(106 days)
The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures.
The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market under K022935. To do this, the Light Sabre™ Spinal Access Device incorporates a collimating channel and light-dispersing element directly into the stylet assembly. When the Light Sabre™ Spinal Access Device is aligned with the laser beam of the SabreSource™ Targeting System, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out of the path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal Access Device ceases to glow.
The provided 510(k) summary for the Light Sabre™ Spinal Access Device does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria in the way typically discussed for AI/ML-based medical devices. This document describes a medical device (biopsy needle) and focuses on substantial equivalence to a predicate device, manufacturing standards, and biological safety.
Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.
Here's a breakdown of what can be derived from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" or provide performance metrics in quantitative terms for the device's function (e.g., biopsy success rate, accuracy of guidewire placement). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Material Biocompatibility | All materials used will be evaluated through biological qualification safety tests as outlined in applicable sections of ISO 10993. (Implies meeting biocompatibility requirements of ISO 10993, but no specific pass/fail rates or test results are provided in this summary.) |
| Manufacturing Standards | Will be manufactured in accordance with the following standards (implies compliance with these standards): |
- ASTM F1140-00
- ANSI/AAMI/ISO 11137:1994
- ANSI/AAMI/ISO 11737-1:1995
- AAMI TIR 17:1997
- AAMI TIR 27:2001
- ANSI/AAMI/ISO TIR 15843:2000
- ANSI/AAMI ST 72:2002
- ASTM D-5276-98(2004)
- ASTM F88-06
- ISO 11607
- ISO 9626:1991
- ISO 594:1986
- ISO 10993-1:2003
- ISO 10993-5:1999
- ISO 10993-10:2002 |
| Sterility | Provided sterile for single use (Implies meeting sterility requirements, likely dictated by ANSI/AAMI/ISO 11137:1994 and related standards). |
| Mechanical Features | Needle Length: 10 - 15cm
Needle Gauge/Diameter: 8, 11, 13 Gauge
Stainless Steel Material: Stainless Steel 304
Stylet/Cannula Hub Material: Gamma Stable Polycarbonate
Includes method to remove biopsy sample: Included in Packaging is Core Sampler made of Stainless Steel 304
Able to connect Syringe for Aspiration or Injection: Luer Lock per ISO 594-2:1998 (E) on Luer Adapter Component |
| Substantial Equivalence | Considered substantially equivalent to the Light Sabre™ Bone Biopsy Needle (K982735). |
| Laser Targeting Integration | Integrates a collimating channel and light-dispersing element into the stylet assembly to work with the MINRAD SabreSource™ Targeting System (K022935). (Implies functional compatibility with the targeting system). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of clinical performance data for an AI/ML device. The testing mentioned refers to material qualification and compliance with industry standards, not a clinical study on patient data.
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)
Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 a medical device (biopsy needle), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would relate to its physical properties, sterility, and biocompatibility, which are assessed through laboratory tests against established standards, not clinical ground truth like pathology for a diagnostic device.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.