(264 days)
No
The summary mentions "interpretive analysis" and a "computer-generated analysis" but does not use terms like AI, ML, deep learning, or neural networks. It describes standard ECG and spirometry analysis and data management features.
No.
This device is described as an ECG analysis system and spirometer used for acquiring, analyzing, displaying, and recording diagnostic information about a patient's cardiac and respiratory function, rather than for treating a disease or condition.
Yes
The device explicitly states its intended use is to "conduct diagnostic spirometry testing" and provides "computer-generated analysis of potential patient cardiac abnormalities," and "provides parameters required for the diagnosis."
No
The device description explicitly mentions it is an "ECG recording machine with 12 channels" and includes details about printing reports and optional internal battery, indicating it is a hardware device with integrated software.
Based on the provided information, the Cardio10 ECG Analysis System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Cardio10's Function: The Cardio10 acquires, analyzes, displays, and records electrocardiographic information (electrical signals from the heart) and measures respiratory parameters through spirometry. These are direct measurements from the patient's body, not examinations of specimens taken from the body.
- Intended Use: The intended use clearly describes the device's function in acquiring and analyzing physiological signals (ECG and spirometry) from patients.
- Device Description: The device description reinforces that it measures and records ECG and spirometry directly from the patient.
Therefore, the Cardio10 falls under the category of a medical device that performs physiological measurements and analysis, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.
Pediatric population is defined as patients between the ages from 3 and less than 16 years.
Basic systems deliver 12 lead ECG's, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients. 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.
Product codes (comma separated list FDA assigned to the subject device)
DPS, BZG
Device Description
Cardio 10 is a device to measure and record ECG of a patient as an ECG recording machine with 12 channels.
It provides parameters required for the diagnosis. ECG records of a patient, and automatic diagnosis and prints ECG records and output report if entering patient or user information and efficiently use them for the chart management. At the same time, it is possible to transmit saved data to the PC connected to the network and manage digital files.
In addition, it is possible to measure ECG by pressing the button only once in consideration of the convenience of a user as much as possible and save, transmit, and print data all at once after completing the automatic diagnosis.
Parameter and automatic diagnosis required on the spirometer record and diagnosis of patients are provided to users while printing the A4 size and Letter size report along with the spirometer records by entering the information of patients or users for the efficient management of chart. At the same time, saved data are delivered to the PC connected to the network managing digital files.
In addition, the battery can be internally saved as an optional component making it feasible to carry and use for checkup while moving.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years.
For spirometry testing: adults and pediatric patients, 5 years and older.
Intended User / Care Setting
Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
For spirometry testing: in general practice, specialty physician, and hospital settings.
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)
Non-Clinical Test Summary:
- Electrical Safety, Electromagnetic Compatibility and Performance: The Cardio 10 comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Testing to confirm compliance with IEC 60601-1:2005/AMD1:2012
- Testing to confirm compliance with IEC 60601-1-2:2014
- Testing to confirm compliance with IEC 60601-1-6:2010
- Testing to confirm compliance with IEC 60601-2-25: 2011
- Testing to confirm compliance with ISO 26782:2009
- Testing to confirm compliance with ISO 23747:2009
- ANSI AAMI EC53
- Software Validation: The Cardio10 contain Major level of concern software as firmware. The software was designed and developed according to a software development process and was verified and validated.
- 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
- Biocompatibility:
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
November 15, 2022
Bionet Co., Ltd. Kyungeun Park Assistant Manager 5F, 61 Digital-ro 31 gil, Guro-gu Seoul. 08375 South Korea
Re: K220535
Trade/Device Name: Cardio10 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS, BZG Dated: October 12, 2022 Received: October 12, 2022
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 (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 located 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.
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; 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 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,
Shruti N. Mistry -S
for
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
2
Indications for Use
510(k) Number (if known) K220535
Device Name Cardio10
Indications for Use (Describe)
The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.
Pediatric population is defined as patients between the ages from 3 and less than 16 years.
Basic systems deliver 12 lead ECG's, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients. 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, 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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3
Image /page/3/Picture/0 description: The image shows the logo for Bionet. The logo consists of the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase as well. Above the word "bionet" is a stylized butterfly with blue wings. The butterfly is positioned slightly to the left of the word "bionet".
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
February 18, 2022
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
Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] 3.
| Trade/Device Name | Cardio10 |
|---|---|
| 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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Image /page/4/Picture/0 description: The image shows the logo for Bionet. The logo features the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase. Above the word "bionet" is a stylized butterfly in a light blue color. The butterfly is positioned so that it appears to be flying upwards and to the right.
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate device
- 510(k) Number: K113306 ●
- Applicant: Bionet Co., Ltd. ●
- Trade/Device Name Cardio7
- Regulation Number 870.2340
- Electrocardiograph Regulation Name:
2
- Regulation Class:
- . DPS Product Code:
Reference device
- . 510(k) Number: K130322
- Applicant: Bionet Co., Ltd.
- Trade/Device Name SPM-300
- Regulation Number 868.1840
- Regulation Name: Diagnostic spirometer
- Regulation Class: 2
- Product Code: BZG ●
The predicate device and reference device has not been subject to a design-related recall.
5. Description of the Device [21 CFR 807.92(a)(4)]
Cardio 10 is a device to measure and record ECG of a patient as an ECG recording machine with 12 channels.
It provides parameters required for the diagnosis. ECG records of a patient, and automatic diagnosis and prints ECG records and output report if entering patient or user information and efficiently use them for the chart management. At the same time, it is possible to transmit saved data to the PC connected to the network and manage digital files.
In addition, it is possible to measure ECG by pressing the button only once in consideration of the convenience of a user as much as possible and save, transmit, and print data all at once after completing the automatic diagnosis.
Parameter and automatic diagnosis required on the spirometer record and diagnosis of patients are provided to users while printing the A4 size and Letter size report along with the spirometer records by entering the information of patients or users for the efficient management of chart. At the same time, saved data are delivered to the PC connected to the network managing digital files.
In addition, the battery can be internally saved as an optional component making it feasible to carry and use for checkup while moving.
K220535 Page 2 / 8
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Image /page/5/Picture/0 description: The image shows the logo for Bionet. The logo features the word "bionet" in a sans-serif font, with the "b" in lowercase and the rest of the letters in lowercase. Above the word "bionet" is a stylized butterfly with a light blue color. The butterfly is positioned so that it appears to be flying upwards and to the right.
6. Indications for use [21 CFR 807.92(a)(5)]
The Cardio10 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.
Pediatric population is defined as patients between the ages from 3 and less than 16 years.
Basic systems deliver 12 lead ECG's, interpretive analysis, and can be upgraded to provide software analysis options such as a high resolution signal averaging of QRS and P wave portions of the electrocardiogram. The 12-lead ECG interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.
The Cardio10 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.
Cardio10 is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients, 5 years and older, in general practice, specialty physician, and hospital settings. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, COPD, SVC, MVV.
7. Determination of Substantial Equivalence
The Cardio10 is substantially equivalent to legally marketed predicate devices with respect to indications for use and technology characteristics.
| Subject Device | Predicate Device | |
|---|---|---|
| Product Name | Cardio10 | Cardio7 |
| 510(k) Number | K220535 | K113306 |
| Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. |
| Product Code | DPS | DPS |
| Device Class | 2 | 2 |
| Indications for | ||
| Use | The Cardio10 ECG Analysis System is | |
| intended to acquire, analyze, display, | ||
| and record electrocardiographic | ||
| information from adult and pediatric | ||
| populations. Pediatric population is | ||
| defined as patients between the ages | ||
| from 3 and less than 16 years. | ||
| Basic systems deliver 12 lead ECG's, | ||
| interpretive analysis, and can be | ||
| upgraded to provide software | ||
| analysis options such as a high | ||
| resolution signal averaging of QRS | Cardio7 is intended for use as a | |
| diagnostic tool by trained operators | ||
| in health facilities. It provides the | ||
| following functions: | ||
| • Acquire ECG waveform data from | ||
| up to twelve (12) leads through | ||
| surface electrodes adhered to the | ||
| patient's body. | ||
| • Input patient data. | ||
| • View, store and print captured | ||
| data. | ||
| Subject Device | Predicate Device | |
| and P wave portions of the | ||
| electrocardiogram. The 12-lead ECG | ||
| interpretive algorithm provides a | ||
| computer-generated analysis of | ||
| potential patient cardiac | ||
| abnormalities, which must be | ||
| confirmed by a physician with other | ||
| relevant clinical information. | ||
| Transmission and reception of ECG | ||
| data to and from a central ECG | ||
| cardiovascular information system is | ||
| optional. | ||
| The Cardio10 is intended to be used | ||
| under the direct supervision of a | ||
| licensed healthcare practitioner, by | ||
| trained operators in a hospital or | ||
| medical professional's facility. | ||
| Cardio10 is intended for | ||
| prescription use only to conduct | ||
| diagnostic spirometry testing of | ||
| adults and pediatric patients, 5 years | ||
| and older, in general practice, | ||
| specialty physician, and hospital | ||
| settings. The device is intended to be | ||
| used as a spirometer which | ||
| measures patient respiratory | ||
| parameters including FVC, COPD, | ||
| SVC, MVV. | • Analyze captured data; display | |
| and print analysis results. | ||
| • Retain captured data and analysis | ||
| results for up to 120 patients. | ||
| • Transfer retained data to a PC | ||
| (via server IP) or directly to | ||
| insertable USB memory. | ||
| Target | ||
| Population | Adult and pediatric patients | Adult and pediatric patients |
| ECG Leads | Simultaneous 12 channel ECG and | |
| acquisition | Simultaneous 12 leads resting ECG | |
| connect directly to Cardio7 system | ||
| unit | ||
| Gain | 2.5, 5, 10, 20, Auto (I~aVF: 10, | |
| V1~V6: 5) mm/mV | 2.5, 5, 10, 20, auto(I~aVF: 10, | |
| V1~V6: 5) mm/mV | ||
| Sampling Rate | Analysis Sampling Rate – 500Hz | |
| Digital Sampling Rate -8,000Hz | 500 samples/sec/channel | |
| Filters | AC (50/60 Hz, -20dB or better), | |
| Muscle (25~35Hz, -3dB or better), | ||
| Base line drift (0.05Hz, 0.1Hz, 0.2Hz, | ||
| -3dB or better), | AC (50/60 Hz, -20dB or better), | |
| Muscle (25~35Hz, -3dB or better), | ||
| Base line drift (0.1Hz, -3dB or better), | ||
| Subject Device | Predicate Device | |
| Low pass filter(off, 40Hz, 100Hz, | ||
| 150Hz) | Low pass filter(off, 40Hz, 100Hz, | |
| 150Hz) | ||
| Patient data | ID, Name, Birthday, Age, Gender, | |
| Height, Weight, Race, Smoke, | ||
| Department, Room no., Study desc., | ||
| Accession No.,Referring Physician | ID, Name, Age, Gender, Height, | |
| Weight, Race, Smoke | ||
| Basic | ||
| Measurement | Heart rate(30~300bpm ±3), PR/RR | |
| int., QRS dur., QT/QTc int., | ||
| P-R-T axis, SV1/RV5/R+S amp. | Heart rate, PR int, QRS dur, QT/QTc, | |
| P-R-T axis | ||
| Battery | 10 hours of normal use or print 350 | |
| ECG(12 channel format at 25mm/s | ||
| and 10mm/mV) or Spiro pages. | ||
| Battery recharge to full capacity in | ||
| 3hours. (The device is turned off) | 1 hours of normal use or print 100 | |
| ECG pages. | ||
| Battery recharge to full capacity in | ||
| 4hours. (The device is turned off) | ||
| Data storage | Internal Storage for 500 data : Built | |
| in memory | Internal Storage for up to 120 ECG | |
| Additional storage available using | ||
| built in SD RAM slot | ||
| Dimension | 300(W) x 299(H) x 123(D) mm | |
| (monitor tilt down) | ||
| 300(W) x 299(H) x 237(D) mm | ||
| (monitor tilt up) | ||
| Approx.4kg(Main Body) | 296 x 305 x 92 mm | |
| Approx. 3.5kg |
Comparison of Subject Device to Predicate Device K113306
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Image /page/6/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized blue butterfly above the word "bionet" in a sans-serif font. The butterfly is a light blue color and appears to be in flight. The word "bionet" is in black and is written in lowercase letters.
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Image /page/7/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized butterfly in a light blue color, positioned above the word "bionet" in a bold, black sans-serif font. The butterfly is designed with three distinct sections, resembling wings, and is oriented towards the upper left.
Comparison of Subject Device to Reference Device K130322
| Subject Device | Reference Device | |
|---|---|---|
| Product Name | Cardio10 | SPM-300 |
| 510(k) Number | K220535 | K130322 |
| Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. |
| Product Code | DPS | BZG |
| Device Class | 2 | 2 |
| Indications for | ||
| Use | The Cardio10 ECG Analysis System is | |
| intended to acquire, analyze, display, | ||
| and record electrocardiographic | ||
| information from adult and pediatric | ||
| populations. Pediatric population is | ||
| defined as patients between the ages | ||
| from 0 and less than 16 years. | ||
| Basic systems deliver 12 lead ECG's, | ||
| interpretive analysis, and can be | ||
| upgraded to provide software | The SPM-300 Spirometer is intended | |
| for prescription use only to conduct | ||
| diagnostic spirometry testing of | ||
| adults and pediatric patients in | ||
| general practice, specialty physician. | ||
| and hospital settings. | ||
| Subject Device | Reference Device | |
| analysis options such as a high | ||
| resolution signal averaging of QRS | ||
| and P wave portions of the | ||
| electrocardiogram. The 12-lead ECG | ||
| interpretive algorithm provides a | ||
| computer-generated analysis of | ||
| potential patient cardiac | ||
| abnormalities, which must be | ||
| confirmed by a physician with other | ||
| relevant clinical information. | ||
| Transmission and reception of ECG | ||
| data to and from a central ECG | ||
| cardiovascular information system is | ||
| optional. | ||
| The Cardio10 is intended to be used | ||
| under the direct supervision of a | ||
| licensed healthcare practitioner, by | ||
| trained operators in a hospital or | ||
| medical professional's facility. | ||
| Cardio10 is intended for | ||
| prescription use only to conduct | ||
| diagnostic spirometry testing of | ||
| adults and pediatric patients, 5 years | ||
| and older, in general practice, | ||
| specialty physician, and hospital | ||
| settings. The device is intended to be | ||
| used as a spirometer which | ||
| measures patient respiratory | ||
| parameters including FVC, COPD, | ||
| SVC, MVV. | ||
| Target | ||
| Population | Adult and pediatric patients | Adult and pediatric patients |
| Measuring | ||
| values | - 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%, Error | ||
| Code, Extrapolation volume |
- COPD : 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%, - SVC : SVC, TV, ERV, IRV, EC, IC, RV
- MVV : MVV, FB, TV |
| Presentation | Flow Volume loop
Volume Time Graph
Measurement values table | Volume/Time curve
Flow/Volume curve
Measurement Values Table |
| | Subject Device | Reference Device |
| Measuring range | Flow : 0 to 14 L/s
Volume : 0 to 12 L | Flow : 0 to ± 14 L/s
Volume : 0 to + 11 L |
| Measuring
method | Differential pressure method | Differential pressure method |
| Measuring
accuracy | Complies with ISO26782 and
ISO23747 | Complies with ISO26782 and
ISO23747 |
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Image /page/8/Picture/0 description: The image shows the logo for Bionet. The logo features a stylized butterfly in a light blue color, positioned above the word "bionet" written in a bold, black sans-serif font. The butterfly has a simple, modern design, and the overall logo has a clean and professional appearance.
9
Image /page/9/Picture/0 description: The image shows the logo for "bionet". The logo features the word "bionet" in a sans-serif font, with the letters in black. Above the word "bionet" is a stylized butterfly in a gradient of blue. The butterfly is positioned to the left of the word, giving the logo a clean and modern look.
The Cardio 10 and predicate devices are similar in their target population, functions, technical characteristics includes ECG leads, Gain, Sampling rate, measurement, etc.
Differences between Cardio10 and the predicate device such as base line drift of filter, type of patient data, measuring range, and dimension 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 10 comply with the electrical safety and electromagnetic compatibility requirements established by the standards. -
Testing to confirm compliance with IEC 60601-1:2005/AMD1:2012 ● Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
. Testing to confirm compliance with IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
-
Testing to confirm compliance with IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
-
Testing to confirm compliance with IEC 60601-2-25: 2011 . Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
-
Testing to confirm compliance with ISO 26782:2009 Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
-
. Testing to confirm compliance with ISO 23747:2009 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the
10
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assessment of pulmonary function in spontaneously breathing humans
- ANSI AAMI EC53
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- Software Validation
The Cardio10 contain Major 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 (Cardio10) is substantially equivalent in terms of technological characteristics to the predicate device (K113306) and reference device (K130322).
9. Conclusion [21 CFR 807.92(b)(3)]
The Cardio10 has similar intended use and technical characteristics to the predicate device. Based on the information summarized above, the Cardio10 is substantially equivalent to the predicate device and does not raise any new questions regarding safety or effectiveness.