Who is the manufacturer of Cardio P1?

Bionet Co., Ltd. filed the 510(k) submission for Cardio P1 (K231150).

What is the FDA product code for Cardio P1?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Cardio P1?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Cardio P1?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cardio P1

K231150 · Bionet Co., Ltd. · DPS · Nov 9, 2023 · Cardiovascular

Device Facts

Record ID	K231150
Device Name	Cardio P1
Applicant	Bionet Co., Ltd.
Product Code	DPS · Cardiovascular
Decision Date	Nov 9, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Cardio P1 Analysis System is intended to acquire, analyze, display, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. 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 P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

Device Story

Cardio P1 is a 12-channel ECG recording system; acquires and records patient ECG signals; provides automated interpretive analysis of heart condition; transmits data to PC for management; optional integration with Hospital Information Systems. Used in hospitals or medical facilities by trained personnel under licensed practitioner supervision. Device connects to a standalone PC; user-oriented design allows examination with single button push. Output consists of ECG records and diagnostic reports; healthcare providers use these to confirm cardiac status and inform clinical decision-making. Benefits include efficient chart management and standardized ECG analysis.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6), performance (IEC 60601-2-25, ANSI AAMI EC53), software validation, and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

12-channel ECG acquisition; 500Hz analysis sampling rate; 8,000Hz digital sampling rate. Includes AC, muscle, baseline drift, and low-pass filters. Software-based analysis using Bionet ECG analysis algorithm (V 3.26). Standalone PC-based architecture. Biocompatible materials per ISO 10993. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-2-25, and ANSI AAMI EC53.

Indications for Use

Indicated for adult and pediatric patients (ages 3 to <16 years) for the acquisition, analysis, display, and recording of 12-lead ECG information. Must be used by trained personnel in clinical settings under the supervision of a licensed healthcare practitioner.

Regulatory Classification

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.

Predicate Devices

Cardio10 (K220535)

Related Devices

K102767 — CARDIO XP · Bionet Co., Ltd. · Jun 3, 2011
K173830 — MAC VU360 Resting ECG Analysis System · Ge Medical Systems Information Technologies, Inc. · Sep 18, 2018
K170182 — CARDIOVIT FT-1 · Schiller AG · Jul 19, 2017
K203786 — MAC 7 - Resting ECG Analysis System · Ge Medical Systems Information Technologies, Inc. · Apr 30, 2021
K251670 — MAC 7 Resting ECG Analysis System · Ge Medical Systems Information Technologies, Inc. · Jan 26, 2026

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other. November 9, 2023 Bionet Co., Ltd. Kyungeun Park – Assistant Manager 5F, 61 Digital-ro 31 gil, Guro-gu Seoul. South Korea 08375 Re: K231150 Trade/Device Name: Cardio P1 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: October 13, 2023 Received: October 13, 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" (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). {1}------------------------------------------------ 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 QS 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, # Stephen C. Browning -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) K231150 Device Name Cardio P1 ### Indications for Use (Describe) The Cardio P1 Analysis System is intended to acquire, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. 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 a qualified medical professional along with other relevant clinical information. Sending ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary [As required by 21 CFR 807.92] ### Date Prepared [21 CFR 807.92(a)[a]] 1. 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 ● ### Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)] 3. | Trade/Device Name | Cardio P1 | |-------------------|--------------------| | K Number | K231150 | | Common Name | Electrocardiograph | | Regulation Number | 870.2340 | | Regulation Name | Electrocardiograph | | Regulation Class | 2 | | Product Code | DPS | {4}------------------------------------------------ ## 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: K220535 ● - Applicant: Bionet Co., Ltd. ● - . Trade/Device Name Cardio10 - Regulation Number 870.2340 / 868.1840 ● - Regulation Name: Electrocardiograph / Diagnostic spirometer ● - Regulation Class: 2 - DPS / BZG ● Product Code: The predicate device has not been subject to a design-related recall. ## 5. Description of the Device [21 CFR 807.92[a](4)] Cardio P1 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 user-oriented design enables ECG examination with a single push of a button. The Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience. ### Indications for use [21 CFR 807.92(a)(5)] 6. The Cardio P1 Analysis System is intended to acquire, analyze, display, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. 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 P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner. {5}------------------------------------------------ Image /page/5/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 letters are rounded and connected, giving the word a smooth and modern appearance. The overall design is simple and clean, with a focus on readability. ### 7. Determination of Substantial Equivalence The Cardio10 is substantially equivalent to legally marketed predicate devices with respect to indications for use and technology characteristics. Comparison of Proposed Device to Predicate Device K220535 | | Proposed Device | Predicate Device | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | Cardio P1 | Cardio10 | | 510(k) Number | K231150 | K220535 | | Manufacturer | Bionet Co., Ltd. | Bionet Co., Ltd. | | Product Code | DPS | DPS / BZG | | Device Class | 2 | 2 | | Indications for Use | The Cardio P1 Analysis System is intended to acquire, analyze, display, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. 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 P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner. | 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. | | | Proposed Device | Predicate Device | | | | 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. | | Data storage | According to connected PC specifications | Internal Storage for 500 data : Built in memory | | Dimension | - 90.75(W) x 103.5(D) x 24.93(H)mm - Approx. 110g | 1) Main Body - 300(W) x 299(H) x 123(D) mm (monitor tilt down) - 300(W) x 299(H) x 237(D)mm (monitor tilt up)296 - Approx.4kg 2) Spiro Handle - 48(W) x 39(D) x 201(H) mm - Approx. 250g | | Target Population | Adult and pediatric patients | Adult and pediatric patients | | ECG | | | | ECG Leads | Simultaneous 12 channel ECG and acquisition | Simultaneous 12 channel ECG and acquisition | | Gain | 2.5, 5, 10, 20, Auto (I~aVF: 10, V1~V6: | 2.5, 5, 10, 20, Auto (I~aVF: 10, V1~V6: | | | Proposed Device | Predicate Device | | | 5) mm/mV | 5) mm/mV | | Sampling Rate | Analysis Sampling Rate – 500Hz Digital Sampling Rate -8,000Hz | Analysis Sampling Rate – 500Hz Digital Sampling Rate -8,000Hz | | Filters | AC (50/60 Hz, -20dB or better), Muscle (25~35Hz, -3dB or better), Baseline Drift (0.05Hz, 0.1Hz, 0.2Hz, -3dB or better), Low Pass Filter(off, 40Hz, 100Hz, 150Hz) | 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), Low pass filter(off, 40Hz, 100Hz, 150Hz) | | Patient data | ID, Name, Date of Birth, Age, Gender, Height, Weight, Race, Smoke, Department, Room No., Study Desc., Accession No., Referring Physician | ID, Name, Date of Birth, Age, Gender, Height, Weight, Race, Smoke, Department, Room no., Study desc., Accession No., Referring Physician | | Basic Measurement | Heart Rate (30~300bpm ±3bpm), PR/RR Int, QRS Dur, QT/QTc Int, P-R-T axis, SV1/RV5/R+S Amp Bionet ECG analysis algorithm(V 3.26) | Heart rate (30~300bpm ±3), PR/RR Int, QRS dur., QT/QTc int., P-R-T axis, SV1/RV5/R+S amp. Bionet ECG analysis algorithm(V 3.26) | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "bionet" in a stylized font. The first three letters, "bio", are in a light blue color. The last three letters, "net", are in black. {7}------------------------------------------------ The Cardio P1 and predicate devices are same in intended use, their target population and technical characteristics includes ECG leads, Gain, Sampling rate, filters, patient data, measurement, etc. Differences between Cardio P1 and the predicate device such as Data storage, dimension do not raise any new concerns with respect to safety or effectiveness. The spirometer function of the predicate device is an optional function that does not affect its main function, ECG. The proposed device and predicate device are both designed to meet the IEC 60601-2-25. ## Non-Clinical Test Summary - 1) Electrical Safety, Electromagnetic Compatibility and Performance: The Cardio P1 comply with the electrical safety and electromagnetic compatibility requirements established by the standards. {8}------------------------------------------------ Image /page/8/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 connected and form a single word. - 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 - ANSI AAMI EC53 ● - 2) Software Validation The Cardio P1 contain moderate level of concern software and 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 - 3) 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. {9}------------------------------------------------ Image /page/9/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 rounded and have a modern appearance. The word is presented horizontally. ## 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 P1) is substantially equivalent in terms of technological characteristics to the predicate device (K220535). ### Conclusion [21 CFR 807.92(b)(3)] 9. The Cardio P1 has same intended use and technical characteristics to the predicate device. Based on the information summarized above, the Cardio P1 is substantially equivalent to the predicate device and does not raise any new questions regarding safety or effectiveness.