(28 days)
To maintain a nasal airway while providing septal support following surgery.
The Doyle Combo Nasal Airway Splint is designed to provide septal support and allow nasal breathing post-operatively through the integral airway. The patented design features an expandable PVA sponge layer for added comfort and stabilization. For additional security, the splints can be sutured through the pre-formed holes in the anterior tips. The Doyle Combo Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.
The provided text is a 510(k) summary for the Doyle Combo Nasal Airway Splint. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a detailed clinical study demonstrating performance metrics like sensitivity or specificity.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's why and what information is available:
- Acceptance Criteria and Reported Device Performance: This information is not present. The 510(k) summary focuses on the device description, indications for use, contraindications, and identification of predicate devices. There are no performance metrics (e.g., accuracy, sensitivity, specificity, or specific measurements) reported, nor are there acceptance criteria defined.
- Sample size and data provenance: No clinical study data is presented, so no sample size information is available.
- Number of experts and qualifications: Not applicable as no expert-derived ground truth or performance study is detailed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or summarized.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable as no clinical performance study is detailed.
- Sample size for the training set: Not applicable as no machine learning algorithm development or training set information is relevant to this submission.
- How the ground truth for the training set was established: Not applicable.
What the document does state regarding "Testing":
The document mentions: "Testing: Device is constructed using well-established medical grade silicone and PVA sponge." This refers to material verification rather than clinical performance testing against specific criteria for effectiveness. The FDA's 510(k) clearance in {1} confirms substantial equivalence based on this and the comparison to predicate devices, not on a detailed study proving performance against acceptance criteria.
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| Boston Medical Products |
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JUL - 7 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 Doyle Combo Nasal Airway Splint is designed to provide septal support and allow nasal breathing post-operatively through the integral airway. The patented design features an expandable PVA sponge layer for added comfort and stabilization. For additional security, the splints can be sutured through the pre-formed holes in the anterior tips. The Doyle Combo Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.
Indication For Use: To maintain a nasal airway while providing septal support following surgery.
Contraindications: None known.
Predicate Device: Product No. 20-10500 manufactured by Invotec International, Inc., 11243-1 St. John's Industrial Parkway South, Jacksonville, FL 32246, and Product No. Q601318 manufactured by M-Pact, 1040 OCL Parkway, Eudora, KS 66025.
Testing: Device is constructed using well-established medical grade silicone and PVA sponge.
IR ///// htm, President
Submitted by:
Stuart K. Montgomery, President
Date:
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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 eagle with three lines representing its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stuart K. Montgomery President Boston Medical Products 117 Flanders Road Westborough, MA 01581
JUL - 7 1997
Re: K972151
Doyle Combo Nasal Airway Splint Dated: June 26, 1997 Received: July 1, 1997 Unclassified/Procode: 77 LYA
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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.
h.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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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:
Indications For Use:
Doyle Combo Nasal Airway Splint
To maintain a nasal airway while providing septal support 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)
Ra-Ce. Pacey
(Division Sign-Off)
Division of Reproductive. And Redition inal. ENT. and Radiological Devices
510(k) Number K972151
§ 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.