(52 days)
Not Found
No
The summary describes an incubator with time-lapse microscopy and data logging, but there is no mention of AI or ML being used for analysis, interpretation, or decision-making based on the acquired data. The focus is on providing a controlled environment and capturing images.
No
The device is an embryo incubator and imaging system for observation and development logging, not for direct therapeutic intervention on a patient.
No
The device is described as an embryo incubator that performs measurements and logs incubation conditions, as well as an imaging system for viewing embryos. Its purpose is to provide an optimal environment for embryo development, not to diagnose a condition.
No
The device description clearly states it is an "embryo incubator" with an integrated microscope and imaging system, indicating it is a hardware device with embedded software for control and data acquisition.
Based on the provided information, the EmbryoScope™ - (Version D) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a controlled environment for embryo development and viewing. It facilitates the process of embryo culture and observation, but it does not perform a diagnostic test on a sample taken from the human body to provide information about a physiological state, health, or disease.
- Device Description: The description focuses on its function as an incubator with integrated microscopy for observation. It doesn't describe any components or processes that would analyze a biological sample for diagnostic purposes.
- Lack of Diagnostic Claims: There are no mentions of diagnosing any condition, measuring biomarkers, or providing information for diagnosis.
- Performance Study: The performance study focuses on the device's ability to support embryo development and the safety of the imaging process, not on the accuracy of a diagnostic test.
While the device is used in the context of assisted reproductive technology, which involves biological samples (embryos), its function is to support and observe the development of these samples, not to perform a diagnostic test on them.
N/A
Intended Use / 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 five days (120 hr) covering the time from post-fertilization to day 5 of development.
Product codes (comma separated list FDA assigned to the subject device)
85 MQG
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.
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)
Clinical data showed that the EmbryoScope™ - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in the EmbryoScope™ -- (Version D) with 5 days of incubation compared to three days of incubation. 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.
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
AUG 1 1 2011
Image /page/0/Picture/1 description: The image contains the logo for UNISENSE FERTILITECH, which is written in bold, capitalized letters. Above the company name is a graphic of three circles connected together with a line going through them. To the right of the logo is the text "pg 1 of 2" in handwritten font. The image appears to be a document or page from a larger set of materials.
510(k) Summary - K111715
Administrative information:
| Name: | Unisense FertiliTech A/S | |
|---|---|---|
| Address: | Tueager 1 | |
| DK-8200 Aarhus N | ||
| Denmark | ||
| Contact person: | Mette Munch, QA Consultant | |
| Telephone Number: | +45 89449500 | |
| Fax Number: | +45 89449549 | |
| E-mail: | mm@unisense.com | |
| Date of summary: | 24-July-2011 |
Propose of submission: Change in Indication for Use to allow device use for up to 5 days (120 hr) of culture. Device design has not been changed from the device cleared under K092183.
Device name:
| Trade name | Common name | Device | Class | CFR Reference | Procode |
|---|---|---|---|---|---|
| EmbryoScope™ | |||||
| (Version D) | IVF Incubator | Assisted | |||
| reproduction | |||||
| accessories | II | 884.6120 | 85 MQG |
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 five days (120 hr) covering the time from post-fertilization to day 5 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.
Phone: +45 89 44 95 00 Fax: +45 89 44 95 49 sales@fertilitech.com www.fertilitech.com
1
Image /page/1/Picture/0 description: The image shows a logo for UNISENSE FERTILITECH with a graphic of three circles connected by lines above the text. To the right of the logo are handwritten notes that say K111715 and pg. 2 of 2. The text UNISENSE FERTILITECH is in bold, with UNISENSE on top and FERTILITECH on the bottom.
Table 1: Comparison of EmbryoScope™ - (Version D) K 092183 to Embry - (Version D) K 111715:
| | EmbryoScope™
(Version D)
K092183 | EmbryoScope™
(Version D)
K111715 |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 five days (120 hr)
covering the time from post-
fertilization to day 5 of
development. |
| 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 | Underwent and passed
electrical safety
electromagnetic
compatibility, environmental
and operating performance
testing. Classification
according to IEC 60601-1 |
Summary: The differences between the EmbryoScope™ - (Version D) used for 5 days incubation do not alter the safety and effectiveness of the device. The EmbryoScope™ - (Version D) is similar, with respect to the FDA published predicate device description.
Clinical Testing:
Clinical data showed that the EmbryoScope™ - (Version D) performs according to the intended use of the device. No significant difference was found between the rates of ongoing pregnancies in the EmbryoScope™ -- (Version D) with 5 days of incubation compared to three days of incubation. No adverse effects of image acquisition were observed.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Dr. Mette Munch QA Consultant Unisense FertiliTech A/S Tueager l DK-8200 AARHUS N DENMARK
AUG 1 1 2011
Re: K111715
Trade/Device Name: EmbryoScope™ - (Version D) Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MQG Dated: June 15, 2011 Received: June 20, 2011
Dear Dr. 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
3
Page 2
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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely vours,
Hubert Lenoir MD
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
4
Indications for Use
510(k) Number (if known):
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 inverted microscope and imaging system for embryo viewing. Device use is limited to five days (120 hr) covering the time from post-fertilization to day 5 of development.
ਮ Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aonath
Page 1 of
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111715