(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.
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November 4, 2022
TMRW Life Sciences, Inc. Christina Miracle VP, QARA 250 Hudson Street, 6th Floor New York, NY 10013
Re: K221086
Trade/Device Name: CryoRobot Select System Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: QUJ Dated: October 3, 2022 Received: October 3, 2022
Dear Christina Miracle:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael T. Bailey -S
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221086
Device Name CryoRobot Select System
Indications for Use (Describe)
The CryoRobot Select System consists of the CryoRobot Select, CryoBeacons, and CryoTransporter. The indications for use for the CryoRobot Select System is shown below:
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K221086
I. SUBMITTER:
| Manufacturer: | TMRW Life Sciences, Inc.250 Hudson Street, 6th FloorNew York, NY 10013 | |
|---|---|---|
| Phone: | 1-866-733-TMRW | |
| Email: | ra@tmrw.org | |
| Contact Person: | Christina Miracle | |
| Date Prepared: | November 1, 2022 | |
| II. | DEVICE | |
| Trade Name of Device: | CryoRobot Select System | |
| Common Name: | Automated Cryopreservation Storage System | |
| Regulation Name: | Assisted Reproduction Accessories | |
| Regulation Number: | 21 CFR 884.6120 | |
| Regulatory Class: | Class II | |
| Product Code: | QUJ (Automated Cryopreservation Storage System) | |
| III. | PREDICATE DEVICE | |
| Primary Predicate Device: | Kryo ART Controlled Rate Freezer (K032086) | |
| Manufacturer: | PLANER, plc. | |
| Product Code: | MQG (Assisted Reproduction Accessory) |
The predicate device has not been subject to a design-related recall.
The Agency cleared the predicate device with the product code MQG. On July 11, 2017, Federal Register Notice 82 FR 31976 exempted controlled-rate cryopreservation freezers. A 510(k) is not needed to market a controlled-rate cryopreservation freezer if it does not exceed the limitation of
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exemption found in 21 CFR 884.9. Therefore, the predicate device now falls under product code PUB (Accessory, Assisted Reproduction, Exempt).
A 510(k) submission was required for the subject device, as it exceeded the limitations of exemption per 21 CFR 884.9.
DEVICE DESCRIPTION IV.
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.
V. INDICATIONS FOR USE
The CryoRobot Select System consists of the CryoRobot Select, CryoBeacons, and CryoTransporter. The indications for use for the CryoRobot Select System is shown below:
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.
COMPARISON OF THE INTENDED USE AND TECHNOLOGICAL VI. CHARACTERISTICS OF THE SUBJECT AND PREDICATE DEVICE
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| Parameter | Subject Device(K221086) | Predicate Device(K032086) | Comparison |
|---|---|---|---|
| Indications for Use | The CryoRobot SelectSystem consists of theCryoRobot Select,CryoBeacons, andCryoTransporter. Theindications for use forthe CryoRobot SelectSystem is shownbelow:The CryoRobot SelectSystem is intended toprovide an automatedliquid nitrogen storagesystem for oocytes,embryos, and sperm tofacilitate theidentification, storage,and retrieval ofspecimens. | The Kryo ART brandof controlled ratefreezers are intended tobe used to freezegametes or embryos ata user determined rate. | The indications for useof the subject device isnot identical to that ofthe predicate device.However, the twodevices have the sameintended use, which isto contain, freeze, andmaintain gametesand/or embryos at anappropriate freezingtemperature. |
| Software | Software-controlled | Software-controlled | Same |
| Design | The CryoRobot SelectSystem includes aninsulatedCryoTransporter totransport CryoBeaconsholding cryodevicescontaining gametes andembryos to theloading/retrieval drawerof the CryoRobotSelect. The CryoRobotSelect identifies thepresence or absence ofCryoBeacons in thedrawer and uses thisinformation todetermine whether astorage or retrievalprocedure will occur.The CryoRobot Selectwill then transport theCryoBeacons to orfrom the storage tank | Controlled rate liquidnitrogen freezers withdifferent chamber sizesto cryopreservesamples. | Different |
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| 0.00000*****;1888 | 200 | Course00 | 1 | (XCOOL |
|---|---|---|---|---|
| 00 | 00 |
| CryoRobot Selectmaintains the samplesat cryogenictemperatures bymaintaining exposureto liquid nitrogenthroughout sampletransport. | |||
|---|---|---|---|
| Gamete/Embryo-Contacting | No. Samples incryodevices are loadedin device. | No. Samples incryodevices are loadedin device. | Same |
| 250 L storage tank | Dewar sizes:1.7 L3.3 L16 L | Different | |
| Tank Size | |||
| Number of Samples | 1,386 CryoBeacons | Not known | Different |
| Touchscreen andspecimen managementsoftware | MRV controller system | Different | |
| User Interface | |||
| CryoRobot SelectCryoBeaconsCryoTransporter | Not known | Different | |
| Components | |||
| RFID | Yes | No | Different |
As shown in the table, the subject and predicate device do not have identical indications for use statements; however, they have the same intended use (i.e., to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature).
There are similarities in the technologies between the subject and proposed predicate device, including the following:
- Both are software-controlled devices.
- . Both monitor temperature and use liquid nitrogen to freeze and/or maintain samples at cryogenic temperatures for purposes of long-term storage.
- Both include features to provide liquid nitrogen from storage tanks to cool and maintain ● the cryogenic state of samples.
- Both devices are able to provide information on their status/performance to device users. ●
Differences in technology include the following:
- . The subject device includes RFID features to identify the presence of CryoBeacons in the drawer of the CryoRobot Select that inform the system to prepare for an automated loading or retrieval procedure initiated by the user. This represents automation of the manual process done for samples after freezing using the predicate device. Although the predicate does not include these features, they do not raise different questions of S&E as compared to the proposed predicate (i.e., both devices raise similar S&E questions: will samples remain frozen during device use?, will a failure lead to sample damage or loss?, will a sample be mis-identified?, etc.).
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- The subject device CryoTank design is for long-term storage as opposed to the design of the proposed predicate that is for holding samples for a short duration after freezing. This difference does not raise different questions of safety and effectiveness, as both devices are intended to maintain samples in a cryogenic state while within the device (similar questions to that stated above).
- The subject device transfers a maximum of 24 CryoBeacons to or from the storage tank . during a loading or retrieval operation and can hold a maximum of 1,386 CryoBeacons in the 250 L storage tank. The maximum number of samples the predicate device equipped with dewar sizes of 1.7-16 L can freeze and maintain in a single run is not known. Differences in the number of samples that can be processed in a single use of the device or the total number of samples that can be maintained in the device do not raise different questions of S&E between the two devices (i.e., both devices raise similar S&E questions: can the devices maintain the cryogenic state of the maximum number of samples loaded in device?).
- . The subject and predicate devices have different user interface systems that are used to operate and receive information on device function status. Differences in user interface systems do not raise different questions of safety and effectiveness.
VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
Reprocessing
Reprocessing 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 Electromagnetic Compatibility
Testing was 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
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
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
Cybersecurity was evaluated in accordance with the 2014 FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
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Image /page/8/Picture/1 description: The image shows the word "TMRW" spelled out with blue circles. The letters are formed by arranging the circles in a grid-like pattern. The letters are spaced closely together, and the overall effect is a playful and modern design. The "R" has a registered trademark symbol next to it.
Performance Testing
Performance testing was conducted to demonstrate the system performs as expected in the following areas:
- . Auto position testing to demonstrate capability of the robot to pick and place samples to and from the CryoTransporter and CryoRobot Select storage tank.
- . Manual drawer opening/closing to confirm that the drawer can be opened and closed manually.
- . Thermal performance tests to monitor 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 to ensure the reliability of the RFID features. ●
- System safety verification testing to ensure that all safety systems operate as intended (e.g., alarms, emergency liquid nitrogen system activation, uninterruptable power supply function, drawer position, drawer finger trap testing, etc.).
- . Freezer hold time assessment to verify the hold time window in which specimens remain below the acceptable temperature without power and liquid nitrogen supply.
- . CryoTank verification tests to ensure the tank maintains samples during storage.
CONCLUSIONS VIII.
The results of the testing described above demonstrate that the subject device is as safe and effective as the predicate device and support a determination of substantial equivalence.
§ 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.