The G210 InviCell Plus with SignipHy™ pH Monitoring System is a bench-top incubator that is intended to provide a controlled environment at or near body temperature and gas levels (CO2, O2, and N2) for the development of gametes and/or embryos during In Vitro Fertilization (IVF) / Assisted Reproductive Technology (ART) treatments.

The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

Device Description

The G210 InviCell Plus with SignipHy™ pH Monitoring System is an assisted reproduction incubator that includes an accessory pH monitoring feature. The incubator component of this device (G210 Invicell) is regulated under 21 CFR 884.6120, product code PBH (exempt). The incubator includes 10 incubation chambers and one larger preparation chamber that is used for the equilibration of plates/oil before use. The tri-gas incubator provides a controlled environment (temperature, CO2/O2/N2) for gametes and embryos in the incubation chambers.

The pH monitoring feature of the G210 InviCell Plus with SignipHy™ pH Monitoring System is controlled separately and does not impact the operation or incubator functions of the device. The SignipHy™ pH Monitoring System consists of the following components:

. SignipHy™ TrakPod – An LED-based, optical pH measurement instrument. The SignipHy TrakPod is physically supported within the chassis of the incubator and allows monitoring of one incubator chamber. It is a USB connected fluorescent measurement device with a fiber optic cable and fixture that connects to the SignipHy sv2 Sensor inside an incubator chamber. The SignipHy TrakPod and SignipHy sv² Sensor together detect the pH of a liquid sample.
. SignipHy™ sv2 Sensor – The SignipHy sv2 Sensor is a single-use, polystyrene, ethylene oxide sterilized vessel that is loaded with a sample of bicarbonate-buffered assisted reproduction technology (ART) media with a pH between 6.8 and 7.2 for pH tracking. The bottom of the sensor includes a membrane that is impregnated with a dye that is affected by the pH of the media sample. The sensor fits into the SignipHy TrakPod fiber optic fixture located in an incubation chamber. SignipHy sv2 Sensors can be used for measuring pH at one-minute intervals for three days or 30-minute intervals for seven days.
. SignipHy™TrakStation – A tablet computer running proprietary software that initiates pH readings, displays results, and stores pH measurement data over time. Up to eight SignipHy TrakPods can be connected to a single SignipHy TrakStation.
SignipHy™ qc² Alignment Tool - A fluorescent reference device for use in system alignment and quality control.

To make a pH measurement, the SignipHy TrakPod sends green light flashes (peak 518 nm) through the fiber optic fixture. The dye in the membrane reacts by sending back flashes of light at a different wavelength (peak 600 nm). The SignipHy TrakPod reads this result and calculates the pH of the media sample that is then displayed on and stored in the SignipHy™TrakStation.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the studies performed for the G210 InviCell Plus with SignipHy™ pH Monitoring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Parameter	Reported Device Performance (as stated in the document)
pH Monitoring Validation Testing
Linearity	Met all specifications
Stability	Met all specifications
Precision	Met all specifications
Accuracy	Met all specifications
Interfering substances	Met all specifications
Mouse Embryo Assay (MEA)	≥90% blastocysts at 96h
Light Safety (Worst-case exposure)	Light wavelengths and worst-case light energy exposure duration did not raise safety concerns as compared to conventional imaging using standard laboratory ART imaging procedures.

Note: Specific quantitative values for "all specifications" for pH monitoring, or the exact numerical results for linearity, stability, precision, accuracy, and interfering substances, are not detailed in the provided text. The document states they "met all specifications."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the test sets in the "Non-Clinical Performance Testing" section. It describes the types of tests conducted:

Shelf-Life of SignipHy™ sv2 Sensors: Tested "real-time aged samples after shipping/distribution." The number of samples is not specified.
Mouse Embryo Assay (MEA): Tested under "worst-case conditions (samples taken every minute for 96h)." The number of embryo samples is not specified.
pH Monitoring Validation Testing: Tested various parameters, but the number of samples for each is not provided.

The data provenance is not explicitly mentioned (e.g., country of origin). Based on the context of an FDA submission for a US company (CooperSurgical Inc., Trumbull, CT), it is highly likely the studies were conducted in the US or in compliance with US regulatory standards. The studies appear to be prospective in nature, as they involve testing the device's performance under specified conditions.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts or their qualifications for establishing ground truth in the specific performance tests mentioned.

In the Shelf-Life of SignipHy™ sv2 Sensors performance testing, the ground truth for pH measurement was established by comparison to a "gold standard (blood gas analyzer)." This implies the use of a validated, established method as the reference truth, rather than expert consensus on subjective interpretation.
For the Mouse Embryo Assay (MEA), the acceptance specification uses a clear biological endpoint ("≥90% blastocysts at 96h"), which would be objectively assessed rather than requiring expert consensus to establish ground truth for each case.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods (e.g., 2+1, 3+1) for the test sets. The tests performed are objective performance measurements against established standards or gold standards (like a blood gas analyzer), which typically do not involve subjective expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The device is an incubator with a pH monitoring system, not an imaging or diagnostic device that requires human interpretation of outputs. Therefore, a study comparing human readers with and without AI assistance is not applicable to this device.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance studies were done for the pH monitoring system. The "pH Monitoring Validation Testing" directly assesses the device's ability to measure pH against specifications for linearity, stability, precision, accuracy, and interfering substances, without human intervention in the pH measurement process itself. Similarly, the "Shelf-Life" testing on the SignipHy™ sv2 Sensor performance compared subject device pH measurements to a "gold standard (blood gas analyzer)." The MEA also assessed the device's impact directly.

7. Type of Ground Truth Used

The ground truth methods used in the performance studies include:

Comparison to a Gold Standard: For pH measurement accuracy and performance at end of shelf-life, the device's pH measurements were compared to a "gold standard (blood gas analyzer)."
Objective Biological Endpoint: For the Mouse Embryo Assay (MEA), the ground truth was the objective biological outcome of embryo development ("≥90% blastocysts at 96h").
Established Industry Standards and Specifications: Many tests adhere to ISO, AAMI, ASTM, and IEC standards, where the ground truth is compliance with the defined parameters and limits of those standards (e.g., seal strength, electrical safety, EMC).

8. Sample Size for the Training Set

The document does not provide details on the sample size for any training set. The device appears to be a hardware-based system with proprietary software for measurement and display, rather than a machine learning/AI diagnostic system that typically requires large training datasets. The software documentation mentioned (minor level of concern) also suggests it's not primarily a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no training set details are provided or implied for a learning algorithm, there is no information on how its ground truth might have been established. The documented testing focuses on validating the device's physical and functional performance against established benchmarks and specifications.

Summary

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January 14, 2020

CooperSurgical Inc. Kyle Hooper Regulatory Affairs Associate 95 Corporate Drive Trumbull, CT 06611

Re: K191020

Trade/Device Name: G210 InviCell Plus with SignipHyTM pH Monitoring System Regulation Number: 21 CFR 884.6120 Regulation Name: Assisted Reproduction Accessories Regulatory Class: II Product Code: PUB Dated: December 12, 2019 Received: December 13, 2019

Dear Kyle Hooper:

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. You must comply with all the Act's

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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Monica D. Garcia, Ph.D. Acting 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) K191020

Device Name

G210 InviCell Plus with SignipHyTM pH Monitoring System

Indications for Use (Describe)

The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

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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K191020 Page 1 of 7

510(k) Summary

K191020

Submitter Information

Company Name:	CooperSurgical Inc.
Company Address:	95 Corporate DriveTrumbull, CT 06611 USA
Contact Person:	Kyle HooperTelephone: +1-203-601-5200Fax: +1-203-601-9870

January 13, 2020

Device Information

Date Prepared:

Trade Name:	G210 InviCell Plus with SignipHy™ pH Monitoring System
Common Name:	Embryo Incubator with pH monitoring
Regulation Number:	21 CFR 884.6120
Regulation Name:	Assisted Reproduction Accessories
Product Code:	PUB (Accessory, Assisted Reproduction, Exempt)
Regulatory Class:	II

Predicate Device Information

Trade Name: BT37 Incubator (510(k) number: K121566) Common Name: IVF Incubator Classification Name: Accessory, Assisted Reproduction (21 CFR 884.6120) Product Code: MQG

The predicate device has not been subject to a design-related recall.

Device Description

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Image /page/4/Picture/1 description: The image shows the logo for CooperSurgical. The logo is in blue and consists of the words "CooperSurgical" in a stylized font. Below the logo is the tagline "Healthy women, babies, and families™" also in blue.

. SignipHy™ TrakPod – An LED-based, optical pH measurement instrument. The SignipHy TrakPod is physically supported within the chassis of the incubator and allows monitoring of one incubator chamber. It is a USB connected fluorescent measurement device with a fiber optic cable and fixture that connects to the SignipHy sv2 Sensor inside an incubator chamber. The SignipHy TrakPod and SignipHy sv² Sensor together detect the pH of a liquid sample.
. SignipHy™ sv2 Sensor – The SignipHy sv2 Sensor is a single-use, polystyrene, ethylene oxide sterilized vessel that is loaded with a sample of bicarbonate-buffered assisted reproduction technology (ART) media with a pH between 6.8 and 7.2 for pH tracking. The bottom of the sensor includes a membrane that is impregnated with a dye that is affected by the pH of the media sample. The sensor fits into the SignipHy TrakPod fiber optic fixture located in an incubation chamber. SignipHy sv2 Sensors can be used for measuring pH at one-minute intervals for three days or 30-minute intervals for seven days.
. SignipHy™TrakStation – A tablet computer running proprietary software that initiates pH readings, displays results, and stores pH measurement data over time. Up to eight SignipHy TrakPods can be connected to a single SignipHy TrakStation.
SignipHy™ qc² Alignment Tool - A fluorescent reference device for use in system alignment and quality control.

Indications for Use

The G210 InviCell Plus with SignipHy™ pH Monitoring System includes an accessory for pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures.

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Table 1 provides a comparison of the indications for use and technological characteristics of the subject device and predicate device.

Attribute	SubjectG210 InviCell Plus with SignipHy™ pH Monitoring System	PredicateBT37 Incubator	Discussion
510(k) Number	K191020	K121566	Not Applicable
Manufacturer	CooperSurgical, Inc.	Planer Plc	Not Applicable
Indications forUse	The G210 InviCell Plus withSignipHy™ pH Monitoring Systemis a bench-top incubator that isintended to provide a controlledenvironment at or near bodytemperature and gas levels (CO2,O2, and N2) for the developmentof gametes and/or embryosduring In Vitro Fertilization (IVF) /Assisted ReproductiveTechnology (ART) treatments.The G210 InviCell Plus withSignipHy™ pH Monitoring Systemincludes an accessory for pHmonitoring of surrogate samplesof bicarbonate-based culturemedia used for ART procedures.	The Planer BT37 Incubator isintended to be used to providean environment with controlledtemperature at or near bodytemperature, CO2, O2 and N2gases, and elevated humidity forthe development of gametes andembryos during in vitrofertilization (IVF) / assistedreproductive technology (ART)treatments	Different:The subject and predicate devicesare both indicated formaintaining temperature and gasconcentrations sufficient tosupport gametes and embryos.The predicate device indicationalso lists maintenance ofhumidity within the chamber.Lack of humidity control in thesubject device does impact theoverall intended use of thedevice (maintaining environmentfor ART procedures). FDA hascleared humidified and non-humidified ART incubators.The subject device indications foruse also lists the ability of thedevice to measure pH ofbicarbonate-based media withinthe incubator. The pHinformation is given to laboratorypersonnel to provide additionalinformation on theenvironmental conditions withinthe incubator, as pH changes areinfluenced by CO2 concentrations.Although the predicate devicedoes not include a pHmeasurement function, theoverall intended use of thesubject and predicate devices isthe same (i.e., providing acontrolled environment forgamete and embryodevelopment in vitro).
Attribute	SubjectG210 InviCell Plus with SignipHy™pH Monitoring System	PredicateBT37 Incubator	Discussion
General Design	Bench-top incubator with 10incubation chambers and onepreparation chamber	Bench-top incubator with 2incubation chambers	Different: The subject device hasmore incubation chambers andan additional chamber toequilibrate plates/oil before use.This difference does not raisedifferent questions of safety andeffectiveness (S&E).
Gas SupplyType	Internally regulated mixture ofCO2, O2 and N2	Premixed blend of 6% CO2, 5% O2,89% N2	Different: The subject andpredicate devices use differentmechanisms to control gasconcentrations in incubatorchambers. This difference doesnot raise different S&E questions.
Gas SupplyPressure	0.5-1.0 bar(50 – 100 kPa)	150 kPa +/- 15 kPa	Different: The subject andpredicate devices have differentgas supply pressures based onthe different gas supply/controlmethods. This difference doesnot raise different S&E questions.
Gas flow ratecapability	1 l/h CO2 & 5 l/h N2	0 mL/min to 450 ml/min. Normalbleed set to 15 ml/min and purgeat 180 ml/min for 3 minutes.Flows fully adjustable in 1 ml/minincrements	Different: The subject andpredicate devices have differentgas flow rates based on thedifferent gas supply/controlmethods. This difference doesnot raise different S&E questions.
Gas flow rateaccuracy	CO2: 1.5 l/hN2: 7 l/h	±10% or ± 3% ml/min	Different: The flow rate accuracyis different for the subject andpredicate devices that usedifferent gas supply types.Differences in flow rate accuracydo not raise different questionsof S&E.
Gas flowpattern	Constant	Pulsed or non-pulsed (constant)flow pattern.	Different: The subject devicedoes not include a pulsed flowmode. This difference does notraise different S&E questions.
IncubationChamberHeating	Resistive heating foil - bottom,sides and lid of each chamber	Not known	Different: The heatingmechanism used in the predicatedevice is not known. However,differences in heating methodsdo not raise different S&Equestions.
Chambertemperaturecapability	Ambient to 42.9 °C	5 °C above ambient to 40 °C	Similar
Chambertemperatureaccuracy	± 0.2 °C calibration point	± 0.2 °C calibration point	Same
Attribute	SubjectG210 InviCell Plus with SignipHy™pH Monitoring System	PredicateBT37 Incubator	Discussion
Humidificationsystem	No	Yes	Different: The subject devicedoes not include a humidificationfeature. This difference does notraise different S&E questions.FDA has cleared both humidifiedand non-humidified ARTincubators.
pHMeasurementFunction	Device includes a pHmeasurement system thatincludes a non-contact fiber opticpH probe and sensor that holds arepresentative media within oneincubation chamber, while aseparate display showing pHinformation is on the exterior ofthe incubator.	No	Different: The predicate devicedoes not include a pHmeasurement system. Theinclusion of the pH system in oneincubation chamber providesadditional information on theincubation environment. Thisdifference does not raisedifferent questions of S&E ascompared to the predicate (e.g.,the ability to aid in maintainingan appropriate cultureenvironment, materials do notraise potential embryotoxicityconcerns, etc.).

Table 1: Subject and Predicate Device Comparison

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Healthy women, babies, and families™

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Healthy women h

As shown in the table above, the subject and predicate devices have different indications for use statements; however, the intended uses of the predicate and subject devices are the same (i.e., providing a controlled environment for gamete and embryo development in vitro during assisted reproduction technology procedures).

In regards to technological characteristics, the subject and predicate devices have similarities (e.g., more than one incubation chamber, chamber temperature accuracy, etc.); however, as noted in the table above, technological differences were identified between the subject and predicate devices (e.g., pH monitoring system, gas supply, gas management, total number of incubation chambers, humidification of chambers, etc.). As stated in the table, the technological differences between the subject and predicate devices do not raise different questions of safety and effectiveness.

Non-Clinical Performance Testing

The following performance data were provided in support of the substantial equivalence determination:

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Healthy women, babies, and families™

Sterilization Validation of SignipHy™ sv2 Sensors: ●
- o ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --Requirements for the development, validation and routine control of a sterilization process for medical devices
- AAMI TIR28:2016 Product Adoption and Process Equivalence for Ethylene Oxide o Sterilization
- Residual testing was not conducted, as the sensor is non-patient and nono gamete/embryo contacting.
Shelf-Life of SignipHy™ sv2 Sensors: ●
- o Package integrity testing at the end of shelf-life in real-time aged samples after shipping/distribution:
  - Visual Inspection per ASTM F1886/F1886M-16 .
  - . Seal Strength per ASTM F88/F88M-15
  - I Dye penetration per ASTM F1929-15
- o SignipHy™ sv2 Sensor Performance at the end of shelf-life in real-time aged samples after shipping/distribution:
  - Comparison of subject device pH measurements to gold standard (blood gas analyzer) at a single time point.
  - I Assessment of pH under worst-case conditions (samples collected at one minute intervals for three days) as compared to gold standard (blood gas analyzer).
Reprocessing: Cleaning and disinfection validation testing conducted in accordance with ● the FDA guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Electrical Safety, Electromagnetic Compatibility (EMC), and Wireless Technology:
- o Electrical Safety Testing:
  - IEC 61010 2-010: 2014 (Third Edition)
  - . IEC 61010-2-101: 2015 (Second Edition)
- o EMC Testing:
  - = IEC 61326-1:2012
- Wireless Technology: Information provided in accordance with the FDA o guidance document, "Radio Frequency Wireless Technology in Medical Devices.
Software and Cybersecurity: ●
- o Software documentation in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" to support device software with a minor level of concern.
- Cybersecurity information in accordance with FDA guidance document "Content o of Premarket Submissions for Management of Cybersecurity in Medical Devices."

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pH Monitoring Validation Testing: ●
- o The submission included testing to support the ability of the device to measure pH in bicarbonate-based ART media. Testing showed that the device met all specifications for each parameter assessed below:
  - I Linearity
  - l Stability
  - Precision
  - Accuracy
  - Interfering substances
Light Safety: Light energy exposure testing was performed to assess the potential for light toxicity associated with pH measurements taken under worst-case exposure conditions (samples taken every minute – total light exposure of 8.8 seconds/day). The results showed that the light wavelengths and worst-case light energy exposure duration did not raise safety concerns as compared to conventional imaging using standard laboratory ART imaging procedures.
Mouse Embryo Assay (MEA): Testing was performed to assess the impact of the device ● (SignipHy TrakPod and SignipHy sv2 Sensor) when in operation under worst-case conditions (samples taken every minute for 96h). The results of testing met the acceptance specification of "1-Cell MEA: ≥90% blastocysts at 96h."
Incubator Performance Testing: The incubator component of this device is 510(k) exempt and remains unchanged from that currently marketed. The additional pH monitoring system is separate from the incubator and does not impact its function. Therefore, performance testing on the incubator was not requested.

Conclusion

The results of the testing described above demonstrate that the subject G210 InviCell Plus with SignipHy™ pH Monitoring System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.