(37 days)
- To be used for control of posterior nasal epistaxis.
- To be used as a inter-surgical posterior nasal packing to help prevent fluid aspiration.
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.
The provided text describes a 510(k) submission for the Post-Stop™ Epistaxis Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics in the way a clinical trial for a new drug or novel medical device might.
Therefore, many of the requested categories are not applicable or cannot be extracted from this document because it is a regulatory summary for a device seeking substantial equivalence, not a standalone clinical study report.
Here's an attempt to address the request based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or specific performance metrics in the format of a clinical study. The "acceptance criteria" for a 510(k) submission are typically met by demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Implied by 510(k) Process) | Reported Device Performance (from document) |
|---|---|
| Substantially equivalent to predicate device (Invotec International, Inc. Product No. 20-10710) in intended use, technological characteristics, and safety/effectiveness. | "We have reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976..." |
| Constructed from well-established medical grade materials. | "Device is constructed using well-established medical grade silicone." |
| Effective for control of posterior nasal epistaxis. | Intended Use: "To be used for control of posterior nasal epistaxis." (Performance implied by intended use and substantial equivalence) |
| Effective as an inter-surgical posterior nasal packing to help prevent fluid aspiration. | Intended Use: "To be used as an inter-surgical posterior nasal packing to help prevent fluid aspiration." (Performance implied by intended use and substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The 510(k) summary does not describe a clinical test set in the traditional sense. It relies on the claimed substantial equivalence to a predicate device, which implies that the predicate device's performance data (or general understanding of such devices) is the basis for equivalence, not a new test set for this specific device.
- Data Provenance: Not applicable. No specific clinical data from a "test set" is presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. As no new clinical test set is described, there's no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This is a medical device (catheter) and the submission refers to a 510(k) for substantial equivalence, not an AI-powered diagnostic or therapeutic device. No MRMC study or AI component is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
- Not applicable in the context of a new clinical study. The "ground truth" for a 510(k) submission is the established safety and effectiveness of the predicate device that the new device is compared against.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
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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
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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
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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
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
§ 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.