The High Resolution Impedance Manometry (HRiM) Probe is intended for use by gastroenterologists, surgeons, and medically trained personnel for gastrointestinal tract studies to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data.

The device is used in conjunction with a manometry system. Studies performed with this system require a skilled interpretation by a physician to aid in making a diagnosis of gastrointestinal motility disorders.

The device is indicated for use on adult populations only.

Device Description

The Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is a flexible polyurethane tube with a series of pressure and impedance sensors evenly spaced along the distal section of the device, an atraumatic tip, and a proximal end electrical connector/handle with an internal signal processor.

This probe is used in conjunction with the Sandhill Scientific Gastrointestinal Motility System (K012232). This motility system consists of a Central Unit, an Interface Cable. Software, and a system cart to organize and hold the system components and computer. The Central Unit receives and conditions electrical signals from the probe to display manometric information through the software. The predicate probe from Unisensor currently uses this same Sandhill Scientific Gastrointestinal Motility (Manometry) system. The overall system provides information to trained clinicians as an aid in documenting and diagnosing digestive motility disorders. The probe is the primary patient measurement device during a gastrointestinal tract motility study.

The HRiM Probe pressure transducers produce electrical signals that vary in direct proportion to the maqnitude of the applied pressure from muscular contractions (peristalsis) within the qastrointestinal tract. The pressure sensor elements are semiconductor strain gauge devices that convert the applied external forces to proportional electrical signals. These pressure sensors each have a unique digital address controlled by the internal signal processor in the proximal end connector/handle of the probe. The probe uses a time multiplexor that generates the address of the pressure sensor to activate, sends that request to the sensor, and then reads the results. Pressure during a motility study is used to assess GI tract clearance via peristalsis.

In addition to pressure sensors for monitoring peristalsis, the probe also contains impedance sensors to provide data to assess bolus transit dynamics. The impedance sensor data is used to detect the direction and transition time of the fluid or food bolus in the GI tract by making use of their natural conductivity. These sensors are made from stainless steel and are designed to show relative impedance changes between GI tract baseline impedance and the impedance seen when a fluid/bolus passes the sensors.

Using pressure (manometry) and impedance together clarifies which patients with manometric abnormalities may have GI tract function disorders.

AI/ML Overview

The provided text describes the non-clinical performance data for the Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe to support its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the format requested. However, I can extract the reported performance and the type of studies conducted.

Here is a summary of the information available:

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

The document does not explicitly present acceptance criteria in a tabular format with corresponding reported performance for specific metrics. Instead, it describes various bench tests performed to demonstrate equivalence to the predicate device and compliance with relevant standards.

Here's an interpretation of the performance demonstrated through the testing:

Acceptance Criteria (Inferred)	Reported Device Performance (Demonstrated)
Mechanical Compatibility: Connects properly to the designated motility system.	HRiM Probe (HRMR201-000) mechanically compatible with accessory cable (H12R-7610) and motility system central unit (inSIGHT Ultima® H12R-2000).
Probe Communication: Successful transmission and display of pressure and impedance data.	Demonstrated probe communication of pressure and impedance data through serial communication interface to the system central unit. Firmware and software functionality verified.
Performance Equivalence to Predicate: Comparable pressure sensor spacing, span, location, module diameter, sensitivity, impedance channel measurements, and depth marking. Performance maintained after reprocessing, simulated use, and aging.	Demonstrated equivalence in these parameters to the Unisensor predicate device. Pressure and impedance sensor functions verified after reprocessing, 200 cycles of simulated use, and 2 years of accelerated aging.
Joint Strength and Integrity: Maintained after reprocessing, simulated use, and aging.	Reprocessed, simulated use, and aged probe joints tested for strength and integrity per BS EN 1618. (Results implied to be satisfactory as no adverse findings are mentioned).
Biocompatibility: Meets applicable standards.	Complies with all applicable parts of ISO 10993-1.
Electrical Safety and EMC: Meets applicable standards.	Complies with IEC 60601-1-2:2014 (Ed 4) and IEC 60601-1:2005 (Ed 3) + Corr. 1:2006 + Corr. 2:2007 + A1:2012.
Reusability/Shelf Life: Withstands 200 cleaning/disinfection cycles and 200 simulated intubation/extubation cycles, and 2 years of aging, while maintaining sensor function.	Designed to withstand 200 cleaning/disinfection and 200 simulated intubation/extubation cycles. Test articles subjected to 200 life cycles and 2 years aging per ASTM F1980-16; probe sensor function verified.
Reprocessing Effectiveness: Reprocessing instructions (manual cleaning + high-level disinfection) are validated.	Validation covered reprocessing instructions outlined in the HRiM Probe IFU, which included manual cleaning followed by high-level disinfection.
Software Verification and Validation: Meets FDA guidance for software in medical devices, considered "minor" level of concern.	Verification and validation testing conducted per FDA guidance; software considered "minor" level of concern.
Cybersecurity: Addresses recommended cybersecurity issues.	Information gathered to address cybersecurity issues as recommended in FDA guidance, including protection from malware, continued support, traceability, and risk analysis. Cybersecurity section included in IFU.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "samples from initial production lots" were used for testing (Page 7). However, it does not specify the exact sample size (number of probes) for each test. All testing appears to be prospective bench testing conducted by Diversatek Healthcare. There is no information provided about the country of origin of the data beyond "Diversatek Healthcare performed bench testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the studies described are non-clinical bench tests comparing the device against a predicate and established engineering standards, rather than clinical studies requiring expert interpretation of results for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the studies described are non-clinical bench tests.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was deemed unnecessary to support substantial equivalence. The nonclinical testing performed supports safety and efficacy of the device and provides data to show substantial equivalence to the predicate device." (Page 8). This device is a measurement probe, not an AI-assisted diagnostic tool.

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

This information is not applicable in the context of standalone algorithm performance. The device is a "High Resolution Impedance Manometry (HRiM) Probe" designed to obtain physiological data, not an algorithm in the traditional sense of AI. Its "standalone" performance is assessed through its ability to accurately measure pressure and impedance, which was demonstrated through the bench testing described. The probe does contain embedded firmware (software) which was verified and validated (Section 9).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical performance evaluation was based on:

Predicate device's performance: The Diversatek Healthcare HRiM Probe's function and performance were compared directly against the Unisensor predicate device for parameters like sensor spacing, span, sensitivity, etc.
Established engineering standards: Compliance with standards like ISO 10993-1 (biocompatibility), IEC 60601-1-2 and IEC 60601-1 (electrical safety and EMC), ASTM F1980-16 (accelerated aging), and BS EN 1618 (joint strength) served as the "ground truth" for those specific tests.
Internal specifications and design objectives: The device was designed to withstand certain cycles of use and aging, and verification confirmed it met these objectives.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model that requires a training set in the conventional sense.

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

This information is not applicable. The device does not utilize a "training set" for an AI model.

Summary

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October 3, 2019

Diversatek Healthcare Laura Boll Vice President - Quality and Regulatory Affairs 9150 Commerce Center Circle Suite 500 Highlands Ranch, CO 80129

Re: K190208

Trade/Device Name: Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: September 17, 2019 Received: September 18, 2019

Dear Laura Boll:

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.

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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 (OS) 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.

Martha Betz, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K190208

Device Name

Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

Indications for Use (Describe)

The device is indicated for use on adult populations only.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.

1. Submission Sponsor and Contact

Submitter's Name: Diversatek Healthcare (formerly Sandhill Scientific) Submitter's Address: 9150 Commerce Center Circle Highlands Ranch, CO 80129 2023374 Establishment Registration No.: Contact Person: Laura Boll Vice President, Quality and Regulatory Affairs Telephone: 414-755-4806 (direct) 414-265-7620 ext. 4806 Email: lboll@diversatek.com Date Prepared: December 7, 2018 Date Revised: September 26, 2019

2. Device Identification

Trade Device Name:

Manometry (HRIM) Probe
------------------------

Common Device Name:	HRIM Probe
FDA Product Code	FFX
FDA Classification Name:	Gastrointestinal Motility Monitoring System
Regulation Number:	21 CFR 876.1725
Regulatory Class:	II

3. Predicate Device Identification

Predicate 510(k) No.: Predicate Trade Name: Predicate FDA Product Code: Predicate FDA Classification Name: Predicate Regulation No.: Predicate Regulatory Class:

K062222

Unisensor UniTip High Resolution GI Catheter FFX Gastrointestinal Motility Monitoring System 21 CFR 876.1725 ll

Diversatek Healthcare High Resolution Impedance

This predicate device has not been subject to a design-related recall.

No reference devices were used in this submission.

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4. General Device Description

This probe is used in conjunction with the Sandhill Scientific1 Gastrointestinal Motility System (K012232). This motility system consists of a Central Unit, an Interface Cable. Software, and a system cart to organize and hold the system components and computer. The Central Unit receives and conditions electrical signals from the probe to display manometric information through the software. The predicate probe from Unisensor currently uses this same Sandhill Scientific¹ Gastrointestinal Motility (Manometry) system. The overall system provides information to trained clinicians as an aid in documenting and diagnosing digestive motility disorders. The probe is the primary patient measurement device during a gastrointestinal tract motility study.

Using pressure (manometry) and impedance together clarifies which patients with manometric abnormalities may have GI tract function disorders.

5. Intended Use

The High Resolution Impedance Manometry (HRiM) Probe is intended for use by gastroenterologists, surgeons, and medically trained personnel for gastrointestinal tract studies to obtain a high resolution mapping of peristaltic activity or pressure within the orqans of the qastrointestinal tract, and to allow storage of the corresponding data.

1 Please note that Sandhill Scientific was purchased by Diversatek Healthcare in December 2013 and is currently undergoing a name change from Sandhill Scientific to Diversatek Healthcare

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The device is indicated for use on adult populations only.

6. Technological Characteristics

The following table is a summary of the Diversatek Healthcare HRiM Probe technological characteristics as compared to the predicate device from Unisensor.

Table 5.1 Summary of design, features and principles of operation between the Diversatek Healthcare HRiM Probe and Predicate Device Unisensor UniTip High Resolution Catheter

Characteristic	Diversatek Healthcare	Unisensor
Trade Name	High Resolution ImpedanceManometry(HRiM) Probe	UniTip High ResolutionCatheter
510(k) Number	TBD	K062222
Product Code	FFX	FFX
Regulation Number	876.1725	876.1725
Regulation Name	Gastrointestinal motilitymonitoring system	Gastrointestinal motilitymonitoring system
Manufacturing Design	Thermoplastic catheter tubingwith pressure and impedancesensors, atraumatic tip, andproximal electrical connector	Thermoplastic catheter tubingwith pressure and impedancesensors, atraumatic tip, andproximal electrical connector
Materials	Polyurethane tubing, stainlesssteel impedance rings,ceramic piezoelectric pressuresensors, silicone encapsulate	Polyurethane tubing, stainlesssteel impedance rings,ceramic pressure sensors,silicone encapsulate
SystemCompatibility	Gastrointestinal Motility(Manometry) System (inSIGHTUltima® System fromDiversatek Healthcare)Reference: K012232	Gastrointestinal Motility(Manometry) System (inSIGHTUltima® System fromDiversatek Healthcare)Reference: K012232
Characteristic	Diversatek Healthcare	Unisensor
Intended Use	The High Resolution Probe isintended for use bygastroenterologists, surgeons,and medically trainedpersonnel for gastrointestinaltract studies to obtain a highresolution mapping ofperistaltic activity or pressurewithin the organs of thegastrointestinal tract, and toallow storage of thecorresponding data.The device is used inconjunction with a manometrysystem.	The catheter probe is used toobtain a high resolutionmapping of peristaltic activityor pressure within the organsof the gastrointestinal tract,and to allow storage of thecorresponding data.
Environment	Professional Healthcare OfficeEnvironment, which includeshospitals, clinics, practitioneroffices, and clinicallaboratories	Professional Healthcare OfficeEnvironment, which includeshospitals, clinics, practitioneroffices, and clinicallaboratories
Patient Population	No special patient population;patients requiring GI tractfunction testingAdult use only	No special patient population;patients requiring GI tractfunction testingAdult use only
Patient ContactCategorization	Gastrointestinal Tract	Gastrointestinal Tract
Configuration	Non-sterile reusable devicerequiring high level disinfectionbefore use	Non-sterile reusable devicerequiring high level disinfectionbefore use
Reusable Device	YesReusable medical devicesinitially supplied as non-sterileto the user and requiring theuser to process (i.e., clean,clean and disinfect, or cleanand sterilize) the device forinitial use, as well as toreprocess the device aftereach use	YesReusable medical devicesinitially supplied as non-sterileto the user and requiring theuser to process (i.e., clean,clean and disinfect, or cleanand sterilize) the device forinitial use, as well as toreprocess the device aftereach use
Shelf Life	200 uses (2 years)	200 uses (2 years)

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7. Non-Clinical Performance Data

Diversatek Healthcare performed bench testing to support substantial equivalence. The following testing was performed on Diversatek Healthcare samples from initial production lots (where applicable):

a. Compatibility with Gastrointestinal Motility (Manometry) System

Mechanical compatibility of the Diversatek Healthcare HRiM Probe with the designated Gastrointestinal Motility (Manometry) System was tested by connecting the Diversatek HRiM Probe (HRMR201-000) to the accessory cable (H12R-7610) which connects to the motility system central unit (inSIGHT Ultima® H12R-2000).

b. Probe Communication to Gastrointestinal Motility (Manometry) System

The Diversatek Healthcare HRiM Probe functional testing was started by demonstrating probe communication of pressure and impedance data through the serial communication interface of the Probe connector to the System central unit (inSIGHT Ultima® H12R-2000). This test verified the firmware and software functionality of the HRiM Probe with the Gastrointestinal Motility (Manometry) System.

c. Comparison to Predicate Function and Performance

The Diversatek Healthcare HRiM Probe performance and function was tested aqainst the predicate device from Unisensor to demonstrate equivalence. This testing included a comparison of the pressure sensor spacing, pressure sensor span, pressure sensor location, pressure sensor module diameter, pressure sensor sensitivity, impedance channel measurements, and depth marking on the probe catheters to aid in placement. The testing ran through the ranges of pressure and impedance measurements to simulate clinical use in a motility study and compared the results of the Diversatek Healthcare HRiM Probe to the predicate probe from Unisensor. The HRiM Probe was then subjected to reprocessing, simulated use of 200 cycles, and aging for 2 years per ASTM F1980-16. Pressure and impedance sensor functions were verified after this to demonstrate the device performance is not affected by reprocessing, the stresses of use, and/or aging. Additionally, the reprocessed/simulated use/aged probe joints were tested for strength and integrity per BS EN 1618.

d. Safety

Diversatek Healthcare confirmed the safety of the HRiM Probe through risk assessment, biocompatibility testing, and electrical safety testing.

Biocompatibility testing was completed on the Diversatek Healthcare HRiM Probe per ISO 10993-1. This device complies with all applicable parts of the standard. Complete test reports are in Section 15 of this Submission.

Electrical safety and EMC testing were conducted on the Diversatek Healthcare HRiM Probe. This device complies with the applicable requirements of IEC 60601-1-2:2014 (Ed 4) and IEC 60601-1:2005 (Ed 3) + Corr. 1:2006 + Corr. 2:2007 + A1:2012. Complete test reports are in Section 17 of this Submission.

e. Reusability / Shelf Life

The Diversatek Healthcare HRiM Probe was designed to withstand 200 cleaning / disinfection cvcles followed by 200 simulated intubation / extubation cvcles. The predicate device is also labeled with a 200 uses / 2 year warranty. Since function of

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both HRiM probes is confirmed during procedural setup. This test was performed on a section of the probe that is representative of the probe and simulated 200 probe life cycles including air calibration, intubation, manometry procedure, extubation, cleaning/disinfection, and storage. The test articles were then subjected to the equivalent of 2 years of aging per accelerated aging standard ASTM F1980-16. The probe sensor function was verified after aging/200 life cvcles.

f. Reprocessing

The HRiM Probe is a reusable device that requires reprocessing after each use. This reusable device falls within the scope of FDA Guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", issued March 17, 2015. The validation covered the reprocessing instructions outlined in the HRiM Probe IFU, which included manual cleaning to remove gross contaminants followed by high level disinfection.

8. Electrical Testing

9. Software (Embedded Firmware) Verification and Validation

The High Resolution Impedance Manometry (HRiM) Probe contains embedded firmware. Verification and validation testing was conducted per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device was considered a "minor" level of concern since failure or latent flaw in the software will not pose any risk of harm to the patient or user.

Diversatek Healthcare reviewed and collected the information needed to address the cvbersecurity issues as recommended in Section 6 of the FDA quidance titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". This included a review of the following areas: protection from malware during the production and distribution of the software, continued support of the product after it has been introduced into the field, traceability for cybersecurity, and cybersecurity risk analysis and management. Based on that information, a Cybersecurity section was included within the HRiM Probe IFU.

10. Clinical Testing

Clinical testing was deemed unnecessary to support substantial equivalence. The nonclinical testing performed supports safety and efficacy of the device and provides data to show substantial equivalence to the predicate device.

11. Conclusion

Diversatek Healthcare HRiM Probe has the same intended use as the predicate device.

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Based on the technological characteristics and overall performance of the devices in bench testing, Diversatek Healthcare believes the proposed HRiM Probe and the predicate device are substantially equivalent.

Through risk assessment and bench testing, Diversatek Healthcare has concluded the HRiM Probe does not raise any new issues of safety and effectiveness and performs as well as the legally marketed predicate device.

Based on the results of the non-clinical testing, Diversatek Healthcare has concluded the HRiM Probe is as safe, as effective, and performs as well as the legally marketed predicate device.

Regulation Number and Section

§ 876.1725 Gastrointestinal motility monitoring system.

(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).