(120 days)
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.
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.
This document is a 510(k) summary for a Sinuscope device and focuses on establishing substantial equivalence to a predicate device rather than presenting a study related to acceptance criteria for a new, breakthrough AI-driven medical device. Therefore, much of the requested information regarding AI device studies cannot be found or inferred from the provided text.
Here is the information that can be extracted or inferred based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
There is no explicit table of acceptance criteria with reported device performance in the context of a new efficacy study for this device. The document primarily focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Voluntary Standard Compliance: | |
| IEC 60601-2-18 | Complies |
| DIN 58105, part 1 and 2 | Complies |
| DIN 17442 (medical steel) | Complies |
| DIN 980 | Complies |
| Biocompatibility: | |
| Materials of same specifications as predicate devices | Ensured (conforms to applicable ISO standards) |
| Sterilization: | |
| Ability to repeatedly adequately sterilize | Confirmed by validation protocol |
| Substantial Equivalence to Predicate Device (K981751): | |
| Specifications and intended use | Same |
| Design or conditions of intended use | No significant differences |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document describes a traditional medical device (sinuscope) being reviewed for substantial equivalence, not an AI/ML device undergoing performance testing with a specific test set of data. Therefore, there is no test set of patient data, nor is there data provenance in the context of an AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described in point 2, there is no test set of data requiring expert-established ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described in point 2, there is no test set of data requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
Not applicable. Ground truth for an AI device is not relevant here. The "ground truth" in this 510(k) context is the established safety and effectiveness of the predicate device (Sinuscope K981751), which the current device aims to be substantially equivalent to by meeting similar specifications and performance.
8. The Sample Size for the Training Set
Not applicable. This document is not describing an AI model, and therefore, there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As described in point 8, there is no training set for which ground truth would need to be established.
Summary of the Study (as described in the document):
The "study" described in this 510(k) pertains to demonstrating substantial equivalence to an already legally marketed predicate device (Sinuscope, K981751). The core of this demonstration relies on:
- Comparison of specifications and intended use: The document states that the specifications and intended use of the new asap ENT endoscope are "the same" as the predicate.
- Comparison of design and conditions of intended use: It states "no significant differences."
- Material comparison: The device is constructed of materials of "the same specifications" as the predicate to ensure biocompatibility and conforms to applicable ISO standards.
- Sterilization validation: The ability to repeatedly adequately sterilize the device was "confirmed by validation protocol."
This is a traditional medical device submission, not a study involving AI/ML performance. The "acceptance criteria" are compliance with relevant voluntary standards and demonstrating that the device is as safe and effective as the predicate, based on design, materials, and validated processes (like sterilization).
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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 GmbHTullastr. 87 a79108 Freiburg / Germany |
|---|---|
| Name of contact: | Dr. Martina GuenderothRegulatory Affairs ManagerC.R.C. PartnerschaftsgesellschaftKatharinenstr. 523554 Luebeck, Germany |
| Phone: +49 (451) 388 2864Fax: +49 (451) 388 2867Email: 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.
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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.
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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
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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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510(k) Numbe
§ 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.