FISSO HOLDING SYSTEM

K070509 · Baitella AG · GCJ · Mar 22, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070509
• Device Name: FISSO HOLDING SYSTEM
• Applicant: Baitella AG
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

Table-mounted, self-retaining endoscope holder system; consists of stainless steel tubular, articulated arms connected to a vertical stand. Device allows for free adjustment within an articulating radius; all joints lock simultaneously via a central adjustment knob. Accessories include holders for 4mm to 10mm scopes and class-I holding devices. Used in surgical settings by surgeons to stabilize endoscopes/arthroscopes during diagnostic and therapeutic procedures. Device is reusable and provided non-sterile; requires cleaning and sterilization before use. Provides stable positioning of surgical instruments, reducing manual fatigue and assisting in procedural precision.

Clinical Evidence

Bench testing only. Design analysis and verification testing were performed to confirm functional equivalence to predicate devices.

Technological Characteristics

Stainless steel construction; articulated tubular arm design; table-mounted vertical stand; manual mechanical locking mechanism via central adjustment knob; accommodates 4mm to 10mm diameter endoscopes; reusable; non-sterile (requires sterilization).

Indications for Use

Indicated for use by surgeons to hold endoscopes and arthroscopes (4mm-10mm diameter) during general diagnostic/therapeutic procedures and diagnostic/therapeutic neurologic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Armand Endoscope Holder (K050051)
• Neuroview Instrument Holder, Model 300-33 (K992006)
• Abdominal Wall Retractor (K950214)

Submission Summary (Full Text)

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K070509

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Date: | February 15, 2007 | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Submitter: | | |
| Name: | Baitella AG | |
| Address: | Thurgauerstrasse 70<br>Zurich CH-8050<br>SWITZERLAND | |
| | MAR 2 2 2007 | |
| Contact Person: | Dr. Reto Baitella<br>VP 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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#### 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 [phone]. 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 [phone] or [phone] 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:

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

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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