(717 days)
Not Found
Not Found
No
The summary mentions "image acquisition, processing, and display" but does not mention AI, ML, or any related terms like neural networks or deep learning. The performance studies focus on procedural outcomes rather than the performance of an AI/ML algorithm in identifying anatomical features.
No
Explanation: The device is indicated to aid in the localization of a lumbar interspinous space and marking of an identified insertion site for neuraxial procedures, which are diagnostic and therapeutic. However, the device itself is a "Spinal Imaging Device" that helps the physician plan and approach needle placement. It does not directly provide therapy or affect the body's structure or function for therapeutic purposes. It is a tool for guiding a procedure, not a therapeutic device itself.
No
The device is indicated to aid in the localization and marking of an insertion site for neuraxial procedures. While these procedures can be diagnostic (e.g., lumbar punctures for analysis), the device itself aids in the procedure rather than performing a diagnosis. It helps physicians plan and approach needle placement by providing a pressure map of spinal anatomy.
No
The device description explicitly states it includes a "reusable Monitor" which is a hardware component responsible for image acquisition, processing, and display. It also mentions a "VerTouch handle" and a "marker included in the VerTouch Kit," indicating physical components beyond just software.
Based on the provided information, the VerTouch device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that VerTouch is indicated to aid in the localization of a lumbar interspinous space and the marking of an insertion site for neuraxial procedures. These are clinical procedures performed directly on the patient's body.
- Device Description: The device description reinforces this by stating its purpose is to provide a pressure map of posterior spinal anatomy to help the physician plan and approach needle placement during neuraxial procedures.
- Mechanism of Action: The device uses tactile imaging (a 2D pressure map) to visualize anatomical features on the patient's skin surface.
- Lack of In Vitro Activity: IVDs are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. VerTouch does not interact with or analyze any biological specimens.
- Clinical Studies: The performance studies focus on procedural outcomes (needle insertions, redirections, success rates) related to performing the neuraxial procedure on the patient, not on the analysis of biological samples.
In summary, VerTouch is a medical device used in vivo (on the living body) to assist with a clinical procedure, not an IVD used in vitro (outside the body) to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
VerTouch is indicated to aid in the localization of a lumbar interspinous space, and the marking of an identified insertion site, for diagnostic and therapeutic neuraxial procedures.
VerTouch is indicated for use in hospital facilities and clinics by right- and left-handed emergency medicine, neurology, anesthesiology, and pain medicine professionals for assistance with spinal punctures.
The VerTouch handle is intended to be held with the left hand. Imaging and marking are intended to be performed with the right hand.
VerTouch is indicated for use on patients at least 18 years of age with BMI
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR VERTOUCH SPINAL IMAGING DEVICE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Spinal imaging system for neuraxial procedures. A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures.
NEW REGULATION NUMBER: 21 CFR 868.1985
CLASSIFICATION: Class II
PRODUCT CODE: QXD
BACKGROUND
DEVICE NAME: VerTouch Spinal Imaging Device
SUBMISSION NUMBER: DEN220009
DATE DE NOVO RECEIVED: February 1, 2022
SPONSOR INFORMATION:
IntuiTap Medical 1623 W Fulton St. Chicago. IL. 60612 USA
INDICATIONS FOR USE
VerTouch is indicated to aid in the localization of a lumbar interspinous space, and the marking of an identified insertion site, for diagnostic and therapeutic neuraxial procedures.
VerTouch is indicated for use in hospital facilities and clinics by right- and left-handed emergency medicine, neurology, anesthesiology, and pain medicine professionals for assistance with spinal punctures.
The VerTouch handle is intended to be held with the left hand. Imaging and marking are intended to be performed with the right hand.
VerTouch is indicated for use on patients at least 18 years of age with BMI 65) n [%] | 6 [14.3%] | 7 [14.6%] | 13 [14.4%] | |
| Gender | Males | 13 [31.0%] | 12 [25.0%] | 25 [27.8%] | 0.53 |
| n [%] | Females | 29 [69.0%] | 36 [75.0%] | 65 [72.2%] | |
| | Pregnant | 12 [41.4%] | 12 [34.3%] | 24 [37.5%] | |
| | Not Pregnant | 17 [58.6%] | 23 [65.7%] | 40 [62.5%] | |
| Ethnic | Hispanic or Latino | 9 [21.4%] | 14 [29.2%] | 23 [25.6%] | 0.35 |
| Group | Non-Hispanic or Latino | 33 [78.6%] | 33 [68.8%] | 66 [73.3%] | |
| Summary | | VerTouch | Palpation | All Subjects | P-value |
| Race
n [%] | Not Reported | 0 [0.0%] | 1 [2.1%] | 1 [1.1%] | |
| | Asian | 2 [4.7%] | 1 [2.1%] | 3 [3.3%] | 0.96 |
| | Black or African American | 8 [18.6%] | 10 [20.8%] | 18 [20.0%] | |
| | Native Hawaiian or Pacific
Islander | 1 [2.3%] | 1 [2.1%] | 2 [2.2%] | |
| | White | 27 [62.8%] | 32 [66.7%] | 59 [65.6%] | |
| | Other | 4 [9.3%] | 4 [8.3%] | 8 [8.9%] | |
| Height | N | 42 | 47 | 89 | 0.83 |
| | Mean (cm) | 165.7 | 165.3 | 165.5 | |
| | SD | 9.53 | 10.36 | 9.93 | |
| | Median | 167.6 | 162.6 | 165.0 | |
| | Range | 149.0-185.4 | 149.8-193.0 | 149.0-193.0 | |
| Weight | N | 42 | 48 | 90 | 0.79 |
| | Mean (kg) | 81.6 | 80.6 | 81.0 | |
| | SD | 19.40 | 17.71 | 18.42 | |
| | Median | 82.4 | 79.9 | 80.5 | |
| | Range | 50.8-135.8 | 45.5-117.0 | 45.5-135.8 | |
| BMI
n [%] | N | 42 | 47 | 89 | 0.89 |
| | Mean (kg/m²) | 29.6 | 29.4 | 29.5 | |
| | SD | 5.94 | 6.56 | 6.24 | |
| | Median | 29.9 | 29.1 | 29.4 | |
| | Range | 19.4-40.6 | 18.3-42.0 | 18.3-42.0 | |
| | Underweight ( 65) n [%] | 2 8.0%) | 5 [12.206] | 7 [10.6%] | |
| Gender | Males | 4 [16.0%] | 9 [22.0%] | 13 [19.7%] | 0.551 |
| n [%] | Females | 21 [84.0%] | 32 [78.0%] | 53 [80.39%] | |
| | Pregnant | 9 [42.90%] | 12 38.796] | 21 [40.4%] | |
| | Not Pregnant | 12 [57.1%] | 19 [61 366] | 31 [59.6%] | |
| Ethnic | Hispanic or Latino | 6 [24.00%] | 12 [29.3%] | 18 [27.3%] | 0.538 |
| Group | Non-Hispanic or Latino | 19 [76.00%] | 28 [68.306] | 47 [71.2%] | |
| 11 96] | Not Reported | 0 [0.0%] | 1 2.4%] | 1 [ 1.5%] | |
| Race | Asian | 1 [ 4.0%] | 1 [ 2.4%] | 2 [ 3.0%] | 0.907 |
| 日 (88) | Black of African American | 6 [24.09%] | 7 [17.1%] | 13 [19.7%] | |
| | Native Hawaiian or Pacific Islander | 1 4.00%] | 1 [ 2.4%] | 2 [ 3.096] | |
| | White | 16 [64.096] | 29 [70.7%] | 45 [68.296] | |
| | Other | 1 4.0%] | 3 7.3%] | 4 [ 6.1%] | |
| Height | N | 25 | 41 | 66 | 0.577 |
| | Mean (cm) | 163 5 | 164.8 | 164.3 | |
| Summary | | VerTouch | Palpation | All Subfects | P-value1 |
| | SD | 8.74 | 10.45 | 9.79 | |
| | Median | 167.0 | 162.6 | 162.8 | |
| | Runge | 149.0-185.5 | 149.8 - 193.0 | 149.0. 193.0 | |
| Weight | 11 | ટેને | 41 | રેણ | 0.626 |
| | Mean (kg) | 77.6 | 79.9 | 79.0 | |
| | SD | 18.44 | 17.86 | 17.97 | |
| | Median | 753 | 79 4 | 79.2 | |
| | Range | 50.8 - 117.8 | 45.5- 117.0 | 45.5 - 117.8 | |
| BMI | N | ર્ડ | 41 | 66 | 0.740 |
| 11 (96) | Mean (kg m2) | 29.0 | 29.5 | 29.3 | |
| | SD | 6.10 | 6.37 | 6.37 | |
| | Median | 28.4 | 29.1 | 28.5 | |
| | Range | 19.4-40.5 | 18.3-42.0 | 18.3-42.0 | |
| | Underweight (10 Years | 7 | 1.7 (1.25) | 10 | 3.7 (3.53) | Method x Years in Practice Interaction | 0.139 |
| Procedures | 20G | 1 | 1.0 (NA) | 1 | 1.0 (NA) | | |
| | Tuohy | | | | | | |
| | CSE | | | | | | |
| VerTouch | Marking | 17 | 1.5 (1.46) | NA | NA | VerTouch Workflow | 0.496 |
| Workflow | Introducer Placement | 4 | 1.8 (1.50) | | | | |
| | Needle Placement | 15 | 2.1 (1.68) | | | | |
| BMI | Underweight (65) | 5 | 2.0 (1.41) | 6 | 2.2 (1.33) | | |
| Gender | Female | 27 | 1.9 (1.73) | 36 | 2.2 (2.23) | Method | 0.213 |
| | Male | 9 | 1.3 (0.71) | 10 | 2.3 (1.42) | Gender | 0.622 |
| | | | | | | Method x Gender Interaction | 0.480 |
Table 28. ANOVA for Number of Insertions - Intent-To-Treat Population
Results: Secondary/Exploratory Outcomes
Secondary outcomes were identified and were to be evaluated sequentially if the primary endpoint reached statistical significance with each additional endpoint requiring the preceding analyses to reach statistical significance to be considered. Each hypothesis evaluated the superiority of VerTouch relative to Palpation. Endpoints included: binary success on first attempt success (procedure only required 1 insertion), mean number of re-directions, number of passes (insertions plus re-directions), binary rate of first pass success (one insertion and no redirections), mean discomfort score, mean provider confidence scores, and binary rate of
19
procedure success. None of these secondary outcomes reached statistical significance for the device group.
Additionally, the procedure success rate in the ITT population was higher in the manual palpation group (85.4%) versus the device group (71.4%) when analyzed across all device workflows. However, for the 'marking workflow' that is the intended use of the device, the procedure success rate was 87.5% (refer to below post-hoc analysis discussion). Tertiary and exploratory analyses, which were not associated with any pre-planned claims, included total procedural time and contact with bone and were not found to be significantly different between device and palpation methods. Performance of the 'marking workflow' of the device was determined to be satisfactory, especially by supporting the use of VerTouch by nonanesthesiology physicians for the full range of neuraxial procedures (including laterallypositioned patients).
Results: Adverse Events
Three adverse events were recorded in the ITT population. Two of the events occurred in the VerTouch arm of the study, and 1 in the Palpation arm. The Palpation arm consisted of back and shoulder pain, which mav have been related to the procedure (determination. possible), and was not related to the device. The two adverse events in the VerTouch arm were an episode of syncope and hemorrhage, occurring in separate subjects. The hemorrhage was determined to be not related to the device and the syncope was determined to be unlikely to be related to the device.
No additional treatment actions were taken for either subject. There was no significant difference between VerTouch and Palpation approaches for additional safety metrics including unintended dural puncture, paresthesia, traumatic taps, referral to radiology or conversion from spinal to epidural.
Post-Hoc Analysis: Clinically Meaningful Results
Further post-hoc analysis of STU-001 results examined the rates of success/failure for cases in which VerTouch was used. For all workflows. VerTouch was used on 35 subjects (42 randomized to the Device arm less the 5 subjects that crossed over with no Device use and the 2 subjects that had no procedure attempted). Of these 35 subjects, 16 recorded the needle/introducer workflow, 17 recorded the marking workflow; and 2 did not record a workflow. Per the protocol, workflow was recorded prior to initiating the procedure, however, 3 cases did not proceed to the stage of marking or placing a needle/introducer through the Device. These 3 cases were excluded in a workflow-specific analysis, resulting in 32 subjects that used the Device and had an insertion. Of the 32 subjects, 16 used needle/introducer and 16 used marking. The rates of success/failure for these two subgroups were: Marking: 87.5% (14/16) success, 12.5% (2/16) failure; and Needle/introducer: 68.8% (11/16) success, 31.3% (5/16) failure. With regard to the marking-workflow cases, the success rate is nearly the same as that of
20
the overall success rate for palpation (89.1%). Considering all marking cases were performed in a sterile fashion for STU-001, these data support the safety and efficacy of a sterile marking workflow.
Overall, the device appears to be safe and as effective as standard of care for the marking workflow, although it was determined that sufficient benefit for the needle workflow was not demonstrated by the study results in STU-001.
STU-002
Does the VerTouch Device Improve Insertion Site Identification for Lumbar Neuraxial Procedures when Compared to Palpation or Ultrasound Guided Site Selection? A Prospective Randomized Controlled Trial
A feasibility study of the VerTouch™ device was performed in the obstetric anesthesiology department at Prentice Women's Hospital at Northwestern Memorial (NMH). demonstrating successful use of the device in identifying a target insertion site (TIS) for neuraxial procedures with minimal device education, as published in 2021 (McCrory, E.H. & Vaidyanathan. M. (2020). Feasibility study of a force-sensing resistor device for landmark detection for neuraxial procedures and anesthesiologists' impact on device improvement. Journal of Medical Engineering & Technology, DOI: 10.1080/03091902.2020.1799094). After further development from a prototype to a manufactured unit, a single-center superiority randomized clinical trial was performed in the same department, with prospective controls of palpation and ultrasound (NCT04630171, manuscript submitted for publication). (NMH study number: STU00213282; IntuiTap study number: STU-002). The study evaluated the number of reinsertions, redirections, procedure time, and other endpoints for each methodology, with a hypothesis that the VerTouch group would demonstrate improvements in insertion performance with no significant impact on time. Obstetric anesthesiology fellows were selected as proceduralists for the study due to their extensive experience with neuraxial procedures. The study population was exclusively expectant mothers who consented to placement of lumbar epidural catheters for labor analgesia. Each target insertion site was identified by the randomized technique (VerTouch 'marking workflow', ultrasound, or palpation) and then followed with standard lumbar epidural placement in a sterile fashion.
Study Objective:
To determine if there is an identifiable difference in the number of insertions and redirections of the needle for a lumbar neuraxial procedure when the VerTouch device is used, when compared with palpation (current gold standard) or ultrasound guidance (US), for the identification of the procedural insertion site.
Study Endpoints:
The primary endpoint is the combined total number of insertions or redirection of the epidural needle Secondary endpoints included procedural timing; reinsertions; "confidence in mark" (1 = "not confident at all": 5 = "very confident")
Recruitment Criteria:
21
Inclusion Criteria:
Any adult patients undergoing a neuraxial procedure, including pregnant women who make up a large portion of neuraxial procedures.
Exclusion Criteria:
Patients who do not speak English, have a plastic allergy, special populations such as pediatrics and prisoners. Notably, exclusion criteria did not limit BMI nor spinal deformity of patient. The highest BM1 of enrolled subjects was 50.7 kg/m2 and spinal anatomical issues included 7 patients with scoliosis/kyphosis, 2 patients with positioning challenges, 2 patients with history of spinal survery. No patients were enrolled that endorsed a history of prior difficulty with neuraxial procedures.
Study details:
All proceduralists were trained with a brief tutorial by a clinically trained device expert followed by extensive practice on a lumbar model. The device expert was available the first day of their device use, but only by phone later if any issues arose. All insertion videos were reviewed by three blinded observers who independently counted redirections and reinsertions of each procedure. The VerTouch device was used in a non-sterile fashion to mark TIS with kitted marker prior to establishing sterile field and performing lumbar epidural per standard workflow; all patients were in a seated position.
Results:
The following table summarizes study demographics and results. Redirections had an interclass correlation coefficient (ICC) of 0.87, with ICC > 0.75 indicating good reliability. Reinsertion ICC was 0.97, with ICC > 0.90 indicating excellent reliability.
| Variable | Palpation
(N = 26) | Ultrasound
(N = 26) | VerTouch
(N = 29) | P-value |
|----------------------------|-----------------------|------------------------|----------------------|---------|
| Demographics | | | | |
| Age (years) | $34.77\pm2.8$ | $34.46\pm3.2$ | $35.14\pm3.5$ | 0.740 |
| BMI (kg/m²) | $31.16\pm4.4$ | $31.72\pm6.2$ | $28.84\pm4.6$ | 0.100 |
| Height (cm) | $163.7\pm5.0$ | $164.7\pm6.0$ | $165.8\pm6.9$ | 0.451 |
| Weight (kg) | $83.31\pm11.0$ | $85.8\pm16.3$ | $83.51\pm30.0$ | 0.897 |
| Primary Outcome | | | | |
| Redirections | $2.35\pm3.9$ | $2.81\pm3.7$ | $0.72\pm0.9$ | 0.041 |
| Secondary Outcomes | | | | |
| Timing Data | | | | |
| Total Procedure Time (min) | $7.88\pm3.1$ | $9.81\pm4.1$ | $8.66\pm2.6$ | 0.121 |
| Start to Mark | $0.73\pm0.5$ | $1.23\pm0.9$ | $2.38\pm2.2$ |