(539 days)
No
The summary describes a time-lapse microscopy system for embryo incubation and viewing, but there is no mention of AI or ML being used for analysis, interpretation, or decision-making based on the acquired images or data. The focus is on the imaging and environmental control capabilities.
No.
The device functions as an incubator and imaging system for embryos, facilitating development and viewing, but does not directly treat a disease or condition.
No
The device is an incubator for embryo development with integrated imaging, primarily for viewing and logging incubation conditions, not for diagnosing a disease or condition. While it monitors embryo development, it does not explicitly state that it provides a diagnosis.
No
The device description clearly states it is an embryo incubator with integrated hardware components like a microscope, imaging system, and processing units, not solely software.
Based on the provided information, the EmbryoScope™ - (Version D) is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is intended to provide an environment for the development of embryos and includes an imaging system for viewing them. While it doesn't directly diagnose a condition in a patient, it is used in the context of in vitro fertilization (IVF), which is a process performed outside the body to aid in conception. The development and selection of viable embryos are critical steps in the IVF process, and the device's function directly supports this.
- Device Description: It's an incubator with integrated microscopy and imaging for monitoring embryo development. This monitoring provides information that is used by clinicians to make decisions about which embryos to transfer, which is a key part of the IVF diagnostic and treatment pathway.
- Context of Use: The intended user is an IVF clinic, and the device is used for embryo development, a core component of IVF.
Why it fits the definition of an IVD (broadly):
While the device itself doesn't perform a traditional diagnostic test on a patient sample (like a blood test), it provides critical information about a biological process (embryo development) that is used to inform clinical decisions in the context of an in vitro procedure (IVF). Regulatory bodies often classify devices used in assisted reproductive technologies (ART) like IVF as IVDs because they are used to evaluate biological material (embryos) in vitro to guide clinical management.
Why it might not be a traditional IVD:
It doesn't directly measure a specific analyte or biomarker to diagnose a disease in a patient. Its primary function is to provide an environment and imaging for observation.
However, given the context of IVF and the use of the imaging system to assess embryo development for clinical decision-making, it strongly aligns with the regulatory definition of an IVD device used in the context of assisted reproduction.
The predicate devices listed (incubators and dishes) also support the idea that this device falls within the scope of devices used in IVF, which are often regulated as IVDs.
Therefore, based on the provided information, it is highly probable that the EmbryoScope™ - (Version D) is classified as an IVD device.
N/A
Intended Use / Indications for Use
EmbryoScope™ - (Version D):
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to three days (72 hr) covering the time from post-fertilization to day 3 of development.
EmbryoSlide™ (FT-S-ES-D):
Preparing, storing, and transferring human embryos. To be used only with the EmbryoScope device.
Product codes (comma separated list FDA assigned to the subject device)
85 MQG, 85 MQK, MOG, MOK, MTX (This combination likely covers both devices.)
Device Description
EmbryoScope™ - (Version D)
The EmbryoScope™ - (Version D) is an embryo incubator, which performs a series of unattended measurements including time-lapse microscopy at multiple planes and logging of incubation conditions on individual embryos during their development. The device has a build-in microscope within a red light source. Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation. The Device allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides™ each with capacity for 12 embryos.
EmbryoSlide™ (FT-S-ES-D)
The EmbryoSlide™ (FT-S-ES-D) is designed to fit the EmbryoScope™ – (Version D) incubator arm in order to control temperature. The EmbryoSlides are made of polystyrene, E-beam sterilized (SAL of 106) and tested according to the ISO 11137 standard and relevant bioassays are performed. The slides are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL), have passed the cytotoxicity test and are nonembryotoxic as tested by the mouse embryo assay (MEA).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Time-lapse microscopy
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)
Clinical data showed that the EmbryoScope TM - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in a standard incubator and the EmbryoScope™ - (Version D). No adverse effects of image acquisition were observed.
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.
COOK Mini-Incubator K983642, Nunc IVF 4-Well Dish K070047
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.
Custom products IVF Workstation K991216, The Forma Scientific Incubator K991408
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/1 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of the words "UNISENSE" and "FERTILITECH" stacked on top of each other, with the trademark symbol to the right of "UNISENSE". Above the words is a graphic of what appears to be a cell with a needle inserted into it.
510(k) Summary
JAN 1 1 2011
Administrative information:
| Name: | Unisense FertiliTech A/S |
|---|---|
| Address: | Tueager I |
| DK-8200 Aarhus N | |
| Denmark | |
| Contact person: | Mette Munch, QA Manager |
| Telephone Number: | +45 89449500 |
| Fax Number: | +45 89449549 |
| E-mail: | mm@unisense.com |
| Date of summary: | 05-January-2011 |
Device name:
| Trade name | Common name | Device | Class | CFR
Reference | Procode |
|------------------------------|----------------------------|-----------------------------------------|-------|------------------|---------|
| EmbryoScopeTM
(Version D) | IVF Incubator | Assisted
reproduction
accessories | II | 884.6120 | 85 MQG |
| EmbryoSlideTM
(FT-S-ES-D) | IVF incubator
accessory | Assisted
reproduction
labware | II | 884.6160 | 85 MQK |
EmbryoScope™ - (Version D):
Indication for Use: To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to three days (72 hr) covering the time from post-fertilization to day 3 of development.
Device Description:
The EmbryoScope™ - (Version D) is an embryo incubator, which performs a series of unattended measurements including time-lapse microscopy at multiple planes and logging of incubation conditions on individual embryos during their development. The device has a build-in microscope within a red light source. Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation. The Device allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides™ each with capacity for 12 embryos.
Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark
1
Image /page/1/Picture/0 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of the words "UNISENSE" in large, bold letters, with a registered trademark symbol to the right of the word. Below this is the word "FERTILITECH" in a smaller, bold font. Above the words is a graphic of two circles connected together, with a line going through them.
EmbryoSlide™ (FT-S-ES-D):
Indication for Use: Preparing, storing, and transferring human embryos. To be used only with the EmbryoScope device.
Device Description:
The EmbryoSlide™ (FT-S-ES-D) is designed to fit the EmbryoScope™ – (Version D) incubator arm in order to control temperature. The EmbryoSlides are made of polystyrene, E-beam sterilized (SAL of 106) and tested according to the ISO 11137 standard and relevant bioassays are performed. The slides are tested non-pyrogenic by Limulus Amebocyte Lysate (LAL), have passed the cytotoxicity test and are nonembryotoxic as tested by the mouse embryo assay (MEA).
Comparison to Predicate Device:
The Cook Mini-Incubator is the device identified by Unisense FertiliTech A/S for the substantial equivalence comparison .This is based on the fact that both incubators use direct heating which is considered as an important parameter according to intended use.
| | EmbryoScope™
(Version D) | COOK Mini-Incubator
K983642 |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | To provide an environment
with controlled temperature,
CO2 (and other gases) for the
development of embryos.
This model has an integrated
inverted microscope and
imaging system for embryo
viewing. Device use is limited
to three days (72 hr) covering
the time from post-
fertilization to day 3 of
development. | The COOK Mini-Incubator is
intended to be used to store
and preserve gametes and/or
embryos at or near body
temperature. |
| Discussion of Non-Clinical
Tests performed for
Determination of Substantial
Equivalence | Underwent and passed
electrical safety
electromagnetic
compatibility, environmental
and operating performance
testing. Classification
according to IEC 60601-1 | Subjected to electrical safety,
electromagnetic
compatibility acceptability
and operating performance.
The incubator passed all
these tests. |
Table 1: Comparison of EmbryoScope™ - (Version D) to COOK Mini-Incubator -K983642
Unisense FertiliTech A/S Tueager I DK-8200 Aarhus N Denmark
2
Image /page/2/Picture/0 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of a graphic element above the text. The graphic element appears to be a stylized representation of cells or biological structures with a line extending from the top right. Below the graphic is the word "UNISENSE" in bold, followed by the registered trademark symbol. Underneath "UNISENSE" is the word "FERTILITECH," also in bold.
| | EmbryoSlide™ | Nunc IVF 4-Well Dish
K070047 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | Preparing, storing, and
transferring human
embryos. To be used only
with the EmbryoScope
device. | In vitro fertilization
techniques, cell culture. |
| Contraindication | N/A | N/A |
| Patient / embryo contact
material | Polystyrene surface | Polystyrene surface |
| Design features | The slide is optimised
optically clear. The lid
and slide have a marking
which requires that the lid
always has the same
orientation; thus cross
contamination can be
minimized. The lid can be
handled by one hand
while other lab equipment
can be handled by the
other hand. The wells are
numbered. | The bottom of the plate is
optimised flat and optically
clear. The lid and plate
have a cut off corner which
requires that the lid always
has the same orientation;
thus cross contamination
can be minimized. The lid
can be handled by one hand
while other lab equipment
can be handled by the other
hand. The plates can be
stacked. |
| Safety features | N/A | N/A |
| Other relevant
characteristics | Sterile (SAL 10-6)
• Tested non-
pyrogenic by
LAL
• Passed 1-cell
mouse embryo | Sterile (SAL 10-6)
• Tested non-
pyrogenic by LAL
• Passed 1-cell
mouse embryo test
(MEA) |
Table 2: Comparison of EmbryoSlide™ to Nunc IVF 4-well Dish.
Summary of comparison to predicate devices:
The EmbryoScope™ - (Version D) and the COOK Mini-Incubator incubator are both incubators controlling the environment according to primarily gas and temperature. The devices enhance safety by continuously monitoring the critical functions. Both incubators use direct heating of the culture dish. This principle is shown to be very effective in order to control the temperature as "the direct heat transfer culture incubator has superior temperature maintenance compared to a large volume air convection incubator" in: Cooke et al., "Objective Assessments of Temperature Maintenance Using In Vitro Culture techniques". 2002, Journal of Assisted Reproduction and Genetics, Vol 19, p. 368-375.
The EmbryoScope™ - (version D) has a build in microscope. This feature is not an option in the predicate device but the light intensity is compared to conventional light microscopes used in the IVF clinic and the data shows that it is comparable and thus safe for the embryos and in addition the embryo disturbance is minimized as the
EmbryoSlides stay in the controlled incubation environment during microscopy. The Unisense FertiliTech A/S
Tueager I DK-8200 Aarhus N Denmark
3
Image /page/3/Picture/0 description: The image shows the logo for UNISENSE FERTILITECH. The logo consists of a graphic of three circles connected together with a line going through them. Below the graphic, the words "UNISENSE" and "FERTILITECH" are written in bold, stacked on top of each other. The logo appears to be for a company in the fertility technology industry.
concept with a build-in microscope is not new but an option in workstations as " Custom products IVF Workstation" from MidAtlantic Diagnostics, Inc - K991216. It should also be noted that microscopes for use in general assisted reproductive procedures are classified as Class I exempt products under 21 CFR 884.6190. Assisted Reproductive Microscopes and Microscope Accessories).
In the EmbryoScope™ - (Version D) the oxygen range (3-20%) can be controlled. The concept of controlling Oxygen levels in incubators is not new. Ex.: The Forma Scientific Incubator - K991408) allows for the direct control of oxygen levels (2-20%).
By using an oil overlay and a dedicated slide lid increased humidity is avoided in the EmbryoScope™ – (Version D) thus reducing the contamination risk. This is different from the Predicate Device.
The EmbryoSlides™ and the Nunc IVF 4-Well Dish have similar applications, which include cell culturing and IVF. Both devices are sterile (SAL of 106), non-pyrogenic, and non-embryotoxic. They are made of the same material, polystyrene and are similar in configuration, with each well having optically clear surface. The design as such is different as each EmbryoSlide "" has 12 wells and other well dimensions, but the embryo survival rate is shown to be comparable to the Predicate Device.
Summary: The differences between the EmbryoScope™ ~ (Version D), EmbryoSlide™ and the Predicate Devices do not alter the safety and effectiveness of the device. The EmbryoScope™ - (Version D) and related accessory the EmbryoSlide "" are similar, with respect to the FDA published predicate device description.
Clinical Testing:
Clinical data showed that the EmbryoScope TM - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in a standard incubator and the EmbryoScope™ - (Version D). No adverse effects of image acquisition were observed.
Unisense FertiliTech A/S Tueager 1 DK-8200 Aarhus N Denmark
4
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Mette Munch QA Manager Unisense FertiliTech A/S Brendstrupgaardsvej 21F DK-8200 Aarhus N DENMARK
Re: K092183
Trade Name: EmbryoScope™ (Version D) EmbryoSlide™ Regulation Number: 21 CFR §884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MOG, MOK, MTX Dated: January 5, 2011 Received: January 7, 2011
JAN 1 1 2011
Dear Ms. Munch:
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. 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
5
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Hubert H. Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
6
Indications for Use Form
JAN 1 1 2011
510(k) Number (if known): _ K092183
EmbryoScope™ - (Version D) Device Name:
Indications for Use:
To provide an environment with controlled temperature, CO2 (and other gases) for the development of embryos. This model has an integrated inverted microscope and imaging system for embryo viewing. Device use is limited to three days (72 hr) covering the time from post-fertilization to day 3 of development.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of to Vitro Diagnostic Device Evaluation and Safety
510AK)
Norma M. White
(Division Sign Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K092183
Page 1 of
7
Indications for Use Form
JAN 1 1 2011
510(k) Number (if known): _ K092183
EmbryoSlide™ Device Name: _
Indications for Use:
Preparing, storing, and transferring human embryos. To be used only with the EmbryoScope device.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K092183
Page 1 of