(241 days)
Not Found
No
The summary describes data acquisition, visualization, and analysis tools based on sensor data and basic calculations (pressure gradients, resting/contraction pressures). There is no mention of AI/ML algorithms for image processing, diagnosis, or prediction.
No
The device is intended for diagnosis and evaluation by acquiring ultrasound images, tactile images (pressure maps), and assessing pelvic floor muscle strength. It provides visualization, analysis tools, and information to assist in diagnosis, not directly treat.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "assisting in the diagnosis and evaluation." Additionally, the "Device Description" mentions that the acquired data and analysis results "can be used by a physician for quantitative biomechanical assessment of the vagina and pelvic floor conditions," which points to a diagnostic purpose.
No
The device description explicitly details a physical probe with multiple sensors (pressure, ultrasound, orientation, temperature) and micro-heaters, which are hardware components. While the device includes software for data processing and visualization, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Vaginal Tactile Ultrasound Imager operates within the body (in vivo) by being inserted into the vagina. It directly acquires pressure and ultrasound data from the vaginal walls and pelvic floor muscles.
- Intended Use: The intended use describes the device as assisting in the diagnosis and evaluation based on the acquired pressure and ultrasound data from within the body.
The device is a medical imaging and assessment device used directly on the patient, not for testing samples taken from the patient.
No
The input explicitly states, "FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction." This confirms that no PCCP was included or authorized for this device.
Intended Use / Indications for Use
The Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.
Product codes (comma separated list FDA assigned to the subject device)
HIR, IYO
Device Description
The Vaginal Tactile Ultrasound Imager (TIUSv) acquires ultrasound images and tactile images (pressure maps) from within the vagina and assesses the strength of pelvic floor muscles within the vagina. The device provides data on the pressures applied to vaginal walls along with the probe location to visualize pelvic floor support structures, and to record pelvic floor muscle contraction. The TIUSv software provides measurement, imaging, and reporting tools. The acquired data and the analysis results provided by TIUSv software can be used by a physician for quantitative biomechanical assessment of the vagina and pelvic floor conditions.
The TIUSv probe is equipped with 96 pressure (tactile) sensors, 192 ultrasound transducers, an orientation sensor (accelerometer), temperature sensors, and micro-heaters. During the clinical procedure, the probe is used to acquire dynamic ultrasound images and pressure responses from the vaginal walls under applied loads. The TIUSv examination procedure includes data collection from all segments of the vagina. Real-time data are sampled from the probe sensors via the interface electronics. The TIUSv software displays the acquired data in real time. The resulting pressure maps (tactile images) of the vagina integrate all the acquired pressure and positioning data for each of the pressure sensing elements. The TIUSv records the dynamic contraction for pelvic floor muscle(s). The probe surfaces that contact the vaginal walls are preheated to human body temperature.
The TIUSv supports physician data analysis by means of a playback function, which replays a stored session using previously recorded data instead of the real time data. The TIUSv also provides data and graphs such as pressure applied to the probe and location, resting pressures, muscle contraction pressures and calculated pressure gradients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians Surgeons Medically trained personnel
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)
The components of the Vaginal Tactile Ultrasound Imager (TIUSv) were tested individually and together at the system level and the necessary test reports were generated. Other verification reports include the biocompatibility test reports, cleaning and disinfection test reports, applied IEC 60601-1-2 reports and bench verification/validation test reports.
The nonclinical performance data described above demonstrate the Vaginal Tactile Ultrasound Imager is safe and effective.
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).
Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).
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July 9, 2024
Advanced Tactile Imaging Inc. Brendan Francy Biomedical Engineer 1457 Lower Ferry Rd Ewing, New Jersey 08618
Re: K231875
Trade/Device Name: Vaginal Tactile Ultrasound Imager Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: Class II Product Code: HIR
Dear Brendan Francy:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on February 22, 2024. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jason Roberts, OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, 240-402-6400, jason.roberts(@fda.hhs.gov.
Sincerely,
Jason Roberts -S
Jason R. Roberts, 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
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Image /page/1/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
July 9, 2024
Advanced Tactile Imaging Inc. Vladimir Egorov CEO 1457 Lower Ferry Rd Ewing, New Jersey 08618
Re: K231875 Trade/Device Name: Vaginal Tactile Ultrasound Imager Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Received: June 26, 2023
Dear Vladimir Egorov:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on February 22, 2024.
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Jason Roberts -S
Jason R. Roberts, 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
3
Enclosure
4
Indications for Use
510(k) Number (if known) K231875
Device Name
Vaginal Tactile Ultrasound Imager (TIUSv)
Indications for Use (Describe)
The Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.
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) |
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1. IDENTIFICATION
| Submission Date: | February 22, 2024 |
|---|---|
| Applicant's/Owner's Name: | Advanced Tactile Imaging, Inc. |
| 1457 Lower Ferry Rd | |
| Trenton, NJ 08618 USA | |
| Contact Person: | Vladimir Egorov |
| Phone number: | 609 883-0100 |
| Fax number: | n/a |
| Email: | egorov@tactile-imaging.com |
| Device Common Name: | Pressure Mapping Perineometer |
| Device Trade/Proprietary Name: | Vaginal Tactile Ultrasound Imager (TIUSv) |
| Device Class: | Class II |
| Classification Name: | Perineometer/Ultrasonic pulsed echo imaging system |
| Product Code: | HIR/IYO |
| Regulation Number: | 884.1425/892.1560 |
2. LEGALLY MARKETED DEVICES FOR SUBSTANTIAL EQUIVALENCE
- K142355. Vaginal Tactile Imager (Advanced Tactile Imaging, Inc.),
3. DESCRIPTION
The Vaginal Tactile Ultrasound Imager (TIUSv) acquires ultrasound images and tactile images (pressure maps) from within the vagina and assesses the strength of pelvic floor muscles within the vagina. The device provides data on the pressures applied to vaginal walls along with the probe location to visualize pelvic floor support structures, and to record pelvic floor muscle contraction. The TIUSv software provides measurement, imaging, and reporting tools. The acquired data and the analysis results provided by TIUSv software can be used by a physician for quantitative biomechanical assessment of the vagina and pelvic floor conditions.
The TIUSv probe is equipped with 96 pressure (tactile) sensors, 192 ultrasound transducers, an orientation sensor (accelerometer), temperature sensors, and micro-heaters. During the clinical procedure, the probe is used to acquire dynamic ultrasound images and pressure responses from the vaginal walls under applied loads. The TIUSv examination procedure includes data collection from all segments of the vagina. Real-time data are sampled from the probe sensors via the interface electronics. The TIUSv software displays the acquired data in real time. The resulting pressure maps (tactile images) of the vagina integrate all the acquired pressure and positioning data for each of the pressure sensing elements. The TIUSv records the dynamic contraction for pelvic floor muscle(s). The probe surfaces that contact the vaginal walls are preheated to human body temperature.
6
The TIUSv supports physician data analysis by means of a playback function, which replays a stored session using previously recorded data instead of the real time data. The TIUSv also provides data and graphs such as pressure applied to the probe and location, resting pressures, muscle contraction pressures and calculated pressure gradients.
4. INTENDED USE
The Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.
| Device & Predicate Device(s): | K231875 | K142355 | Comment |
|---|---|---|---|
| Device Name | Vaginal Tactile | ||
| Ultrasound Imager | Vaginal Tactile | ||
| Imager | - | ||
| Primary Product Code | HIR | HIR | Same |
| Duration of Procedure | Up to 5 minutes | 1 - 2 minutes | Similar |
| Method of Data Collection | Contact tissue surface | ||
| (vaginal mucosa) | Contact tissue | ||
| surface (vaginal | |||
| mucosa) | Same | ||
| Handheld Probe | Yes | Yes | Same |
| Probe Size | 17 - 31mm | 17 - 31mm | Same |
| Probe Length | 120mm | 120mm | Same |
| Probe Material | Plastic, Silicone | Plastic, Silicone | Same |
| Pressure Sensor Technology | Capacitive pressure | ||
| sensor | Capacitive pressure | ||
| sensor | Same | ||
| Number of Pressure Sensors | 96 | 96 | Same |
| Pressure Range | 30 kPa | 33 kPa | Similar |
| Pressure Accuracy | 0.5 kPa | 0.5 kPa | Same |
| Accelerometer | Yes | Yes | Same |
| Ultrasound Technology | Yes | No | Different |
| Number of Ultrasound Transducers | 192 | N/A | Different |
| Probe Sterilization | Non-sterile | Non-Sterile | Same |
| Method of Data Presentation | Pressure color | ||
| mapped and | |||
| ultrasound images. | Tactile Images | Similar |
5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
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| 110 – 240V AC | 110 – 240V AC | ||
|---|---|---|---|
| Power Source | 47 – 63 Hz | ||
| 1.25 – 0.5A | 47 – 63 Hz | ||
| 1.25 – 0.5A | Same |
The Vaginal Tactile Imager has very similar technological characteristics to the subject device, including, the size and material of the probe, the number of pressure sensors, use of an accelerometer, ability to preheat, and the medical diagnostic cart platform.
The Vaginal Tactile Imager (Predicate Device) contains very similar intended use as the subject device except it does not include the use of Ultrasound Imaging capabilities or technology. Both devices develop a pressure map of the vagina to measure the strength of female pelvic floor. Both devices have the same intended user and environment.
The subject device and the Acuson (Reference device) have similar transvaginal ultrasound transducers with B-mode imaging. Additionally, the subject device and the Acuson have very similar Ultrasound arrays with the same number of elements, imaging depth, and frequency bandwidth.
The ArtUs Ultrasound System is used in the subject device to provide B-mode ultrasound imaging. ArtUs ultrasound electronics allows for the reception of ultrasound signals from the probe's ultrasound array and transmission to the computer on the cart.
The differences between the subject device and the predicate device does not raise any different questions of safety or effectiveness.
6. OVERVIEW OF THE PERFORMANCE DATA
The components of the Vaginal Tactile Ultrasound Imager (TIUSv) were tested individually and together at the system level and the necessary test reports were generated. Other verification reports include the biocompatibility test reports, cleaning and disinfection test reports, applied IEC 60601-1-2 reports and bench verification/validation test reports.
Device Protection against Electrical Shock: Class IIa TIUSv probe: Type B Applied Part Device IP Code: IP20 TIUSv probe IP Code: IP47 Mode of Operation: Continuous Operation Sanitary Requirement: High-level disinfection of TIUSv probe Power Consumption: 110 W Input Voltage: 110 - 240 V AC, 47 - 63 Hz, 1.25 - 0.5 A 37 kg Weight:
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| Size: | 51 cm (width) x 51 cm (depth) x 140 cm (height) | |
|---|---|---|
| Operational Conditions: | Temperature Range: from 20 °C to 30 °C, | |
| Relative Humidity Range: 0% - 90%, non-condensing | ||
| Methods for device securing | ||
| against unexpected motion: | Four brakes on cart casters | |
| Measurement Values: | Pressure (kPa) | |
| Orientation of the probe (degree), | ||
| Temperature of the micro-heaters (°C). | ||
| Measurement Ranges: | Pressure: 0 – 30 kPa | |
| Orientation: 0±360 degrees for rotation | ||
| 0 ± 45 degrees for elevation | ||
| Temperature: from +20 °C to +40 °C |
Table 1. Measurement Performance (accuracy) for Pressure
| Pressure range | Accuracy
(Calculated by standard deviation
for all pressure sensors) | Maximum deviation for
individual sensor |
|----------------|----------------------------------------------------------------------------|--------------------------------------------|
| 0 — 30 kPa | ± 0.7 kPa | ± 2.5 kPa |
| Measurement Performance:
(accuracy) | Temperature: ±0.5 °C
Orientation: ± 1.0 degrees |
|-----------------------------------------|------------------------------------------------------------|
| Number Ultrasound Transducers | 192 Elements |
| Ultrasound Frequency | 4-7 MHz |
| Ultrasound lateral resolution | 2.0 mm |
| Ultrasound lateral positioning accuracy | ±1.0 mm |
| Axial resolution | 1.0 mm |
| Ultrasound axial positioning accuracy | ±2.0 mm |
| Calculated Values: | Pressure gradient (kPa/mm)
Distance (mm), |
| Calculated Ranges: | Pressure gradient: 0 – 4 kPa/mm
Distance:
0 – 120 mm |
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Intended Users:
Physicians Surgeons Medically trained personnel
7. PERFORMANCE TESTING
The performance testing completed on the Vaginal Tactile Ultrasound Imager included the following:
Cleaning and High-Level Disinfection
- Cleaning and high-level disinfection validation of vaginal probe ●
Biocompatibility testing
- The biocompatibility evaluation was conducted in accordance with the FDA Guidance for . Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
- Biocompatibility testing (cytotoxicity, sensitization, and irritation) per ISO 10993-1:2009 ●
Electromagnetic Compatibility and Electrical Safety
- The subject device models were assessed for conformity with the relevant requirements of ● the following standards and found to comply:
- Electromagnetic compatibility testing per IEC 60601-1-2 : 2014/AMD1:2021 ●
- Basic safety and essential performance of medical electrical equipment per IEC 60601-1 ● 2005/AMD1:2012
- Basic safety and essential performance of ultrasonic medical diagnostic and monitoring ● equipment IEC 60601-2-37: 2007/AMD1:2015
Software Verification and Validation Testing
Software verification and validation testing was conducted and completed, and software ● documentation was provided as recommended by FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005 for a moderate software level of concern.
-
. Software verification and validation IEC/EN 62304:2006+A1:2015
The following quality assurance measures are applied to the development of the system: -
Risk analysis
-
Component testing (Verification) ●
-
System performance testing (Verification & Validation) ●
-
Safety testing (Verification) ●
The nonclinical performance data described above demonstrate the Vaginal Tactile Ultrasound Imager is safe and effective.
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8. CONCLUSION
The Vaginal Tactile Ultrasound Imager has the same intended use as the predicate. Performance testing has demonstrated that the subject device is as safe and effective as the legally marketed predicate device.