(170 days)
Not Found
No
The summary describes a standard flexible endoscope for visualization and does not mention any AI/ML capabilities, image processing beyond basic video output, or performance studies related to algorithmic analysis.
No
The device is described as an examination tool for viewing and does not mention any therapeutic function or intervention.
Yes
The device is described as being intended to "examine the larynx, nasal cavity and nasal pharynx", which is a diagnostic purpose.
No
The device description explicitly details physical hardware components such as an insertion tube, bendable distal tip with camera, handle, and umbilical unit, indicating it is a hardware device with integrated video capabilities, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
- Device Function: The Jedmed ORL Video Nasopharyngo-Laryngoscope is used to directly visualize internal structures (larynx, nasal cavity, nasal pharynx) within the human body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for examining these anatomical sites, not for analyzing samples.
- Device Description: The description focuses on the physical components for insertion and visualization.
- Performance Studies: The performance studies described relate to the functional performance of the scope (field of view, clarity, etc.) and disinfection, not the analysis of biological samples.
Therefore, this device falls under the category of a medical device used for direct visualization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EQN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Camera System
Anatomical Site
larynx, nasal cavity, nasal pharynx, upper respiratory tracts of the nasal passage, vocal cords
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional testing and cleaning/high-level disinfection testing indicate substantial equivalence to the predicate device.
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.
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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
1
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)
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.
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 Company
5416 JEDMED Court
St. Louis, MO 63129 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Craig Parks
Regulatory Affairs /QA Manager
Phone: 314-845-3770
Email: 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, Nasopharyngoscope
a) product code: EQN
b) regulation number: 874.4760 |
| Legally Marketed Device | Flexible naso-pharyngo-laryngoscope to which Equivalence is claimed
JEDMED Instrument Company K132039
ERGOFLEX NasoPharyngolaryngoscope |
| Claimed: | Vision Science Flexible ENT 5000 K102733 |
| 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. |
| Indications for Use: | 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. |
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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 Device
K132039 | Predicate Device
K102733 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ORL Video NasoPharyngo-
Laryngoscope | ERGOFLEX NasoPharyngo-
Laryngoscope JEDMED Instrument | Vision Science ENT-5000 |
| Indication for Use | Examination of the larynx, nasal
cavity, nasal pharynx and is
used between the upper nasal
respiratory 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 cavity
of 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 |