(41 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 it is used for treatment and prevention of a medical condition.
No
Explanation: The device is a nasal splint designed to provide physical support and prevent adhesions after surgery. It does not perform any diagnostic function.
No
The device description clearly states it is a physical splint constructed of medical grade flouroplastic, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The Bivalve Nasal Splint is a physical device inserted into the nasal cavity to provide structural support and prevent adhesions after surgery. It does not analyze any biological specimens.
- Intended Use: The intended use is to provide mechanical support and prevent physical complications (adhesions) within the nasal cavity. This is a therapeutic/supportive function, not a diagnostic one.
Therefore, based on the provided information, the Bivalve Nasal Splint is a surgical implant/support device, not an IVD.
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 Bivalve Nasal Splint, constructed of medical grade flouroplastic (i.e. Teflon®), is designed to provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splint is available in two sizes, standard and large, with two thicknesses (0.25mm and 0.50mm) for each size. The standard size is for routine use, while the large size can be be trimmed for individual applications. Both sizes feature a lengthwise slit facilitating placement and removal, and pre-formed suture holes for stabilizing the splint.
The Bivalve Nasal Splint is supplied sterile, two splints per packages per box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
nasal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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.
Not Found
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.
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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. On the left is a heart-shaped symbol with a Y-shaped figure inside. To the right of the symbol is the text "Boston Medical Products" stacked vertically. The text is in a sans-serif font and is black.
JUL 1 5 1997
SMDA Summarv
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 Bivalve Nasal Splint, constructed of medical grade flouroplastic (i.e. Teflon®), is designed to provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery. The splint is available in two sizes, standard and large, with two thicknesses (0.25mm and 0.50mm) for each size. The standard size is for routine use, while the large size can be be trimmed for individual applications. Both sizes feature a lengthwise slit facilitating placement and removal, and pre-formed suture holes for stabilizing the splint.
The Bivalve Nasal Splint is supplied sterile, two splints per 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. 20-10650, 20-10655, 20-10660, and 20-10665 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 flouroplastic ..
Submitted by: Phillip, President
Stuart K. Montgomery, President
Date:
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stuart K. Montgomery President Boston Medical Products, Inc. 117 Flanders Road Westborough, MA 01581 USA Re: K972096 Bivalve Nasal Splint Dated: June 3, 1997 Received: June 4, 1997 Regulatory class: Unclassified Procode: 77 LYA
JUL 1 5 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 intenstions 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 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 (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 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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked 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 questions on the promotion 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,
W.Liau Yin
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
510(k) Number (if known):
Device Name:
Bivalve Nasal Splint
Kazyuq6
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)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Thind h. Slymom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENR and Radiological Device
510(k) Number K972196