Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and vocal cords.

Device Description

This flexible scope is designed with the insertion tube with its bendable distal tip w/camera, the handle, the umbilical unit which has the leakage tester, and connection for light source port and power/video port The handle incorporates the control lever to bend the distal tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ORL Video Nasopharyngo-Laryngoscope." It references a study conducted to demonstrate substantial equivalence to predicate devices, but it does not describe an AI medical device or a study involving AI. Therefore, I will respond to the prompt by extracting the relevant information about the non-AI device's acceptance criteria and study, indicating where certain AI-specific questions are not applicable.

Here's the information extracted from the provided text, formatted to address your questions:

Acceptance Criteria and Device Performance Study for the ORL Video Nasopharyngo-Laryngoscope

This document describes a 510(k) premarket notification for a medical device that does not involve Artificial Intelligence (AI). The study conducted was to demonstrate substantial equivalence to predicate devices based on functional performance and cleaning/disinfection validation.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" for the functional tests with specific numerical targets. Instead, it states that the device was "found to be comparable" to the predicate device in several functional areas. The table below compares the specifications of the device under review with its predicate devices. The "acceptance criteria" here implicitly means that the performance values should be similar to or within acceptable ranges of the predicate devices for achieving substantial equivalence.

Feature	Predicate Device (K132039) Performance / Criteria	Device Under Review Performance
Field of View	90°	90°
Depth of View	10mm-55mm	10mm-55mm
Angulation (Up/Down)	130° Up / 130° Down	130° Up / 130° Down
Working Length	310mm	310mm
Tube Diameter	4mm	4mm
Video Format	NTSC---PAL	NTSC---PAL/NTSC
Resolution	320x240 & 500x582/510x492	320x240 500x582 510x492
Cleaning/Disinfection	Significant microbial reduction (implied)	Fully met validation requirements

Predicate Device (K102733) Differences Noted:

Working Length: 300mm (Device under review: 310mm)
Depth of View: 3mm-50mm (Device under review: 10mm-55mm)
Tube Diameter: 3mm (Device under review: 4mm)
Angulation: 140° Up / 140° Down (Device under review: 130° Up / 130° Down)
Product Code: EOB and HRX and GCJ (Device under review: EQN)
Resolution: (Not explicitly stated for K102733, but K132039 provides a direct comparison)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" in terms of number of patients or cases for the functional comparison. Instead, the "test set" consisted of the ORL Video Nasopharyngo-Laryngoscope itself and the predicate device (ErgoFlex Naso-Pharyngo-Laryngoscope K132039) which were tested in a controlled environment.

Sample Size for Functional Test: Two devices (the new device and one predicate).
Sample Size for Cleaning/Disinfection Test: The ORL Video Naso-Pharyngo-Laryngoscope.
Data Provenance: The testing appears to have been conducted by the manufacturer (JEDMED Instrument Company) or a contracted laboratory (Geneva Laboratories for disinfection). The location is implied to be in the USA (St. Louis, Missouri). This was a prospective test conducted for the purpose of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the functional testing, the comparison was performed by "knowledgeable field staff." The document does not specify the exact number of staff or their detailed qualifications (e.g., years of experience, specific certifications). For the cleaning and high-level disinfection test, it was performed by "Geneva Laboratories per the IFU," implying qualified laboratory personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the study described is a technical comparison of device specifications and functional performance, not a clinical trial requiring ground truth adjudication by multiple experts for diagnostic outputs.

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

This question is not applicable as the device is not an AI medical device, and no MRMC study was conducted. The study was a comparison of device specifications and a validation of cleaning/disinfection.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is not an AI medical device. The functional comparison focuses on the device's inherent physical and optical characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the functional tests (Field of View, Depth of View, Angulation, Color Output, Clarity, Tip Diameter), the "ground truth" was established by direct measurement and observation of the device's technical specifications and performance against the known specifications of the predicate device.

For the cleaning and high-level disinfection test, the ground truth was microbiological reduction efficacy, validated against established standards for sterilization/disinfection (implied by "significant level of microbial reduction must result from tests for both vegetative microorganisms and mycobacteria").

8. The sample size for the training set

This question is not applicable as the device is not an AI medical device and does not involve a training set.

9. How the ground truth for the training set was established

This question is not applicable as the device is not an AI medical device and does not involve a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most prominent and the bottom profile being the least prominent. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 23, 2015

Jedmed Instrument Company % Mr. Craig R. Parks Regulatory Affairs/OA Manager 5416 JEDMED Court St. Louis, Missouri 63129

Re: K150248

Trade/Device Name: ORL Video Nasopharyngo-laryngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EQN Dated: February 3, 2015 Received: June 25, 2015

Dear Mr. Parks:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric A. Mann -S

for 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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Indications for Use

510(k) Number (if known) K150248

Device Name

ORL Video Nasopharyngo-Laryngoscope

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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5416 JEDMED COURT • ST. LOUIS, MO 63129 PHONE: (314) 845-3770 •FAX: (314) 845-3771 E-MAIL: INFO@JEDMED.COM WEB SITE: WWW.jedmed.com

6. 510(k) - Summary

Submitter:	JEDMED Instrument Company5416 JEDMED CourtSt. Louis, MO 63129
Contact:	Craig ParksRegulatory Affairs /QA ManagerPhone: 314-845-3770Email: craigp@jedmed.com
Date:	07-21-2015
Name of Device:	ORL Video NasoPharyngo-Laryngoscope
Common Name:	Naso-pharyngo-laryngo-flexible scope
Classification Name of Device:	Laryngo, Nasopharyngoscopea) product code: EQNb) regulation number: 874.4760
Legally Marketed Device	Flexible naso-pharyngo-laryngoscope to which Equivalence is claimedJEDMED Instrument Company K132039ERGOFLEX NasoPharyngolaryngoscope
Claimed:	Vision Science Flexible ENT 5000 K102733
Description:	This flexible scope is designed with the insertion tube with its bendable distal tipw/camera, the handle, the umbilical unit which has the leakage tester, andconnection for light source port and power/video port The handle incorporates thecontrol lever to bend the distal tip.
Indications for Use:	Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine thelarynx, nasal cavity and nasal pharynx. They are used between the upper respiratorytracts of the nasal passage and vocal cords.

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5416 JEDMED COURT • ST. LOUIS, MO 63129 PHONE: (314) 845-3770 •FAX: (314) 845-3771 E-MAIL: INFO@JEDMED.COM WEB SITE: WWW.jedmed.com

6. 510(k) - Summary

Similarities/differences to predicates:

The submitted devices are equivalent to the flexible endoscopes referred to in K132039 Ergoflex NasoPharyngo-Laryngoscope . The fiberscopes in the submission use the same basic design and device material

as predicate device. This device does have an eyepiece for visualization, and can be connected to a camera system while the submitted device incorporates the camera in the tip and does not have direct visualization

The submitted devices are equivalent to the Flexible ENT 5000 scope from Vision Sciences 510(k)# 102733. Both devices use a camera system for visualization without the eyepiece. There are only differences regarding diameters and lengths of the device insertion tube and the outer appearance and shaping of the shell parts and control elements which has no bearing on the safety or effectiveness.

All the devices have the same intended use, to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal cords

Testing: The ORL Video Naso-Pharyngo-Laryngoscope was tested functionally and compared to the predicate device the ErgoFlex Naso-Pharynqo-Laryngoscope 510(k)# K132039 and found to be comparable. The test included Field of View, Depth of View, Angulation of the Bendable Tip, Color Output, Clarity, and Tip Diameter. Both scopes were tested with the same test fixtures and results compared by our knowledgeable field staff.

A cleaning and high-level disinfection test was also performed on the ORL Video Naso-Pharyngo-Laryngoscope for both Cidex 2.4% Activated Dialdehyde and Cidex OPA disinfectant solutions. The test dictated that a significant level of microbial reduction must result from tests for both vegetative microorganisms and mycobacteria. Based on the test criteria, the general disinfection processing employing both Cidex 2.4% Activated Dialdehyde and Cidex OPA (performed by Geneva Laboratories per the IFU) fully met the validation acceptance requirements for the Jedmed ORL Laryngo-Nasopharyngoscope.

The submitted devices pose the same type of questions about safety and effectiveness as the compared devices. The different technological characteristics have no influence on safety or effectiveness, therefore is substantially equivalent to the previously cleared device.

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	Device under Review	Predicate DeviceK132039	Predicate DeviceK102733
Device Name	ORL Video NasoPharyngo-Laryngoscope	ERGOFLEX NasoPharyngo-Laryngoscope JEDMED Instrument	Vision Science ENT-5000
Indication for Use	Examination of the larynx, nasalcavity, nasal pharynx and isused between the upper nasalrespiratory tracts and of the na-sal passage and vocal chords.	Same	Same with the addition of ar-throscopic and endoscopic vi-sualization of an interior cavityof the body thru natural or surgi-cal openings.
Viewing Method	Camera System	Same	Same
Working Length	310mm	310mm	300mm
Field of View	90°	90°	90°
Depth of View	10mm-55mm	10-55mm	3mm-50mm
Tube Diameter	4mm	4mm	3mm
Angulation	130° Up 130° Down	130° Up 130° Down	140° Up 140° Down
Video Format	NTSC---PAL/NTSC	NTSC---PAL	CCD
Resolution	320x240 500x582 510x492	320x240 & 500x582/510x492
Product Code	EQN	EQN	EOB and HRX and GCJ
Light Guide Connector	ACMI-Wolf-Storz-Olympus	ACMI-Wolf-Storz-Olympus	ACMI-Wolf-Storz-Olympus
Direct View Eyepiece	None	None	None

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.