(69 days)
The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.
The OnControl Bone Access and Bone Biopsy System by Vidacare consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve. 1 beveled needle set and 2 sharps protectors. The OnControl Bone Access System Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the OnControl Bone Access System (cleared via K112468, The OnControl Bone Access System by Vidacare®) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K112468, The OnControl Bone Access System by Vidacare®.
Under fluoroscopic imaging quidance, activation of the driver assists the clinician to insert the needle set through the cortex of the bone, into the vertebral body or area of lesion. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.
The driver is then separated from the needle assembly for specimen removal.
The provided text is a 510(k) summary for the OnControl™ Bone Access and Bone Biopsy System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria.
Therefore, the requested information, specifically:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Cannot be extracted directly from the provided text.
The document describes the device, its intended use, and compares its technological characteristics to predicate devices (K112468, K022169, K962425) to establish substantial equivalence. It highlights similarities in anatomical sites, biocompatibility, dimensional specifications, driver design, energy type, environmental specifications, ergonomics, firmware, and indications for use.
The FDA's letter (pages 3-5) confirms the substantial equivalence determination based on the premarket notification, but it does not detail specific performance studies with acceptance criteria, sample sizes, or ground truth methodologies as would be found in a clinical study report. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through bench testing and comparison of technical characteristics, rather than de novo clinical efficacy trials against specific performance targets.
§ 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.