(14 days)
The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit are indicated for real-time imaging of selected blood vessels and nearby anatomic structures before and during percutaneous procedures, ultrasonic guidance for needle placement and vessel catheterization in a sterile environment, and Doppler confirmation of directional blood flow.
The Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System with associated transducer and accessories is designed and manufactured to provide hands-free ultrasound vascular imaging (simultaneous transverse and longitudinal views) for percutaneous vascular punctures (needle placement and vessel catheterization). The PunctSURE® System consists of three major subsystems: (1) the Transducer and Cable, (2) the Dual Image Monitor, and (3) the Sterile Vascular Imaging Procedure Kit. The sterile, single use, and disposable PunctSURE® Vascular Imaging Procedure Kit contains products used for the diagnostic procedure (magnetic laminate, acoustic coupling gel, sheath, snap ring, transducer cover, gauze sponges, and cotton swabs).
The provided text describes the 510(k) summary for the Inceptio Medical Technologies, L.C. PunctSURE® Ultrasound Vascular Imaging System. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness with human readers.
Here's the breakdown of what is available in the provided text:
Acceptance Criteria and Reported Device Performance
The document describes the device's technological and operational characteristics in comparison to a predicate device (Site~Rite 3). The "performance testing" section primarily references compliance with FDA guidance and various safety and electromagnetic compatibility standards, rather than clinical performance metrics.
| Characteristic | Acceptance Criteria (Implied by Predicate Device Equivalence) | Reported Device Performance (PunctSURE®) |
|---|---|---|
| Intended Use | Vascular imaging for needle guidance | Yes |
| Fundamental Technology | Pulsed echo ultrasound | Pulsed echo ultrasound |
| Real time | Yes | Yes |
| B-Mode | Yes | Yes |
| Digital | Yes | Yes |
| Software-controlled | Yes | Yes |
| Hands-free visualization | No (for predicate) | Yes |
| Doppler confirmation of directional blood flow | No (for predicate) | Yes |
| Probes (Imaging element) | 9.0 MHz, 7.5 MHz, 5.9 MHz, 3.5 MHz (for predicate) | 7.5 MHz |
| Probes (Doppler element) | N/A (for predicate) | 5.0 MHz |
| Sterilizable probe | No | No |
| Probe disinfection instructions | Yes | Yes |
| Focal Depth (Imaging element) | Min: 0.5 cm (9.0 MHz probe), Max: 18 cm depth (3.5 MHz probe) for predicate | 20 mm ± 5 mm |
| Focal Depth (Doppler element) | N/A (for predicate) | 35 mm ± 5 mm |
| Sector angle | 26 degrees (9.0 and 7.5 MHz probes), 75 degrees (3.5 MHz) for predicate | N/A |
| Views | Transverse or Longitudinal | Transverse and Longitudinal |
| Dual image monitor | No | Yes |
| Screen size | 4 ½" diagonal CRT | 12.1" diagonal LCD |
| Freeze frame | Yes | No |
| Video output | Yes | No |
| Battery powered | Yes | No |
| AC powered | Yes | Yes |
| Portable System | Yes | Yes |
| Sterile kit | Yes (from other source) | Yes (part of system package) |
Note on Acceptance Criteria: The document primarily uses the predicate device (Site~Rite 3) for establishing substantial equivalence. Thus, the "acceptance criteria" are largely implied by meeting or demonstrating similar functionality/safety as the predicate, along with compliance to recognized standards. There are no explicit quantitative performance metrics (e.g., sensitivity, specificity) stated as acceptance criteria in this summary.
Study Details
The provided text does not include information about a clinical study with a test set, ground truth, or expert review that would typically prove device performance in terms of diagnostic accuracy or effectiveness. The "Performance Testing" section states:
"The PunctSURE® Ultrasound Vascular Imaging System and associated PunctSURE® Vascular Imaging Procedure Kit were tested according to and demonstrated in compliance with requirements set forth in FDA Guidance "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" (1997) including the following, FDA-recognized, voluntary standards... In addition, verification and validation testing demonstrates that the System fulfills performance specifications."
This indicates that internal verification and validation were performed to ensure the system meets its own specifications and complies with regulatory standards, which are largely related to safety, electrical, and electromagnetic compatibility. It does not describe a clinical performance study as typically understood in the context of diagnostic accuracy.
Therefore, the following information is not available in the provided text:
- Sample size used for the test set and the data provenance: Not mentioned. The testing described is compliance-focused, not clinical performance-focused with a test set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned as there's no described clinical performance study with a ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is an ultrasound imaging system from 2002, and the concept of "AI assistance" in this context is likely not applicable.
- If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not mentioned. The device is described as an imaging system intended for real-time human-in-the-loop use.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.