(52 days)
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.
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.
The provided document describes a 510(k) submission for a change in the indication for use of the EmbryoScope™ - (Version D) device. Therefore, the "acceptance criteria" discussed are related to demonstrating that the device remains safe and effective for the extended use duration, rather than performance metrics of an AI model.
Here's an analysis based on the information provided, framed to address the requested categories for a device rather than an AI:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implied by the need to demonstrate that extending the incubation period from 3 days to 5 days does not alter the safety and effectiveness of the device, specifically relating to ongoing pregnancies and adverse effects. The study aimed to show "non-inferiority" or "no significant difference" in relevant clinical outcomes.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Device remains safe (no adverse effects due to image acquisition or extended incubation) | "No adverse effects of image acquisition were observed." The device underwent and passed electrical safety, electromagnetic compatibility, environmental, and operating performance testing (as reported for both 3-day and 5-day use indications). |
| Device remains effective (e.g., similar ongoing pregnancy rates) for the extended 5-day incubation compared to 3-day incubation. | "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." |
2. Sample size used for the test set and the data provenance
The document states: "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."
- Sample Size: Not explicitly stated. The phrase "Clinical data" suggests a study was performed, but the number of embryos, patients, or cycles included in this "clinical data" is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics).
- Retrospective/Prospective: Not explicitly stated. However, "Clinical data showed..." implies an analysis of collected data, which could be either. The comparison to "three days of incubation" suggests either a prospective comparative trial or a retrospective analysis comparing cohorts.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable in the context of this device and submission. The "ground truth" here is objective clinical outcomes (ongoing pregnancies, observed adverse events), not a subjective assessment requiring expert consensus on image interpretation or similar tasks that an AI might perform.
4. Adjudication method for the test set
This section is not applicable. The "test set" here refers to clinical data for human fertility outcomes, not a set of items requiring human adjudication (like medical images).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. The EmbryoScope™ is an IVF incubator with an imaging system; it is not an AI-powered diagnostic device for which human reader performance would be assessed with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is an incubator and imaging system, not a standalone algorithm. Its "performance" is its ability to maintain a suitable environment and acquire images effectively, ultimately supported by clinical outcomes.
7. The type of ground truth used
The ground truth used for assessing the device's effectiveness was clinical outcomes data, specifically:
- Rates of ongoing pregnancies.
- Observation of adverse effects potentially related to image acquisition or the extended incubation period.
8. The sample size for the training set
This section is not applicable. The device is not an AI model that requires a training set in the conventional sense. The "training" for the device would be its engineering, design, and manufacturing processes, supported by non-clinical testing (electrical safety, EMC, environmental, operating performance) rather than a data training set.
9. How the ground truth for the training set was established
This section is not applicable for the reasons stated above. The "ground truth" for the device's design and engineering is established through engineering principles, regulatory standards (e.g., IEC 60601-1), and extensive non-clinical testing to ensure hardware and software functionality, safety, and performance within specified environmental controls.
{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 1DK-8200 Aarhus NDenmark | |
| 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 | Assistedreproductionaccessories | 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 environmentwith controlled temperature,CO2 (and other gases) for thedevelopment of embryos.This model has an integratedinverted microscope andimaging system for embryoviewing. Device use is limitedto three days (72 hr) coveringthe time from post-fertilization to day 3 ofdevelopment. | To provide an environmentwith controlled temperature,CO2 (and other gases) for thedevelopment of embryos.This model has an integratedinverted microscope andimaging system for embryoviewing. Device use islimited to five days (120 hr)covering the time from post-fertilization to day 5 ofdevelopment. |
| Discussion of Non-ClinicalTests performed forDetermination of SubstantialEquivalence | Underwent and passedelectrical safetyelectromagneticcompatibility, environmentaland operating performancetesting. Classificationaccording to IEC 60601-1 | Underwent and passedelectrical safetyelectromagneticcompatibility, environmentaland operating performancetesting. Classificationaccording 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
§ 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.