(23 days)
20-10700
Not Found
No
The device description and intended use focus on a mechanical balloon catheter for nasal bleeding control and packing. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is described as controlling anterior and posterior nasal epistaxis (bleeding) and acting as a nasal packing following surgical procedures, which are therapeutic interventions.
No
The device is described as a two-balloon catheter used for controlling nasal epistaxis and as a nasal packing after surgical procedures, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states it is a "two-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:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The Epi-Max™ is a physical device inserted into the nasal cavity to control bleeding and provide packing. It does not perform any tests on biological samples.
- Intended Use: The intended uses are for controlling bleeding and providing packing, which are physical interventions, not diagnostic tests.
- Device Description: The description details a physical catheter with balloons, not a system for analyzing biological samples.
Therefore, the Epi-Max™ falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- To be used for control of anterior and posterior nasal epistaxis.
- To be used as a nasal packing following septoplasty, rhinoplasty, and other intra-nasal surgical procedures.
Product codes
77 EMX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-nasal / 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)
Product No. 20-10700 manufactured by Invotec International, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
12076
Image /page/0/Picture/1 description: The image shows the logo for Boston Medical Products. On the left is a stylized heart shape with a "Y" shape inside. To the right of the logo are the words "Boston Medical Products" stacked vertically. A line is drawn underneath the word "Products".
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:
-
To be used for control of anterior and posterior nasal epistaxis.
-
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: 508-898-9300 Fax: 508-898-2373
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a human figure.
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 (301) 594-4591 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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
2
Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 ATT: Stuart K. Montgomery (508) 898-9300 ext. 240
Page 1 of 1
K972076 510(k) Number (if known):
Device Name:
Epi-Max™ Epistaxis Catheter
Indications For Use:
-
To be used for control of anterior and posterior nasal epistaxis.
-
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