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K Number
K033616
Device Name
TRAPMATIC SYSTEM SET
Manufacturer
H.S HOSPITAL SERVICE S.P.A.
Date Cleared
2004-03-01

(105 days)

Product Code
KNW
Regulation Number
876.1075
Type
Traditional
Panel
GU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This biopsy instrument is used for drawing of osteomedulary substance and or for explantation of bone marrow.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) Premarket Notification for a bone marrow biopsy needle, the "TrapMatic System® Set." It is a regulatory submission to the FDA, not a study report detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information from the provided text.

The text primarily focuses on:

  • Regulatory Information: Applicant details, contact person, submission date, trade name, common name, classification, and product code.
  • Indication for Use: "This biopsy instrument is used for drawing of osteomedullary substance and or for expllantation of bone marrow."
  • FDA Communication: A letter from the FDA determining substantial equivalence to predicate devices, outlining regulatory requirements, and permitting marketing.

There is no information on:

  • A table of acceptance criteria or reported device performance.
  • Sample sizes for test sets or training sets.
  • Data provenance.
  • Number/qualifications of experts.
  • Adjudication methods.
  • MRMC studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used or how it was established.

This document is a formal notification for market clearance based on substantial equivalence, not a clinical or performance study report.

§ 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.