(23 days)
Product No. 20-10715
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or any related concepts in the provided text.
Yes
The device is used to control anterior nasal epistaxis (bleeding) and as a nasal packing following surgical procedures, which are therapeutic interventions.
No.
The device is used for control of nasal bleeding and as a nasal packing after surgery; it does not diagnose any condition.
No
The device description clearly states it is a "single balloon catheter with integral airway" and is supplied with a "20cc syringe for balloon inflation," indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are for controlling nasal bleeding (epistaxis) and as a nasal packing after surgery. These are direct therapeutic and surgical support applications within the body.
- Device Description: The description details a physical device (a balloon catheter) used for mechanical purposes within the nasal cavity.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be inserted into the body for direct treatment or support.
N/A
Intended Use / Indications for Use
- 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.
Product codes (comma separated list FDA assigned to the subject device)
77 EMX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Product No. 20-10715 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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