(29 days)
Not Found
Not Found
No
The device description and other sections do not mention any AI or ML components or functionalities. The device is a physical splint.
Yes
The device is described as providing "septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery," which indicates a therapeutic purpose to aid in post-surgical healing and prevent complications.
No
The device's intended use is to provide physical support and prevent adhesions, which are therapeutic functions, not diagnostic. It does not identify or detect a disease or condition.
No
The device description explicitly states the device is constructed of medical grade flouroplastic or silicone and is supplied as physical splints.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device's intended use is to provide physical support and prevent adhesions following surgery. It is a physical implant used directly on the anatomical site (septum and lateral nasal wall).
- Lack of Biological Sample Analysis: There is no mention of this device interacting with or analyzing any biological samples from the patient.
Therefore, based on the provided information, this device falls under the category of a surgical implant or device used for mechanical support and tissue management, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
Product codes (comma separated list FDA assigned to the subject device)
77 LYA
Device Description
The Custom Nasal Splints, constructed of medical grade flouroplastic (i.e. Teflor®) or medical grade silicone, are designed to be trimmed by the surgeon for custom applications. The splints provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splints are available in various thicknesses.
The Custom Nasal Splint are supplied sterile, two splints per package, five packages per box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal wall, septum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Device is constructed using well-established medical grade flouroplastic or medical Testing: grade silicone.
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 Nos. 20-10670, 20-10675, 20-10685, 20-10680, and 20-10686 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
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(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 the limitations in § 874.9.
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 heart-shaped symbol is made up of two curved lines that meet at the bottom and form a point. The text is in a simple, sans-serif font.
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.
Description: The Custom Nasal Splints, constructed of medical grade flouroplastic (i.e. Teflor®) or medical grade silicone, are designed to be trimmed by the surgeon for custom applications. The splints provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splints are available in various thicknesses.
The Custom Nasal Splint are supplied sterile, two splints per package, five packages per box.
Indication For Use: To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
Contraindications: None known.
Predicate Device: Product Nos. 20-10670, 20-10675, 20-10685, 20-10680, and 20-10686 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246.
Device is constructed using well-established medical grade flouroplastic or medical Testing: grade silicone.
by:
Submitted by:
Stuart K. Montgomery, President
Date:
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is made up of three curved lines that form the shape of the bird's wings and body.
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: K972082 Custom Nasal Splint Dated: June 12, 1997 Received: June 16, 1997 Unclassified/Procode: 77 LYA
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, 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 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 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 vitto 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.
William 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 WeStborough, MA 0100mery (508) 898-9300. ext. 240 ...... ....... ... ... ... ...
Page 1 of 1
972082
510(k) Number (if known):
Device Name:
Custom Nasal Splint
Indications For Use:
To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
(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)
ਾਸ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David A. Segner
(Division Sign. Off.)
(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological D 510(k) Number