ARMAND ENDOSCOPE HOLDER

K050051 · KLS-Martin L.P. · GCJ · May 16, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050051
• Device Name: ARMAND ENDOSCOPE HOLDER
• Applicant: KLS-Martin L.P.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Armand Endoscope Holder is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 14.6mm to 15.8mm during diagnostic and therapeutic procedures.

Device Story

Manually operated surgical device; holds rigid and flexible endoscopes (14.6mm–15.8mm diameter) in fixed position during diagnostic/therapeutic procedures. Composed of table clamp, adjustable stainless steel rods, and endoscope clamp. Surgeon operates device via single knob clamp assembly for endoscope and single knob for rod positioning. Provides stable visualization platform; reduces manual fatigue for surgeon; improves procedural efficiency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: surgical grade stainless steel and anodized aluminum. Mechanical design: table clamp, adjustable rods, single knob clamp assembly. Dimensions: compatible with 14.6mm–15.8mm diameter endoscopes. Manual operation; no energy source.

Indications for Use

Indicated for surgeons to hold rigid and flexible endoscopes (14.6mm–15.8mm diameter) during diagnostic and therapeutic 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

• Neuroview ® Instrument Holder (Model 300-33) (K992006)
• KSEA Endoscope Holder (K990334)

Submission Summary (Full Text)

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K050051

MAY 1 6 2005

## 510(K) SUMMARY

| Submitter: | KLS-Martin, L.P.<br>11239-1 St. Johns Industrial Parkway South<br>Jacksonville, FL 32246<br>Phone: [phone]<br>Fax: [phone] |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Damato<br>Director RA/QA |
| Date of Summary: | 31 December 2004 |
| Device Name: | Armand Endoscope Holder |
| Trade Name: | Endoscope Holder |
| Common Name: | Endoscope Holder |
| Classification Name and Number: | Endoscope and/or accessories (CFR 876.1500) |
| Regulatory Class: | Class II |
| Predicate Devices: | Neuroview ^® Instrument Holder (Model 300-33) (K992006)<br>KSEA Endoscope Holder (K990334) |
| Intended Use: | The Armand Endoscope Holder is intended for use by surgeons for holding rigid and flexible endoscopes with diameters from 14.6mm to 15.8mm during diagnostic and therapeutic procedures. |
| Device Description: | The Armand Endoscope Holder is a manually |

The Armand Endoscope Holder is a manually operated surgical device. It is composed of surgical grade stainless steel and anodized aluminum. The holder consists of a table clamp, adjustable stainless steel rods, and an endoscope clamp. The endoscope clamp is designed to hold endoscopes in diameter from 14.6mm to 15.8mm. The device uses a single knob clamp assembly to hold the endoscope and a single knob to tighten and lock the stainless steel rods into the desired position.

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Technological Characteristics:

Similarities to Predicate

The Armand Endoscope Holder is similar in materials and description to the Neuroview ® Instrument Holder (Model 300-33) (K992006) and the KSEA Endoscope Holder (K990334)

## Substantial Equivalence:

The Armand Endoscope Holder is substantially equivalent in application and function to the Neuroview ® Instrument Holder (Model 300-33) (K992006) and the KSEA Endoscope Holder (K990334).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2005

Ms. Jennifer Damato Director RA/QA KLS Martin, L.P P.O. Box 50249 Jacksonville, Florida 32250-0249

Re: K050051

Trade/Device Name: Armand Endoscope Holder Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 22, 2005 Received: April 25, 2005

Dear Ms. Damato:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for asc stated in the encreativent of the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterere, mans 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 it may be saojoer to back as a submit and 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 r lease be action and i termination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I ederal statuated and equirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT an 6077, adoling (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by Bections (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Jennifer Damato

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to oegin maning of substantial equivalence of your device to a legally prematics notification. "The PDF Intentig esfication 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 If you desire specific advice for Jour acon 2011 - 11:51 Also, please note the regulation entitled, a Comaci the Office of Compulance in (21 the Part 807.97). You may obtain Misoranuing by reference to prenessonsibilities under the Act from the Division of Small other general International and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet and Octises http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Deviccs Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): K050051

Device Name: Armand Endoscope Holder

Indications for Use:

The Armand Endoscope Holder is intended for use by surgeons to hold rigid and flexible endoscopes from 14.6mm to 15.8mm in diameter during diagnostic and therapeutic procedures.

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K050051