(667 days)
Not Found
No
The document explicitly states that the device "does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis." It also does not mention AI, DNN, or ML in the relevant sections.
No.
The device is described as an ambulatory ECG recorder intended for long-term recording and viewing of ECG information, with no stated therapeutic function.
No
The device is an ECG recorder that saves and views ECG information, but it explicitly states that it "does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis" and that the real-time display is "not intended for any clinical or diagnostic use."
No
The device description explicitly lists "AT-Patch device" as a component, which is a hardware device attached to the skin surface to acquire and store ECG data. It also includes a dedicated cable, BLE dongle, and USB memory, all of which are hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body. The core function of an IVD is to examine biological samples like blood, urine, tissue, etc., to provide information about a patient's health.
- This device measures a physiological signal from the body. The device directly measures the electrical activity of the heart (ECG) by attaching to the skin surface. It is recording a signal generated by the body itself, not analyzing a sample taken from the body.
The device's purpose is to record and store ECG data for later review, which falls under the category of a physiological monitoring device or an ECG recorder.
N/A
Intended Use / Indications for Use
The device is intended to measure, save, and view continuous electrocardiogram (ECG) information for long-term recording (up to 14 days) from ambulatory patients by attaching to the skin surface. ECG records are stored in the the device for review after the recording period (up to 14 days) is completed, and are not intended for for real-time monitoring. The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis. The device allows patient and clinicians to view the ECG signal recorded in real-time solely for the purpose of visual assessment of the recording quality; the ECG signal displayed in real time is not intended for any clinical or diagnostic use. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.
Product codes
DSH
Device Description
AT-Patch consists of 1) AT-Patch device, 2) Software for ECG viewing (ATR-C130), 3) App (ATN-C130) that communicates with the device and allows the patient to view the ECG waveform for visual assessment of the recording quality, and included parts (Dedicated Cable, BLE Dongle and USB memory).
AT-Patch an ambulatory ECG recorder, designed to continuously acquire and store patient's ECG for up to 14 days. The AT-Patch can connect to the device applicaitn (ATN-C130) torecord symptoms with the App during operation and to check the ECG recording. The device is not intended for real-time monitoring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin surface
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Patient and clinicians / Ambulatory
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)
- Electrical Testing and EMC Testing: Performed in accordance with IEC 60601-1:2005/2012, IEC 60601-2-47:2012, IEC 60601-1-2:2020, IEC 60601-1-11:2015. Results met electrical safety and EMC requirements.
- Biocompatibility: Performed in accordance with ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-12:2012, ISO 10993-23:2021(E).
- Sterilization and Shelf life test: Device is not sterile. Shelf life of 1 year, and can be used for up to 14 days.
- ATP-C130 intended using time test: Verified capable of being used for up to 14 days.
- Patch adhesion persistence test: Performed in accordance with ANSI/AAMI EC12:2000 (R2015).
- ECG Electrodes performance test: Performed in accordance with ANSI/AAMI EC12:2000 (R2015).
- Cybersecurity test: Performed in accordance with "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices issued in 2018".
- Extractable Substance Test: Performed for PH, Potassium permanganate reducible substances, Residue on evaporation, UV spectrum and Heavy metals.
- ECG Electrodes test: Performed in accordance with 'ANSI/AAMI EC12:2000(R2015)'.
- Software: Validation evaluated according to IEC62304:2015.
- Energy reduction: Performed using alternative method of IEC 60601-1 Clause 8.5.5.2. Device demonstrated to be safe in case of defibrillation, but is not defibrillation-proof.
- QoS: Performed according to ANSI TIR 69:2017.
- Usability: Formative & summative tests were performed according to IEC 62366-1:2015 and FDA guidance.
- Key results: The test results met the performance requirements. The differences between the subject device and the predicate device do not raise new or different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).
0
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October 12, 2022
ATsens Co., Ltd % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. Seoul 06210 Korea, South
Re: K203638
Trade/Device Name: AT-Patch Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: DSH Dated: September 13, 2022 Received: October 7, 2022
Dear Do Kim:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 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 medical devices and radiation-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 Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203638
Device Name AT-Patch
Indications for Use (Describe)
The device is intended to measure, save, and view continuous electrocardiogram (ECG) information for long-term recording (up to 14 days) from ambulatory patients by attaching to the skin surface. ECG records are stored in the the device for review after the recording period (up to 14 days) is completed, and are not intended for for real-time monitoring. The device does not include automated ECG analysis functions, and the recorded ECGs are not intended for automated analysis. The device allows patient and clinicians to view the ECG signal recorded in real-time solely for the purpose of visual assessment of the recording quality; the ECG signal displayed in real time is not intended for any clinical or diagnostic use. It is indicated for use on patients 18 years or older who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, light-headedness, fatigue, or anxiety.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Preparation Date: October 7, 2022
1. Applicant / Submitter
Applicant/Submitter: ATsens Co.,Ltd/KeonHoon Lee Address: Point Town 803, 11, Gumi-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13637 Korea Tel: +82-70-5220-0220 Fax: +82-70-8270-0738 Email: khlee@atsens.com
2. Submission Contact Person
Contact Person: Do Hyun Kim, BT Solutions, Inc. Address: 904, Eonju-ro 86-gil 5, Gangnam-gu, Seoul, 06210, Republic of Korea Tel: +82-2-538-9140 Fax: +82-2-539-9140 Email: ceo@btsolutions.co.kr
3. Device Information
| Trade Name | AT-Patch |
|---|---|
| Common Name | AT-Patch |
| Classification Name | Medical magnetic Tape Recorder |
| Classification Regulation | 21CFR870.2800 |
| Device Class | 2 |
| Product Code | DSH |
4. Predicate Device
| Manufacturer | iRhythm technologies, Inc. |
|---|---|
| Device Name | Zio SkyRunner(SR) ECG Monitoring service |
| 510(k) number | K143513 |
5. Description
4
AT-Patch consists of 1) AT-Patch device, 2) Software for ECG viewing (ATR-C130), 3) App (ATN-C130) that communicates with the device and allows the patient to view the ECG waveform for visual assessment of the recording quality, and included parts (Dedicated Cable, BLE Dongle and USB memory).
AT-Patch an ambulatory ECG recorder, designed to continuously acquire and store patient's ECG for up to 14 days. The AT-Patch can connect to the device applicaitn (ATN-C130) torecord symptoms with the App during operation and to check the ECG recording. The device is not intended for real-time monitoring.
| ATP-
| C130 | ||
|---|---|---|
| Item | Description | |
| ECG | Type | BF type |
| Sampling Rate | 250 sample/sec | |
| Input Offset Dynamic Range | $\pm$ 300mV | |
| Channel | 1 channel | |
| ADC Resolution | 10 bits | |
| Input Impedance | $\geq$ 10MΩ | |
| Frequency Response | 0.05Hz to 40Hz | |
| Electrode | AC impedance | Less than 3KΩ (10Hz) |
| RF | RF communication | 2.4GHz BLE 4.2 |
| Effective Radiated Power |