(31 days)
To be used for non-surgical closure of nasal perforations.
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.
The provided document is a 510(k) summary for the Boston Medical Products Nasal Septal Button. This type of regulatory submission is not typically accompanied by detailed studies proving acceptance criteria in the way a new, innovative device might require. Instead, it focuses on demonstrating "substantial equivalence" to a legally marketed predicate device.
Therefore, the specific information requested, such as a table of acceptance criteria with reported device performance metrics, sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and details on training sets, are not present in this document.
Here's an explanation based on the available information:
1. A table of acceptance criteria and the reported device performance:
- Not present. The document states: "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting." However, it does not present specific acceptance criteria (e.g., "epistaxis decrease by X%") or quantitative performance data from a specific study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not present. No information about a specific test set, its sample size, or data provenance is provided. The document refers generally to "Studies" that have shown decreased symptoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not present. No details on expert involvement for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not present. No information about adjudication methods.
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/Not present. This device is a physical medical implant (nasal septal button), not an AI-driven diagnostic or image analysis tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not present. As this is a physical device, not an algorithm, standalone performance as described for AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated, but implied by 'substantial equivalence'. For a 510(k), the "ground truth" for demonstrating safety and effectiveness often comes from the established clinical use and performance of the predicate device. The general statement "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting" suggests that clinical outcomes (symptom reduction) served as a basis for understanding effectiveness, likely derived from clinical observations or existing literature on such devices.
8. The sample size for the training set:
- Not applicable/Not present. This product is a physical device and does not involve a "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established:
- Not applicable/Not present. As above, no training set is relevant.
Summary of the document's core message regarding "testing":
The primary "testing" mentioned in this 510(k) summary is:
- Material Compatibility: "Device is constructed using medical grade silicone, a well-established material for this application." This implies that the safety and biocompatibility of the material itself are well-understood and accepted, negating the need for novel material studies.
- Clinical Effectiveness (Historical/Literature-based): "Studies have shown that use of a nasal septal button has decreased symptoms of nasal perforations including epistaxis and crusting." This statement refers to the general clinical experience and evidence supporting the class of device, rather than specific performance data for this particular device model in a controlled study presented in the submission. The substantial equivalence argument relies on this existing evidence for similar devices and the fact that this device shares similar design and materials with its predicate.
In conclusion, this 510(k) document establishes "substantial equivalence" based on similar materials, design, and intended use as a predicate device, relying on the generally accepted clinical outcomes for this type of device, rather than presenting a detailed study with specific acceptance criteria and performance data for this new device.
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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:
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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
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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.
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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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