EPI-MAX EPISTAXIS CATHETER

K972076 · Boston Medical Products, Inc. · EMX · Jun 26, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972076
• Device Name: EPI-MAX EPISTAXIS CATHETER
• Applicant: Boston Medical Products, Inc.
• Product Code: EMX · Ear, Nose, Throat
• Decision Date: Jun 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4100
• Device Class: Class 1
• Attributes: Therapeutic

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 Story

Epi-Max™ is a two-balloon catheter with an integral airway; designed for control of intra-nasal hemorrhage. Smaller balloon controls posterior chamber bleeding; larger balloon controls anterior chamber bleeding. Functions as nasal packing post-septoplasty, rhinoplasty, and other intra-nasal surgeries. Supplied sterile with a 20cc syringe for balloon inflation. Used in clinical settings by healthcare providers to manage epistaxis and post-surgical nasal packing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Two-balloon catheter with integral airway; constructed of medical-grade silicone; supplied sterile; includes 20cc inflation syringe.

Indications for Use

Indicated for patients requiring control of anterior and posterior nasal epistaxis or nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Product No. 20-10700 (Invotec International, Inc.)

Submission Summary (Full Text)

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12076

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JUN 26 997

## SMDA Summary

## This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Product: Epi-Max™ Epistaxis Catheter

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.

## Indications for Use:

1. To be used for control of anterior and posterior nasal epistaxis.

2. To be used as a nasal packing following septoplasty, and other intra-nasal surgical procedures.

Predicate Device: Product No. 20-10700 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.

Testing: Device is constructed using well-established medical grade silicone.

by:

Stuart K. Montgomery, President

5/30/97

Submitted by:

Stuart K. Montgomery, President

Date:

Boston Medical Products, Inc 117 Flanders Road, Westborough, MA 01581 USA CUSTOMER SERVICE: 1-800-433-BMPI (2674) Tel: [phone] Fax: [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stuart K. Montgomery President Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581

Re: K972076 Epi-Max™ Epistaxis Catheter Dated: May 30, 1997 Received: June 3, 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX JUN 26 1997

Dear Mr. Montgomery:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please aste: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations,

This letter will allow you to begin marketing your device as described in your 510(tr) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro disgnostic devices), please contact the Office of Compliance at [phone] for Radiology devices, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Mllian

Lillian Yin, Ph.D. Director. Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 ATT: Stuart K. Montgomery [phone] ext. 240

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K972076 510(k) Number (if known):

Device Name:

Epi-Max™ Epistaxis Catheter

Indications For 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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ C (Per 21 CFR 801.109)

OH

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Kevind A. Leggison

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device

510(k) Number K972076