(268 days)
Not Found
No
The summary explicitly states, "The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data." and there are no mentions of AI, DNN, or ML.
No.
The device is described as a recorder system for acquiring ECG signals and does not perform any analysis or offer treatment.
Yes
The device is described as a "Holter Recorder System" and is "intended to acquire ambulatory 2 or 3 channel ECG signals...from the chest surface." This data collection is for diagnostic purposes, even though the device itself "does not perform any analysis of the ECG data," as the data is then used by a licensed healthcare practitioner.
No
The device description explicitly mentions a "Compact Digital Holter Recorder System" which is a physical device that acquires and stores ECG data. It also mentions a "Cardy Controller02" which is used to download and check data. This indicates the system includes hardware components beyond just software.
Based on the provided information, the Cardy302Max Compact Digital Holter Recorder System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Cardy302Max Function: The Cardy302Max acquires ECG signals directly from the chest surface of a patient. This is a non-invasive procedure performed on the living body (in vivo). It records electrical activity of the heart, not analyzes samples taken from the body.
- Intended Use: The intended use clearly states it acquires "ambulatory 2 or 3 channel ECG signals from the chest surface." It does not mention any analysis of biological samples.
- Device Description: The description reinforces that it acquires "ECG signal from the chest surface."
- Lack of Sample Handling: There is no mention of handling or analyzing biological samples in the description or intended use.
Therefore, the Cardy302Max falls under the category of a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card.
The Cardy302Max Compact Digital Holter Recorder System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.
The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data.
The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.
Product codes (comma separated list FDA assigned to the subject device)
MWJ
Device Description
The Cardy302Max Compact Digital Holter System is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for up to 48 hours. The device stores the acquired ECG data on its removable memory card.
The Cardy Controller02 downloads patient demographic information into the Cardy302Max Compact Digital Holter Recorder and allows the user to check the signal quality of the ECG data at hookup time. At the end of recording, the ECG data can be transferred to the controller by removing the SD memory card from the recorder and installing it into the Cardy Controller02.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest surface
Indicated Patient Age Range
pediatric or adult patients
Intended User / Care Setting
trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.
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)
Testing reports demonstrate successful outcomes to compliance testing to the voluntary standards listed below. These successful outcomes indicate that the Cardy302Max meets the (1) general requirements for safety, (2) electromagnetic compatibility, and (3) particular requirements for safety, including essential performance, for ambulatory electrocardiographic systems for medical electrical equipment.
(1) IEC 60601-1 (2) IEC 60601-1-2 (3) IEC 60601-2-47
The following quality assurance measures were applied to the development of this device.
-
- Risk Analysis
-
- Requirement Reviews
-
- Design Reviews
-
- Testing on Unit Level (Module Verification)
-
- Integration Testing (System Verification)
-
- Final Acceptance testing (Validation)
-
- Performance Testing
-
- Safety Testing
-
- Environmental Testing
Independent water ingress testing was successfully conducted in accordance with IEC 60529: 2001 for IPX5, X8H for the Cardy302Max device.
Software verification and validation testing was conducted, which demonstrated that all modes and functions of the Cardy302Max device operated as designed and in accordance with the indications for use.
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.
SEER Light Extend (K050731)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K101024
pg 1 of 2
5. 510(k) SUMMARY
·
| Submitter: | Suzuken Co., Ltd.
8 Higashikataha-machi Higashi-ku
Nagoya, Aichi, Japan 461-0015 | JAN - 6 2011 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mr. Shuji Funahashi
Senior Manager, Kenz Product Development R&D Section
TEL: +81-52-701-4402
FAX: +81-52-703-0914
s.funahashi@suzuken.co.jp | |
| Date Prepared: | December 7, 2010 | |
| Trade Name: | Kenz® Cardy302Max Digital Holter System | |
| Common Name: | Digital Ambulatory Holter Recorder | |
| Classification
Name: | Electrocardiograph, Ambulatory (without analysis)
Medical Magnetic Tape Recorder | |
| Predicate Device: | SEER Light Extend (K050731) | |
| Device Description: | The Cardy302Max Compact Digital Holter System is designed to acquire
ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric
or adult patients for up to 48 hours. The device stores the acquired ECG data
on its removable memory card.
The Cardy Controller02 downloads patient demographic information into the
Cardy302Max Compact Digital Holter Recorder and allows the user to check
the signal quality of the ECG data at hookup time. At the end of recording,
the ECG data can be transferred to the controller by removing the SD
memory card from the recorder and installing it into the Cardy Controller02. | |
| Statement of
Intended Use: | The Cardy302Max Compact Digital Holter Recorder System is intended to
acquire ambulatory 2 or 3 channel ECG signals from the chest surface of
pediatric or adult patients. The device stores this data along with patient
demographic information onto a removable SD memory card.
The Cardy302Max Compact Digital Holter Recorder System is intended to
be used by trained operators under the direct supervision of a licensed
healthcare practitioner in a hospital or medical professional's facility.
The Cardy302Max Compact Digital Holter Recorder System does not
perform any analysis of the ECG data.
The Cardy302Max Compact Digital Holter Recorder System is not intended
for use on patients weighing less than 10 kg. | |
1
K101024
pg 2 of 2
Summary of Technological Characteristics: The proposed Compact Digital Holter Recorder System employs the same functional scientific technology as the predicate device SEER Light Extend Compact Digital Holter System (K050731).
Summary of Test Data:
Testing reports demonstrate successful outcomes to compliance testing to the voluntary standards listed below. These successful outcomes indicate that the Cardy302Max meets the (1) general requirements for safety, (2) electromagnetic compatibility, and (3) particular requirements for safety, including essential performance, for ambulatory electrocardiographic systems for medical electrical equipment.
(1) IEC 60601-1 (2) IEC 60601-1-2 (3) IEC 60601-2-47
The following quality assurance measures were applied to the development of this device.
-
- Risk Analysis
-
- Requirement Reviews
-
- Design Reviews
-
- Testing on Unit Level (Module Verification)
-
- Integration Testing (System Verification)
-
- Final Acceptance testing (Validation)
-
- Performance Testing
-
- Safety Testing
-
- Environmental Testing
Independent water ingress testing was successfully conducted in accordance with IEC 60529: 2001 for IPX5, X8H for the Cardy302Max device.
Software verification and validation testing was conducted, which demonstrated that all modes and functions of the Cardy302Max device operated as designed and in accordance with the indications for use.
Conclusion:
The documented design output, device labeling, and test results demonstrate that the Cardy302Max Compact Digital Holter System is equivalent to the predicate device regarding safety, effectiveness, and performance.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Suzuken Co. Ltd. c/o Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Suite 280 Richardson, TX 75080
JAN - 6 2011
Re: K101024
Trade/Device Name: Cardy302Max Digital Holter System Regulation Number: 21 CFR 870.2800 Regulation Name: Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: December 7, 2010 Received: December 8, 2010
Dear Ms. Rutherford:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Ms. Diane Rutherford
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification".(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
JAN - 6 2011
510(k) Number: K101024
Page: 1 of 1
Device Name: Cardy302Max Compact Digital Holter Recorder System
Indications for Use:
The Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card.
The Cardy302Max Compact Digital Holter Recorder System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility.
The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data.
The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
W.M.D.
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K101024