(208 days)
The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.
The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop. The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.
This document is not a study, but rather a 510(k) Premarket Notification for a medical device (BiomarC Coaxial Needle). It doesn't contain information about a clinical study with acceptance criteria and reported device performance in the way a traditional clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Therefore, many of the requested fields regarding acceptance criteria, study design, sample sizes, experts, and ground truth are not applicable or cannot be extracted from this type of document.
However, I can extract information related to the device's intended performance and how its characteristics are compared to predicate devices, which implicitly serves as the basis for its safety and effectiveness claims for regulatory purposes.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
This document does not present explicit "acceptance criteria" and "reported device performance" in the context of a clinical study with measured outcomes against predefined thresholds. Instead, it relies on demonstrating that the proposed device has technological characteristics and performance substantially equivalent to legally marketed predicate devices.
The table below summarizes the comparison between the proposed device and its predicates, which serves as the implicit "proof" of meeting performance expectations for substantial equivalence.
| Characteristic | Acceptance Criteria (Implicit by Equivalence to Predicates) | Reported Device Performance (as stated for the proposed device) |
|---|---|---|
| Primary Performance Feature | Ability to create a channel through soft tissue | |
| Ability to allow delivery of injectable materials (for predicate) or guide another device (for predicate) | Able to create a channel through soft tissue | |
| Able to allow delivery of fiducial markers through channel created | ||
| Indications for Use | To allow delivery of injectable materials into tissue during an endoscopic procedure (P1) | |
| To be used as a guiding needle in obtaining core, biopsy samples (P2) | To allow delivery of fiducial markers into soft tissue. | |
| Use | Single use (matching predicates) | Single use |
| Sterility | Sterilized by EO with an SAL of 1x10-6 (matching P1) or Sterilized by EO (matching P2) | Sterilized by EO with an SAL of 1x10-6 |
| Pyrogens | Pyrogen free (matching predicates) | Pyrogen free |
| Cannula/Stylet Material | Stainless steel, type 304 (for proposed device, matching general "stainless steel" for predicates) | Stainless steel, type 304 |
| Tip Style | Trocar tip or Spinal tip (P1) or Trocar or blunt tip (P2) | Trocar tip |
| Biocompatibility/Safety | Safety established through history of use of similar devices for identical nature and duration of patient contact (matching P1, P2 unknown but implied by predicate use) | Safety has been established for the identical nature and duration of patient contact through a history of use in other similar devices. |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable. This document does not describe a test set or comparative study with specific sample sizes. The submission relies on a comparison of technological characteristics to predicate devices already on the market.
- Data Provenance: Not applicable. The "study" here is a regulatory submission demonstrating substantial equivalence, not a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There was no "test set" requiring ground truth established by experts in the context of a performance study.
4. Adjudication method for the test set
Not applicable. There was no "test set" requiring adjudication.
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
Not applicable. This is not an AI/software device and no MRMC study was performed or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (coaxial needle), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There was no "ground truth" in the clinical study sense. The "ground truth" for the device's acceptability is its substantial equivalence to legally marketed devices, implying that their established safety and effectiveness applies to the new device given its similar characteristics and intended use.
8. The sample size for the training set
Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.