SCB/VALLEYLAB FORCE FX INTERFACE UNIT

K041912 · KARL STORZ Endoscopy-America, Inc. · ODA · Oct 25, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041912
• Device Name: SCB/VALLEYLAB FORCE FX INTERFACE UNIT
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: ODA · Gastroenterology, Urology
• Decision Date: Oct 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.

Device Story

Interface unit connecting Storz Communication Bus (SCB) computer to ValleyLab Force FX electrosurgical generator; enables display and control of electrosurgical parameters on SCB monitor. Device acts as connector box; software relays functions without performing calculations. Used in surgical settings by surgeons for convenient control of electrosurgical equipment. Benefits include centralized monitoring and control of generator functions via SCB interface.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Interface control box; non-sterile reusable component; requires sterile cover; connects SCB computer to electrosurgical generator; software-based relay of control parameters; no computational processing.

Indications for Use

Indicated for use as an interface control box to display and control electrosurgical generator parameters on a Storz Communication Bus (SCB) computer and screen for surgeon use.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

Karl Storz Endoscopy – America, Inc.
Ms. Susie S. Chen
Director, Regulatory Affairs
600 Corporate Point 5th Floor
Culver City, CA 90230-7600

JUL 27 2015

Re: K041912
Trade/Device Name: SCB/ValleyLabs FX Interface Unit
Regulation Number: 21 CFR § 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: ODA
Dated (Date on orig SE ltr): September 27, 2004
Received (Date on orig SE ltr): September 30, 2004

Dear Ms. Chen,

This letter corrects our substantially equivalent letter of October 25, 2004.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D.
Director
Division of Reproductive, Gastro-Renal, and Urological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# INDICATION FOR USE STATEMENT

510(k) Number (if known): K041912

Device Name: SCB/ValleyLabs Force FX Interface Unit

NON-STERILE REUSABLE COMPONENT

NON-STERILE, THE INTERFACE UNIT MUST BE COVERED WITH A STERILE COVER BEFORE USE

INTENDED USE: The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.

# STORZ

Karl Storz Endoscopy

| Karl Storz | 600 Corporate Pointe | Phone [phone] |
| --- | --- | --- |
| Endoscopy-America, Inc. | Culver City, CA 90230-7600 | Toll Free 800 421 0837 |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Davie C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K041912

Prescription Use ☑ OR Over-The-Counter Use
(Per 21 C.F.R. 801.109)

(Optional Format 3-10-98)

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K041912

252004

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
[phone]

**Contact:**
Kam H. Leung, Ph.D.
[phone] x 5386

**Device Identification:**
Remote Control
SCB/ValleyLab Force FX Control

**Indication:**
The Storz Communication Bus/ValleyLabs Force FX Control is an interface control box between the SCB computer and the electrosurgical generator. It contains software to display ValleyLab Force FX electrosurgical generator's control parameters on a SCB computer and screen. The Interface Unit serves as a connector box from the Force FX unit to the SCB compatible computer. The unit's software does not perform calculations. It only relays Force FX functions and controls on the SCB monitor for the surgeon's convenient control.

**Device Description:**
The Karl Storz SCB/ValleyLab Force FX Control connects a Storz Communication Bus computer to the ValleyLab Force FX electrosurgical generator. It enables the SCB computer to display and control the FX's functions.

**Substantial Equivalence:**
The Karl Storz SCB/ValleyLab Force FX Interface Unit is substantially equivalent to the predicate device since the basic features and intended uses are the same. The minor differences between the Karl Storz SCB-ValleyLabs Force FX Interface Unit and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

Signed:
Kam H. Leung, Ph.D.
Senior Regulatory Specialist.

K041912 00.350