FISSO Holding System consists of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 4mm 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

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. All joints are locked in position simultaneously via the adjustment knob located on the central joint. Accessories include endoscope holders for 4mm to 10mm scopes as well as multiple class-l holding devices. The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.

AI/ML Overview

The provided 510(k) summary for the FISSO Holding System describes a medical device, specifically an endoscope holder. The information outlines its intended use and comparison to predicate devices, but it does not include information about acceptance criteria or a study proving that the device meets specific performance criteria in the way that an AI/ML device would.

This device is not an AI/ML diagnostic or therapeutic system. It is a physical medical device (an endoscope holder). Therefore, the typical "acceptance criteria" and "study" questions relevant to AI/ML performance metrics (like sensitivity, specificity, AUC) and ground truth establishment are not applicable in this context.

Here's a breakdown of why many of your requested items cannot be answered from the provided text, and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable in the AI/ML sense. The document states: "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."
Implied Acceptance Criteria (for a physical device): The device is expected to:
- Hold endoscopes and arthroscopes with a diameter of 4mm to 10mm securely.
- Be table-mounted and self-retaining.
- Allow for free adjustment within its articulating radius.
- Have all joints lock simultaneously via a central knob.
- Be reusable and sterilizable.
- Be substantially equivalent in basic features and intended uses to the predicate devices.
Reported Device Performance: The document confirms "verification testing" was done, and the conclusion is that the device is "substantially equivalent" to predicate devices, implying it met the functional requirements for holding endoscopes as intended. No specific quantitative performance metrics (e.g., maximum load, stability under specific forces, duration of hold) are provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. There is no "test set" in the context of an AI/ML algorithm evaluating data. The "testing" referred to is likely mechanical or functional testing of the physical device. The document does not specify a sample size for such tests or geographical origin, as it's a hardware device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. Ground truth, in the sense of expert annotation of data, is not relevant for this physical device. The "ground truth" for a physical device is its ability to perform its mechanical function.

4. Adjudication Method for the Test Set:

Not Applicable. There is no "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, not in the AI/ML sense. An MRMC study is relevant for evaluating human performance with and without an AI aid. This is a physical device, not an AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

For a physical device, "ground truth" would relate to its engineering specifications and functional performance. The ground truth would be whether it holds the endoscope securely, locks properly, withstands sterilization, etc., as determined by engineering tests and comparisons to predicate devices. This isn't pathology, outcomes data, or expert consensus on diagnostic images.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. This is not an AI/ML device requiring a training set.

In summary, the provided document describes a traditional medical device (an endoscope holder) and its 510(k) summary for substantial equivalence review. It does not provide the kind of information requested for an AI/ML medical device submission. The "performance data" section indicates that "design analysis and comparison as well as verification testing" were performed to confirm equivalence to predicate devices, but no specific details of those tests or their results, or any explicitly stated acceptance criteria (beyond meeting the functional requirements of an endoscope holder), are given in this summary.

Summary

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K070509

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Date:	February 15, 2007
Submitter:
Name:	Baitella AG
Address:	Thurgauerstrasse 70Zurich CH-8050SWITZERLAND
	MAR 2 2 2007
Contact Person:	Dr. Reto BaitellaVP Medical Products
Telephone:	+41.44.3058000
Fax:	+41.44.3058005
Product:
Trade Name:	FISSO Holding System
Classification:	Class II
Common Name:	Endoscope Holder
Classification Name:	Neurological Endoscope
Predicate Devices:
Name	Manufacturer	K-No.
Armand Endoscope Holder	KLS-Martin L.P.	K050051
Neuroview Instrument Holder, Model 300-33	Integra Neurocare LLC.	K992006
Abdominal Wall Retractor	Omni-Tract Surgical	K950214
	FISSO Holding System is 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. All joints are locked in position simultaneously via the adjustment knob located on the central joint. Accessories include endoscope holders for 4mm to 10mm scopes as well as multiple class-l holding devices.
	The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
Intended Use:	FISSO Holding System consists of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 4mm 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, FISSO Holding System has been shown to be substantially equivalent to current legally marketed predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle-like symbol on the right, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2007

Baitella AG % Business Support International Ms. Angelika Scherp Regualtory Affairs Amstel 320-I Amsterdam, 1017AP The Netherlands

Re: K070509

Trade/Device Name: FISSO Holding System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 12, 2007 Received: February 22, 2007

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

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Page 2 - Ms. Angelika Scherp

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.

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 your

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: FISSO Holding System

Indications for Use:

Procedural

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number L070509

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)

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Regulation Number and Section

§ 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.