(241 days)
No
The description focuses on the hardware (sensors, probe) and the system's function of collecting and displaying data for physician interpretation. There is no mention of automated analysis, pattern recognition, or learning algorithms.
No
The device is described as an aid in diagnosing gastrointestinal motility disorders and provides information for diagnosis, but it does not directly treat or prevent a disease.
Yes
The device is intended to aid in making a diagnosis of gastrointestinal motility disorders by providing high-resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract. It explicitly states that studies performed with the system require skilled interpretation by a physician to "aid in making a diagnosis."
No
The device description explicitly states that the device 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 describes a physical hardware component, not a software-only device. While it works in conjunction with a software system, the device itself is a probe with sensors and processing capabilities.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Device Function: The HRiM Probe is a device that is inserted into the gastrointestinal tract (in vivo) to measure pressure and impedance directly within the organs. It does not analyze samples taken from the body.
- Intended Use: The intended use is to obtain a high-resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract. This is a direct measurement of physiological function, not an analysis of a biological sample.
- Device Description: The description details sensors that measure pressure and impedance within the GI tract, not components for analyzing samples.
Therefore, the HRiM Probe is a medical device used for in vivo measurements, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
FFX
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Adult use only
Intended User / Care Setting
gastroenterologists, surgeons, and medically trained personnel / Professional Healthcare Office Environment, which includes hospitals, clinics, practitioner offices, and clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
Bench testing was performed to support substantial equivalence.
a. Compatibility with Gastrointestinal Motility (Manometry) System: Mechanical compatibility was tested by connecting the HRiM Probe to the accessory cable which connects to the motility system central unit.
b. Probe Communication to Gastrointestinal Motility (Manometry) System: Functional testing demonstrated probe communication of pressure and impedance data through the serial communication interface to the system central unit. This verified firmware and software functionality.
c. Comparison to Predicate Function and Performance: The HRiM Probe's performance and function were tested against the predicate device to demonstrate equivalence. This included comparing pressure sensor spacing, span, location, module diameter, sensitivity, impedance channel measurements, and depth markings. Testing ran through pressure and impedance ranges to simulate clinical use, and results were compared to the predicate. The HRiM Probe was subjected to reprocessing, simulated use of 200 cycles, and aging for 2 years per ASTM F1980-16. Pressure and impedance sensor functions were verified afterward to show performance is not affected by reprocessing, use stresses, or aging. Reprocessed/simulated use/aged probe joints were tested for strength and integrity per BS EN 1618.
d. Safety: Safety was confirmed through risk assessment, biocompatibility testing (per ISO 10993-1), and electrical safety testing (per IEC 60601-1-2:2014 and IEC 60601-1:2005).
e. Reusability / Shelf Life: Designed to withstand 200 cleaning/disinfection cycles followed by 200 simulated intubation/extubation cycles. A section of the probe was tested for 200 life cycles (including calibration, intubation, procedure, extubation, cleaning/disinfection, storage) and subjected to 2 years of aging per ASTM F1980-16. Sensor function was verified after aging/life cycles.
f. Reprocessing: Validation followed FDA Guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" (March 17, 2015). Validation covered manual cleaning and high-level disinfection as outlined in the HRiM Probe IFU.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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
2
Indications for Use
510(k) Number (if known) K190208
Device Name
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
Indications for Use (Describe)
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.
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
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 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.
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.
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 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.
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 Impedance | |
| Manometry(HRiM) Probe | UniTip High Resolution | |
| Catheter | ||
| 510(k) Number | TBD | K062222 |
| Product Code | FFX | FFX |
| Regulation Number | 876.1725 | 876.1725 |
| Regulation Name | Gastrointestinal motility | |
| monitoring system | Gastrointestinal motility | |
| monitoring system | ||
| Manufacturing Design | Thermoplastic catheter tubing | |
| with pressure and impedance | ||
| sensors, atraumatic tip, and | ||
| proximal electrical connector | Thermoplastic catheter tubing | |
| with pressure and impedance | ||
| sensors, atraumatic tip, and | ||
| proximal electrical connector | ||
| Materials | Polyurethane tubing, stainless | |
| steel impedance rings, | ||
| ceramic piezoelectric pressure | ||
| sensors, silicone encapsulate | Polyurethane tubing, stainless | |
| steel impedance rings, | ||
| ceramic pressure sensors, | ||
| silicone encapsulate | ||
| System | ||
| Compatibility | Gastrointestinal Motility | |
| (Manometry) System (inSIGHT | ||
| Ultima® System from | ||
| Diversatek Healthcare) | ||
| Reference: K012232 | Gastrointestinal Motility | |
| (Manometry) System (inSIGHT | ||
| Ultima® System from | ||
| Diversatek Healthcare) | ||
| Reference: K012232 | ||
| Characteristic | Diversatek Healthcare | Unisensor |
| Intended Use | The High Resolution 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. | The catheter probe is used 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. | ||
| Environment | Professional Healthcare Office | |
| Environment, which includes | ||
| hospitals, clinics, practitioner | ||
| offices, and clinical | ||
| laboratories | Professional Healthcare Office | |
| Environment, which includes | ||
| hospitals, clinics, practitioner | ||
| offices, and clinical | ||
| laboratories | ||
| Patient Population | No special patient population; | |
| patients requiring GI tract | ||
| function testing | ||
| Adult use only | No special patient population; | |
| patients requiring GI tract | ||
| function testing | ||
| Adult use only | ||
| Patient Contact | ||
| Categorization | Gastrointestinal Tract | Gastrointestinal Tract |
| Configuration | Non-sterile reusable device | |
| requiring high level disinfection | ||
| before use | Non-sterile reusable device | |
| requiring high level disinfection | ||
| before use | ||
| Reusable Device | Yes | |
| Reusable medical devices | ||
| initially supplied as non-sterile | ||
| to the user and requiring the | ||
| user to process (i.e., clean, | ||
| clean and disinfect, or clean | ||
| and sterilize) the device for | ||
| initial use, as well as to | ||
| reprocess the device after | ||
| each use | Yes | |
| Reusable medical devices | ||
| initially supplied as non-sterile | ||
| to the user and requiring the | ||
| user to process (i.e., clean, | ||
| clean and disinfect, or clean | ||
| and sterilize) the device for | ||
| initial use, as well as to | ||
| reprocess the device after | ||
| each 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
8
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
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.
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.