(272 days)
Not Found
No
The description details a system for monitoring pH using optical measurements and a tablet for data display and storage. There is no mention of algorithms, learning, or any characteristics indicative of AI/ML.
No.
The device provides a controlled environment for the development of gametes and/or embryos and monitors the pH of culture media. It does not directly treat a disease or condition in a patient.
No
This device is a bench-top incubator with an accessory pH monitoring system for bicarbonate-based culture media used in IVF/ART procedures. It does not diagnose any medical condition in a patient.
No
The device includes significant hardware components such as the incubator itself, the SignipHy™ TrakPod (an optical measurement instrument), and the SignipHy™ sv2 Sensor (a single-use vessel with a membrane). While it includes software on a tablet, it is not solely software.
Based on the provided information, the G210 InviCell Plus with SignipHy™ pH Monitoring System is an IVD (In Vitro Diagnostic) device, specifically the pH monitoring component.
Here's why:
- Intended Use: The pH monitoring system is intended for "pH monitoring of surrogate samples of bicarbonate-based culture media used for ART procedures." This involves testing a sample (culture media) in vitro to provide information relevant to the ART treatment.
- Device Description: The SignipHy™ pH Monitoring System components (TrakPod, sv2 Sensor, TrakStation) are designed to measure the pH of a liquid sample (culture media) outside of the human body.
- Performance Studies: The non-clinical performance testing includes "pH Monitoring Validation Testing (Linearity, Stability, Precision, Accuracy, Interfering substances)," which are typical performance characteristics evaluated for IVD devices that measure a specific analyte (in this case, pH).
- Regulatory Context: While the incubator component is regulated under 21 CFR 884.6120 (exempt), the pH monitoring feature is described as a separate component with its own functionality and testing. This suggests it's being considered for its diagnostic function.
In summary, the pH monitoring system performs a test on a sample (culture media) in vitro to provide information relevant to the ART procedure, which aligns with the definition of an In Vitro Diagnostic device. The incubator itself is a medical device, but the pH monitoring system is the component that fits the IVD classification.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PUB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical pH measurement instrument
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-Clinical Performance Testing:
- Sterilization Validation of SignipHy™ sv2 Sensors:
- 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 Sterilization
- Residual testing was not conducted, as the sensor is non-patient and non-gamete/embryo contacting.
- Shelf-Life of SignipHy™ sv2 Sensors:
- 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
- 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).
- Package integrity testing at the end of shelf-life in real-time aged samples after shipping/distribution:
- 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:
- Electrical Safety Testing:
- IEC 61010 2-010: 2014 (Third Edition)
- . IEC 61010-2-101: 2015 (Second Edition)
- EMC Testing:
- = IEC 61326-1:2012
- Wireless Technology: Information provided in accordance with the FDA guidance document, "Radio Frequency Wireless Technology in Medical Devices.
- Electrical Safety Testing:
- Software and Cybersecurity:
- 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 of Premarket Submissions for Management of Cybersecurity in Medical Devices."
- pH Monitoring Validation Testing:
- 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:
- Linearity
- Stability
- Precision
- Accuracy
- Interfering substances
- 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:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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 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.
| 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
Submitter Information
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, CT 06611 USA | |
| Contact Person: | Kyle Hooper |
| Telephone: +1-203-601-5200 | |
| Fax: +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
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.
4
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.
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.
Indications for Use
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.
5
Table 1 provides a comparison of the indications for use and technological characteristics of the subject device and predicate device.
| Attribute | Subject
G210 InviCell Plus with SignipHy™ pH Monitoring System | Predicate
BT37 Incubator | Discussion |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K191020 | K121566 | Not Applicable |
| Manufacturer | CooperSurgical, Inc. | Planer Plc | Not Applicable |
| Indications for
Use | 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. | The Planer BT37 Incubator is
intended to be used to provide
an environment with controlled
temperature at or near body
temperature, CO2, O2 and N2
gases, and elevated humidity for
the development of gametes and
embryos during in vitro
fertilization (IVF) / assisted
reproductive technology (ART)
treatments | Different:
The subject and predicate devices
are both indicated for
maintaining temperature and gas
concentrations sufficient to
support gametes and embryos.
The predicate device indication
also lists maintenance of
humidity within the chamber.
Lack of humidity control in the
subject device does impact the
overall intended use of the
device (maintaining environment
for ART procedures). FDA has
cleared humidified and non-
humidified ART incubators.
The subject device indications for
use also lists the ability of the
device to measure pH of
bicarbonate-based media within
the incubator. The pH
information is given to laboratory
personnel to provide additional
information on the
environmental conditions within
the incubator, as pH changes are
influenced by CO2 concentrations.
Although the predicate device
does not include a pH
measurement function, the
overall intended use of the
subject and predicate devices is
the same (i.e., providing a
controlled environment for
gamete and embryo
development in vitro). |
| Attribute | Subject
G210 InviCell Plus with SignipHy™
pH Monitoring System | Predicate
BT37 Incubator | Discussion |
| General Design | Bench-top incubator with 10
incubation chambers and one
preparation chamber | Bench-top incubator with 2
incubation chambers | Different: The subject device has
more incubation chambers and
an additional chamber to
equilibrate plates/oil before use.
This difference does not raise
different questions of safety and
effectiveness (S&E). |
| Gas Supply
Type | Internally regulated mixture of
CO2, O2 and N2 | Premixed blend of 6% CO2, 5% O2,
89% N2 | Different: The subject and
predicate devices use different
mechanisms to control gas
concentrations in incubator
chambers. This difference does
not raise different S&E questions. |
| Gas Supply
Pressure | 0.5-1.0 bar
(50 – 100 kPa) | 150 kPa +/- 15 kPa | Different: The subject and
predicate devices have different
gas supply pressures based on
the different gas supply/control
methods. This difference does
not raise different S&E questions. |
| Gas flow rate
capability | 1 l/h CO2 & 5 l/h N2 | 0 mL/min to 450 ml/min. Normal
bleed set to 15 ml/min and purge
at 180 ml/min for 3 minutes.
Flows fully adjustable in 1 ml/min
increments | Different: The subject and
predicate devices have different
gas flow rates based on the
different gas supply/control
methods. This difference does
not raise different S&E questions. |
| Gas flow rate
accuracy | CO2: 1.5 l/h
N2: 7 l/h | ±10% or ± 3% ml/min | Different: The flow rate accuracy
is different for the subject and
predicate devices that use
different gas supply types.
Differences in flow rate accuracy
do not raise different questions
of S&E. |
| Gas flow
pattern | Constant | Pulsed or non-pulsed (constant)
flow pattern. | Different: The subject device
does not include a pulsed flow
mode. This difference does not
raise different S&E questions. |
| Incubation
Chamber
Heating | Resistive heating foil - bottom,
sides and lid of each chamber | Not known | Different: The heating
mechanism used in the predicate
device is not known. However,
differences in heating methods
do not raise different S&E
questions. |
| Chamber
temperature
capability | Ambient to 42.9 °C | 5 °C above ambient to 40 °C | Similar |
| Chamber
temperature
accuracy | ± 0.2 °C calibration point | ± 0.2 °C calibration point | Same |
| Attribute | Subject
G210 InviCell Plus with SignipHy™
pH Monitoring System | Predicate
BT37 Incubator | Discussion |
| Humidification
system | No | Yes | Different: The subject device
does not include a humidification
feature. This difference does not
raise different S&E questions.
FDA has cleared both humidified
and non-humidified ART
incubators. |
| pH
Measurement
Function | Device includes a pH
measurement system that
includes a non-contact fiber optic
pH probe and sensor that holds a
representative media within one
incubation chamber, while a
separate display showing pH
information is on the exterior of
the incubator. | No | Different: The predicate device
does not include a pH
measurement system. The
inclusion of the pH system in one
incubation chamber provides
additional information on the
incubation environment. This
difference does not raise
different questions of S&E as
compared to the predicate (e.g.,
the ability to aid in maintaining
an appropriate culture
environment, materials do not
raise potential embryotoxicity
concerns, 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:
8
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).
- o Package integrity testing at the end of shelf-life in real-time aged samples after shipping/distribution:
- 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.
- o Electrical Safety Testing:
- 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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Image /page/9/Picture/1 description: The image shows the logo for CooperSurgical. The logo is in blue and features the company name in a modern, sans-serif font. Below the company name is the tagline "Healthy women, babies, and families" also in blue.
- 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
- 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:
- 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.