(14 days)
The MicroEndoscope is intended to provide an endoscopic means to view a body cavity for ear, nose or throat procedures.
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 provided document for the Acclarent MicroEndoscope is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, the document explicitly states: "The MicroEndoscope met all performance testing acceptance criteria." However, it does not provide the specific acceptance criteria, the detailed results, or the methodology of the study.
Based on the provided information, I cannot complete the requested tables and sections with the specific details about acceptance criteria, detailed device performance, sample sizes, ground truth establishment, or multi-reader studies. The document only offers a general statement of compliance.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Met all performance testing acceptance criteria. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not detail any human expert review or ground truth establishment relevant to a clinical performance study. The performance testing is likely related to engineering and functional specifications of the endoscope itself (e.g., image quality, illumination, durability, sterilization effectiveness).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Given the nature of a medical device submission focused on physical and functional performance rather than diagnostic accuracy, adjudication methods as typically understood in AI/imaging studies are not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a physical medical device (MicroEndoscope) for visualization, not an AI or diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a direct visualization tool; there is no "algorithm only" performance. Its primary function is to provide an image for a human user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. For this type of device, "ground truth" would likely relate to objective measurements of image quality, illumination, structural integrity, and successful sterilization, rather than clinical diagnostic outcomes or pathology.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See #8)
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APPENDIX A: 510(k) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.1525-B O'Brien DriveMenlo Park, California 94025 |
|---|---|
| Contact Person: | Debbie CoganQuality EngineerPhone: (650) 687-5857Fax: (650) 687-5889 |
| Date of Submission: | October 6, 2006OCT 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 forvisualization of the ear, nose, and throat. The device is labeled non-sterile and must be sterilized prior to use. The MicroEndoscope isaccompanied by a camera coupler, which allows theMicroEndoscope to connect to a standard endoscopic camera. |
| Indications for Use: | The MicroEndoscope is intended to provide an endoscopic means toview a body cavity for ear, nose or throat procedures. |
| TechnologicalCharacteristics | The MicroEndoscope contains illumination and image fibers thattransmit an image from the distal to the proximal end of the device. |
| Performance Data | The MicroEndoscope met all performance testing acceptancecriteria. |
| Summary ofSubstantialEquivalence: | The MicroEndoscope is substantially equivalent to the predicatedevices as confirmed through relevant performance tests. |
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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.
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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
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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)
§ 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.