The ENTity NasoView is a modification of the OL-1 Airway Fiberscope. The device has been modified to include a battery-operated LED light source internal to the device control body. An accessory charger is provided for charging the battery outside the scope.

AI/ML Overview

The provided text for the OPTIM's ENTity NasoView LED Nasopharyngoscope does not contain the information requested for a detailed study description with acceptance criteria and device performance.

The document is a 510(k) summary for a Special 510(k) notice, indicating a modification to an existing device (OL-1 Airway Fiberscope). The main modification is the inclusion of a battery-operated LED light source internal to the device control body.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., illumination intensity, battery life, image clarity standards). The document mentions "Verification and validation activities have been completed for the device modifications" and that the modifications "do not raise any new questions of safety or effectiveness." It also states that "Validation and verification testing demonstrates that the ENTity NasoView is as safe and effective as the predicate devices." This implies that the acceptance criteria are related to maintaining the safety and effectiveness profile of the predicate device with the new LED light source.
Reported Device Performance: No specific performance data (e.g., illumination output, battery duration, resolution, field of view) of the ENTity NasoView is provided. The document only generally states that it meets design control requirements and is as safe and effective as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not mentioned. No specific test sets are described.
Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/Not mentioned. No "ground truth" establishment by experts is described as this is not a diagnostic device relying on expert interpretation of results.

4. Adjudication Method

Not applicable/Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not done. This device is a direct visualization tool (nasopharyngoscope), not a diagnostic algorithm that requires human-in-the-loop performance evaluation or comparison against human readers. The change is a light source modification.

6. Standalone Performance Study

Not explicitly described. While "verification and validation activities" were completed for the device modifications, the document does not detail a specific "standalone" study in the context of an algorithm's performance without human input. The validation would have been on the physical device's functionality (e.g., light output, battery performance, mechanical integrity) but this is not detailed.

7. Type of Ground Truth Used

Not applicable in the conventional sense of diagnostic algorithms. The "ground truth" for a medical device like a nasopharyngoscope would relate to its physical and optical specifications, safety standards, and functional performance, not diagnostic accuracy against a disease state.

8. Sample Size for the Training Set

Not applicable/Not mentioned. This is a hardware device modification, not a machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable/Not mentioned.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of a modified medical device to its predicates based on design control requirements and general verification/validation activities. It does not contain the detailed performance metrics, study designs, sample sizes, and expert ground truth establishment that would be associated with a new diagnostic algorithm or a study proving specific performance against acceptance criteria.

Summary

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510(k) SUMMARY

OPTIM's ENTity NasoView LED Nasopharyngoscope APR - 2 2008

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

OPTIM Incorporated

64 Technology Park Road Sturbridge, MA 01566-1253

Phone: (508) 347-5100 Facsimile: (508) 347-2380

Contact Person: Robert Krupa

Date Prepared: March 5, 2008

Name of Device and Name/Address of Sponsor

ENTity NasoView LED Nasopharyngoscope

OPTIM, Incorporated 64 Technology Park Road Sturbridge, MA 01566-1253

Common or Usual Name

Nasopharyngoscope

Classification Name and Product Code

Nasopharyngoscope; EOB

Predicate Devices

OL-1 Airway Fiberscope, K864821 Vision-Sciences EF100 nasopharyngoscope, K942265 Vision-Sciences ENT-3000 nasopharyngoscope, K050972 Vision-Sciences ENT-5000 nasopharyngoscope, K072073

Purpose of the Special 510(k) Notice

The ENTity NasoView is a modification of the OL-1 Airway Fiberscope.

VI. - 1

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Intended Use / Indications for Use

For oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.

Technological Characteristics

Performance Data

In support of this Special 510(k), OPTIM has certified compliance with 21 CFR § 820.30, Design Control Requirements, including a risk analysis assessment. Verification and validation activities have been completed for the device modifications.

Substantial Equivalence

ENTity NasoView has the same intended use and indications for use, and similar technological characteristics and principles of operation, as the predicates. The modifications incorporated in the ENTity NasoView do not raise any new questions of safety or effectiveness. Validation and verification testing demonstrates that the ENTity NasoView is as safe and effective as the predicate devices. Thus, the ENTity NasoView is substantially equivalent to legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of several curved lines and shapes, and it is oriented towards the right side of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 2 2008

OPTIM Incorporated c/o Robert Krupa 64 Technology Park Road Sturbridge, MA 01566-1253

Re: K080622

Trade/Device Name: ENTity NasoView LED Nasopharyngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: March 5, 2008 Received: March 5, 2008

Dear Dr. Krupa:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Marlina B. Egleston, Md

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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Ko 80622

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

OPTIM's ENTity NasoView LED Nasopharyngoscope

Indications for Use:

For oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.

Prescription Use X (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kurent Boker

Division Sign-Off Division of Ophthalmic Ea Nose and Throat Devis

510(k) Number

V. - 1

Regulation Number and Section

§ 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.