(104 days)
Not Found
No
The summary describes a standard flexible endoscope with mechanical controls and fiber-optic illumination. There is no mention of image processing, AI, ML, or any data-driven analysis of the images captured by the device.
No
The device is used to examine anomalies and allow for biopsies, which are diagnostic procedures, not therapeutic ones.
Yes
The device is described as allowing the "recognition of anomalies in the tissue of the accessible organs" and having a working channel to "carry out a biopsy," both of which are diagnostic activities.
No
The device description clearly outlines physical hardware components such as an insertion tube, handle, eyepiece, focus ring, control lever, and connectors for a leakage tester and fiber-optic light-guide cable.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the nasopharyngoscope is used to examine or treat the nasal cavity and nasal pharynx. It is a tool for direct visualization and potentially intervention (biopsy).
- No Sample Analysis: The device does not analyze samples taken from the body. It is used to directly observe and interact with the anatomical structures.
Therefore, the function and intended use of this nasopharyngoscope fall outside the scope of an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal cavity and nasal pharynx, between the upper respiratory tracts of the nasal passage and the vocal chords.
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)
Not Found
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
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 GmbH
Pankstr. 8-10
13127 Berlin
Germany
Phone +49 (0)30 474 987 56
Fax +49 (0)30 474 987 11 | JUN 1 3 2007 |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Alexander Kliem
Email 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: EOB
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: | 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. | |
.
.
.
1
| SE Device | Predicate Device | ||
|---|---|---|---|
| XION Device | Richard Wolf Device | ||
| Name | Nasopharyngoscope | ||
| (flexible or rigid) | Flexible nasopharyngo- | ||
| laryngoscope and flexible | |||
| bronchoscope, | |||
| Richard Wolf Medical Instruments | |||
| Corp. | |||
| Identification | EF-N | ||
| EF-NS | |||
| EF-N Slim | |||
| EF-N14 | |||
| EF-N14S | 130 400 034 | ||
| 130 400 134 | |||
| 130 400 028 | |||
| 130 414 040 | |||
| 130 414 140 | 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 angle | |||
| Up | 130° | 130° | |
| Down | 130° | 130° | |
| Bending radius | 8 mm | ||
| Optical system | |||
| Field 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 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 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 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) | XION construction, cleanable by | ||
| removing; | |||
| 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 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 | |||
| Labelling | Image: XION Device Labelling | Image: Richard Wolf Device Labelling |
Technological Characteristics in Comparison to Predicate Device
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2
:
3
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 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.
Some flexible nasopharyngoscopes have a fixed light cable instead of a
removable one; some of them have a working channel. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
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.
4
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.
5
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
6
Image /page/6/Picture/0 description: The image shows the logo for XION medical. The logo consists of the word "XION" in bold, sans-serif font, with a small circle above the "I". Below the word "XION" and slightly offset to the right is the word "medical" in a smaller, italicized font.
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