(205 days)
The CryoRobot Select System is intended to provide an automated liquid nitrogen storage system for oocytes, embryos, and sperm to facilitate the identification, storage, and retrieval of specimens.
The CryoRobot Select System includes the CryoRobot Select (the robot), CryoBeacons, and the CryoTransporter. The CryoRobot Select System provides an automated liquid nitrogen storage system for oocytes, embryos, and sperm to facilitate the identification, storage, and retrieval of specimens. The system consists of a cryogenic tank, robotic hardware for automation, dedicated robot control software, RFID-enabled storage units ("CryoBeacons") and an insulated container for carrying multiple CryoBeacons ("CryoTransporters"). The robot has an automated container picking system, designed to pick and transport individual CryoBeacons to and from the cryogenic tank. The robot allows users to load 24 CryoBeacons at a time, with a freezer storage capacity of 1,386 through a user-accessible drawer. The system maintains cryogenic temperatures during the specimen storage and retrieval processes. The CryoBeacon is a radio-frequency identification (RFID) enabled storage unit that holds up to eight dimensionally compatible cryodevices. TMRW does not manufacture cryodevices for use with CryoBeacons. Cryodevices compatible with the CryoBeacon include devices up to 135 mm long with the gametes or embryos located at or below 50 mm when measured from the distal end of the closed device. The CryoTransporter is an insulated cryogenic container for carrying 24 CryoBeacons to and from the CryoRobot Select system. The CryoTransporter is filled with liquid nitrogen to maintain a cryogenic environment during CryoBeacon transport. For safe carrying, the CryoTransporter has a handle and a vented, transparent lid for viewing its contents. The CryoTransporter is placed in the drawer of the CryoRobot Select to transfer or retrieve CryoBeacons from the cryogenic tank.
The CryoRobot Select System is an automated liquid nitrogen storage system for oocytes, embryos, and sperm. The device was evaluated through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Performance Testing | Auto position testing | Demonstrated the capability of the robot to pick and place samples to and from the CryoTransporter and CryoRobot Select storage tank. |
| Manual drawer opening/closing | Confirmed that the drawer can be opened and closed manually. | |
| Thermal performance tests | Monitored the temperature of cryodevices during loading, storage, and retrieval to ensure the sample is not compromised and to ensure delivery of liquid nitrogen when necessary. | |
| RFID traceability verification tests | Ensured the reliability of the RFID features. | |
| System safety verification testing | Ensured that all safety systems operate as intended (e.g., alarms, emergency liquid nitrogen system activation, uninterruptible power supply function, drawer position, drawer finger trap testing, etc.). | |
| Freezer hold time assessment | Verified the hold time window in which specimens remain below the acceptable temperature without power and liquid nitrogen supply. | |
| CryoTank verification tests | Ensured the tank maintains samples during storage. | |
| Reprocessing | Reprocessing based on validated cleaning and disinfection testing | Instructions were based on validated cleaning and disinfection testing conducted in accordance with the 2015 FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." |
| Electrical Safety and EMC | IEC 60601-1-2:2014 & IEC 61010-1 Edition 3.1 2017-01 | Testing conducted in accordance with: IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. IEC 61010-1 Edition 3.1 2017-01 Consolidated version, Standard for Safety for Electrical Equipment for Measurement, Control and Laboratory Use, Part 1: General Requirements. |
| Wireless Technology | Assessment in accordance with FDA guidance | The wireless technology features of the device were assessed in accordance with the 2007 FDA guidance "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff." |
| Software | Evaluation in accordance with FDA guidance | Software was evaluated in accordance with the 2005 FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Cybersecurity | Evaluation in accordance with FDA guidance | Cybersecurity was evaluated in accordance with the 2014 FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify the exact sample sizes (e.g., number of CryoBeacons, cryodevices, or individual gametes/embryos) used for each performance test. The testing is described generally as "Performance Testing" to demonstrate the system performs as expected.
The provenance of data (e.g., country of origin, retrospective or prospective) is not explicitly stated. However, given that this is a 510(k) submission for the U.S. FDA, the testing would typically be conducted to meet U.S. regulatory standards, likely in a controlled laboratory environment. This would be considered prospective testing for the purpose of regulatory clearance.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. The study describes non-clinical performance testing of hardware, software, electrical safety, and wireless technology, rather than a clinical study requiring expert ground truth for interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The described study focuses on engineering and system performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance testing of the device itself, rather than a study comparing human reader performance with and without AI assistance. The device is an automated storage system, not an AI-assisted diagnostic or interpretive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The "Performance Testing" described effectively represents a standalone evaluation of the device's automated functions. The tests (auto-positioning, thermal performance, RFID traceability, system safety, freezer hold time, CryoTank verification) assess the device's ability to perform its intended functions without human intervention during the automated process (though humans initiate and monitor the process). The device's "robot control software" is essentially the "algorithm" here, and its performance is evaluated in these tests.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical performance tests would be defined by engineering specifications, physical measurements, and industry standards. For example:
- Thermal Performance: Ground truth would be the pre-defined acceptable temperature range for cryopreserved specimens and the accurate measurement of actual temperatures using calibrated sensors.
- Auto Position Testing: Ground truth would be the precise robotic movements and accurate placement of CryoBeacons as per design specifications.
- RFID Traceability: Ground truth would be the correct identification and tracking of unique RFID tags as programmed.
- Safety Systems: Ground truth would be the proper activation of alarms and emergency systems under simulated fault conditions as per safety standards.
8. The Sample Size for the Training Set:
This information is not provided. The document describes non-clinical performance testing for regulatory clearance, not a machine learning model development where training sets are typically discussed. The "robot control software" likely underwent internal development and testing, but details on data used for its development are not disclosed here.
9. How the Ground Truth for the Training Set was Established:
This information is not provided because, as mentioned, the document describes performance testing for regulatory clearance, not the development of a machine learning model's training set. For the development of the device's control software, ground truth would have been established through engineering design specifications, simulated environments, and iterative testing during the development process to ensure the software accurately controls the robotic and cryogenic functions.
§ 884.6120 Assisted reproduction accessories.
(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.