Who is the manufacturer of Follicle Clarity?

Cycle Clarity filed the 510(k) submission for Follicle Clarity (K212012).

What is the FDA product code for Follicle Clarity?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Follicle Clarity?

510(k) clearance (submission type: Traditional).

Does Follicle Clarity use AI or machine learning?

Yes. Follicle Clarity (K212012) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Follicle Clarity?

QLAB Advanced Quantification Software 13.0 (K191647).

Who can help prepare an FDA 510(k) submission like Follicle Clarity?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Follicle Clarity get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Follicle Clarity

K212012 · Cycle Clarity · QIH · Jan 19, 2022 · Radiology

Device Facts

Record ID	K212012
Device Name	Follicle Clarity
Applicant	Cycle Clarity
Product Code	QIH · Radiology
Decision Date	Jan 19, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Follicle Clarity Software is a software application package. It is designed to view and quantify image data acquired on compatible ultrasound systems.

Device Story

Cloud-based SaMD; processes DICOM transvaginal ultrasound volume sweeps of ovaries. Uses locked, non-adaptive machine learning/AI algorithms with automatic segmentation to identify and measure hypoechoic structures (follicles). Displays images, clinician-made measurements, and software-calculated measurements in graphical/tabular formats. User can input patient data (cycle day, hormone levels) and edit measurements. Used by clinicians in clinical settings to assist in follicle monitoring. Benefits include automated, consistent quantification of follicle number and size, aiding clinical decision-making in fertility monitoring.

Clinical Evidence

Prospective clinical study compared Follicle Clarity to manual ultrasonographer measurements and SonoAVC. Primary endpoint: median follicle size (mm). Secondary endpoint: number of follicles identified. Results demonstrated Follicle Clarity met predetermined endpoints and showed substantially equivalent performance to SonoAVC. Non-clinical validation included phantom trials and manual measurement comparisons for low (≤3) and high (≥10) follicle counts, confirming accuracy within human measurement margins of error.

Technological Characteristics

Cloud-based software application (SaMD). Uses machine learning/AI for automatic segmentation of hypoechoic structures. Inputs: DICOM ultrasound volume sweeps. Outputs: Graphical/tabular measurement reports. Compatible with Philips, Voluson, and Siemens Acuson systems. Locked, non-adaptive algorithm.

Indications for Use

Indicated for interpreting clinicians as an aid in calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

QLAB Advanced Quantification Software 13.0 (K191647)

Reference Devices

Voluson E6/E8/E8 Expert/E10 Diagnostic Ultrasound System (K122327)

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Submission Summary (Full Text)

{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