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K Number
K971782
Device Name
BONE AND MARROW COLLECTION SYSTEM KIT
Manufacturer
BIOMEDICAL ENT., INC.
Date Cleared
1997-07-29

(76 days)

Product Code
GEY
Regulation Number
878.4820
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To be used with the Bone and Marrow Collection System™ (BMCS). The trocar is used to cut and reflect soft-tissue allowing the BMCS to be placed on bone, the suction connector for converting the BMCS into an aspiration handle and the plunger for extruding tissue from the BMCS.

Device Description

Bone and Marrow Collection System (BMCS) Instrument Kit

AI/ML Overview

I am sorry, but based on the provided document, the information required to answer your request is not available. The document is a 510(k) clearance letter from the FDA for a "Bone and Marrow Collection System Kit." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain:

  1. Acceptance criteria and reported device performance: It only states the device is "substantially equivalent" but does not provide specific performance metrics or criteria.
  2. Details of the study: There is no mention of a clinical or performance study, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
  3. Training set information: As no study details are provided, there is no information on a training set or its ground truth.

The document is primarily a regulatory approval letter, indicating the device can be legally marketed based on its equivalence to existing devices, rather than a detailed report of a performance study.

§ 878.4820 Surgical instrument motors and accessories/attachments.

(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.