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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.

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.

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.

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