(236 days)
Disposable Needle Guides and Grids are used to assist and aid physicians in performing an endocavity diagnosis ultrasound needle guided procedure using guided intervention fixed guiding for the precise insertion of linear instruments, such as needle Guides and Grids are designed to aid adult patient population, in need of a biopsy of an internal organ, or internal delivery or removal of fluid within the body cavity, via the use of a needle, during an ultrasound procedure by retaining the needle tip and barrel within the ultrasound beam.
Advance Medical Designs' disposable needle guides & grids devices used to direct needles or instruments along a fixed path to a target location with an ultrasound traducer. They are provided in a variety of sizes to fit different equipment and situations. The Needle Guides and Grids are packaged separately, or within kits, provided sterile, and are labelled as single use only. Each disposable needle guide & grid contains a bracket and needle adapter. Each kit includes a disposable needle guide, a 20ml packet of ASonic® sterile gel, two latex free elastic bands, and a transducer cover (Latex or Latex-Free). The needle guides are non-invasive and have contact with only intact skin.
The provided document is a 510(k) Pre-market Notification for a medical device called "Disposable Needle Guides and Grids" by Advance Medical Designs, Inc. This document details the device's characteristics, indications for use, comparison to predicate and reference devices, and testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document implicitly defines acceptance criteria through the various tests and their corresponding pass/fail conditions. While not presented in a single table, the summary of non-clinical and bench testing demonstrates the device's performance against these criteria.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 and ASCA-Pilot Biocompatibility Guidance requirements for limited contact duration (surface devices of breached/compromised surface, external communicating tissue, indirect blood path). Specific tests include: Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material-Mediated Pyrogenicity (ISO 10993-11 and USP 151), Direct/Indirect Hemolysis/Hemocompatibility (ISO 10993-4 and ASTM F756). | Sufficient evidence provided to validate AMD's claim that subject materials/device are non-toxic, non-sensitizing, non-irritating, non-hemolytic, and non-pyrogenic. (Section 10) |
| Mechanical Performance | Cover Breach and Probe Damage Testing: No damage to cover or probe due to material attachment of needle guide over a cover. | Water leak testing performed during Design Input, Design Output, and Design Validation stages demonstrated material attachment of needle guide over a cover did not cause damage to cover or probe. (Section 11) |
| Retention and Movement Testing: Minimum force of 8N to dislodge the guide. | Force testing on needle guide attachment ensured a minimum force of 8N would not cause the guide to dislodge. (Section 11) | |
| Needle Drag Testing: Force less than 1.5N when passing a cannula through the needle guide, with no binding. | Force testing performed by passing a cannula through the needle guide ensured binding would not occur and force was less than a 1.5N threshold. (Section 11) | |
| Needle Path Verification Testing: Needle path falls within specified design tolerances. | Needle guides tested on test fixtures to ensure needle path falls within the design tolerances specified for the design. (Section 11) | |
| Usability | Simulated Usability Testing: Design conforms to user needs and intended use. | Simulated use evaluations performed by customers ensured the design of the needle guide conforms to the user needs and intended use, as well as imaging testing conducted through laboratory evaluations. (Section 11) |
| Sterilization | Ethylene Oxide sterilization with SAL 10⁻⁶. | The manufacturing process includes 100% EtO sterilization with SAL 10⁻⁶, which was evaluated for biological effects. (Section 10) |
| Shelf-Life | 3 Years. | Device has a 3-year shelf-life, matching the predicate device. (Section 9) |
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 does not explicitly state the sample sizes for the specific tests, nor does it detail the provenance of the data (e.g., country of origin, retrospective or prospective nature of the test subjects if applicable). The tests mentioned are predominantly non-clinical bench tests and simulated use evaluations, implying laboratory settings rather than patient data.
- Bench Testing: The description of tests like "Water leak testing," "Force testing," and "Needle path verification testing" suggests that these were conducted on a sample of the manufactured devices.
- Simulated Usability Testing: "Simulated use evaluations were performed by customers." The number of customers involved or how the evaluation was conducted (e.g., number of sessions, different scenarios) is not specified.
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):
The concept of "ground truth" and "experts" as typically understood in studies involving diagnostic accuracy (e.g., image interpretation by radiologists) is not directly applicable here. This device, "Disposable Needle Guides and Grids," is a mechanical accessory; its primary function is to physically guide a needle.
- For the mechanical performance tests, the "ground truth" is established by engineering specifications and physical measurements (e.g., 8N force threshold, 1.5N drag threshold, design tolerances for needle path). These are typically assessed by engineers or quality control personnel.
- For simulated usability testing, "customers" performed evaluations. Their qualifications are not mentioned, but it's implied they are intended users (physicians or clinicians) who would assess the device's ease of use and how well it meets their needs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Adjudication methods like "2+1" or "3+1" are relevant for studies where expert disagreement on diagnostic interpretation needs to be resolved. Since this device is a mechanical guide and the testing focuses on physical and biological performance, such adjudication methods are not applicable. The bench test results would likely be determined by meeting predefined engineering specifications.
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:
An MRMC comparative effectiveness study was not done. The device is a physical accessory, not an AI-powered diagnostic tool, so the concept of human readers improving with AI assistance does not apply. The submission explicitly states: "Clinical tests were not required to demonstrate substantial equivalence." (Section 12).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is also not applicable. The device is a physical, non-electronic accessory. There is no algorithm or standalone performance in the sense of an AI or software product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As discussed in point 3, the "ground truth" for this device's evaluation is primarily based on:
- Engineering Specifications/Physical Measurements: For mechanical performance tests (retention, drag, needle path accuracy).
- Biocompatibility Standards: ISO 10993 series and ASCA-Pilot Biocompatibility Guidance for material safety.
- User Feedback: "Simulated use evaluations were performed by customers" to ensure conformity to user needs.
There is no mention of expert consensus, pathology, or outcomes data, as these types of ground truth are usually associated with diagnostic or therapeutic efficacy studies involving patient data, which was not the focus of this 510(k) submission.
8. The sample size for the training set:
There is no mention of a "training set" as this device is not a machine learning or AI-based product. The testing performed is to validate the physical and biological characteristics of the manufactured device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.