(54 days)
Not Found
No
The device description and intended use describe a purely mechanical, self-retaining endoscope holder system with no mention of software, image processing, or AI/ML terms.
No.
The device is an endoscope holder system, which is a surgical tool used to hold endoscopes during diagnostic and therapeutic procedures. It is not directly therapeutic itself; rather, it facilitates therapeutic procedures performed by surgeons.
No
Explanation: The device is an endoscope holder system. Its function is to hold endoscopes during diagnostic and therapeutic procedures, but it does not perform any diagnostic function itself. It is a tool used during procedures that may have a diagnostic component.
No
The device description clearly states it is a "Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms" and accessories, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to hold endoscopes and arthroscopes during general diagnostic and therapeutic procedures, including neurologic procedures. This is a surgical support device, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details a mechanical, table-mounted system for holding instruments. This aligns with a surgical support device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the ASSISTO® Arm Systems are a surgical instrument holder, not an IVD.
N/A
Intended Use / Indications for Use
ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.
Product codes
GCJ, GWG, KOG, HRX
Device Description
Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. Accessories include endoscope holders for 2.7mm to 10mm scopes.
The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Design analysis and comparison as well as verification testing confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a handwritten string of alphanumeric characters. The string is "K052745". The characters are written in a simple, slightly irregular style, typical of handwriting.
Image /page/0/Picture/1 description: The image shows the text "Page 1 of 1" written in cursive. The number 1 is circled. This indicates that it is the first page of a document that is only one page long.
510(k) summary of safety and effectiveness
| Date: | September 15, 2005 | ||||
|---|---|---|---|---|---|
| Submitter: | Name: | Geomed Medizin-Technik GmbH & Co. | |||
| Ludwigstaler Strasse 27 | |||||
| Postfach 4047 | |||||
| Tuttlingen, Germany 78532 | NOV 2 3 2005 | ||||
| Contact Person: | Thomas Haug | ||||
| General Manager | |||||
| Telephone: | |||||
| Fax: | +49.7461.93550 | ||||
| +49.7461.935593 | |||||
| Product: | Trade Name: | ASSISTO® Arm Systems | |||
| Classification: | |||||
| Common Name: | |||||
| Classification | |||||
| Name: | Class II | ||||
| Endoscope Holder | |||||
| Laparoscope, General & Plastic Surgery (GCJ, | |||||
| 876.1500) | |||||
| Endoscope, Neurological (GWG, 21 CFR 882.1480) | |||||
| Endoscope and/or Accessories (KOG, 21 CFR | |||||
| 876.1500) | |||||
| Arthroscope (HRX, 21 CFR 888.1100) | |||||
| Predicate | |||||
| Devices: | Name | ||||
| Armand Endoscope Holder | |||||
| Neuroview Instrument Holder, Model | |||||
| 300-33 | Manufacturer | ||||
| KLS-Martin L.P. | |||||
| Integra Neurocare | |||||
| LLC. | K-No. | ||||
| K050051 | |||||
| K992006 | |||||
| Abdominal Wall Retractor | Omni-Tract Surgical | K950214 | |||
| ASSISTO® Arm Systems are substantially equivalent to the predicate | |||||
| devices since the basic features and intended uses are the same. | |||||
| Device | |||||
| Description: | Table-mounted self-retaining endoscope holder system consisting of | ||||
| stainless steel tubular, articulated arms that are connected to a vertical stand | |||||
| and are freely adjustable within the articulating radius according to the | |||||
| requirements of the particular surgical procedure. Accessories include | |||||
| endoscope holders for 2.7mm to 10mm scopes. | |||||
| The device is reusable and provided non-sterile. It must be cleaned and | |||||
| sterilized before use. | |||||
| Intended | |||||
| Use: | ASSISTO® Arm Systems consist of a table-mounted endoscope holder | ||||
| system intended for use by surgeons to hold endoscopes and arthroscopes | |||||
| with a diameter of 2.7mm to 10mm during general diagnostic and | |||||
| therapeutic procedures. The device is also intended for use by qualified | |||||
| surgeons for holding endoscopes during diagnostic and therapeutic | |||||
| neurologic procedures. | |||||
| Performance | |||||
| Data: | Design analysis and comparison as well as verification testing confirm that | ||||
| basic functional characteristics are substantially equivalent to the predicate | |||||
| devices cited and raise no new issues of safety and effectiveness. | |||||
| Conclusion: | Based upon the product technical information provided, intended use and | ||||
| performance information provided in this premarket notification, the | |||||
| ASSISTO® Arm Systems have been shown to be substantially equivalent to |
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Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is a simple, abstract design, and the text is in a sans-serif font. The logo is clean and professional, and it is easily recognizable.
NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Geomed Medizin-Technik GmbH & Company c/o Angelika Scherp Business Support International Amstel 320-I Amsterdam 1017AP Netherlands
Re: K052745
Trade/Device Name: ASSISTO® Arm Systems Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG, GCJ Dated: September 28, 2005 Received: September 30, 2005
Dear Ms. Scherp:
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.
2
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Varbara Buehel
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
510(k) Number (if known): K052745
Device Name: ASSISTO® Arm Systems
Indications for Use:
ASSISTO® Arm Systems consist of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 2.7mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures.
Prescription Use _ X (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)
Barbara Buehrig
Division of General, Restorative, and Neurological Devices
510(k) Number K052745
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