The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The non-invasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow.

The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.

Device Description

The CT3000Pro system is an urodynamics testing system which combines an all-in-one touchscreen PC with the CT3000Pro console. Patient information and all data from the tests are stored on the PC's hard disk and the printer enables the user to print a hard copy report of the recorded data. It features a scale to record urine flow, as well as a pump for cystometrogram and urethral pressure profile studies.

The CT3000Pro PC software runs three types of tests: (a) catheterized urodynamics, (b) non- invasive urodynamics, and (c) uroflow studies.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the CT3000Pro's performance, but it primarily focuses on substantial equivalence for regulatory clearance rather than a detailed AI model performance study. The text does not describe an AI/ML-driven device.

From the provided text, the CT3000Pro is a urodynamics measurement system. The performance data section describes standard device verification and validation activities, software validation, and clinical data from literature regarding the UroCuff for non-invasive urodynamic studies. There is no mention of an AI/ML algorithm or related performance metrics like sensitivity, specificity, or AUC. Therefore, a direct answer to the acceptance criteria and study of an AI/ML device is not possible based on the provided document.

However, I can extract information related to the device's functional performance and the clinical evidence presented for its substantial equivalence, interpreting "acceptance criteria" as meeting regulatory standards for a non-AI medical device.

Based on the provided document, here's an interpretation of the requested information, acknowledging the absence of AI/ML specifics:

1. A table of acceptance criteria and the reported device performance:

Since this is a non-AI device application, the "acceptance criteria" are not related to typical AI performance metrics (like sensitivity, specificity, or AUC). Instead, they are related to the device's functional and safety characteristics, and its equivalence to a predicate device. The document implies compliance with relevant standards and successful completion of verification and validation.

Acceptance Criteria (Implied from Regulatory Requirements and Testing)	Reported Device Performance
Functional Requirements Met	Comprehensive end-to-end testing of functional requirements performed; full functional test on 100% of units during production release. All tests met required acceptance criteria for software.
Product Life and Durability	Testing performed.
Biocompatibility	CT3000Pro console and non-patient contact components have no biocompatibility considerations. Patient-contacting components from third parties are FDA registered and used without modification. UroCuff-DC biocompatibility evaluated per ISO 10993-1 and met requirements.
Electrical Safety	Evaluated by a third-party certified laboratory and met IEC 60601-1:2005 + A1:2012.
Electromagnetic Compatibility (EMC)	Evaluated by a third-party certified laboratory and met IEC 60601-1-2:2014.
Software Verification and Validation	Developed, validated, and documented in accordance with IEC 62304 and FDA Guidance "General Principles of Software Validation." Activities included code reviews, design reviews, evaluations, analyses, traceability assessment, and manual testing. All tests met the required acceptance criteria.
Risk Management	Conducted in accordance with ISO 14971; all control measures verified and found effective; individual and overall residual risk acceptable; same safety characteristics and risk profile as predicate.
Clinical Performance (Non-invasive Uroflow)	Clinical effectiveness and safety of UroCuff demonstrated through published literature, including a study on over 50,000 UroCuff patients from 103 US hospitals and urology offices, supporting effectiveness and safety profile.
Substantial Equivalence to Predicate	Concluded to be substantially equivalent based on matching intended use, use environment, patient population, users, catheterized urodynamics test types/techniques, uroflow test technique, communication, data storage, system components, electrical classification, ingress protection, mode of operation, and similar electromechanical characteristics (with some differences but these did not raise new safety/effectiveness questions).

2. Sample size used for the test set and the data provenance:

Test Set (Clinical Data for Non-invasive Uroflow): The clinical performance for the non-invasive uroflow measurement technique (UroCuff) was demonstrated through published literature. A specific study mentioned involved over 50,000 UroCuff patients.
Data Provenance: The explicit provenance of this large patient dataset is "103 US hospitals and urology offices." The study is described as having been published in the Journal of Urology by authors practicing at Mayo Clinic, Mount Sinai Hospital, and Chesapeake Urology. The data collection would be retrospective as it's based on clinical experiences that have already occurred and been published.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document describes a urodynamics measurement system, not an AI model requiring ground truth established by experts for image or signal interpretation. The "ground truth" for this device's performance is the accurate measurement of physiological parameters (e.g., urine flow, pressure, EMG signals) during urodynamic testing and the clinical outcomes for UroCuff use. The validity of these measurements and clinical outcomes is established through standard medical practice and the rigor of published clinical studies. Experts (physicians) use the device and interpret its output in the clinical setting; their qualification would be "licensed physician or health care professional." For the clinical studies referenced, the "experts" are the authors and clinicians from institutions like Mayo Clinic, Mount Sinai Hospital, and Chesapeake Urology, who "utilize UroCuff." No specific number of "experts" for establishing ground truth in the context of an AI test set is relevant here.

4. Adjudication method for the test set:

Not applicable, as this is not an AI/ML performance study requiring adjudication of expert interpretations. The clinical data cited from literature represents clinical experience and measured outcomes.

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:

Not applicable. This is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The CT3000Pro is a medical device, not a standalone AI algorithm. Its function is to perform physiological measurements for diagnosis, always with a human healthcare professional in the loop.

7. The type of ground truth used:

For the device's functional performance, the "ground truth" is adherence to engineering specifications, accuracy of measurements, and compliance with electrical safety and EMC standards. For the UroCuff clinical performance, the "ground truth" is outcomes data and clinical experience from a large patient cohort, as reported in peer-reviewed literature, demonstrating the effectiveness and safety of the non-invasive measurement technique in assessing bladder activity.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/ML device that requires a training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

December 21, 2021

SRS Medical Lee Brody CEO 76 Treble Cove Road, Building #3 North Billerica, MA 01862

Re: K212830

Trade/Device Name: CT3000Pro Regulation Number: 21 CFR§ 876.1620 Regulation Name: Urodynamics Measurement System Regulatory Class: II Product Code: FEN, EXQ Dated: November 22, 2021 Received: November 23, 2021

Dear Lee Brody:

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.

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.

{1}------------------------------------------------

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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,

Jessica K. Nguyen, Ph.D. Assistant 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K212830

Device Name CT3000Pro

Indications for Use (Describe)

The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.

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 complete 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for SRS Medical. The logo is in a light blue color. The text "SRS Medical" is in a sans-serif font. Below the text "SRS Medical" is the text "Driven by bladder function" in a smaller font.

510(k) Summary

1. Submitter:

Company:	SRS Medical76 Treble Cove Road, Building #3North Billerica, MA 01862
Contract Person:	Lee Brody - CEOTelephone: 978-663-2800Fax: 425-882-1935Email: brody@srsmedical.com
Date Prepared:	December 17, 2021

2. Device:

Trade Name:	CT3000Pro
Common/Usual Name:	Urodynamics measurement system
Classification Name:	Urodynamics measurement system
Regulation Number:	21 CFR 876.1620
Product Codes:	FEN, EXQ
Regulatory Class:	Class II
Panel:	Gastroenterology/Urology

3. Predicate Device:

Laborie Urodynamics System with Tetra, Product Code FEN, EXQ; cleared under K073552. The predicate device has not been subjected to a design-related recall.

4. Device Description:

The CT3000Pro PC software runs three types of tests: (a) catheterized urodynamics, (b) non- invasive SRS Medical

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image contains the logo for SRS Medical. The logo is in a light blue color. The text "SRS Medical" is in a sans-serif font. Below the text is the phrase "Driven by bladder function" in a smaller font.

urodynamics, and (c) uroflow studies. A brief overview of the three test procedures is given below:

a. For catheterized urodynamics studies, the device has up to three pressure channels which record pressure from one or two catheters (Vesical and optionally Abdominal). Perianal surface electromyography (EMG) can be recorded. The CT3000Pro also has a remote control and an electronic leak point detector for recording events.
b. For non-invasive urodynamics studies, the device utilizes a non-invasive UroCuff to apply pressure to the urine stream to determine the pressure required to interrupt the urine flow during a voiding pressure study. Perianal and/or Abdominal surface EMG can be recorded.
c. For uroflow studies, the device utilizes the urine scale, which is used on voiding pressure studies as well.

5. Indications for Use:

The CT3000Pro is intended for urodynamic testing. The equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The noninvasive option utilizes a penile cuff (UroCuff-Classic or UroCuff-DC) for non-invasive testing of bladder activity, by assessing the pressure necessary to interrupt urine flow.

The CT3000Pro is intended for use under the direction of a licensed physician or health care professional in an office or hospital setting.

6. Comparison of Technological Characteristics with Predicate Device:

Characteristic	Predicate Device (Laborie Urodynamics K073552)	CT3000Pro
Indications for Use	Laborie Urodynamic systems are intended forUrodynamic testing. The traditional equipmentperforms standard tests including uroflowmeter,cystometry, micturition, electromyography andurethral pressure profiles. The accessory to ourstandard equipment, Tetra near infrared spectroscopy,for non-invasive testing of bladder activity, aiding inthe diagnosis of patients with lower urinary tractsymptoms - that is patients who suffer from urinaryincontinence.All Urodynamic equipment including the LaborieUrodynamic system with Tetra Accessory are for useunder the direction of a licensed physician or healthcare professional in an office or hospital setting.	The CT3000Pro is intended for urodynamictesting. The equipment performs standardtests including uroflowmeter, cystometry,micturition, electromyography and urethralpressure profiles. The non-invasive optionutilizes a penile cuff (UroCuff-Classic orUroCuff-DC) for non-invasive testing ofbladder activity, by assessing the pressurenecessary to interrupt urine flow.The CT3000Pro is intended for use underthe direction of a licensed physician orhealth care professional in an office orhospital setting.
Use Environment	Office or hospital setting.	Same
Patient Population	Patients who suffer from Urinary Incontinence andother lower urinary tract symptoms.	Same
Users	Licensed physician or health care professional	Same
CatheterizedUrodynamics TestTypes	Uroflometry, cystometry, micturition,electromyography, and urethral pressure profiles.	Same
CatheterizedUrodynamics TestTechnique	Traditional Catheters, infusion pump, scale.	Same

SRS Medical

{5}------------------------------------------------

CT3000Pro - Traditional 510(k)		510(k) Summary
Non-invasiveUrodynamics TestTechnique	Non-invasive testing of bladder activity using Nearinfrared spectroscopy.	Non-invasive testing of bladder activityusing penile cuff.
Uroflow TestTechnique	Urine Scale	Same
Surface EMGTechnique	Standard disposable EMG electrodes. One Channelto record the electrical activity of the musclesassociated with urination.	Standard disposable EMG electrodes. TwoChannels to record the electrical activity ofthe muscles associated with urination.
Communication	Direct connection to the PC via USB cable	Same
Data Storage	Local PC	Same
SystemComponents	Instrument console, personal computer, scale, pump.	Same
Electromechanical Characteristics
ElectricalClassification	Class I Equipment Type BE Applied Parts	Same
Degree ofProtection AgainstIngress of Water	IPXO Equipment	Same
Mode of Operation	Continuous	Same
Uroflow Rate	0 - 50 ml/s	Same
Uroflow Volume	0 - 1100 ml	0 - 1500 ml
Pressure	-40 to 350 cmH2O	0 to 215 cmH2O
EMG	-225 - 225 uV; Frequency: 2 to 800 Hz	225 uV; Frequency: 20-500Hz
Pump	5 to 140 ml/min	0 - 100 ml/min
Infusion	0 - 1000 ml	Same
T-Doc	-68 to 408 cmH2O	Same

As evidenced by the above table, the subject and predicate device have different technological characteristics. Both the subject and the predicate devices are intended for urodynamic testing under the direction of a licensed physician or health care professional in an office or hospital setting. Both devices use traditional equipment to perform standard tests including uroflowmetry, micturition, electromyography and urethral pressure profiles. Both devices also perform non-invasive testing of bladder activity. Therefore, the subject and predicate device have the same intended use.

The main differences between the devices are: (a) the CT3000Pro has an optional second surface EMG channel, (b) the CT3000Pro utilizes a penile cuff for non-invasive measurements while the predicate utilized an indirect measurement technique. There are also some differences in the device hardware specifications. However, these differences do not raise different questions of safety or effectiveness and the testing mentioned below showed that the substantially equivalent with the predicate.

7. Performance Data:

Performance Data - Bench

CT3000Pro was subjected to verification and validation activities utilizing various methods and techniques to verify device performance including:

Device Verification and Validation testing (comprehensive end-to-end t ting of functional requirements).

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains the logo for RS Medical. The logo is in a light blue color. The text "RSMedical" is displayed in a sans-serif font.

Full functional test performed on 100% of units as part of the final test during production ● release.
Product life and durability testing. ●

Biocompatibility testing

1. The CT3000Pro console and associated components and accessories manufactured by SRS Medical or third-party suppliers are non-contact parts, therefore, have no biocompatibility considerations.
The CT3000Pro system requires patient-contacting components for some of the tests, such as 2. catheterized urodynamics test or non-invasive urodynamics test. Except the UroCuff-DC component all the other patient-contacting components are purchased from third party manufacturers and those components are FDA registered and used with the CT3000Pro system without modifications.
1. Biocompatibility evaluation for the patient-contacting material of the UroCuff-DC was conducted in accordance with FDA's guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The material met the requirements.

Electrical safety and electromagnetic compatibility (EMC)

CT3000Pro was evaluated by a third-party certified laboratory for Electromagnetic Compatibility (EMC) and Electrical Safety. The subject device met the following standards:

· IEC 60601-1-2:2014 Medical electrical equipment Part 1-2 General requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
· IEC 60601-1:2005 + A1:2012 Medical electrical equipment = Part 1: General requirements for safety and essential performance

Software Verification and Validation

The CT3000Pro software was developed, validated, and documented in accordance with IEC 62304 and FDA Guidance "General Principles of Software Validation." Software verification and validation activities including code reviews, design reviews, evaluations, analyses, traceability assessment, and manual testing were performed in accordance with standards and guidance documents to demonstrate device performance and functionality. All tests met the required acceptance criteria.

Risk Management

Risk Management activities were conducted in accordance with ISO 14971 to assure that all risk related to invasive and non-invasive urodynamic testing, including use related risks and cybersecurity risks, are appropriately controlled. All control measures were verified and found to be effective. All individual and overall residual risk is acceptable. The new device has the same safety characteristics as the Predicate Device and same risk profile.

Clinical Data

Clinical performance of the non-invasive uroflow measurement technique is demonstrated through clinical data from published literature. The use of UroCuff for non-invasive urodynamic studies has been evaluated by independent research teams and published in peer-reviewed literature. There have

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image contains the logo for SRS Medical. The logo is in a light blue color. Underneath the logo is the text "Driven by bladder function".

CT3000Pro - Traditional 510(k)

510(k) Summary

been 28 Original Research Articles published on UroCuff, as well as an additional 44 Original Research Abstracts, and 20 Technology Assessments, Clinical Guidelines and Review Articles. Specifically, a study on the use of UroCuff-Classic and UroCuff-DC using the CT3000Pro (and its predecessor CT3000Plus) supporting the safety and effectiveness was published in the Journal of Urology. This publication reports on the clinical experiences on over 50,000 UroCuff patients from 103 US hospitals and urology offices. The publication's authors practice at Mayo Clinic, Mount Sinai Hospital, and Chesapeake Urology. Each of these institutions utilizes UroCuff. From the literature data it was established that the effectiveness and safety profile of the subject device are acceptable.

8. Conclusion:

Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.

Regulation Number and Section

§ 876.1620 Urodynamics measurement system.

(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.