(290 days)
Not Found
No
The device description explicitly states that the KIDScore D3 utilizes "manually annotated parameters" and assigns scores by "comparing the parameters above in embryos to the model criteria, one criterion at a time". This describes a rule-based or algorithmic approach based on predefined criteria, not a system that learns from data like AI/ML. There is no mention of training or learning from data to develop the scoring model.
No
Explanation: The device is a decision support tool that aids embryologists in selecting embryos. It does not directly treat a disease or condition in a patient.
Yes
The device provides "decision support for prediction of embryos developing to the blastocyst stage" and "aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development." It assigns scores to embryos based on specific parameters to determine their suitability, which are diagnostic functions.
No
The device is described as an "optional accessory to the EmbryoViewer software" and is used with "EmbryoScope timelapse incubator systems." While the core function is an algorithm, it is explicitly tied to and dependent on specific hardware systems (EmbryoScope and EmbryoScope+ incubators) and associated software (EmbryoViewer and ES Server). It is not a standalone software application.
Based on the provided information, the KIDScore D3 tool is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the KIDScore D3 tool "provides decision support for prediction of embryos developing to the blastocyst stage by scoring them according to their statistical viability." This is a diagnostic purpose – it's providing information about the potential outcome of the embryo's development.
- Adjunctive Information: While it's described as "adjunctive information," it directly aids in the "selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development." This selection process is based on the assessment of the embryo's viability, which is a diagnostic assessment.
- Device Description: The description details how the tool "is designed to support embryologists in their decision about which embryos are suitable for transfer." This decision is based on the tool's assessment of the embryo's characteristics and potential for development.
- Performance Studies: The inclusion of performance studies with metrics like specificity, sensitivity, positive predictive value, negative predictive value, and odds ratios are typical for IVD devices, as they demonstrate the diagnostic accuracy and clinical utility of the device.
- Comparison to Predicate Device: The mention of a predicate device (K142147, Eeva(TM) System) which is also likely an IVD in the context of embryo assessment further supports the classification of KIDScore D3 as an IVD.
While the device doesn't directly analyze a biological sample in the traditional sense (like blood or urine), it analyzes data derived from the embryo's development within the incubator. The output of the device (the score) is used to make a clinical decision about the embryo's viability and suitability for transfer, which falls under the scope of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The KIDScore D3 tool provides decision support for prediction of embryos developing to the blastocyst stage by scoring them according to their statistical viability.
Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
The KIDScore D3 tool is only to be used with the EmbryoScope timelapse incubator systems.
Product codes (comma separated list FDA assigned to the subject device)
PBH
Device Description
The KIDScore D3 decision support tool is an adjunctive algorithm that is designed to support embryologists in their decision about which embryos are suitable for transfer. The tool is an optional accessory to the EmbryoViewer software. It is used in the "Compare & Select" function. The "D3" in the name refers to the use of the algorithm on Day 3 for aiding the embryologist in preparing for transfer of the embryo to the female patient.
KIDScore D3 utilizes the following manually annotated parameters to aid in identifying embryos that are suitable for transfer:
- Pronuclei (number of pronuclei): ●
- tPNf (time from insemination until pronuclei is fading) ●
- t2 (time from insemination to complete division to two cells) ●
- t3 (time from insemination to complete division to three cells) ●
- t4 (time for insemination to complete division to four cells) .
- t5 (time from insemination to complete division to five cells) ●
- t8 (time from insemination to complete division to eight cells) ●
The KIDScore D3 assigns scores by comparing the parameters above in embryos to the model criteria, one criterion at a time until the process stops either because the embryo did not pass one of the criteria in the sequence or because the last criterion in the model was reached. From the information available at day three of incubation, the KIDScore D3 divides embryos into five score groups (1-5, as described below):
- 0 = The embryo is not 2PN
- 1 = Initial development was too fast or the embryo displayed a direct cleavage from one to three cells
- 2 = The embryo was slow to develop
- 3 = Embryo development was irregular and the development pace increased from day two to day three
- 4 = Embryo development was irregular and the development pace slowed from day two to day three
and/or
The number of cells annotated at 66 hours was not as expected
5 = The embryo passed all of the avoidance criteria included in the model.
One or more computers running the EmbryoViewer software may be connected to the ES Server. KIDScore D3 is stored on the computer running the ES Server software. Calculations related to the model in KIDScore D3 are performed on the computer running the ES Server software.
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
embryologists in their decision about which embryos are suitable for transfer.
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
The data included embryos from 81 patients who underwent in vitro fertilization (IVF) treatment using their own eggs or donor eggs. These data are a subset taken from a total collection of 4152 embryos from 1338 treatments where all sibling embryos have been annotated for the morphokinetic events required by KIDScore D3. These data originate from treatments that were carried out in European IVF clinics, in the period 2009 - 2014.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: A prospective, single arm, multi-center clinical study. Non-interventional clinical study where the KIDScore D3 was not used during patient treatment. Double-blinded, multi-center study.
Sample Size: 81 patients, subset of 4152 embryos from 1338 treatments.
Key Results: The study demonstrated that the adjunct use of KIDScore D3 improved the selection of embryos for transfer compared with morphology alone. In the primary endpoint, it was shown that the adjunct use of KIDScore D3 was informative for blastocyst outcome. The study showed that both the KIDScore D3 and the Eeva system were predictive of blastocyst outcome, with odds ratios greater than one for both systems.
Odds Ratio: KIDScore D3: 4.13 (95% CI: 3.48 - 4.9, P value:
§ 884.6195 Assisted Reproduction Embryo Image Assessment System.
(a)
Identification. An Assisted Reproduction Embryo Image Assessment System is a prescription device that is designed to obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing.(b)
Classification. Class II (special controls). The special control(s) for this device are:(1) Clinical performance testing must demonstrate a reasonable assurance of safety and effectiveness of the device to predict embryo development. Classification performance (sensitivity and specificity) and predictive accuracy (Positive Predictive Value and Negative Predictive Value) must be assessed at the subject and embryo levels.
(2) Software validation, verification, and hazard analysis must be provided.
(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Total light exposure and output testing;
(ii) A safety analysis must be performed based on maximum (worst-case) light exposure to embryos, which also includes the safety of the light wavelength(s) emitted by the device;
(iii) Simulated-use testing;
(iv) Mouse Embryo Assay testing to assess whether device operation impacts growth and development of mouse embryos to the blastocyst stage;
(v) Cleaning and disinfection validation of reusable components;
(vi) Package integrity and transit testing;
(vii) Hardware fail-safe validation;
(viii) Electrical equipment safety and electromagnetic compatibility testing; and
(ix) Prediction algorithm reproducibility.
(4) Labeling must include the following:
(i) A detailed summary of clinical performance testing, including any adverse events;
(ii) Specific instructions, warnings, precautions, and training needed for safe use of the device
(iii) Appropriate electromagnetic compatibility information;
(iv) Validated methods and instructions for cleaning and disinfection of reusable components; and
(v) Information identifying compatible cultureware and explain how they are used with the device.
0
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July 19, 2019
Vitrolife A/S Belinda Dueholm Regulatory Affairs Specialist Jens Juuls Vej 20 Viby J, 8260 DENMARK
Re: K182798
Trade/Device Name: KIDScore D3 Regulation Number: 21 CFR 884.6195 Regulation Name: Assisted reproduction embryo image assessment system Regulatory Class: Class II Product Code: PBH Dated: June 17, 2019 Received: June 20, 2019
Dear Belinda Dueholm:
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.
1
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 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 (QS) 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 medical devices and radiation-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,
For Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182798
Device Name KIDScore D3
Indications for Use (Describe)
The KIDScore D3 tool provides decision support for prediction of embryos developing to the blastocyst stage by scoring them according to their statistical viability.
Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
The KIDScore D3 tool is only to be used with the EmbryoScope timelapse incubator systems.
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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510(k) Summary - KIDScore D3 K182798
1. Submitter Information
| Submitter | Vitrolife A/S
Jens Juuls Vej 20
8260 Viby J
Denmark |
|-------------------------------|-----------------------------------------------------------------------|
| Contact Person:
Telephone: | Ms. Belinda Dueholm
+45 7221 7900 (main)
+45 2076 3707 (direct) |
-
- Date Prepared: July 19th, 2019
3. Device Information
| Proprietary Name: | KIDScore D3 |
|---|---|
| Common Name: | Assisted Reproduction Embryo Image Assessment System |
| Regulation Number: | 21 CFR 884.6195 |
| Regulation Name: | Assisted Reproduction Embryo Image Assessment System |
| Product Code: | PBH (Embryo Image Assessment System, Assisted Reproduction |
| Regulatory Class | II |
4. Predicate Device
Eeva(TM) System, K142147, Auxogyn Inc.
The predicate device has not been subject to any design related recalls.
5. Device Description
The KIDScore D3 decision support tool is an adjunctive algorithm that is designed to support embryologists in their decision about which embryos are suitable for transfer. The tool is an optional accessory to the EmbryoViewer software. It is used in the "Compare & Select" function. The "D3" in the name refers to the use of the algorithm on Day 3 for aiding the embryologist in preparing for transfer of the embryo to the female patient.
KIDScore D3 utilizes the following manually annotated parameters to aid in identifying embryos that are suitable for transfer:
- Pronuclei (number of pronuclei): ●
- tPNf (time from insemination until pronuclei is fading) ●
- t2 (time from insemination to complete division to two cells) ●
4
- t3 (time from insemination to complete division to three cells) ●
- t4 (time for insemination to complete division to four cells) .
- t5 (time from insemination to complete division to five cells) ●
- t8 (time from insemination to complete division to eight cells) ●
The KIDScore D3 assigns scores by comparing the parameters above in embryos to the model criteria, one criterion at a time until the process stops either because the embryo did not pass one of the criteria in the sequence or because the last criterion in the model was reached. From the information available at day three of incubation, the KIDScore D3 divides embryos into five score groups (1-5, as described below):
- 0 = The embryo is not 2PN
- 1 = Initial development was too fast or the embryo displayed a direct cleavage from one to three cells
- 2 = The embryo was slow to develop
- 3 = Embryo development was irregular and the development pace increased from day two to day three
- 4 = Embryo development was irregular and the development pace slowed from day two to day three
and/or
The number of cells annotated at 66 hours was not as expected
5 = The embryo passed all of the avoidance criteria included in the model.
One or more computers running the EmbryoViewer software may be connected to the ES Server. KIDScore D3 is stored on the computer running the ES Server software. Calculations related to the model in KIDScore D3 are performed on the computer running the ES Server software.
6. Indications for Use
The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability.
Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
5
7. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Device
Intended Use
| Devices | Subject device (K182798) – KIDScore D3 | Predicate device (K142147) – Eeva System |
|---|---|---|
| Indications for Use | The KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability. |
Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ time-lapse incubator systems. | The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing. The device may also be used to collect additional time-lapse images until Day 5 of development for embryos not selected for transfer, to allow monitoring of continued embryo development. |
The intended use of the subject device is the same as the predicate device – both are intended to provide adjunctive information (decision support) to the embryologist/clinician at Day 3 of culture to aid the user in selecting embryos for transfer/freezing during assisted reproduction procedures.
Technological Characteristics
| | Subject device
(KIDScoreD3,
K182798) | Predicate device
(Eeva System,
K142147) | Comments |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Design | Integrates the
KIDScore D3 decision
support tool on the
Compare & Select
page of the
Embryoviewer software
present on the
Embryoscope and
Embryoscope +
devices. | Time-lapse system
used in conventional
incubator with analysis
software that
automatically identifies
embryo development
events for use in a
blastocyst prediction
model | Different: The subject
device is a software
accessory to be used
with the Embryoscope
imaging incubator to
provide adjunctive
information regarding
blastocyst quality. The
predicate device is a
time lapse imaging
system to be used in a
conventional incubator
that utilizes automated
image analysis to
provide adjunctive
blastocyst quality
information. These |
6
| | | | differences do not raise
different questions of
safety and
effectiveness. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Algorithm | Software
User annotations of
embryo development
parameters used as
algorithm inputs
Score based on criteria
which are either related
to embryo morphology
or development stage | Software
Cell tracking and event
inference used as
algorithm inputs | Different. The subject
device utilizes an
elimination model with
user annotation as the
input, whereas the
predicate device
utilizes a predictive
algorithm that uses
automated cell tracking
and image analysis
inputs. These
differences do not raise
different questions of
safety and
effectiveness. |
| Annotation method | Manual input of
embryo development
events and timing | Image analysis
software automatically
identifies embryo
development events
and timing | Different. The subject
device utilizes input
from manual
annotations, whereas
the predicate device
utilizes an automated
image analysis system.
These differences do
not raise different
questions of safety and
effectiveness. |
The technological characteristics of the subject and predicate device are different - the subject device has different predictive algorithms for blastocyst quality, and different software and annotation functions. However, different types of safety and effectiveness questions are not raised by these differences in technological characteristics.
8. Summary of Non-Clinical Performance Testing
Devices classified under 21 CFR 884.6195 (Assisted Reproduction Embryo Image Assessment System) and product code PBH must address several non-clinical special controls, including software validation, verification, and hazard analysis, an assessment of light exposure and output, simulated use, cleaning and disinfection, package integrity and transit testing, electrical safety and electromagnetic compatibility testing, and prediction algorithm reproducibility.
As the subject device is an optional accessory to the EmbryoViewer software used in the EmbryoScope+ incubator (cleared under K173264), some of the special controls do not apply to this submission. The previously cleared version of the Embryoscope+ has met the special controls associated with the majority of the non-clinical performance testing listed above.
In the current submission, the sponsor has addressed the special controls associated with software and algorithm reproducibility. The software verification testing provided in this
7
submission met the requirements of the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005. The reproducibility of the prediction algorithm is addressed in the summary of clinical testing described below.
9. Summary of Clinical Testing
Devices classified under 21 CFR 884.6195 (Assisted Reproduction Embryo Image Assessment System) and product code PBH must address a clinical special control to demonstrate reasonable assurance of safety and effectiveness of the device to predict embryo development. The clinical study is described below.
The safety and effectiveness of the KIDScore D3 was investigated in a prospective, single arm, multi-center clinical study conducted at six sites in the United States. This was a non-interventional clinical study where the KIDScore D3 was not used during patient treatment. The purpose of the study was to collect data to evaluate the safety and effectiveness of the KIDScore D3's ability to predict which embryos are most likely to develop to blastocyst stage. This was evaluated by using the KIDScore D3 as adjunct information to traditional morphological grading. Imaging data was collected on embryos cultured to day 5. Embryologists were masked to imaging data and evaluation was only based on morphology and KIDScore D3 scores.
Objective
The study was aimed at analyzing the utilization of established morphology methods with adjunct outcome of an algorithm (KIDScore D3) that provides a score (1 - 5) from timings of morphokinetic events.
Study Design
A double-blinded, multi-center study, designed to evaluate the odds ratios and other measures for outcomes of methodologies used for embryo assessment: day 3 morphology alone and day 3 morphology with KIDScore D3 results as adjunct information.
Selection of Study Data
The data included embryos from 81 patients who underwent in vitro fertilization (IVF) treatment using their own eggs or donor eggs. These data are a subset taken from a total collection of 4152 embryos from 1338 treatments where all sibling embryos have been annotated for the morphokinetic events required by KIDScore D3. These data originate from treatments that were carried out in European IVF clinics, in the period 2009 - 2014.
Primary endpoint
The primary endpoint of the study was to assess the association between the adjunct prediction of blastocyst outcome and the actual blastocyst outcome. The purpose was to determine if KIDScore D3 was informative for embryos graded as an A, B, or C using Day 3 morphology category assignment as compared to the predicate device (Eeva system). For those Good/Fair embryos, the blastocyst Odds Ratio (OR) for the adjunct prediction is required to be statistically significantly greater than 1.
8
Secondary endpoints
The following calculations were assessed as secondary endpoints:
- Embryo level diagnostic performance measures .
- o specificity
- o sensitivity
- negative predictive value o
- positive predictive value o
- negative likelihood ratio o
- positive likelihood ratio o
- . Top 2 Embryo analysis
- Treatment level analysis
Results
The study demonstrated that the adjunct use of KIDScore D3 improved the selection of embryos for transfer compared with morphology alone. In the primary endpoint, it was shown that the adjunct use of KIDScore D3 was informative for blastocyst outcome.
The study showed that both the KIDScore D3 and the Eeva system were predictive of blastocyst outcome, with odds ratios greater than one for both systems, as described in the figure below:
| KIDScore D3 | Eeva | |
|---|---|---|
| Odds ratio | 4.13 | 2.57 |
| 95% CI | 3.48 - 4.9 | 1.88 - 3.51 |
| P value |