(37 days)
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Not Found
No
The device description and intended use focus on a mechanical catheter for controlling nasal bleeding and preventing fluid aspiration. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is used for the "control of posterior intra-nasal hemorrhaging" and "to aid in prevention of fluid aspiration," which are medical interventions aimed at treating or preventing a condition, directly aligning with the definition of a therapeutic device.
No
The device is described as an epistaxis catheter used for controlling posterior nasal epistaxis and as inter-surgical packing to prevent fluid aspiration. Its function is to treat a condition (bleeding, fluid aspiration) rather than to diagnose or detect a disease state.
No
The device description clearly describes a physical catheter with a balloon, suction capabilities, and an internal guide wire, indicating it is a hardware 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 devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Post-Stop™ Epistaxis Catheter is a physical device used within the body (intra-nasal) to control bleeding and prevent fluid aspiration. It does not analyze biological specimens.
- Intended Use: The intended uses are for controlling bleeding and providing packing, which are therapeutic and procedural actions, not diagnostic testing of samples.
Therefore, the Post-Stop™ Epistaxis Catheter falls under the category of a medical device used for treatment and procedural support, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- To be used for control of posterior nasal epistaxis.
- To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration.
Product codes (comma separated list FDA assigned to the subject device)
77 EMX
Device Description
The Post-Stop™ Epistaxis Catheter is a single balloon catheter with integral suction catheter designed for control of posterior intra-nasal hemorrhaging. It can also be used as an inter-operative packing to aid in prevention of fluid aspiration. The balloon is designed to control bleeding in the posterior chamber. The multi-port suction/irrigator catheter can be used to keep the nasal area clear and to help prevent the catheter from clogging. An internal guide wire is included to help direct the catheter into the posterior chamber and is removed after catheter placement.
The Post-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
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Anatomical Site
posterior intra-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. 20-10710 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. On the left is a stylized heart shape made of two curved lines. To the right of the heart shape is the text "Boston Medical Products" stacked vertically in a sans-serif font. A horizontal line underlines the text.
SMDA Summary
JUL 1 0 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: Post-Stop™ Epistaxis Catheter
Description: The Post-Stop™ Epistaxis Catheter is a single balloon catheter with integral suction catheter designed for control of posterior intra-nasal hemorrhaging. It can also be used as an inter-operative packing to aid in prevention of fluid aspiration. The balloon is designed to control bleeding in the posterior chamber. The multi-port suction/irrigator catheter can be used to keep the nasal area clear and to help prevent the catheter from clogging. An internal guide wire is included to help direct the catheter into the posterior chamber and is removed after catheter placement.
The Post-Stop™ is supplied sterile and includes a 20cc syringe for balloon inflation.
Indications for Use:
-
To be used for control of posterior nasal epistaxis.
-
To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration.
Predicate Device: Product No. 20-10710 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: S. Montgomery, President
uart K. Montgomerv. 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 is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is the department's symbol, which consists of a stylized caduceus, a symbol often associated with medicine and healthcare.
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: K972078 Post-Stop Epistaxis Catheter Dated: May 30 .. 1997. ...... .. Received: June 3, 1997 Regulatory class: I 21 CFR 874.1000/Procode: 77 EMX
JUL 10 1997
Dear Mr. Montgomery:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined 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 Device Amendments, or to 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 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 Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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,
h. Tliau Yu
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
K972018 510(k) Number (if known):
Device Name:
Indications For Use:
-
To be used for control of posterior nasal epistaxis.
-
To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Post-Stop™ Epistaxis Catheter
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Formai 1-2-96)
Ra. A. Phillips
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K972078