ORL Video NasoPharyngo-Larngoscope

{0}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "Page 6-1" in a simple, sans-serif font. The text is positioned at the top of the image. A horizontal line is placed below the text, adding a visual separation. The background is plain white. 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<br>5416 JEDMED Court<br>St. Louis, MO 63129 | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Craig Parks<br>Regulatory Affairs /QA Manager<br>Phone: 314-845-3770<br>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<br>a) product code: EQN<br>b) regulation number: 874.4760 | | Legally Marketed Device | Flexible naso-pharyngo-laryngoscope to which Equivalence is claimed<br>JEDMED Instrument Company K132039<br>ERGOFLEX NasoPharyngolaryngoscope | | Claimed: | Vision Science Flexible ENT 5000 K102733 | | Description: | This flexible scope is designed with the insertion tube with its bendable distal tip<br>w/camera, the handle, the umbilical unit which has the leakage tester, and<br>connection for light source port and power/video port The handle incorporates the<br>control lever to bend the distal tip. | | Indications for Use: | Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the<br>larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory<br>tracts of the nasal passage and vocal cords. | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text "Page6-2" at the top of the image. The text is in a simple, sans-serif font and is left-aligned. Below the text is a black graphic design that appears to be a pattern of connected lines and shapes. The pattern is bold and abstract, contrasting with the clean text above. 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. {5}------------------------------------------------ | | Device under Review | Predicate Device<br>K132039 | Predicate Device<br>K102733 | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | ORL Video NasoPharyngo-<br>Laryngoscope | ERGOFLEX NasoPharyngo-<br>Laryngoscope JEDMED Instrument | Vision Science ENT-5000 | | Indication for Use | Examination of the larynx, nasal<br>cavity, nasal pharynx and is<br>used between the upper nasal<br>respiratory tracts and of the na-<br>sal passage and vocal chords. | Same | Same with the addition of ar-<br>throscopic and endoscopic vi-<br>sualization of an interior cavity<br>of the body thru natural or surgi-<br>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 |