(53 days)
The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.
The device consists of a cannula and an occlusion plug.
This medical device submission for the "Frontal Sinus Trephination Cannula" is a 510(k) premarket notification, which establishes substantial equivalence to existing predicate devices rather than proving safety and effectiveness through clinical trials with acceptance criteria. As such, the provided text does not contain any information about:
- Acceptance criteria or reported device performance
- Sample sizes or data provenance for test sets
- Number or qualifications of experts for ground truth
- Adjudication methods
- MRMC comparative effectiveness studies
- Standalone algorithm performance
- Type of ground truth used
- Sample size or ground truth establishment for training sets
The document focuses on:
- Device Description: It details the device (cannula and occlusion plug).
- Intended Use: Specifies its indication for frontal sinus irrigation for up to thirty days.
- Substantial Equivalence (Predicate Devices): It identifies two predicate devices:
- Medtronic Xomed Frontal Sinus Mini-Trephine Set irrigation cannula (for the trephination aspect).
- Vansonnenberg Chest Drainage Tubes (K925176) and common peritoneal catheters (for the short-term indwelling aspect as an introduction/drainage catheter).
- Bard Medical's Catheter Plug (for the occlusion plug).
- Regulatory Classification: States the device's classification as Class I with specific product codes (77KBF, 79GBX).
- FDA Clearance Letter: The letter from the FDA confirms substantial equivalence to legally marketed predicate devices and permits the device to be marketed, subject to general controls.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and performance metrics because this type of information is not typically part of a 510(k) submission focused on substantial equivalence for a Class I device.
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510(k) Summary
1.0 Date Prepared
December 16, 1999
2.0 Submitter (Contact) Martin D. Sargent Medtronic Xomed, Inc Jacksonville, FL
(904) 279-7586
3.0 Device Name
| Proprietary Name: | Frontal Sinus Trephination Cannula |
|---|---|
| Common Name(s): | Irrigation Cannula |
| Classification Name(s): | Introduction/Drainage Catheter and Accessories |
5.0 Device Classification
| Sinus Trephine, Sinus Irrigation: | ||
|---|---|---|
| Procode 77KBF | Class I | 21 CFR 874.4420 |
| Irrigation Cannula: | ||
| Procode 79GBX | Class I | 21 CFR 878.4200 |
6.0 Device Description
The device consists of a cannula and an occlusion plug.
7.0 Intended Use
The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated for patients with sinus disease the
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K994262
Substantial Equivalence 8.0
The Frontal Sinus Irrigation Cannula is substantially equivalent to the Medtronic Xomed Frontal Sinus Mini-Trephine Set irrigation cannula.
The short-term indwelling aspect of the device is substantially equivalent in intended use to introduction/drainage catheters as defined in 21 CFR 878.4200 which provide shortterm access to body cavities. Predicates include common peritoneal catheters and chest drainage tubes including the Vansonnenberg Chest Drainage Tubes as described in K925176.
The occlusion plug provided to close the cannula lumen between irrigation procedures is substantially equivalent in design and intended use to the Catheter Plug marketed by Bard Medical.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing protection and service. The eagle is depicted in a simple, modern design with clean lines.
8 2000 FEB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Martin D. Sargent Senior Regulatory Affairs Specialist Xomed, Inc. 6743 Southpoint Drive, North Jacksonville, FL 32216
Re: K994262
Trade Name: Frontal Sinus Trephination Cannula Regulatory Class: Unclassified Product Code: 77KAM Dated: December 16, 1999 Received: December 17, 1999
Dear Mr. Sargent:
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 legally marketed predicate 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 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 requirements, 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Martin D. Sargent
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, pormits 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) 594639. Also, please note the regulation entitled, "Misbranding by reference to premarket notificion" (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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): Device Name: __ Frontal Sinus Trephination Cannula Indications for Use:
The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.
(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)
Г
Or
Over-the-Counter Use _
Karen S. Bahr
(D:
(Optional Format 1-2-96)
510(k) Number K994462
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 § 878.9.