(104 days)
Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.
Flexible nasopharyngoscopes with or without a working channel are built of 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 fibre-optic light- guide cable.
The provided document, K070580, describes a 510(k) premarket notification for the XION Nasopharyngoscope models (EF-N, EF-NS, EF-N Slim, EF-N 14, EF-N 14S). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the flexible nasopharyngo-laryngoscope and flexible broncho-scope from Richard Wolf Medical Instruments Corp. (K992526).
This type of submission focuses on comparing the new device's characteristics to a predicate device to establish that it is as safe and effective. It does not typically involve extensive clinical studies with acceptance criteria for device performance based on statistical measures of accuracy, sensitivity, or specificity in the way AI/ML software devices might. Instead, the "acceptance criteria" are the demonstration of substantial equivalence to the predicate device in terms of intended use, technological characteristics, and safety/effectiveness profiles.
Therefore, the answers below are framed within the context of a 510(k) substantial equivalence determination for a medical device, which differs significantly from studies proving performance for AI/ML algorithms.
Acceptance Criteria and Study to Prove Device Meets Criteria
The "acceptance criteria" in this context are primarily the demonstration that the XION Nasopharyngoscope is substantially equivalent (SE) to the predicate device in terms of its indications for use, technological characteristics, and safety and effectiveness. The "study" proving this is the 510(k) submission itself, which presents a comparison of the new device to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Note: For a 510(k) of a traditional medical device like an endoscope, "acceptance criteria" are not based on statistical performance metrics (like accuracy, sensitivity, specificity) but rather on alignment with the predicate device and relevant standards. The "reported device performance" is a comparison of specifications to the predicate device.
| Aspect of Equivalence | Acceptance Criteria (based on predicate device K992526) | Reported Device Performance (XION Nasopharyngoscope) |
|---|---|---|
| Intended Use | To examine or treat the nasal cavity and nasal pharynx, recognition of tissue anomalies, and biopsy (for models with working channel). | Matches Predicate: Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy. |
| Technological Characteristics | Similar design, materials, and functional specifications to the predicate device (Richard Wolf Medical Instruments Corp. K992526). | Similarities to Predicate Device:- Basic design and device material are the same.- Some flexible nasopharyngoscopes have a fixed light cable instead of a removable one; some of them have a working channel (similar variations exist in predicate).Differences to Predicate Device (minor):- Sheath diameter: XION (2.8 - 4.1 mm) vs. Predicate (3.5 mm)- Working length: XION (320 mm) vs. Predicate (300 mm)- Bending angle (Up/Down): XION (130°) vs. Predicate (130°)- Bending radius: XION (8 mm) vs. Predicate (Not specified, but assumed similar)- Field of view: XION (80°) vs. Predicate (95°)- Depth of field: XION (1 - 50 mm) vs. Predicate (3 - 50 mm)- Weight: XION (230 - 320 g) vs. Predicate (Not specified, but assumed similar)- Forceps channel diameter: XION (1.4 mm) vs. Predicate (1.1 mm)- Control lever, light guide connector, leak tester connector, biopsy channel entry, eyepiece, body cover, suction valves, and focus ring are either compatible with or have similar functional/material descriptions to the predicate, with minor variations in specific construction details (e.g., specific coatings, compatibility with additional brands for connectors).Conclusion: "The new technological characteristics have no influence on safety or effectiveness." |
| Safety and Effectiveness Profile | No new safety concerns or effectiveness questions raised compared to the predicate device. | Conclusion: "The submitted devices pose the same type of questions about safety and effectiveness as the compared devices." and "The submitted devices are substantially equivalent to the 510(k) devices sold by Richard Wolf Medical Instruments Corp." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a 510(k) for a physical medical device (an endoscope), not an AI/ML software device. There is no "test set" in the sense of a dataset of images or clinical cases used to evaluate an algorithm's performance. The "test" is the comparison against the predicate device's established specifications and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. There is no "ground truth" established by experts for a test set in this 510(k) submission. The ground truth for the safety and effectiveness of this type of device is based on accepted medical device manufacturing standards, preclinical testing (not detailed here but typically includes biocompatibility, sterilization, mechanical testing), and the proven safety and effectiveness of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication method described for performance evaluation in this 510(k) submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is not relevant for this type of medical device 510(k) submission, which focuses on substantial equivalence of a physical instrument rather than the performance of an interpretive algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No. This is not an AI/ML algorithm; it is a physical medical instrument.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established safety and effectiveness profile of the predicate device (Richard Wolf Medical Instruments Corp. K992526), alongside compliance with relevant performance standards and materials. The submission uses the predicate device's characteristics as the benchmark for comparison.
8. The Sample Size for the Training Set
Not applicable. There is no training set for an AI/ML algorithm in this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned in this 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for XION medical. The logo consists of the word "XION" in a sans-serif font, with the "i" dotted with a solid black circle. Below the "ION" portion of the logo is the word "medical" in a smaller font size.
510(k) - Summary 6
| Submitter: | XION GmbHPankstr. 8-1013127 BerlinGermanyPhone +49 (0)30 474 987 56Fax +49 (0)30 474 987 11 | JUN 1 3 2007 |
|---|---|---|
| Contact: | Alexander KliemEmail akliem@xion-medical.com | |
| Date: | 05/11/2007 | |
| Name of Device: | Nasopharyngoscope EF-N, EF-NS, EF-N Slim, EF-N 14, EF-N 14 S | |
| Common Name: | Naso-pharyngo-laryngo-fiberscope | |
| Classification Name of Device: | Nasopharyngoscope a) product code: EOBb) regulation number: 874.4760 | |
| Legally Marketed Device to which Equivalence is Claimed: | Flexible nasopharyngo-laryngoscope and flexible bronchoscopeRichard Wolf Medical Instruments Corp.(Premarket notification K992526) | |
| Description: | Flexible nasopharyngoscopes with or without a working channel are built of 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 fibre-optic light- guide cable. | |
| Indications for Use: | Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords. They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy. |
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| SE Device | Predicate Device | ||
|---|---|---|---|
| XION Device | Richard Wolf Device | ||
| Name | Nasopharyngoscope(flexible or rigid) | Flexible nasopharyngo-laryngoscope and flexiblebronchoscope,Richard Wolf Medical InstrumentsCorp. | |
| Identification | EF-NEF-NSEF-N SlimEF-N14EF-N14S | 130 400 034130 400 134130 400 028130 414 040130 414 140 | 7222, 7223, 7224, 7265, 7325,7330 |
| Performance specification | Nasopharyngoscope | Nasopharyngoscope | |
| Sheath diameter | 2.8 - 4.1 mm | 3.5 mm | |
| Working length | 320 mm | 300 mm | |
| Bending angleUp | 130° | 130° | |
| Down | 130° | 130° | |
| Bending radius | 8 mm | ||
| Optical systemField of view | 80° | 95° | |
| Depth of field | 1 - 50 mm | 3 - 50 mm | |
| Weight | 230 - 320 g | ||
| Forceps channel diameter | 1.4 mm | 1.1 mm | |
| SE Device | Predicate Device | ||
| XION Device | 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 stainless steel | Richard Wolf-standard;Manufactured of stainless steel | |
| Biopsy channel entry | Compatible to FUJINON;Manufactured of stainless steel | 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) | XION construction, cleanable byremoving;Manufactured of stainless steel,PTFE and medical grade silicone | 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 | |
| Labelling | Image: XION Device Labelling | Image: Richard Wolf Device Labelling |
Technological Characteristics in Comparison to Predicate Device
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Image /page/3/Picture/0 description: The image shows the logo for XION medical. The logo consists of the word "XION" in a bold, sans-serif font, with a small dot above the "I". Below the word "XION" is the word "medical" in a smaller, italicized font. The logo is simple and modern, and the use of black and white gives it a professional look.
| 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.Some flexible nasopharyngoscopes have a fixed light cable instead of aremovable one; some of them have a working channel. |
|---|---|
| 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. |
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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Xion GmbH c/o Alexander Kliem Quality Management Pankstraße 8-10 D-13127 Berlin Germany
JUN 1 3 2007
Re: K070580
Trade/Device Name: Nasophyngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: May 11, 2007 Received: May 14, 2007
Dear Mr. Kliem:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 – Alexander Kliem
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelman S. MD
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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5 Indications for Use
Nasopharyngoscope
510(k) Number (if known):
Device Name:
Indications for Use:
Nasopharyngoscopes are intended to examine or treat the nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and the vocal chords.
They allow the recognition of anomalies in the tissue of the accessible organs. The EF-N 14 and EF-N 14S models with their working channel allow the insertion of an instrument to carry out a biopsy.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anabolut
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K070580
Prescription Use (Per 21 CFR 801.109)
510 (k) Notification 061204 - 5 Indications for Use
§ 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.