(14 days)
Not Found
No
The description focuses on the physical device (fiberscope, camera coupler) and its intended use for visualization. There is no mention of AI/ML terms, image processing beyond basic visualization, or data sets for training/testing.
No.
The device is for viewing a body cavity, which is a diagnostic purpose, not a therapeutic one. It facilitates viewing but does not treat any condition.
Yes
The device's intended use is to "view a body cavity for ear, nose or throat procedures," which is a diagnostic function because it involves visualizing internal structures to assess their condition.
No
The device description clearly states it is a "semi-rigid fiberscope" and includes a "camera coupler," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide an endoscopic means to view a body cavity for ear, nose or throat procedures." This describes a device used for direct visualization within the body, not for testing samples outside the body.
- Device Description: The description confirms it's a "semi-rigid fiberscope that allows for visualization of the ear, nose, and throat." This is consistent with an endoscopic device used for viewing, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing diagnostic tests in vitro (outside the living body).
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for visualization.
N/A
Intended Use / Indications for Use
The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The MicroEndoscope is a semi-rigid fiberscope that allows for visualization of the ear, nose, and throat. The device is labeled non-sterile and must be sterilized prior to use. The MicroEndoscope is accompanied by a camera coupler, which allows the MicroEndoscope to connect to a standard endoscopic camera. The MicroEndoscope contains illumination and image fibers that transmit an image from the distal to the proximal end of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, nose or throat
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)
The MicroEndoscope met all performance testing acceptance criteria.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "Acclarent" in a stylized font. There is a curved line above the "ent" portion of the word. The font is black and the background is white.
APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
1525-B O'Brien Drive
Menlo Park, California 94025 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Debbie Cogan
Quality Engineer
Phone: (650) 687-5857
Fax: (650) 687-5889 |
| Date of Submission: | October 6, 2006
OCT 24 2006 |
| Device Trade Name: | To be determined |
| Common Name: | MicroEndoscope |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.4760 |
| Classification Name: | Nasopharyngoscope (flexible or rigid) and accessories |
| Product Code: | EOB |
| Predicate Device: | Pollux Endoscopy Sinuscope (K002214)
Acueity ViaDuct MicroEndoscope and Accessories (K011189)
EBI VueCath Spinal Endoscopic System (K010179) |
| Device Description: | The MicroEndoscope is a semi-rigid fiberscope that allows for
visualization of the ear, nose, and throat. The device is labeled non-
sterile and must be sterilized prior to use. The MicroEndoscope is
accompanied by a camera coupler, which allows the
MicroEndoscope to connect to a standard endoscopic camera. |
| Indications for Use: | The MicroEndoscope is intended to provide an endoscopic means to
view a body cavity for ear, nose or throat procedures. |
| Technological
Characteristics | The MicroEndoscope contains illumination and image fibers that
transmit an image from the distal to the proximal end of the device. |
| Performance Data | The MicroEndoscope met all performance testing acceptance
criteria. |
| Summary of
Substantial
Equivalence: | The MicroEndoscope is substantially equivalent to the predicate
devices as confirmed through relevant performance tests. |
1
Image /page/1/Picture/1 description: The image shows the words "HEALTH & HU" in a bold, sans-serif font. The text is black against a white background. The ampersand symbol is used to connect the words "HEALTH" and "HU".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Acclarent, Inc. c/o Debbie Cogan Clinical and Regulatory Manager 1525-B O'Brien Drive Menlo Park, CA 94025
OCT 2 4 2006
Re: K063078
Trade/Device Name: MicroEndoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: October 6, 2006 Received: October 10, 2006
Dear Ms. Cogan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Debbie Cogan
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman Simund
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image shows the word "Acclarent" in a bold, sans-serif font. There is a curved line above the word, starting from the right side of the first "c" and ending above the "t". The word and the curved line are both in black, and the background is white.
Traditional 510(k): MicroEndoscope
.... . .
APPENDIX B: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Trade Name:
To be determined
Common Name:
MicroEndoscope
Indications For Use:
The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of
(Posted November 13, 2003)
Karin Bohm
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K063078
X Prescription Use (Per 21 CFR 801.109)