ANCHORAGE SCOPE, MODEL 000003

K080780 · Epitek, Inc. · FBO · Jul 30, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080780
• Device Name: ANCHORAGE SCOPE, MODEL 000003
• Applicant: Epitek, Inc.
• Product Code: FBO · Gastroenterology, Urology
• Decision Date: Jul 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Anchorage™ Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications: Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology

Device Story

Anchorage Scope is a flexible fiber optic endoscope; sterile single-use device. Input: optical visualization of internal body cavities, organs, canals, and tissues. Operation: manual insertion through natural body cavities or surgical incisions via introducers, needles, trocars, catheters, or sheaths. Output: direct visual image for clinician. Used in clinical settings (OR, clinic) by physicians. Facilitates diagnostic or therapeutic visualization; aids clinical decision-making by providing real-time anatomical assessment.

Clinical Evidence

Bench testing only. Includes in-vitro testing, biocompatibility testing, and conformance to consensus and voluntary standards.

Technological Characteristics

Flexible fiber optic endoscope; sterile single-use. Dimensions defined by outside diameter relative to introducer lumen. No electronic sensing or software-based processing described.

Indications for Use

Indicated for visualization of body cavities, organs, canals, and tissues in patients undergoing ureteroscopy, bronchoscopy, thoracoscopy, nasopharyngoscopy/sinuscopy, general laparoscopy, urology, or gynecology 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

• Flexible Fiber Optic Endoscope and Coupler (K991377)

Submission Summary (Full Text)

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K080780
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# 510(k) Summary Epitek Anchorage™ Scope

### APPLICANT:

JUL 30 2008

Epitek, Inc. 4801 W. 81st St., Suite 105 Bloomington, MN 55437 USA

| Contact Person: | Werner Hampl |
|-----------------|----------------------|
| Telephone: | [phone] |
| e-mail: | [e-mail] |
| Date Prepared: | March 17, 2008 |

### DEVICE:

Proprietary Name: Common/Usual Name: Classification:

Anchorage Scope Endoscope Class II; 21 CFR 876.1500; Endoscope and accessories; Product Code: GCJ

### PREDICATE DEVICE:

The subject device is substantially equivalent (i.e., has the same intended use and technological characteristics) to the Flexible Fiber Optic Endoscope and Coupler (K991377) from OmniSonics Medical Technologies.

# DEVICE DESCRIPTION:

The Anchorage™ Scope is a flexible fiber optic endoscope provided as a sterile single use device. The endoscope is used to visualize body cavities, organs, canals, and tissues. The Anchorage Scope is introduced through natural body cavities or surgical incisions through introducers or trocars, catheters, sheaths or other devices of with lumens having an inside diameter greater than the outside diameter of the endoscope.

# INDICATIONS FOR USE:

The Anchorage™ Scope is a flexible fiber optic endoscope intended for the

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K080780
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visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications:

Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology

## TEST RESULTS:

Results of the in-vitro testing, biocompatibility testing, and conformance to consensus and voluntary standards conducted prior to introduction into commerce demonstrate that the Anchorage Scope is substantially equivalent to the specified predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Cornorate Blvd. Rockville MD 20850

JUL 30 2008

Mr. Werner H. Hampl VP Operations & RA/QA Epitek, Incorporated 4801 West 81" Street, Suite 105 BLOOMINGTON MN 55437-1111

Re: K080780

Trade/Device Name: Ancorage™ Scope Model 000003 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: July 20, 2008 Received: July 22, 2008

Dear Mr. Hampl:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are in the center of the logo in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial".

oling Public 9

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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. Yourselve comply with all the Act's requirements, including, but not limited to: reguired. " four linest CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements is set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicables as sec 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 legally, marketed predicate device results in a classification for your device and thus, towns to 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, release contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 bttp://www.fda.gov/cdrhindustry/support/index.html .

Sincerely yours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K080 780

Device Name: Anchorage™ Scope

Indications for Use:

The Anchorage™ Scope is a flexible fiber optic endoscope intended for the visualization of body cavities, organs, canals, and tissues. The Anchorage Scope is designed to be introduced through natural body cavities or surgical incisions through introducers, needles or trocars, catheters, sheaths or other devices with lumens having an inside diameter larger than the outside diameter of the endoscope. The Anchorage Scope is indicated for the following applications:

- Ureteroscopy Bronchoscopy Thoracoscopy Nasopharyngoscopy/Sinuscopy General laparascopy Urology Gynecology
Prescription Use X (Part 21 CFR 801 Subpart D)

510(k) Number

AND/OR

Over-The-Counter Use (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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

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