body- 300(W) x 299(H) x 123(D)mm (monitor tilt down)- 300(W) x 299(H) x237(D)mm | 285 x 204 x 65 mm1.8kg |
| - Approx. 4.5kg (Max) | (monitor tilt up)296- Approx. 4kg | ||
| 2) Spiro Handle- 48(W) x 39(D) x 201(H) | 2) Spiro Handle- 48(W) x 39(D) x 201(H) | ||
| mm- Approx. 250g | mm- Approx. 250g | ||
| TargetPopulation | Adult and pediatric patients | Adult and pediatric patients | Adults and pediatric patients |
| ECG Leads | Simultaneous 12 channelECG and acquisition | Simultaneous 12 channelECG and acquisition | 12 Leads Standard / Cabrera |
| Gain | 2.5, 5, 10, 20, Auto (I | 2.5, 5, 10, 20, Auto (I | 5, 10, 20 mm/mV |
| SamplingRate | Analysis Sampling Rate -500Hz | Analysis Sampling Rate -500Hz | 500 samples/second/channel |
| Digital Sampling Rate -8,000Hz | Digital Sampling Rate -8,000Hz | ||
| Filters | AC (50/60 Hz, -20dB orbetter),Muscle (25~35Hz, -3dB orbetter), | AC (50/60 Hz, -20dB orbetter),Muscle (25~35Hz, -3dB orbetter), | AC (50/60 Hz)diagnostic fully digital highpass filter; adaptive digitalAC interference filter (50/ |
| Proposed Device | Predicate Device | Reference device | |
| Bionet Baseline Drift(0.05Hz, 0.1Hz, 0.2Hz, -3dBor better)Low Pass Filter(off, 40Hz,100Hz, 150Hz) | Base line drift (0.05Hz,0.1Hz, 0.2Hz, -3dB or better),Low pass filter(off, 40Hz,100Hz, 150Hz) | 60 Hz); digital low pass filter muscular filter 25 and 40 Hz (only for display andprinting) | |
| Patient data | ID, Name, Date of Birth, Age,Gender, Height, Weight, Race,Smoke, Department, RoomNo., Study Desc., AccessionNo., Referring Physician | ID, Name, Birthday, Age,Gender, Height, Weight, Race,Smoke, Department, Roomno., Study desc., AccessionNo., Referring Physician | Not known |
| BasicMeasurement&Interpretation | Heart Rate (30~300bpm,±3bpm), PR/RR Int, QRS Dur,QT/QTc Int,P-R-T axis, SV1/RV5/R+SAmpBionet ECG analysisalgorithm(V 3.26),the University of GlasgowECG analysis algorithm(V30.4) | Heart rate(30~300bpm ±3),PR/RR int. , QRS dur., QT/QTcint.,P-R-T axis, SV1/RV5/R+Samp.Bionet ECG analysisalgorithm(V 3.26) | Heart rate(30~300bpm),Average RR, PR interval,QRS duration, QT/QTc int,P-R-T axis, Skolow-Lyonindex, max R[V5]or[V6]and S[V1], J-Tp and Tp-TeintervalsGlasgow resting ECGinterpretation algorithm (V28.6) |
| Spirometer (Option) | |||
| Measuringvalues | - FVC : FVC, FEV1, FEV1/FVC,FEF 0.2-1.2L, FEF 25-75%,FEF 75-85%, PEF, FEF 25%,FEF 50%, FEF 75%, FIVC,FEV6, PEFT, FET 100%, ErrorCode, Extrapolation volume- FEV1/FEV6 : FEV1, FEV6,FEV1/FEV6, LFI- SVC : SVC, TV, ERV, IRV, EC- MVV : MVV, FB, TV | - FVC : FVC, FEV1, FEV1/FVC,FEF 0.2-1.2L, FEF 25-75%,FEF 75-85%, PEF, FEF 25%,FEF 50%, FEF 75%, FIVC,FEV6, PEFT, FET 100%, ErrorCode, Extrapolation volume- COPD : FEV1, FEV6,FEV1/FEV6, LFI- SVC : SVC, TV, ERV, IRV, EC- MVV : MVV, FB, TV | Not Applicable |
| Presentation | Flow Volume loopVolume Time GraphMeasurement values table | Flow Volume loopVolume Time GraphMeasurement values table | |
| Measuringrange | Flow : 0 to 14 L/sVolume : 0 to 12 L | Flow : 0 to 14 L/sVolume : 0 to 12 L | |
| Measuringmethod | Differential pressure method | Differential pressure method | |
| Proposed Device | Predicate Device | Reference device | |
| PredictionEquation | Morris-Polgar, Knudson-ITS,ECCS-Quanjer, Korea CJK,Pereira, GLI-2012 | Morris-Polgar, Knudson-ITS,ECCS-Quanjer, Korea CJK,Pereira, GLI-2012 | |
| Sample Rate | 200 samples/sec | 200 samples/sec | |
| FlowImpedance | < 0.2 mbar s/L at 12 L/s | < 0.2 mbar s/L at 12 L/s | |
| Measuringaccuracy | Complies with ATS2019,ISO26782 and ISO23747 | Complies with ISO26782 andISO23747 |
Comparison of Proposed Device to Predicate Device K220535 and Reference device K160840
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bio
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Image /page/8/Picture/0 description: The image shows the word "bionet" in a sans-serif font. The "bio" part of the word is in a light blue color, while the "net" part is in black. The letters are closely spaced together, creating a compact and modern look.
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Image /page/9/Picture/0 description: The image shows the word "bionet" in a simple, sans-serif font. The "bio" portion of the word is in a light blue color, while the "net" portion is in black. The letters are rounded and have a clean, modern appearance.
The proposed device and primary predicate device (including reference device) are same in Intended use, Patient population, ECG Leads, Gain, Sampling Rate, Filters, Patient data, Basic Measurement, Target population, interpretation and Spirometer functions.
The only differences between the Cardio Q50, Cardio Q70 and the predicate device are Glasgow ECG analysis algorithm version and the dimension of the main body, which do not raise any new concerns with respect to safety or effectiveness. The subject device and predicate device are designed to meet the IEC 60601-2-25, ISO 26782, ISO 23747.
Non-Clinical Test Summary
-
1 Electrical Safety, Electromagnetic Compatibility and Performance:
The Cardio Q50, Cardio Q70 comply with the electrical safety and electromagnetic compatibility requirements established by the standards. -
Testing to confirm compliance with IEC 60601-1 Edition 3.2 2020-08 ● Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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Testing to confirm compliance with 60601-1-2 Edition 4.1 2020-09 ● Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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Testing to confirm compliance with 60601-1-6 Edition 3.1 2013-10 ● Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
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Testing to confirm compliance with IEC 60601-2-25: 2011 ● Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
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Testing to confirm compliance with ISO 26782:2009 Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
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Testing to confirm compliance with ISO 23747:2009 ●
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K231160 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment
of pulmonary function in spontaneously breathing humans
- ANSI AAMI EC53 ●
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- Software Validation
The Cardio Q50, Cardio Q70 contain Moderate level of concern software as firmware. The software was designed and developed according to a software development process and was verified and validated.
Software information is provided in accordance with FDA guidance:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical ● Devices: Guidance for Industry and FDA Staff
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff
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- Biocompatibility
Most of the contents are prepared by being referenced the following standards:
- Cytotoxicity test by EN ISO 10993-5 ●
- Sensitization test by EN ISO 10993-10 ●
- Intracutaneous reactivity test by ISO 10993-10
#95-1 Biocompatibility Flow Chart for Selection of Toxicity tests for 510(k)s, FDA.
Clinical Test Summary
Clinical testing is not required
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
The non-clinical testing demonstrates the subject device (Cardio Q50) is substantially equivalent in terms of technological characteristics to the predicate device (K220535) and Reference device(K160840).
9. Conclusion [21 CFR 807.92(b)(3)]
The Cardio Q50, Cardio Q70 has similar intended use and technical characteristics to the predicate device and reference device. Based on the information summarized above, the Cardio Q50, Cardio 070 is substantially equivalent to the predicate device and reference device and does not raise any new questions regarding safety or effectiveness as compared to the predicate.
§ 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).