(145 days)
Not Found
No
The device description and performance studies focus on temperature control and electrical/mechanical performance, with no mention of AI or ML algorithms.
No.
The device is used to maintain the temperature of reproductive tissue, which is a supportive function during an assisted reproduction cycle, not a therapeutic intervention itself.
No
The device is designed to maintain the temperature of reproductive tissue, which is a supportive function in an assisted reproduction cycle, not a diagnostic one. It does not analyze data or provide information about a patient's health condition.
No
The device description explicitly details hardware components like a baseplate, heating circuits, ITO coated glass, power resistors, and an aluminium base plate. The performance studies also include testing related to electrical safety, EMC, and thermal properties, which are characteristic of hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain the temperature of human reproductive tissue such as occytes and embryos through an assisted reproduction (AR) cycle." This describes a device used during a medical procedure (assisted reproduction) to support the viability of biological material.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body to provide information about a patient's health status.
- Device Function: The device's function is to provide a controlled temperature environment for the reproductive tissue. It does not analyze the tissue or provide diagnostic information about it.
The device is a piece of equipment used in a clinical setting to facilitate a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
To maintain the temperature of human reproductive tissue such as occytes and embryos through an assisted reproduction (AR) cycle.
Product codes
MOG, MQG
Device Description
The RI Witness Embryology Heated Plate is designed to maintain the temperature of embryos and other reproductive tissues placed in dishes on the surface of the device. It is typically installed in a flow hood or on a work bench and comprises of a central clear window within a solid baseplate containing the temperature controller. There are 5 heating circuits, one for the window that uses ITO coated glass and the other 4 use power resistors screwed in thermal contact to the aluminium base plate.
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)
The following performance data was provided in support of the substantial equivalence determination:
Electrical Safety, Electromagnetic Compatibility (EMC), and Wireless Technology: Electrical safety and EMC testing have been conducted for the RI Witness Embryology Heated Plate. The plate complies with IEC 60601-1:2012 edition safety standards and IEC 60601-1-2:2014 for EMC. The RFID component of the RI Witness Embryology Heated Plate has been tested per the FDA guidance document "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" issued January 3, 2007.
Software Verification and Validation Testing: Software verification and validation testing have been conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of premarket Submissions for software Contained in medical devices." The software for this device is considered a "minor" level of concern.
Bench Testing: The RI Witness Embryology Heated Plate was subjected to testing to ensure satisfactory operating performance. These tests address the following:
- Time to reach temperature set point
- Maximum temperature
- Stability of temperature control
- Uniform distribution of temperature across the device
- Liquid ingress
- Volatile organic compound emissions
- Cable integrity up to 84°C
- Thermal Cycling Life Test
- Packaging Verification
- RFID Read Range and Read Reliability
- Mouse embryo assay to measure the effects of exposure to radiofrequency
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2016
Research Instruments Limited Wendy Hassan Regulatory Affairs Executive Bickland Industrial Park Falmouth, Cornwall TR11 4TA United Kingdom
Re: K160504
Trade/Device Name: RI Witness Embryology Heated Plate Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: MOG Dated: June 16, 2016 Received: June 20, 2016
Dear Wendy Hassan:
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. 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.
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160504
Device Name
RI Witness Embryology Heated Plate
Indications for Use (Describe)
To maintain the temperature of human reproductive tissue such as occytes and embryos through an assisted reproduction (AR) cycle.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
3
Image /page/3/Picture/1 description: The image shows a logo with the letters 'RI' in a bold, serif typeface. The letters are large and prominent, taking up most of the vertical space in the image. Below the letters, there is a curved line that adds a sense of movement and elegance to the design. The overall impression is one of classic style and sophistication.
Bickland Industrial Park, Falmouth, Cornwall, TR11 4TA, UK Tel: 01326 372753 Ilnternational +44 1326 372 7531 Fax: 01326 378783 [International +44 1326 378 783] e-mail: sales@research-instruments.com www.research-instruments.com
510(k) Summary - K160504
| Submitter | |
|---|---|
| Company Name: | Research Instruments Ltd. |
| Registration Number: | 9034672 |
| Address: | Bickland Industrial Park |
| Falmouth, | |
| Cornwall TR11 4TA | |
| United Kingdom | |
| Telephone: | +44 (0) 1326 372 753 |
| Fax: | +44 (0) 1326 378 783 |
| Contact person: | Wendy Hassan |
| Contact email: | wendy@research-instruments.com |
| Date prepared: | Monday, 18 July 2016 |
| Device | |
| Trade Name: | RI Witness Embryology Heated Plate |
| Trade Name: | RI Witness Embryology Heated Plate |
|---|---|
| Device Name: | Assisted reproduction stage warmer |
| Device Regulation: | 21 CFR 884.6120 (Assisted reproduction accessories |
| Regulatory Class: | II |
| Product Code: | MQG |
Predicate Device
Thermoplate Stage Warmer by Tokai Hit Co. Ltd, Shizuoka-ken, Japan, K991263
Description of the device
The RI Witness Embryology Heated Plate is designed to maintain the temperature of embryos and other reproductive tissues placed in dishes on the surface of the device. It is typically installed in a flow hood or on a work bench and comprises of a central clear window within a solid baseplate containing the temperature controller. There are 5 heating circuits, one for the window that uses ITO coated glass and the other 4 use power resistors screwed in thermal contact to the aluminium base plate.
Indications for Use
To maintain the temperature of human reproductive tissue such as oocytes and embryos through an assisted reproduction (AR) cycle.
Comparison with the Predicate Device
Intended Use
The RI Witness Embryology Heated Plate's intended use is identical to the Tokai Hit Thermoplate, as both are intended to maintain the temperature of reproductive tissue samples, for the same patient group, by the same clinician group and within similar healthcare facilities.
Technological Features
The RI Witness Embryology Heated Plate and Thermoplate operate on the same technological principle (i.e. are used to control and maintain the temperature of human reproductive tissues). Both devices provide heat via thermal conduction from a baseplate to the dish containing the tissues. The
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RESEARCH INSTRUMENTS LIMITED
Image /page/4/Picture/1 description: The image shows a logo with the letters 'RI' in a bold, sans-serif font. A curved line is positioned beneath the letters, adding a sense of motion or elegance to the design. The logo is simple, yet visually striking due to the bold font and the contrasting curve.
main appreciable differences between the two devices are that the Thermoplate has an external control unit, whereas the RI Witness Embryology Heated Plate has integral electronics. Furthermore, the Embryology Heated Plate provides a clear heated platform for the area under the microscope bonded to a plate with a large surface area so several dishes at once can be kept warm, whereas the Thermoplate consists only of a clear heated platform. The RI Witness Embryology Heated Plate is part of a radiofrequency identification (RFID) system to identify and track the lineage of the tissue samples being treated on in an assisted reproduction facility.
| Technological
Features | Thermoplate (K991263) | RI Witness Embryology Heated
Plate (K160504) |
|----------------------------|--------------------------------------------|------------------------------------------------------------------------|
| Components | Plate with separate control unit, software | Control unit containing software, integrated into the device |
| Materials and
processes | X2 layers of glass | ITO coated glass, Corian (mineral/acrylic composite) and aluminum base |
| Max heating
Power | 30W | 20W (ITO Channel)
40W (Channel 1 to 4 each) |
| Heating channels | 1 | 5 |
| Accuracy | $+/-$ 0.3 | $+/-$ 0.2 |
| Heating range | 0-50°C | 30-45°C |
Summary of Non-Clinical Performance Data
The following performance data was provided in support of the substantial equivalence determination:
Electrical Safety, Electromagnetic Compatibility (EMC), and Wireless Technology
Electrical safety and EMC testing have been conducted for the RI Witness Embryology Heated Plate. The plate complies with IEC 60601-1:2012 edition safety standards and IEC 60601-1-2:2014 for EMC.
The RFID component of the RI Witness Embryology Heated Plate has been tested per the FDA guidance document "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" issued January 3, 2007.
Software Verification and Validation Testing
Software verification and validation testing have been conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of premarket Submissions for software Contained in medical devices." The software for this device is considered a "minor" level of concern.
Bench Testing
The RI Witness Embryology Heated Plate was subjected to testing to ensure satisfactory operating performance. These tests address the following:
- Time to reach temperature set point ●
- Maximum temperature
- . Stability of temperature control
- Uniform distribution of temperature across the device ●
- Liquid ingress
- . Volatile organic compound emissions
- Cable integrity up to 84°C ●
- . Thermal Cycling Life Test
- Packaging Verification
5
Image /page/5/Picture/1 description: The image shows a logo with the letters 'R' and 'J' in a bold, stylized font. The letters are connected and have a flowing, elegant design. A curved line is placed beneath the letters, adding to the overall sense of movement and sophistication. The logo is simple, yet memorable, and could be used for a variety of businesses or organizations.
- RFID Read Range and Read Reliability ●
- . Mouse embryo assay to measure the effects of exposure to radiofrequency
Conclusion
The results of the testing described above provide a reasonable assurance that the RI Witness Embryology Heated Plate is as safe and effective as the predicate device and supports a determination of substantial equivalence.