(23 days)
- To be used for control of anterior nasal epistaxis.
- To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.
The Epi-Stop™ is a single balloon catheter with integral airway designed for both nasal packing and control of anterior nasal hemorrhage. The Epi-Stop™ can be used to control the bleeding of an anterior epistaxis. As a packing, it can be used following septoplasty, rhinoplasty, and other intra-nasal surgical procedures. The Epi-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.
This document is a 510(k) summary for the Epi-Stop™ Epistaxis Catheter. It describes the device, its intended use, and its predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary states that "Device is constructed using well-established medical grade silicone," implying that the device was deemed substantially equivalent to a predicate device based on material and design, rather than performance studies with acceptance criteria.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for Boston Medical Products. The logo consists of a stylized heart shape on the left and the text "Boston Medical Products" on the right. The heart shape is formed by two curved lines that meet at a point at the bottom. The text is arranged in three lines, with "Boston" on the top line, "Medical" on the second line, and "Products" on the third line.
q12077
SMDA Summarv
JUN 26 1997
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-Stop™ Epistaxis Catheter
Description: The Epi-Stop™ is a single balloon catheter with integral airway designed for both nasal packing and control of anterior nasal hemorrhage. The Epi-Stop™ can be used to control the bleeding of an anterior epistaxis. As a packing, it can be used following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.
The Epi-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.
Indication for Use:
-
To be used for control of anterior nasal epistaxis.
-
To be used as a nasal packing following septoplasty, and other intra-nasal surgical procedures.
Predicate Device: Product No. 20-10715 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.
| 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: 508-898-9300 Fax: 508-898-2373
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 1997
Stuart K. Montgomery President Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581
Re: K972077 Epi-Stop™ Epistaxis Catheter Dated: May 30, 1997 Received: June 3. 1997 Regulatory class: I 21 CFR 874.4100/Procode: 77 EMX
Dear Mr. Montgomery:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determind 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 (Acl). 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 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 substantialion 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 regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 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(1) 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 vito diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear. Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entiled. "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 (800) 638-2041 or (301) 443-6597 or at its Internet address .............................................................................................................................................................................. "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
William Yix
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 (508) 898-9300 ext. 240
Page 1 of 1
K972077 510(k) Number (if known):
Device Name: Epi-Stop™ Epistaxis Catheter
Indications For Use:
- To be used for control of anterior 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_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David A. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devic
510(k) Number K972077
§ 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.