(275 days)
Not Found
No
The summary explicitly states the device uses the "same algorithms" as a predicate device from 2005 (K051658), and there is no mention of AI/ML terms or related concepts like training/test sets.
No
The device is described as a "patient-worn transceiver (PWT)" for "telemetry monitoring," which suggests it is used for observation and data collection rather than treatment. Its derivation from and use of algorithms similar to a "patient monitor" further supports its role as a diagnostic/monitoring tool, not a therapeutic one.
Yes
Explanation: The device is described as performing "telemetry monitoring" of patients, which involves observing and recording a patient's physiological data to assess their health status and diagnose conditions.
No
The device description explicitly states it is a "patient-worn transceiver (PWT)" and is derived from a "patient monitor," indicating it is a hardware device with embedded software, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for determining if a device is an IVD. IVDs typically have specific intended uses related to the examination of specimens derived from the human body.
- Device Description: The description states the device is a "patient-worn transceiver (PWT)" for "telemetry monitoring of ambulatory and non-ambulatory patients." This describes a device that monitors physiological signals directly from the patient, not a device that analyzes samples in vitro.
- Lack of IVD-related information: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic purposes based on laboratory testing
The device description and the lack of any IVD-specific information strongly suggest that the INFINITY TeleSmart is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
74DSI, 74MHX, 74DRT, 74MLD, 74DQA, 74BWS, 74MSX, 74DRG
Device Description
The INFINITY TeleSmart is a patient-worn transceiver (PWT) that is derived from miniaturization of the INFINITY ALPHA patient monitor. This new device performs telemetry monitoring of ambulatory and non-ambulatory patients, using the same algorithms that are incorporated in the INFINITY ALPHA.
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
Not Found
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)
Not Found
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
g lofr
661399
510(k) SUMMARY as required per 807.92(c)
- Submitter's Name and Address:
Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810
FEB 1 6 2007
Charles C. Morganson, Jr., Manager Regulatory Affairs Tel: (978) 379-8309 Fax: (978) 379-8333
Date submission was prepared:
Contact Person:
May 17, 2006
- Trade Name, Common Name and Classification Name:
A. Trade Name:
Infinity TeleSmart Telemetry System
B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Classification Number | Class | Regulation Number |
|---|---|---|---|
| Detector and Alarm | 74DSI | II | 21 CFR 870.1025 |
| Monitor, Physiological, | |||
| Patient (with Arrhythmia | |||
| Detector or Alarms | 74MHX | II | 21 CFR 870.1025 |
| Cardiac Monitor | 74DRT | II | 21 CFR 870.2300 |
| ST Segment Monitor with | |||
| Alarm | 74MLD | II | 21 CFR 870.1025 |
| Pulse Oximeter | 74DQA | II | 21 CFR 870.2700 |
| Pulse Rate Monitor | 74BWS | II | 21 CFR 870.2300 |
| System, Network and | |||
| Communication, | |||
| Physiological Monitors | 74MSX | II | 21 CFR 870.2300 |
| Radiofrequency Physiological | |||
| Signal Transmitter and | |||
| Receiver | 74DRG | II | 21 CFR 870.2910 |
- Predicate Device Identification:
Infinity MultiView Workstation Telemetry K024108
K051658 Infinity Alpha
1
4. Device Description:
The INFINITY TeleSmart is a patient-worn transceiver (PWT) that is derived from miniaturization of the INFINITY ALPHA patient monitor. This new device performs telemetry monitoring of ambulatory and non-ambulatory patients, using the same algorithms that are incorporated in the INFINITY ALPHA.
2 of 2
- Comparison to Predicate Device:
The Infinity TeleSmart Telemetry System is substantially equivalent to the Infinity MultiView Workstation Telemetry cleared for market under 510(k) K024108 and Infinity Alpha, 510(k) K051658.
- Assessment of non-clinical performance data for equivalence:
Refer to section 10
- Assessment of clinical performance data for equivalence:
Was not generated for this submission
8 Biocompatibility:
Not applicable
9.Sterilization:
Not applicable
- Standards and Guidance's:
Refer to section 10