(120 days)
K 981751
Not Found
No
The summary describes a rigid endoscope with a rod-lens system for direct viewing, and there is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies.
No
The device is described as providing "illumination and visualization" for diagnostic and therapeutic procedures, but it does not directly perform any therapeutic action itself. It is a viewing instrument.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures." The explicit mention of "diagnostic" procedures indicates its role in diagnosis.
No
The device description clearly details physical components like an eyepiece, body with light guide, rod-lens system, and surgical steel tubes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures." This describes a device used for direct observation within the body, not for testing samples taken from the body.
- Device Description: The description details a rigid endoscope with lenses and a light guide, designed for internal viewing. This aligns with a medical device used for visualization, not for performing tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, treatment, or prevention of disease. This endoscope is a tool for direct visualization within the body.
N/A
Intended Use / Indications for Use
The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures. The asap ENT endoscope is reusable.
Product codes
EOB
Device Description
The asap ENT endoscope is of the rigid type with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap ENT endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity and nasal pharynx
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol.
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.
Sinuscope (K 981751)
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/0 description: The image shows a sequence of alphanumeric characters, specifically "KO32822". The characters are written in a bold, sans-serif font. The letters and numbers are closely spaced together.
JAN - 8 2004
510(k) Summary
| Applicant: | asap endoscopic products GmbH
Tullastr. 87 a
79108 Freiburg / Germany |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of contact: | Dr. Martina Guenderoth
Regulatory Affairs Manager
C.R.C. Partnerschaftsgesellschaft
Katharinenstr. 5
23554 Luebeck, Germany |
| | Phone: +49 (451) 388 2864
Fax: +49 (451) 388 2867
Email: crc@crc-online.de |
| Device name: | Sinuscope, Types:
10-0036-00, 10-0037-00, 10-0038-00, 10-0039-00,
10-0040-00, 10-0041-00, 10-0042-00, 10-0043-00,
10-0044-00, 10-0045-00, 10-0046-00, 10-0086-00,
10-0047-00 |
| Common name: | Sinuscope |
| Predicate device name: | Sinuscope (K 981751) |
| Classification name: | Nasopharyngoscope (flexible or rigid); 77-EOB |
510(k) Summary of safety and effectiveness
Code of Federal Regulations (CFR) number: 21 CFR 874.4760
General device description
The asap ENT endoscope is of the rigid type with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap ENT endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
Indications for use
The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures. The asap ENT endoscope is reusable.
1
Voluntary standard compliance
The asap ENT endoscope complies with
- applicable portions of voluntary standards IEC 60601-2-18
- DIN 58105, part 1 and 2
- DIN 17442 (medical steel), as well as applicable portions of
- DIN 980
Substantially equivalence - Safety and effectiveness
The specifications and intended use of the asap ENT endoscope are the same to those of the claimed predicate devices. There are no significant differences between the asap ENT endoscope and the claimed predicates in design or conditions of intended use.
The asap ENT endoscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. The asap ENT endoscope conforms to applicable ISO standards.
The device will be sold non-sterile, to be sterilized prior to each procedure by the user. The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol.
Conclusion
In all respects, the asap ENT endoscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA.
It is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility and it conforms to applicable ISO standards.
The ability to repeatedly adequately sterilize the asap ENT endoscope has been confirmed by validation protocol.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three curved lines that resemble a bird in flight. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 2004
Asap Endoscopic Products GmbH c/o Martina Guenderoth Regulatory Affairs Manager C.R.C. Partnerschaftsgellschaft Katharinenstr. 5 23554 Lubeck, Germany
Re: K032822 Trade/Device Name: Asap ENT Endoscope Regulatory Class: Class II Product Code: EOB Dated: August 21, 2003 Received: September 10, 2003
Dear Dr. Guenderoth:
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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I this lotter will and work of substantial equivalence of your device 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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A kalgi korenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_K032822
Device Name:asap ENT endoscopes
Indications For Use:
The asap ENT endoscope is intended to provide the physician with a means for direct viewing of the nasal cavity and nasal pharynx by providing illumination and visualization of these regions during various diagnostic and therapeutic procedures.
The asap ENT endoscope is reusable.
Prescription Use V YES_ (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 CDRH, Office of Device Evaluation (ODE)
ption Use __
21 CFR 801.109)
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