(41 days)
To provide septal support and reduce or prevent adhesions between the septum and lateral nasal wall following surgery.
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.
The provided text describes a medical device, the Bivalve Nasal Splint, and its FDA 510(k) summary for market clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any other details related to proving the device meets acceptance criteria.
The document is a standard FDA 510(k) submission, focusing on:
- Description of the device: Bivalve Nasal Splint, made of medical grade fluoroplastic (Teflon®), available in two sizes and two thicknesses, with a lengthwise slit and suture holes.
- 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: Invotec International, Inc. nasal splints (Product Nos. 20-10650, 20-10655, 20-10660, and 20-10665).
- Testing (briefly mentioned): "Device is constructed using well-established medical grade flouroplastic." This is a general statement and not a description of performance testing against specific acceptance criteria.
- FDA Clearance Letter: Confirming substantial equivalence to predicate devices and allowing the device to be marketed.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory approval document and not a clinical study report. Clinical study data, if any, would typically be in a separate report that might be referenced or summarized in a PMA (Premarket Approval) submission, but a 510(k) for a device like a nasal splint primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than novel clinical effectiveness studies against specific, quantitative performance criteria.
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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:
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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
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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
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
§ 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.