(21 days)
Not Found
No
The device description explicitly states that the recorder performs no cardiac analysis by itself and is intended to be used with separate analysis software. There is no mention of AI or ML in the description of the recorder's function.
No
The device is a diagnostic tool that records ECG data; it does not provide any treatment or therapy.
No
Explanation: The device is explicitly stated to "perform no cardiac analysis by itself" and is "not capable of any diagnosis nor can it provide any interpretation of the data." Its purpose is to record and store ECG data for analysis by separate software and evaluation by a trained medical professional.
No
The device description clearly states that the CM 3000-12 is a "Holter recorder" which is a physical hardware device that acquires, digitizes, and stores ECG data. It has a keypad, LCD screen, uses batteries, and a removable memory card. While it works in conjunction with software (CardioDay®), the device itself is hardware.
Based on the provided text, the CardioMem® CM 3000-12 digital Holter recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CardioMem® CM 3000-12 Function: The description clearly states that the CardioMem® CM 3000-12 is a Holter recorder that records ECG data. It does not analyze or process biological specimens. Its function is to acquire and store electrical signals from the heart.
- Analysis is Separate: The text explicitly mentions that the device performs no cardiac analysis by itself and is intended to be used with the separate analysis software CardioDay®. The analysis and interpretation are done on a PC using the software and by trained medical professionals.
Therefore, the CardioMem® CM 3000-12 is a medical device used for recording physiological data (ECG), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.
Indications for Use: The CardioMem® CM 3000-12 is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.
Product codes
MWJ
Device Description
The CM 3000-12 is a Holter recorder designed to be used in conjunction with the evaluation software CardioDay® (not included in this 510(k)). This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. The CM 3000-12 acquires, digitizes and stores data to be analyzed by CardioDay". The CM 3000-12 uiliizes a 10-lead electrode hookup and placement to provide CardioDay® with 12 channels of full disclosure for H analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12 Holter recorder stores 12 ECG channels continuously for up to 48-hours. A keypad is available to set up system configuration, to enter patient's ID and name, to check lead quality during hook-up. and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12 has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hook-up technician. The CM 3000-12 uses one or two AA batteries, and a removable memory card for data storage.
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
Not Found
Intended User / Care Setting
The CardioMem® CM 3000-12 is intended to be used with the analysis evaluation software CardioDay®. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.
Federal law restricts CardioMem® CM 3000-12 to use on order of a physician.
This device is available only upon the order of a physician or other licensed medical professional.
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)
Quality system regulation 21 CFR 820 (outlined by the FDA) is a basis for the development of the CardioMem® CM 3000-12 Holter recorder. This recorder is safe and effective for the application for which it is intended and has been tested (environmental and safety tests, including EMC (Electromagnetic Compatibility) tests, according to the IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-47 and ANSI/AAMI EC 38:1998 standards) to confirm the safety and efficacy of the recorder.
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
Abbreviated 510(k) Notification
♥ geter
CardioMem® CM 3000-12
510(k) - Summary
Project ID: 0404H1
Section 16-0001-Rev B
| Submitted By: | getemed AG
Oderstr. 59
14513 Teltow
Germany
Tel.: +49 3328 - 3942-0
Fax: +49 3328 - 3942-99 | JUL 1 4 2005 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Dr. Bert Schadow
Regulatory Affairs Manager | |
| Manufacturing Facility: | getemed Medizin- und Informationstechnik AG
Oderstr. 59
14513 Teltow
Germany | |
| Date of Preparation: | 2005-05-25 | |
| Trade Name: | CardioMem® CM 3000-12 Holter recorder | |
| Common Name: | Holter recorder | |
| Classification Name: | Electrocardiograph, ambulatory (without Analysis) | |
| Product Classification: | 21 CFR 870.2800, Class II | |
| Product Code: | MWJ | |
| Legally Marketed Devices: | DR180+ Holter recorder (K004007, NorthEast
Monitoring, Inc.)
H12+ Holter recorder (K021373, Mortara Instrument
Inc.)
CardioID+ (RZ 153+) Holter recorder (K022540,
Rozinn Electronics. Inc.) | |
Reason for Submission
510(k) - Summary
Premarket notification (Abbreviated 510(k)) for CardioMem® CM 3000-12, a New Device, seeking authority to market the device under Section 510(k) as a device that is substantially equivalent to the DR180+ Holter recorder (K004007, NorthEast Monitoring, Inc.), the H12+ Holter recorder (K021373, Mortara Instrument, Inc.) and CardioID+ (RZ 153+) Holter recorder (K022540, Rozinn Electronics, Inc.).
Device Description
The CM 3000-12 is a Holter recorder designed to be used in conjunction with the evaluation software CardioDay® (not included in this 510(k)). This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. The CM 3000-12 acquires, digitizes and stores data to be analyzed by CardioDay". The CM 3000-12 uiliizes a 10-lead electrode
hookup and placement to provide CardioDay® with 12 channels of full disclosure for H analysis. The cardiac data provided by CardioDay® is used by trained medical personnel to assist in the diagnosis of patients with various rhythm patterns. The CM 3000-12 Holter recorder stores 12 ECG channels continuously for up to 48-hours. A keypad is available to set up system configuration, to enter patient's ID and name, to check lead quality during hook-up. and to start the recording. During the recording, the keypad can be used to enter event markers. The CM 3000-12 has a LCD screen to allow ECG display during the hook-up, lead
1
| Abbreviated 510(k) Notification | ● getemed |
|---|---|
| CardioMem® CM 3000-12 | Project ID: 0404H1 |
| 510(k) - Summary | Section 16-0001-Rev B |
quality check, system configuration and various messages for the hook-up technician. The CM 3000-12 uses one or two AA batteries, and a removable memory card for data storage.
Intended use
The CardioMem® CM 3000-12 digital Holter recorder is intended to continuously record up to 48 hours of ECG data on a digital flash memory card. The CardioMem® CM 3000-12 performs no cardiac analysis by itself and is intended to be used with the analysis evaluation software CardioDay®. The recorded data are downloaded to a PC for analysis and following evaluation by a trained physician or health care professional.
Federal law restricts CardioMem® CM 3000-12 to use on order of a physician.
This device is available only upon the order of a physician or other licensed medical professional.
Indications for use
The CardioMem® CM 3000-12 is a Holter recorder which is indicated for patients who may benefit from a long-term continuous electrocardiographic (ECG) recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality.
Comparison of Technology Characteristics
The CardioMem® CM 3000-12 Holter recorder, the DR180+ Holter recorder, the H12+ Holter recorder, and the CardiolD+ (RZ153+) Holter recorder have the following technology specifications:
| Specification | Legally Marketed
Device
DR180+ Holter
recorder | Legally Marketed
Device
H12+ Holter recorder | Legally Marketed
Device
CardiolD+ (R2153+) | New Device
CardioMem
CM3000-12 |
|--------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Online data
monitoring &
alarm | No | No | No | No |
| Patient hookup | 10 ECG electrodes | 10 ECG electrodes | 7 ECG electrodes | 10 ECG electrodes |
| Number of ECG
channels derived | 12 | 12 | 3 | 12 |
| ECG lead names | RA, LA, LL, RL, V1, V2,
V3, V4, V5, V6 | RA, LA, LL, RL, V1, V2,
V3, V4, V5, V6 | Holter configuration per
AAMI EC38 | RA, LA, LL, RL, V1, V2,
V3, V4, V5, V6 |
| A to D sample rate | 720 samples/sec. | 180 samples/sec. | 1024 samples/sec. | 1024 samples/sec. |
| A to D resolution | 12 bit | 20 bit | 12 bit | 12 bit |
| Pacemaker
detection | Yes | Yes | Yes | No |
| Open-Lead
detection | not specified | Yes | Yes | Yes |
| Memory type | CompactFlash™
Memory Card | CompactFlash™
Memory Card | CompactFlash™
Memory Card | CompactFlash™
Memory Card |
| Data transfer
method | Via removable
memory card | Via removable
memory card | Via removable
memory card | Via removable
memory card |
| Memory card data
format | Standard file system | Standard file system | Standard file system | Standard file system |
| Liquid crystal
display (LCD) | Yes | Yes | Yes | Yes |
| Display purpose | Display ECG,
check lead quality,
input patient ID,
display messages | Display ECG,
check lead quality,
input patient ID,
display messages | Display ECG,
check lead quality,
input patient ID,
display messages | Display ECG,
check lead quality,
input patient ID,
display messages |
0404H1-Sec16-0001-RevB-CM3000-12-510k_Summary.doc CONFIDENTIAL AND PROPRIETARY
2
| Abbreviated 510(k) Notification | ||||||
|---|---|---|---|---|---|---|
| CardioMem® CM 3000-12 | Project ID: 0404H1 | |||||
| 510(k) - Summary | Section 16-0001-Rev B | |||||
| Specification | Legally Marketed | |||||
| Device | ||||||
| DR180+ Holter | ||||||
| recorder | Legally Marketed | |||||
| Device | ||||||
| H12+ Holter recorder | Legally Marketed | |||||
| Device | ||||||
| CardiolD+ (RZ153+) | New Device | |||||
| CardioMem | ||||||
| CM 3000-12 | ||||||
| Keyboard | Protected touch keys | |||||
| (membrane) | Protected touch keys | |||||
| (membrane) | Protected touch keys | |||||
| (membrane) | Protected touch keys | |||||
| (membrane) | ||||||
| System | ||||||
| configuration | Check lead quality, | |||||
| input patient ID, | ||||||
| recording mode, | ||||||
| start recording | Check lead quality, | |||||
| input patient ID, | ||||||
| start recording | Check lead quality, | |||||
| input patient ID and | ||||||
| name, | ||||||
| start recording | Check lead quality, | |||||
| input patient ID and | ||||||
| name, | ||||||
| start recording | ||||||
| System | ||||||
| configuration | ||||||
| method | Per keyboard and LCD | |||||
| display | Per keyboard and LCD | |||||
| display | Per keyboard and LCD | |||||
| display | Per keyboard and LCD | |||||
| display | ||||||
| Marker button | Yes | Yes | Yes | Yes | ||
| Size | 125 x 70 x 25 mm | 64 x 91 x 25 mm | 108 x 79 x 22 mm | 108 * 86 * 22 mm | ||
| Weight | 142 g (without battery) | 125 g (without battery) |