(141 days)
The Mini Telemetry system is intended to transmit fetal heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal fetal monitor during the ante partum period and during labor. The system allows ultrasound fetal heart rate, FECG, MECG and uterine activity signals to be monitored individually or in combination.
The Mini Telemetry system is intended for use under the direct supervision of a licensed healthcare practitioner in a defined coverage area.
The Mini Telemetry device is not intended to be operated in mobile vehicles including ambulances or other vehicles associated with health care facilities.
The Mini Telemetry System provides a wireless means of transmitting heart rate and uterine activity signals from an ambulatory mother to a fetal or maternal/fetal monitor. It includes receiver (RX 2051412-004) and transmitter (TX 2051411-004) subsystems.
The system monitors fetal heart rate through ultrasound Doppler technology, ECG (Fetal ECG or Maternal ECG), and uterine activity (TOCO or IUPC) signals individually or in combination.
The transmitter stays along with mother acquiring data from transducers and transmitting it to the remote Receiver placed next to the monitor in the room. The Mini Transmitter is carried by the mother using the strap mechanism. One end of the transducers are connected to the transmitter and the other end comes in contact with the mother to acquire data.
This system acquires and transmits data wirelessly to the receiver.
The Mini Telemetry system itself is an accessory to the main fetal/maternal fetal monitor.
The Mini Telemetry system is compatible with the following Corometrics brand monitors:
CORO 170 Series fetal monitors K993751 / K991905
CORO 120 Series Maternal fetal monitors K0332252
CORO 250 Series Maternal fetal monitors K050583
Here's an analysis of the provided text regarding the acceptance criteria and study for the Mini Telemetry System, presented in the requested format:
It's important to note that this document is a 510(k) Summary for a Premarket Notification, which seeks to demonstrate substantial equivalence to a predicate device rather than proving novel effectiveness. Therefore, the "study" described focuses on verification and validation activities against standards and internal requirements, not a clinical trial proving new medical efficacy or superiority.
Acceptance Criteria and Device Performance Study for Mini Telemetry System
This submission pertains to the Mini Telemetry System, a device intended to transmit fetal heart rate and uterine activity signals wirelessly from an ambulatory mother to a fetal or maternal/fetal monitor. The submission demonstrates substantial equivalence to a predicate device (Corometrics Model 330 Fetal Maternal Telemetry System K910260) through non-clinical testing and adherence to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence and not a clinical efficacy study, the "acceptance criteria" are primarily regulatory and performance standards, and the "reported device performance" is the successful demonstration of compliance.
| Acceptance Criteria (Standards & Requirements) | Reported Device Performance |
|---|---|
| Safety and General Effectiveness | Substantial Equivalence: The device is considered as safe and as effective as the predicate device (Corometrics Model 330) and its performance is substantially equivalent. |
| IEC 60601-1: 1988 + A1 1991 + A2 1995 (Medical Electrical Equipment - General Requirements for Safety) | Demonstrated compliance through verification and testing activities (detailed in Section 17 Annex D.1 of the 510(k) document). |
| IEC 60601-1-6, 2006 (Medical electrical equipment - General requirements for safety - Collateral standard: Usability) | Demonstrated compliance through verification and testing activities (detailed in Section 18 Annex E.12 of the 510(k) document). |
| ISO 10993-1, 2009 (Biological Evaluation of Medical Devices - Part I Evaluation and Testing within a Risk Management Process) | Demonstrated compliance through verification and testing activities (detailed in Section 15 Annex B.I of the 510(k) document), indicating biocompatibility requirements were met. |
| IEC 60601-1-2, 2007 (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility) | Demonstrated compliance through verification and testing activities (detailed in Section 17 Annex D.2 of the 510(k) document), indicating electromagnetic compatibility. |
| IEC 62304, 2006 (Medical Device Software, Software LifeCycle Process) | Demonstrated compliance through appropriate software development lifecycle processes (referred to Section 16 of the 510(k) document). |
| IEC 60601-2-37: 2001 + A1: 2004, +A2: 2005 (Medical electrical equipment Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment) | Demonstrated compliance through verification and testing activities (detailed in Section 18 Annex G.2 of the 510(k) document), specifically for ultrasound aspects. |
| IEC 60601-2-49, 2001 (Particular requirements for the safety of multifunction patient monitoring equipment) | Demonstrated compliance through verification and testing activities (detailed in Section 18 Annex G.2 of the 510(k) document), specifically for monitoring equipment aspects. |
| IEC 60601-1-8 (General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems) | Demonstrated compliance through verification and testing activities (detailed in Section 18 Annex G.3 of the 510(k) document), related to alarm systems. |
| FCC 47 CFR Part 95; Subpart H: WMTS, Subpart I: MEDRADIO (Personal Radio Services) | Demonstrated compliance through testing (detailed in Section 18 Annex G.1 of the 510(k) document), indicating adherence to radio transmission regulations. |
| FCC 47 CFR Part 2 (FCC SAR Test Report) | Demonstrated compliance through testing (detailed in Section 18 Annex G.4 of the 510(k) document), indicating Specific Absorption Rate (SAR) limits were met. |
| Internal Design Requirements (electrical, mechanical, safety, reliability, system, usability, biocompatibility) | "The results demonstrate that the Mini Telemetry system meets all design requirements and performance claims." (As per "Summary of Simulated Use Setting" section). This included unit level, system level, usability, biocompatibility, and safety parameters. "Verification and Testing activities establish the performance, functionality, usability, safety, and reliability characteristics of Mini Telemetry System." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "Design verification of Mini Telemetry System" with "several protocols that include electrical, mechanical, safety Testing, reliability, and system design verification protocols."
- Sample Size: The specific sample sizes for each test protocol (e.g., number of devices tested, duration of reliability tests) are not detailed in the provided summary. It states "testing on unit level, system level."
- Data Provenance: The nature of these tests suggests they are prospective, non-clinical engineering and performance tests conducted by the manufacturer, Wipro GE Healthcare Private Ltd. The country of origin for these tests is not explicitly stated but can be inferred to be associated with India, where the submitter is located, and potentially other GE Healthcare facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable: This submission relies on engineering and performance standards, and comparison to a predicate device. It does not involve a "test set" in the context of diagnostic performance requiring expert-established ground truth. The acceptance criteria are based on established regulatory standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
- Not Applicable: There was no clinical "test set" requiring adjudication by human experts to establish ground truth for algorithm performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: A MRMC comparative effectiveness study was not conducted. This is a 510(k) for substantial equivalence based on non-clinical testing and comparison to a predicate, not demonstrating improved human reader performance with AI assistance. The device itself is a telemetry system, not an AI-driven diagnostic aid.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The device being assessed is a telemetry system, not an "algorithm" in the sense of an AI or diagnostic algorithm operating on complex data. Its core function is to acquire and transmit signals. Therefore, the concept of "standalone algorithm performance" as typically applied to AI/diagnostic tools is not directly applicable. The device's performance (signal acquisition, transmission fidelity, safety) was evaluated in its standalone operational capacity through the various engineering and performance tests mentioned.
7. The Type of Ground Truth Used
- The "ground truth" for the verification and testing activities consisted of:
- Recognized International and National Standards: e.g., IEC 60601 series, ISO 10993, FCC regulations.
- Predicate Device Performance: The Corometrics Model 330 Fetal Maternal Telemetry System (K910260) served as the benchmark for demonstrating "substantial equivalence" in function, indications for use, and technological characteristics.
- Internal Design Requirements: The device was tested against its own pre-defined functional, safety, reliability, and performance specifications.
8. The Sample Size for the Training Set
- Not Applicable: This device is a classic medical device hardware and software system for signal transmission, not a machine learning or AI-based system that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no "training set" for an AI or machine learning model, this question is not relevant to this submission.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).