(81 days)
Not Found
No
The summary describes a rigid endoscope with a rod-lens system and light guide, similar to predicate devices. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is described as being used for visualization during diagnostic procedures, and in conjunction with other instruments for therapeutic procedures, indicating it is an accessory and not therapeutic on its own.
Yes
The "Intended Use / Indications for Use" section explicitly states that the endoscope is "used to visualize the body cavities, hollow organs and canals during diagnostic... procedures."
No
The device description explicitly states it is a rigid type endoscope with physical components like an eyepiece, body, light guide, and rod-lens system made of surgical steel. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures." This describes a device used for direct visualization within the body, not for testing samples outside the body.
- Device Description: The description details a rigid endoscope with an eyepiece, body, light guide, and rod-lens system. This is a physical instrument used for internal examination.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro (in glass, or outside the living organism).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This endoscope is used for direct visualization in vivo (within the living organism).
N/A
Intended Use / Indications for Use
Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
FAJ
Device Description
The asap endoscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system. The basic design of the asap 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
Body cavities, hollow organs and canals
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) Summary of safety and effectiveness
Applicant:
asap endoscopic products GmbH Tullastr. 87 a 79108 Freiburg / Germany
Contact:
Dr. Martina Günderoth C.R.C. Partnerschaftsgesellschaft Katharinenstr. 5 23554 Lübeck, Germany
Phone: +49 (451) 388 2864 Fax: +49 (451) 388 2867 Email: crc@crc-online.de
Device name
| a) | Cystoscope, Types: 10-0025-00, 10-0026-00, 10-0027-00, 10-0028-00, 10-0029-00, 10-0030-00, 10-0031-00 |
|---|---|
| b) | Laparoscope, Types: 10-0013-00, 10-0014-00, 10-0063-00, 10-0064-00, 10-0015-00, 10-0016-00, 10-0089-00 |
| c) | Laryngoscope, Types: 10-0062-00, 10-0048-00 |
| d) | Oesophagoscope, Type: 10-0049-00 |
Common name
Endoscope
Predicate device name
- Cystoscope: Baho Cystoscope (K992983)
- Laparoscope: AED Laparoscope (K993688)
- Laryngoscope: Karl Storz Laryngoscope (K963426)
- Oesophaqoscope: Baho Esophagoscope
Code of Federal Regulations (CFR) number
876.1500
General device description
The asap endoscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap 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.
1
Indications for use
Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
Voluntary standard compliance
- The asap 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 endoscope are the same to those of the claimed predicate devices. There are no significant differences between the asap endoscope and the claimed predicates in design or conditions of intended use.
The asap endoscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. The asap 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 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 endoscopes has been confirmed by validation protocol.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines above it, possibly representing the concept of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2003
Asap Endoscopic Products GmbH c/o Dr. Martina Günderoth C.R.C. Partnerschaftsgesellschaft Katharinenstr. 5 23554 Lübeck, Germany
Re: K031141
Trade/Device Name: asap Cystoscope, Types: 10-0025-00, 10-0026-00, 10-0027-00, 10-0028-00, 110-0029-00, 10-0030-00, 10-0031-00 asap Laparoscope, Types 10-0013-00, 10-0014-00,10-0063-00, 10-0064-00 10-0015-00, 10-0016-00, 10-0089-00 asap Laryngoscope, Types: 10-0062-00, 10-0048-00 asap Oesophagoscope, Type 10-0049-00 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Dated: March 28, 2003 Received: April 30, 2003
Dear Dr. Günderoth:
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 - Dr. Martina Günderoth
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
n o e tër verilli vijën kundje të
| 510(k) Notification | asap endoscopes |
|---|---|
| --------------------- | ----------------- |
Page __
KO31141 510(k) Number (if known)
asap Cystoscope, Types 10-0025-00, 10-0026-00, 10-0027-00, Device Name: a) 10-0028-00, 110-0029-00, 10-0030-00, 10-0031-00
- asap Laparoscope, Types: 10-0013-00, 10-0014-00, 10-0063-00, b) 10-0064-00, 10-0015-00, 10-0016-00, 10-0089-00
- asap Laryngoscope, Types: 10-0062-00, 10-0048-00 c)
- asap Oesophagoscope, Type: 10-0049-00 ರು)
Indications for Use:
Like the predicate devices, the asap endoscope is used to visualize the body cavitles, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
(Division Sign-Off)
Miriam C. Provost
C R C.N1.2 - 18.B.2003
Division of General, Restorative and Neurological Devices
Page 1C of 51
510(k) Number K031141