(75 days)
Not Found
Not Found
No
The summary describes a physical stent and does not mention any software, algorithms, or AI/ML terms.
Yes
The device is a postoperative stent designed to maintain an opening and prevent obstruction, which is a direct therapeutic action to aid healing and maintain physiological function.
No
The device is described as a "postoperative stent to maintain an opening," which indicates a therapeutic or supportive function, not a diagnostic one. It helps prevent obstruction, which is a treatment outcome, not a diagnostic one.
No
The device description clearly states "Sphenoid Sinus Stent," which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain an opening in the sphenoid sinus postoperatively. This is a physical intervention within the body, not a test performed on samples taken from the body.
- Device Description: It's described as a "Sphenoid Sinus Stent," which is a physical device implanted or placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely mechanical and supportive within the body.
N/A
Intended Use / Indications for Use
Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, for ventilation and drainage of the sphenoid sinus cavity during the first 14 days post-surgery and helps prevent obstruction by adhesions.
Product codes
KAM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sphenoid sinus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of several curved lines. The emblem is stylized and simplified, with the lines suggesting the wings and body of the bird.
APR 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micromedics, Inc. c/o Thomas Lopac Manager of Quality Assurance 1270 Eagan Industrial Road Suite 120
Re: K050340
Trade/Device Name: Micromedics Sphenoid Sinus Stent Regulatory Class: Unclassified Product Code: KAM Dated: April 6, 2005 Received: April 12, 2005
Dear Mr. Lopac:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication We have reviewed your Section 910(x) premainted instantially equivalent (for the indications felerenced above and nave determined we are and marketed predicate devices marketed in interstate for use stated in the encrosuly to regally manatise to of the Medical Device Amendments, or to commence province to May 20, 1978, the exactions of the Federal Food. Drug, devices that have been reclassified in acceraanse who was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval and Cosment Act (Act) that to not requence subject to the general controls provisions of the Act. The You may, merclore, market the device, basjer to the ...
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the floor labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in II your device is classified (500 above) and existing major regulations affecting your device can may be subject to such additional controls. Enisting may one of on 898. In addition, FDA may be found in the Out of I satis concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination oes not mean Prease be advised that I DA 3 issuates of a sevice complies with other requirements of the Act
that FDA has made a determination that your device complies with other must that FDA has made a decormination an administered by other Federal agencies. You must of any Federal statutes and regulations anninetees or your not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CPK Part 807), adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Thomas Lopac
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manketing your averal equivalence of your device to a legally premarket nothleation: "The PDA maing of castimation 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), please If you desire specific advice for your ac (301) 827-8910. Also, please note the regulation entitled, Contact the Office of Complanoo at (301) 327 - 31 - 31 807.97). You may obtain Milsolalling by relevelec to premanteensbillities under the Act from the Division of Small other general Information on your response Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Ochsal http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): __________________________________________________________
Device Name: Sphenoid Sinus Stent
Indications for Use:
Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, of Intenaed for use as a postoperative sient to manufacturer worders for ventilation and drainage of uuring the Just 14 aays Journag and helps prevent obstruction by adhesions.
X Prescription Use: (Per 21 CFT 801.109)
OR
Over-The-Counter _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kamat Bolu
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number J
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