(239 days)
The CardioMem® CM 3000-12BT is a Hotter 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.
The CM 3000-12BT is a Holler recorder designed to be used in conjunction with the evaluation software GardioDay® (K051471). This recorder is not capable of any diagnosis nor can it provide any interpretation of the clata. The CM 3000-12BT acquires, digitizes and stores data to be analyzed by CardioDay®. The CM 3000-12BT uitlizes a 10-lead electrode hookup and placement to provide CardioDay" with 12 channels of full disclosure for Holler 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 3000-12BT Holter recorder stores 12 ECG channels continuously for up to 48-hours including the detection of pacemaker pulses. A keyped is available to set up system contiguration, 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 3000-12BT has a LCD screen to allow ECG display during the hook-up, lead quality check, system configuration and various messages for the hock-up technician. The CM 3000-12BT uses one or two AA batterles, and a removable memory card for data storage.
ECG data and palient data can be Iransmitted via a Bluetooth connection (BT module from Amber wireless GmbH) from the CM 3000-12BT to CardidDay" and also from CardioDay® to the CM 3000-12BT
Here's an analysis of the provided text regarding the CardioMem CM 3000-12BT, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific quantitative acceptance criteria or detailed performance metrics from a test study. Instead, it relies on a comparison to predicate devices and adherence to relevant standards. The "New/Modified Device" column serves as the "reported device performance" in this context, compared against the "Legally Marketed Device" columns.
| Specification | Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (CardioMem CM 3000-12BT) |
|---|---|---|
| Online data | No | No |
| Patient hookup | 10 ECG electrodes | 10 ECG electrodes |
| Number of ECG channels desired | 12 | 12 |
| ECG lead names | RA, LA, LL, RL, V1, V2, V3, V4, V5, V6 | RA, LA, LL, RL, V1, V2, V3, V4, V5, V6 |
| A to D sample rate | 1024 samples/sec (from K051686) / 720 samples/sec (from K052556) | 1024 samples/sec |
| A to D resolution | 12 bit | 12 bit |
| Pacemaker detection | No (from K051686) / Not specified (from K052556) | Yes |
| Open-Lead detection | Yes | Yes |
| Memory type | CompactFlash™ Memory Card | CompactFlash™ Memory Card |
| Data transfer method | Via removable memory card | Via removable memory card |
| Online data transfer | Via OptoLink cable OL1000 (from K051686) / Via Bluetooth connection (from K052556) | Via Bluetooth connection or USB connection |
| Memory card data format | Standard file system | Standard file system |
| Liquid crystal display (LCD) | Yes | Yes |
| Display purpose | Display ECG, check lead quality, input patient ID, display messages | Display ECG, check lead quality, input patient ID, display messages |
| Keyboard | Protected touch keys (membrane) | Protected touch keys (membrane) |
| System configuration | 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 |
| Marker button | Yes | Yes |
| Size | 108 * 66 * 22 mm | 108 * 66 * 22 mm |
| Weight |
§ 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).