(234 days)
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.
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.
The provided document is a 510(k) premarket notification summary for the JEDMED Laryngo-Nasopharyngoscope EF-N and EF-N Slim. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or clinical superiority. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of demonstrating equivalence through engineering and performance bench testing, rather than a clinical study with human subjects, ground truth, or expert consensus in the way those terms are typically used for AI/diagnostic devices.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission of this nature, the "acceptance criteria" are typically defined by engineering specifications, safety standards, and performance characteristics compared to the predicate device. The "reported device performance" are the results of bench testing to demonstrate compliance with these criteria and equivalence.
| Acceptance Criteria (Based on Predicate Device & Relevant Standards) | JEDMED EF-N/EF-N Slim Reported Performance |
|---|---|
| Performance Specifications - Physical Characteristics | |
| Sheath diameter | Predicate: 3.5 mm JEDMED: 2.8 and 3.4 mm (Differences noted, but considered equivalent) |
| Working length | Predicate: 300 mm JEDMED: 320 mm (Differences noted, but considered equivalent) |
| Bending angle (Up) | Predicate: 130° JEDMED: 130° |
| Bending angle (Down) | Predicate: 130° JEDMED: 130° |
| Bending radius | Predicate: Not specified (implied to be similar or acceptable via function) JEDMED: 8 mm |
| Field of view | Predicate: Not specified (implied to be similar or acceptable via function) JEDMED: 80° |
| Depth of field | Predicate: 3 - 50 mm JEDMED: 1 - 50 mm (Predicate has a wider range at the near end, but both cover relevant range) |
| Weight | Predicate: Not specified (implied to be similar or acceptable via function) JEDMED: 230 g (8 oz) |
| Forceps Channel Diameter | Predicate: 1.1 mm JEDMED: N/A (JEDMED device does not have a forceps channel, a key difference, but not deemed to impact equivalence for its stated indications for use as an examination scope) |
| Biocompatibility | |
| No relevant cytotoxicity effects (ISO 10993-5, ISO 10993-10) | No relevant cytotoxicity effects found for direct and indirect contact. |
| Reprocessing Effectiveness | |
| Cleaning efficacy (following ANSI/AAMI ST81, AAMI TIR 12, TIR 30, ISO 17664) | Manual cleaning process validated using enzymatic detergent. |
| Disinfection efficacy (e.g., Cidex 2.4, Cidex OPA efficacy, Steris System 1E) | Disinfection instructions validated using Cidex 2.4 and Cidex OPA; met all criteria for acceptance for efficacy and material compatibility. Met all criteria for efficacy and material compatibility for Steris System 1E. |
| Safety Testing - Temperature | |
| Temperature below 41°C (per IEC60601-2-18 Part 2-18 section 201.11) | Tests results showed the temperature was below the 41°C as required. (Tested at 4 sites with 50w Metal Halide, 50w LED, and 150w Halogen bulbs). |
| Durability - Life Cycle and Angulation | |
| Minimum angulation cycles (e.g., 26,000 cycles for 2 years use) | Angulation function cycled a minimum of 50,000 cycles. 130 degree angulation still in tolerance after 30,000 cycles. All tested scopes met the requirement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Testing: Not explicitly stated as a number of distinct devices for all tests. For example, "all tested scopes" for angulation implies multiple devices, but the exact number isn't quantified. For temperature testing, it refers to "4 different test sites" on the device.
- Data Provenance: The studies are bench tests and laboratory validations performed by the manufacturer, JEDMED Instrument Company, and Geneva Test Laboratory (for disinfection). This is not human data or clinical data; it's engineering and material testing. The country of origin of the data is implicitly the USA where JEDMED is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the typical sense for this device.
- There is no "ground truth" derived from human interpretation or clinical outcomes in the context of this 510(k) submission.
- The "acceptance criteria" are based on recognized standards (ISO, AAMI, IEC) and comparison to the predicate device's specifications. Compliance is measured via objective physical and chemical tests rather than expert consensus on a diagnostic outcome.
- The validation of reprocessing and biocompatibility would involve laboratory professionals and engineers.
4. Adjudication Method for the Test Set
Not applicable. There is no ambiguous "test set" requiring adjudication by multiple readers or experts. Performance is measured against objective standards and specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a premarket notification for a medical device (an endoscope), not a diagnostic AI algorithm. The submission focuses on demonstrating substantial equivalence in design, materials, and safety/performance characteristics to a legally marketed predicate device.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is an endoscope, a tool used by a human clinician to visualize anatomical structures. It does not operate as an "algorithm only" or a "standalone" diagnostic system.
7. The Type of Ground Truth Used
Not applicable in the sense of expert consensus, pathology, or outcomes data for making diagnoses. The "ground truth" for this submission are:
- Established national and international standards for medical devices (e.g., ISO, AAMI, IEC).
- The engineering and performance specifications of the predicate device (Richard Wolf Medical Instruments Corp. flexible nasopharyngo-laryngoscope and flexible bronchoscope; K992526).
- Laboratory testing results (e.g., temperature measurements, cycle counts, chemical compatibility results).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/machine learning device.
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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 Company5416 JEDMED CourtSt. Louis, MO 63129 |
|---|---|
| Contact: | Craig ParksRegulatory Affairs /QA ManagerPhone: 314-845-3770Email: 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, Nasopharyngoscopea) product code: EQNb) regulation number: 874.4760 |
| Legally Marketed Deviceto which Equivalence isClaimed: | Flexible nasopharyngo-laryngoscope and flexible bronchoscopeRichard Wolf Medical Instruments Corp.(Premarket notification K992526) |
| Description: | This flexible scope is designed with the insertion tube with its bendable distal tip, thehandle, the eyepiece and the focus ring. The handle incorporates the control lever tobend 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 areintended to examine the larynx, nasal cavity and nasal pharynx.They are used between the upper respiratory tracts of the nasal passage and thevocal cords. |
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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, Nasopharyngoscopeflexible | Flexible nasopharyngo-laryngoscope and flexiblebronchoscope,Richard Wolf Medical InstrumentsCorp. |
| Identification | EF-NEF-N Slim | 7222, 7223, 7224, 7265, 7325,7330 |
| Performance specification | Laryngo, Nasopharyngoscope | Nasopharyngoscope |
| Sheath diameterWorking lengthBending angleUp | 2.8 and 3.4mm320 mm130° | 3.5 mm300 mm130° |
| DownBending radiusOptical system | 130°8 mm | 130° |
| Field of viewDepth of fieldWeightForceps Channel Diameter | 80°1 - 50 mm230 g(8 oz)N/A | 95°3 - 50 mm1.1 mm |
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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 axisacross to longitudinal axis of theendoscope;Milled of aluminium, anodized (formechanical resistance), parylenecoated (for chemical resistance) | Handling by turning, rotation axisacross to longitudinal axis of theendoscope:Milled of aluminium, black coated |
| Light guide connector | Compatible to ACMI, Richard Wolfand Storz light guide cable;Manufactured of stainless steel | Compatible to Richard Wolf lightguide 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 gradeplastics | DIN 58105 (Medical endoscopes);Manufactured of medical gradeplastics |
| Body cover | Manufactured of medical gradesilicone | Milled / drilled of aluminium, blackcoated |
| Suction valves(bronchoscope only) | N/A | Richard Wolf construction,cleanable by removing;Manufactured of stainless steel |
| Focus ring | Handling by turning, rotation axisparallel to longitudinal axis of theendoscope:Manufactured of medical gradeplastics | Handling by turning, rotation axisparallel to longitudinal axis of theendoscope:Manufactured of medical gradeplastics |
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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 predicatedevice: | The submitted devices are equivalent to the flexible endoscopes referredto in K992526 flexible nasopharyngo-laryngoscope and flexiblebronchoscope. The fiberscopes in the submission use the same basicdesign and device material as submitted in K992526. |
|---|---|
| Differences to predicatedevice: | There are only differences regarding diameters and lengths of theinsertion tube and the outer appearance and shaping of the shell partsand 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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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,
Page 1 of 1
§ 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.