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K Number
K972076
Device Name
EPI-MAX EPISTAXIS CATHETER
Manufacturer
BOSTON MEDICAL PRODUCTS, INC.
Date Cleared
1997-06-26

(23 days)

Product Code
EMX
Regulation Number
874.4100
Type
Traditional
Panel
EN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. To be used for control of anterior and posterior nasal epistaxis.
  2. To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.
Device Description

The Epi-Max™ is a two-balloon catheter with integral airway designed for control of intra-nasal hemorrhage. The smaller balloon is designed to control bleeding in the posterior chamber, while the larger balloon controls bleeding in the anterior chamber. As a packing, it can be used following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.

The Epi-Max™ is supplied sterile and includes a 20cc syringe for balloon inflation.

AI/ML Overview

This submission (K972076) pertains to the Boston Medical Products Epi-Max™ Epistaxis Catheter and does not include a study describing acceptance criteria, device performance, or ground truth.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria.

The information provided only states:

  • Product: Epi-Max™ Epistaxis Catheter
  • Description: Two-balloon catheter with integral airway designed for control of intra-nasal hemorrhage.
  • Indications for Use:
    1. Control of anterior and posterior nasal epistaxis.
    2. Nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.
  • Predicate Device: Product No. 20-10700 manufactured by Invotec International, Inc.
  • Testing: "Device is constructed using well-established medical grade silicone."

Therefore, none of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment can be extracted from the provided text.

§ 874.4100 Epistaxis balloon.

(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(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 § 874.9.