(205 days)
Yes
The document explicitly states that the software utilizes "locked" (non-adaptive) machine learning algorithms to identify contours and that both the subject and predicate devices utilize machine learning/AI algorithms for automatic segmentation and quantification.
No
The device is described as an aid to interpreting clinicians for calculating the number and size of ovarian follicles and is used for viewing and quantifying image data, not for providing direct therapeutic benefit.
Yes
The device is designed to aid interpreting clinicians by calculating the number and size of ovarian follicles from ultrasound data, which directly supports a diagnostic process.
Yes
The device is explicitly described as a "cloud-based software application package (software as a medical device, SaMD)" and its function is to process and analyze image data acquired from compatible ultrasound systems, not to acquire the images itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Follicle Clarity's Function: Follicle Clarity analyzes image data acquired from an ultrasound system. It does not directly interact with or analyze biological specimens from the patient. Its purpose is to process and quantify information from medical images.
- Intended Use: The intended use clearly states it's an "aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries." This is an image analysis and quantification tool, not a diagnostic test performed on a biological sample.
While the software provides information that can be used by clinicians in the diagnostic process (e.g., for fertility treatment), the software itself is not performing an in vitro diagnostic test. It's a software tool that processes and presents data from an imaging modality.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked as "Not Found."
Intended Use / Indications for Use
Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.
Product codes
QIH
Device Description
Follicle Clarity is a cloud-based software application package (software as a medical device, SaMD). Follicle Clarity automatically calculates the number and size of hypoechoic structures in the received transvaginal ultrasound images and displays the data graphically and in tabular format in the Follicle Clarity application. Graphic displays include both measurements made by the clinician (as measured by the ultrasonographer) as well as those calculated by Follicle Clarity. Graphs can be adjusted for various views of the data. Ultrasound images received are also displayed within the Application to allow the user to verify the resolution, contrast and anatomic completeness. The user is able to enter patient information such as cycle day, estradiol level and progesterone level in the patient profile for tracking. The user also has the ability to add or delete measurements as they feel are appropriate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The software utilizes "locked" (non-adaptive) machine learning algorithms to identify the contours of the targeted structure within the ultrasound image.
Input Imaging Modality
transvaginal ultrasound
Anatomical Site
ovaries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Interpreting clinicians
Description of the training set, sample size, data source, and annotation protocol
Non-clinical V&V testing included the Machine Learning Algorithm Training and the subsequent Validation Studies performed for the proposed application.
Description of the test set, sample size, data source, and annotation protocol
Validation of the tracking and measurement accuracy of the platform was conducted through a phantom trial in which manual measurements of phantom targets were conducted within a DICOM viewer and compared to Follicle Clarity results. A second validation trial compared ovarian follicle measurements in ovaries with 3 or less follicles per ovary in which manual measurements of follicles were conducted within a DICOM viewer and compared to Follicle Clarity results. A third validation trial compared ovarian follicle measurements in ovaries with 10 or greater follicles per ovary in which manual measurements of follicles were conducted within a DICOM viewer and compared to Follicle Clarity results. All three validation trials demonstrated that in a 1:1 (follicle) comparison, that Follicle Clarity tracking and measurement accuracy was within the margin of error for human measurements.
Clinical validation of the Follicle Clarity application was performed in a prospective study to evaluate the accuracy, precision, and level of agreement of a Follicle Clarity in comparison to manual (ultrasonographer) measurements and SonoAVC measurements. The primary endpoint was the median size (mm) of ovarian follicles measured by Follicle Clarity compared to SonoAVC. The secondary endpoint was the number of ovarian follicles identified by Follicle Clarity compared to SonoAVC. In all cases, Follicle Clarity met the predetermined endpoints and demonstrated substantially equivalent performance in identifying the number and size of follicles.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing conducted to evaluate and compare the technological and performance characteristics included non-clinical performance testing and clinical studies.
Non-clinical V&V testing included the Machine Learning Algorithm Training and the subsequent Validation Studies performed for the proposed application. Pre-determined performance specifications were tested, and verification and validation activities conducted to demonstrate that the Follicle Clarity met the defined performance criteria.
Validation of the tracking and measurement accuracy of the platform was conducted through a phantom trial in which manual measurements of phantom targets were conducted within a DICOM viewer and compared to Follicle Clarity results. A second validation trial compared ovarian follicle measurements in ovaries with 3 or less follicles per ovary in which manual measurements of follicles were conducted within a DICOM viewer and compared to Follicle Clarity results. A third validation trial compared ovarian follicle measurements in ovaries with 10 or greater follicles per ovary in which manual measurements of follicles were conducted within a DICOM viewer and compared to Follicle Clarity results. All three validation trials demonstrated that in a 1:1 (follicle) comparison, that Follicle Clarity tracking and measurement accuracy was within the margin of error for human measurements.
Clinical validation of the Follicle Clarity application was performed in a prospective study to evaluate the accuracy, precision, and level of agreement of a Follicle Clarity in comparison to manual (ultrasonographer) measurements and SonoAVC measurements. The primary endpoint was the median size (mm) of ovarian follicles measured by Follicle Clarity compared to SonoAVC. The secondary endpoint was the number of ovarian follicles identified by Follicle Clarity compared to SonoAVC. In all cases, Follicle Clarity met the predetermined endpoints and demonstrated substantially equivalent performance in identifying the number and size of follicles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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.
Cycle Clarity % John Schnorr, M.D. CEO 1209 Fifteen Mile Landing Rd. AWENDAW SC 29429
January 19, 2022
Re: K212012
Trade/Device Name: Follicle Clarity Software Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: December 20, 2021 Received: December 21, 2021
Dear Dr. Schnorr:
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/cfpmp/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 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
1
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
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K212012
Device Name Follicle Clarity Software
Indications for Use (Describe)
Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and comblete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
K212012
I. Submitter's Information
| Company Name: | Cycle Clarity LLC |
|---|---|
| Address: | 1209 Fifteen Mile Landing Rd. |
| Awendaw, SC 29429 | |
| Phone Number: | 843-883-6200 |
| E-mail: | john.schnorr@cycleclarity.com |
| Fax Number: | |
| Contact Person: | John Schnorr, MD |
| Phone Number: | 843-883-6200 |
| Email Address: | john.schnorr@cycleclarity.com |
Date Prepared: June 18, 2021
II. Device Information
| Device Name: | Follicle Clarity software |
|---|---|
| Common Name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR 892.2050 |
| Product Code: | QIH |
III. Predicate Device
Predicate Device: OLAB Advanced Quantification Software 13.0, Philips Ultrasound Inc., K191647
Reference Device: Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System, GE Healthcare, K122327
IV. Device Description
Follicle Clarity is a cloud-based software application package (software as a medical device, SaMD). Follicle Clarity automatically calculates the number and size of hypoechoic structures in the received transvaginal ultrasound images and displays the data graphically and in tabular format in the Follicle Clarity application. Graphic displays include both measurements made by the clinician (as measured by the ultrasonographer) as well as those calculated by Follicle Clarity. Graphs can be adjusted for various views of the data. Ultrasound images received are also displayed within the Application to allow the user to verify the resolution, contrast and anatomic completeness. The user is able to enter patient information such as cycle day, estradiol level and progesterone level in the patient profile for tracking. The user also has the ability to add or delete measurements as they feel are appropriate.
V. Intended Use
4
Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems.
VI. Indications for Use
Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems. Follicle Clarity is used as an aid to interpreting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.
VII. Technological Characteristics
The technological specifications of Follicle Clarity and its predicate and reference device have been evaluated to determine equivalence. As detailed on Section 012 - Substantial equivalence of this 510(k) submission, upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, Follicle Clarity is determined by Cycle Clarity to be substantially equivalent to existing legally marketed devices (Table 1).
| | QLAB
(Predicate Device) | Voluson
(Reference Device) | Follicle Clarity
(Subject Device) | Equivalence
Description | | |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Administrative Information | | | | | | |
| Product Name | QLAB Advanced
Quantification Software
13.0 | Voluson E6/E8/
E8Expert/E10 Diagnostic
Ultrasound System | Follicle Clarity Software | N/A | | |
| 510(k) Holder | Philips Ultrasound, Inc. | GE Healthcare Austria
GmbH & Co OG | Cycle Clarity LLC | N/A | | |
| 510(k) Number | K191647 | K122327 | TBD | N/A | | |
| Common Name | Picture Archiving and
Communications
System | -Ultrasonic Pulsed Doppler
Imaging System
-Ultrasonic Pulsed Echo
Imaging System
-Diagnostic Ultrasound
Transducer | Picture Archiving and
Communications System | Identical to
predicate | | |
| Regulation | 21 C.F.R. § 892.2050 | 21 C.F.R. §892.1550
21 C.F.R. §892.1560
21 C.F.R. §892.1570 | 21 C.F.R. § 892.2050 | Identical to
predicate | | |
| Product Code | QIH | IYN, IYO, ITX | QIH | Identical to
predicate | | |
| Regulatory Class | II | II | II | Identical to
predicate | | |
| Intended Use | QLAB Advanced
Quantification Software
is a software application
package. It is designed
to view and quantify
image data acquired on
Philips ultrasound
systems. | The device is a general-
purpose ultrasound system.
Specific clinical
applications remain the
same as previously
cleared: Fetal/OB,
Abdominal (including
GYN, pelvic and infertility
monitoring/follicle
development); Pediatric;
Small Organ (breast,
testes, thyroid, etc.);
Neonatal and Adult | Follicle Clarity Software
is a software application
package. It is designed to
view and quantify image
data acquired on
compatible ultrasound
systems. | Same2
Predicate and
subject devices are
software intended to
quantify image data
on compatible
ultrasounds.
The subject device
intended use is the
same as the
SonoAVC software
included in the
reference device. | | |
Table 1: Overview of Substantial Equivalence
Section 005 - 510(k) Summary - Page 2 of 3
5
| Prescription
Only? | Yes | Cephalic; Cardiac (adult
and pediatric); Musculo-
skeletal Conventional and
Superficial; Peripheral
Vascular; Transvaginal;
Transrectal; and
Intraoperative (abdominal,
PV and neurological).1 | Yes | Identical to
predicate |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics | | | | |
| Application
Description | QLAB software
includes multiple
features for automated
detection and
measurement of
structures in
gynecological,
obstetrics, cardiac, and
other clinical
applications. K191647
describes the particular
application for
measuring cardiac
structures within the
ultrasound images using
automatic segmentation
technology. The
software utilizes
"locked" (non-adaptive)
machine learning
algorithms to identify
the contours of the
targeted structure within
the ultrasound image.
A report of
measurement data is
displayed. | SonoAVC software detects
hypoechoic structures (i.e.,
follicles) in transvaginal
ultrasound images and
measures their size. The
software utilizes
algorithms to identify the
contours of the targeted
structure within the
ultrasound image. A
report of measurement
data is displayed. | Follicle Clarity software
detects hypoechoic
structures (i.e., follicles)
in transvaginal ultrasound
images and measures
their size. The application
measures structures
within the ultrasound
images using automatic
segmentation technology.
The software utilizes
"locked" (non-adaptive)
machine learning
algorithms to identify the
contours of the targeted
structure within the
ultrasound image. A
report of measurement
data is displayed. | Equivalent
All of the software
systems utilize
proprietary
algorithms to detect
and quantify
structures within
ultrasound images.
Subject and
predicate devices
utilize machine
learning/AI
algorithms to
identify specific
contours of the
anatomy using
automatic
segmentation
technology and
quantify structures
based on this
analysis.
Subject and
reference devices
specifically detect
and analyze follicle
number and size. |
| Target User
Population | Interpreting clinicians | Interpreting clinicians | Interpreting clinicians | Identical to
predicate |
| How Supplied? | Software application | Software application
(SonoAVC software is
supplied with the Voluson
ultrasound hardware) | Software application | Identical to
predicate |
| Use of machine
learning
algorithm? | Yes | Unknown | Yes | Identical to
predicate |
| Required Patient
Clinical Data
(Imaging) Format | DICOM | NA | DICOM | Identical to
predicate |
| Ultrasound
Compatibility | Philips | Voluson
E6/E8/E8Expert/E10 | - Voluson, E6, E8, E10
- Philips
- Siemens Acuson
Version | Equivalent
Subject device has
been validated to
process ultrasound
images from Philips
and Voluson
ultrasound systems |
1 The reference device intended use and indications for use pertain to the Voluson ultrasound system. SonoAVC is a software component of the Voluson system and intended for the same use as the subject device (as labeled): Sonography-based Automated Volume Count follicle (SonoAVC follicle) automatically calculates the number and volume of hypoechoic structures in a volume sweep.
Section 005 - 510(k) Summary - Page 2 of 3
6
The technological differences between the predicate and subject device do not impact the safety and effectiveness of the subject device as described in Section 012 - Substantial Equivalence.
VIII. Performance Data
Performance Testing conducted to evaluate and compare the technological and performance characteristics included non-clinical performance testing and clinical studies.
Non-Clinical
Design Control activities to assure the safe and effective performance of Follicle Clarity included but were not limited to the following:
- · Requirements Review
- Design Review
- Risk Management
- Software Verification and Validation
Non-clinical V&V testing included the Machine Learning Algorithm Training and the subsequent Validation Studies performed for the proposed application. Pre-determined performance specifications were tested, and verification and validation activities conducted to demonstrate that the Follicle Clarity met the defined performance criteria.
Validation of the tracking and measurement accuracy of the platform was conducted through a phantom trial in which manual measurements of phantom targets were conducted within a DICOM viewer and compared to Follicle Clarity results. A second validation trial compared ovarian follicle measurements in ovaries with 3 or less follicles per ovary in which manual measurements of follicles were conducted within a DICOM viewer and compared to Follicle Clarity results. A third validation trial compared ovarian follicle measurements in ovaries with 10 or greater follicles per ovary in which manual measurements of follicles were conducted within a DICOM viewer and compared to Follicle Clarity results. All three validation trials demonstrated that in a 1:1 (follicle) comparison, that Follicle Clarity tracking and measurement accuracy was within the margin of error for human measurements.
Clinical
Clinical validation of the Follicle Clarity application was performed in a prospective study to evaluate the accuracy, precision, and level of agreement of a Follicle Clarity in comparison to manual (ultrasonographer) measurements and SonoAVC measurements. The primary endpoint was the median size (mm) of ovarian follicles measured by Follicle Clarity compared to SonoAVC. The secondary endpoint was the number of ovarian follicles identified by Follicle Clarity compared to SonoAVC. In all cases, Follicle Clarity met the predetermined endpoints and demonstrated substantially equivalent performance in identifying the number and size of follicles.
IX. Conclusion
Follicle Clarity has the same intended use as the QLAB software and SonoAVC (Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System) software. The conclusion drawn from the nonclinical and clinical tests demonstrate that the proposed device is as effective, and performs as well as or better than the legally marketed predicate device. The design/technological differences do not raise any
7
new types of questions and the performance data provided reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.
Section 005 – 510(k) Summary - Page 2 of 3