(234 days)
Not Found
No
The device description and performance studies focus on the mechanical and optical aspects of a flexible scope, with no mention of AI/ML, image processing, or data analysis capabilities.
No
The device is described as an examination tool ("intended to examine") and is used for visualization ("flexible scope is designed with the insertion tube with its bendable distal tip, the handle, the eyepiece and the focus ring") rather than for treating a condition.
Yes
The device is intended to "examine the larynx, nasal cavity and nasal pharynx," which indicates its use in identifying or monitoring medical conditions, a characteristic of diagnostic devices.
No
The device description explicitly details physical hardware components like an insertion tube, handle, eyepiece, focus ring, control lever, and connectors for a leakage tester and fiber optic light-guide cable. Performance studies also focus on hardware aspects like temperature and angulation testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to examine the larynx, nasal cavity, and nasal pharynx. This is a direct examination of anatomical structures within the body.
- Device Description: The device is a flexible scope with an insertion tube, handle, eyepiece, and focus ring. It uses optical fibers to visualize the internal structures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This device does not process or analyze such specimens.
The device is a medical device used for direct visualization of internal body parts, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended 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.
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, the handle, the eyepiece and the focus ring. The handle incorporates the control lever to bend the distal tip and the connectors for the leakage tester and the fiber optic light-guide cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Reprocessing: Cleaning Instructions were validated using a manual cleaning process incorporating an enzymatic detergent. Disinfection instructions were validated using Cidex 2.4 and Cidex OPA and were tested by Geneva Test Laboratory and met all the criteria for acceptance for efficacy and material compatibility. The scope was submitted to the Steris System 1E test program for disinfecting validation and met all the criteria for efficacy and material compatibility.
Biocompatibility testing: performed according to ISO10993-5 ISO 10993-10 and no relevant cytotoxicity effects were found for direct and indirect contact. This test used the whole endoscope sheath which had already been put thru all the normal manufacturing processes.
Performance bench testing: Temperature testing for patient and user safety. Temperature was tested at (4) different test sites using calibrated Fluke Digital Multimeter with temperature sensing module with a 50w Metal Halide Bulb, a 50w LED buib and a 150w Halogen bulb. Tests results showed the temperature was below the 41 degree C as required bylEC60601-2-18 Part 2-18 section 201.11.
Life cycle and angulation testing: The angulation function was cycled a minimum of 50,000 cycles to determine that the scope would pass the minimum requirement of 26,000 cycles which could be 2 years use or more depending on the practice. All of the tested scopes met the requirement. The 130 degree angulation was still in tolerance after 30,000 cycles.
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.
0
K.132039
FEB 21 2014
Image /page/0/Picture/2 description: The image shows the word "JEDMED" in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance, as if they were printed with a worn-out stamp. The letters are closely spaced together, creating a compact and solid visual block.
An Employee-Owned Company 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
5. 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: | July 1, 2013 |
| Name of Device: | Laryngo-Nasopharyngoscope EF-N, EF-N Slim |
| 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
to which Equivalence is
Claimed: | Flexible nasopharyngo-laryngoscope and flexible bronchoscope
Richard Wolf Medical Instruments Corp.
(Premarket notification K992526) |
| Description: | This flexible scope is designed with the insertion tube with its bendable distal tip, the
handle, the eyepiece and the focus ring. The handle incorporates the control lever to
bend the distal tip and the connectors for the leakage tester and the fiber optic light-
guide cable. |
| Indications for Use: | JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are
intended 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. |
1
Image /page/1/Picture/0 description: The image shows a stylized text graphic that spells out the word "JEDMED" in all capital letters. The font is bold and blocky, with a slightly distressed or textured appearance, giving it a somewhat industrial or vintage feel. The letters are closely spaced, creating a compact and unified visual element.
An Employee-Owned Company 5418 JEDMED COURT • ST. LOUIS, MO 63129 PHONE: (314) 845-3770 •FAX: (314) 845-3771 E-MAIL: INFO@JEDMED.COM WEB SITE: www.jedmed.com
Technological Characteristics in Comparison to Predicate Device
| SE Device | Predicate Device | |
|---|---|---|
| Jedmed EF-N and EF-N Slim | Richard Wolf Device | |
| Name | Laryngo, Nasopharyngoscope | |
| flexible | Flexible nasopharyngo- | |
| laryngoscope and flexible | ||
| bronchoscope, | ||
| Richard Wolf Medical Instruments | ||
| Corp. | ||
| Identification | EF-N | |
| EF-N Slim | 7222, 7223, 7224, 7265, 7325, | |
| 7330 | ||
| Performance specification | Laryngo, Nasopharyngoscope | Nasopharyngoscope |
| Sheath diameter | ||
| Working length | ||
| Bending angle | ||
| Up | 2.8 and 3.4mm | |
| 320 mm | ||
| 130° | 3.5 mm | |
| 300 mm | ||
| 130° | ||
| Down | ||
| Bending radius | ||
| Optical system | 130° | |
| 8 mm | 130° | |
| Field of view | ||
| Depth of field | ||
| Weight | ||
| Forceps Channel Diameter | 80° | |
| 1 - 50 mm | ||
| 230 g(8 oz) | ||
| N/A | 95° | |
| 3 - 50 mm | ||
| 1.1 mm |
2
Image /page/2/Picture/0 description: The image shows the word "JEDMED" in a bold, sans-serif font. The letters are black and appear to be slightly distressed, giving them a textured look. The word is presented in a straightforward, horizontal arrangement.
An Employee-Owned Company 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
| SE Device | Predicate Device | |
|---|---|---|
| Jedmed EF-N and EF-N Slim | Richard Wolf Device | |
| Appearance, shape | ||
| Control lever | Handling by turning, rotation axis | |
| across to longitudinal axis of the | ||
| endoscope; | ||
| Milled of aluminium, anodized (for | ||
| mechanical resistance), parylene | ||
| coated (for chemical resistance) | Handling by turning, rotation axis | |
| across to longitudinal axis of the | ||
| endoscope: | ||
| Milled of aluminium, black coated | ||
| Light guide connector | Compatible to ACMI, Richard Wolf | |
| and Storz light guide cable; | ||
| Manufactured of stainless steel | Compatible to Richard Wolf light | |
| guide cable; | ||
| Manufactured of stainless steel | ||
| Leak tester connector | XION-standard: | |
| Manufactured of plastic | Richard Wolf-standard; | |
| Manufactured of stainless steel | ||
| Biopsy channel entry | N/A | ISO594-2.2(Luer-Lock-innercone); |
| Manufactured of stainless steel | ||
| Eyepiece | DIN 58105 (Medical endoscopes); | |
| Manufactured of medical grade | ||
| plastics | DIN 58105 (Medical endoscopes); | |
| Manufactured of medical grade | ||
| plastics | ||
| Body cover | Manufactured of medical grade | |
| silicone | Milled / drilled of aluminium, black | |
| coated | ||
| Suction valves | ||
| (bronchoscope only) | N/A | Richard Wolf construction, |
| cleanable by removing; | ||
| Manufactured of stainless steel | ||
| Focus ring | Handling by turning, rotation axis | |
| parallel to longitudinal axis of the | ||
| endoscope: | ||
| Manufactured of medical grade | ||
| plastics | Handling by turning, rotation axis | |
| parallel to longitudinal axis of the | ||
| endoscope: | ||
| Manufactured of medical grade | ||
| plastics |
ﺗ
3
Image /page/3/Picture/0 description: The image shows the word "JEDMED" in a bold, sans-serif font. The letters are all capitalized and appear to be slightly distressed, giving them a textured look. The overall impression is a strong, blocky design with a slightly retro feel.
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
| Similarities to predicate
device: | The submitted devices are equivalent to the flexible endoscopes referred
to in K992526 flexible nasopharyngo-laryngoscope and flexible
bronchoscope. The fiberscopes in the submission use the same basic
design and device material as submitted in K992526. |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences to predicate
device: | There are only differences regarding diameters and lengths of the
insertion tube and the outer appearance and shaping of the shell parts
and control elements. |
Reprocessing:
Cleaning Instructions were validated using a manual cleaning process incorporating an enzymatic detergent. The following documents were referenced during the validation:
"Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices", ANSI/AAMI ST81:2004/(R) 2010
AAMI TIR No. 12:2010, "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers".
AAMI TIR No. 30:2011; "A compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices.
"Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices", ISO 17664.2004(E)
"Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guide"; Office of Device Evaluation; April 1996.
Disinfection instructions were validated using Cidex 2.4 and Cidex OPA and were tested by Geneva Test Laboratory and met all the criteria for acceptance for efficacy and material compatibility. The scope was submitted to the Steris System 1E test program for disinfecting validation and met all the criteria for efficacy and material compatibility.
Biocompatibility testing was performed according to ISO10993-5 ISO 10993-10 and no relevant cytotoxicity effects were found for direct and indirect contact. This test used the whole endoscope sheath which had already been put thru all the normal manufacturing processes.
Performance bench testing consisted of:
Temperature testing for patient and user safety. Temperature was tested at (4) different test sites using calibrated Fluke Digital Multimeter with temperature sensing module with a 50w Metal Halide Bulb, a 50w LED buib and a 150w Halogen bulb. Tests results showed the temperature was below the 41 degree C as required bylEC60601-2-18 Part 2-18 section 201.11.
4
Image /page/4/Picture/0 description: The image shows the word "JEDMED" in a bold, sans-serif font. The letters are all capitalized and appear to be slightly distressed, giving them a textured look. The overall impression is a strong, blocky design with a somewhat industrial or vintage feel.
An Employee-Owned Company 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
Life cycle and angulation testing:
The angulation function was cycled a minimum of 50,000 cycles to determine that the scope would pass the minimum requirement of 26,000 cycles which could be 2 years use or more depending on the practice. All of the tested scopes met the requirement. The 130 degree angulation was still in tolerance after 30,000 cycles.
Conclusion:
The submitted devices pose the same type of questions about safety and effectiveness as the compared devices. The new technological characteristics have no influence on safety or effectiveness. The submitted devices are substantially equivalent to the 510(k) devices sold by Richard Wolf Medical Instruments Corp.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird, which is a common representation of health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2014
Jedmed Instrument Company Mr. Craig Parks Regulatory Affairs/QA Manager 5416 JEDMED Court St. Louis, MO 63129
Re: K132039
Trade/Device Name: Laryngo-Nasopharyngoscope EF-N, EF-N Slim Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EQN Dated: January 21, 2014 Received: January 23, 2014
Dear Mr. Parks:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becomined 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 I he general controlly proctice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability additeration. Thease note:
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) in Souther major regulations affecting your device can be It may be subject to additional condelors, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 - Mr. Craig Parks
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Eric Ailwann -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
7
Indications for Use
510(k) Number (if known): K132039
Device Name: Laryngo-Nasopharyngoscope EF-N and EF-N Slim
Indications for Use:
JEDMED's Ergo-Flex EF-N and EF-N Slim Laryngo-Nasopharyngoscopes are intended 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Sunny Park 2014.02.21 09:23:30 -05,00,
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