IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL

K070716 · KARL STORZ Endoscopy-America, Inc. · FET · May 31, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070716
• Device Name: IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: May 31, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Karl Storz Image 1® Video Imaging System with optional insufflators control allows remote control of Karl Storz insufflators by Image 1® camera head control buttons. The Karl Storz Image 1® Video Imaging System is a color video camera system which can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera head is directly coupled to the endoscope. Any compatible Image 1® camera head may be used with the Image 1® Karl Storz Camera Control units (CCU). The endoscopic image can be displayed on any standard operating room video monitor and all standard endoscopic light sources may be used with the Image 1® camera head.

Device Story

Color video camera system for endoscopic procedures; used in operating rooms by qualified personnel. Inputs: optical signals from rigid/flexible endoscopes. Outputs: video feed to standard OR monitors. Modification adds remote control functionality for Karl Storz insufflators via Karl Storz Communication Bus (SCB). Interface allows surgeons to adjust insufflator settings directly from camera head buttons within sterile field. System facilitates centralized control of peripheral equipment; improves workflow efficiency by reducing need for manual adjustments by non-sterile staff.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological and design similarities to existing legally marketed devices.

Technological Characteristics

Digital color video imaging system; modular design; utilizes Karl Storz Communication Bus (SCB) for device interfacing. Compatible with standard OR video monitors and endoscopic light sources. Software-based modification enables remote control of insufflators via camera head buttons.

Indications for Use

Indicated for use as a color video camera system for endoscopic procedures with rigid or flexible endoscopes in an operating room setting. Allows remote control of Karl Storz insufflators via camera head buttons.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Karl Storz, Endoscopy-America, Inc. Regulatory Affairs Department Mr. Paul Lee Senior Regulatory Affairs Specialist 600 Corporate Pointe, 5th Floor Culver City, CA 90230-7600

JUL 27 2015

Re: K070716

> Trade/Device Name: Image 10 Video Imaging System with Optional Insufflators Controls Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated (Date on orig SE ltr): May 21, 2007 Received (Date on orig SE ltr): May 22, 2007

Dear Mr. Lee

This letter corrects our substantially equivalent letter of May 31, 2007.

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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## INDICATIONS FOR USE

510(k) Number (if known):

076716

Device Name: Image 1® Video Imaging System with Optional Insufflators Controls

Indications for Use:

The Karl Storz Image 1® Video Imaging System with optional insufflators control The Karl Storz Image 1 - Video Intaging by Image 1 camera head control buttons.
allows remote control of Karl Storz insufflators by Image website which allows remove control of Nan Olenz wing System is a color video camera system which The Kan Storz Image | "Video Infoging Oycenhile a solos filexible endoscopes." The camera
can be used as an endoscopic accessory with rigid or flexible endoscopes. The camera can be dseal as an endoscople accossoory with mage 1 " camera head may
head is directly coupled to the endoscope. Any complex of the endoscopic
be used with the image 1 " Ka be used with the infage 1 " Ran Storz Outliner Contra Control (e o on video monitor and all standard
image can be displayed on any standard operating room video monitor and a image can be displayed on any standard operating room video manist.
endoscopic light sources may be used with the Image 10 camera head.

Prescription Use:
(Per 21 CFR 801.Subpart D)

Over-The-Counter Use: OR (21 CFR 801 Subpart C)

(Please Do Not WRITE BELOW THIS LINE - Continue on Another Page IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devig 510(k) Number

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K070716
Page 1 of 2

MAY 3 1 2007

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510{k) safety and effectiveness information is being submitted in accerdance rins summaly of 310(N) Salety and encolvents in (SMDA) of 1990 and 21 CFR 807.92. All
with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92.

| Applicant: | Karl Storz Endoscopy - America, Inc.<br>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paul S. Lee<br>Senior Regulatory Affairs Specialist<br>Telephone [phone]<br>Telecopier [phone]<br>E-mail: [e-mail] |
| Device Identification: | Common Name: Video Imaging System<br><br>Trade Name: Image 1® Video Imaging System with optional<br>insufflators controls |
| Indication: | The Karl Storz Image 1® Video Imaging System with optional<br>insufflators control allows remote control of Karl Storz insufflators by<br>Image 1® camera head control buttons. The Karl Storz Image 1®<br>Video Imaging System is a color video camera system which can be<br>used as an endoscopic accessory with rigid or flexible endoscopes.<br>The camera head is directly coupled to the endoscope. Any<br>compatible Image 1® camera head may be used with the Image 1®<br>Karl Storz Camera Control units (CCU). The endoscopic image can<br>be displayed on any standard operating room video monitor and all<br>standard endoscopic light sources may be used with the Image 1®<br>camera head. |
| Device Description: | The Image 1® Video Imaging System with modification for<br>insufflators control is a digital video imaging system used by qualified<br>personnel in the operating room to view endoscopic images and to<br>interface with Karl Storz devices such as selected insufflators<br>through the Karl Storz Communication Bus (SCB). Karl Storz SCB<br>technology, based on a modular design concept, provides<br>centralized remote control over compatible medical equipment and<br>peripheral system via touch screen or camera head buttons in the<br>sterile environment. The modification for insufflators control is a<br>software change only to the Image 1® Video Imaging System to allow<br>the camera to exert control over Karl Storz insufflators functions<br>through Karl Storz SCB |

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K070716
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Substantial Equivalence: The Karl Storz Image 1° Video Imaging System is substantially THE Kar Storz miage i vices since the basic technology and design are similar. The intended usage is similar to predicate design are simmal. The intended safety and effectiveness. The devices and Talses fro new Issues of ouloty and Innoon System and minor differences between the may the performance, function or intended use of the devices.

Signature:

Paul Lee Senior Regulatory Affairs Specialist