(31 days)
Not Found
No
The summary describes a physical medical device made of silicone for mechanical closure of nasal perforations. There is no mention of software, algorithms, or any technology that would suggest AI or ML.
Yes
The device is intended to treat a medical condition (nasal perforations) by closing them non-surgically, which alleviates symptoms such as epistaxis and crusting.
No
Explanation: The device is used for non-surgical closure of nasal perforations, which is a therapeutic treatment rather than a diagnostic process. It does not identify or characterize diseases or conditions.
No
The device description explicitly states it is manufactured using soft medical grade silicone and features physical components (flanges and a post), 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 use is "To be used for non-surgical closure of nasal perforations." This describes a therapeutic or structural intervention within the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical device made of silicone designed to physically close a nasal perforation. This is consistent with a medical device used for treatment or repair, not for diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Nasal Septal Button, as described, falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To be used for non-surgical closure of nasal perforations.
Product codes
77 LFB
Device Description
The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.
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)
Testing: Device is constructed using medical grade silicone, a well-established material for this application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Product No. 20-10400 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for Boston Medical Products. The logo consists of a heart-shaped symbol on the left and the text "Boston Medical Products" on the right. The text is stacked vertically, with "Boston" on top, "Medical" in the middle, and "Products" on the bottom. A horizontal line is located under the word "Products".
JUL - 3 1997
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: Nasal Septal Button
Description: The Nasal Septal Button is designed for non-surgical closure of septal perforations. The device is manufactured using soft medical grade silicone and can be trimmed at the time of placement. Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting. The button features two 3.2cm diameter flanges connected by a central 7mm diameter post.
Indications For Use: To be used for non-surgical closure of nasal perforations.
Predicate Device: Product No. 20-10400 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.
Testing: Device is constructed using medical grade silicone, a well-established material for this application.
President
Stuart K. Montgomery, President
Date:
Submitted by:
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stuart K. Montgomery President Boston Medical Products 117 Flanders Road Westborough, MA 01581 Re: K972060 Nasal Septal Button Dated: June 12, 1997 Received: June 16, 1997 Unclassified/Procode: 77 LFB
JUL - 3 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 misbranion.
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 (OS) 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 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 vours
ht. Jliau 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
K97J060
Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 WeStborough, MANAGomery (508) 898-9300 ext. 240
Page 1 of 1
510(k) Number (if known):
Device Name:
Nasal Septal Button
Indications For Use:
To be used for non-surgical closure of nasal perforations.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Vihil C. Segeam
(Division Sign-Off)
( - Cleron Of Reproductive, Abdominal, ENT,
Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
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