SPYGLASS IRRIGATION SYSTEM

K063700 · Medical Scientific, Inc. · LJH · Feb 8, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063700
• Device Name: SPYGLASS IRRIGATION SYSTEM
• Applicant: Medical Scientific, Inc.
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: Feb 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

To provide irrigation during endoscopic surgical procedures

Device Story

SpyGlass Irrigation System is a peristaltic pump designed for endoscopic procedures; delivers sterile water or saline to rinse blood or bile from procedural sites. System components include pump unit, foot pedal, and sterile single-use disposable tubing set. User operates system via control dial to adjust motor RPM, providing flow rates from 0-45 ml/min at 45 psi; foot pedal activates/stops flow. Used in clinical settings by healthcare providers during open and endoscopic procedures. Output provides irrigation to improve visualization of the procedural site, assisting the clinician in surgical tasks.

Clinical Evidence

Bench testing only. Performance testing was conducted to demonstrate that the system performs as intended, confirming flow rate and pressure specifications.

Technological Characteristics

Peristaltic pump system; includes foot pedal and sterile single-use disposable tubing. Flow rate: 0-45 ml/min; Max pressure: 45 psi. Motor speed controlled via potentiometer and control dial. Electrically activated foot switch. Standalone device.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures requiring irrigation of the procedural site with sterile water or saline.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Endogator Endoscopy Irrigation Pump (K060962, K031773)

Submission Summary (Full Text)

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Medical Scientific Corporation 510(k) Premarket Notification

SpyGlass Irrigation System
K063700

# 510(k) Summary of Safety and Effectiveness Medical Scientific Corporation Spyglass Irrigation System December 1, 2006

8 2007 FEB

Sponsor Name 1. Sponsor/Manufacturer: Medical Scientific Corporation 125 John Hancock Blvd Taunton, MA 02780 Tel: [phone] Fax: [phone]

### Device Name 2.

Proprietary Name: Spyglass Irrigation System Common/Usual Name: Endoscope and accessories

Panel: Gastroenterology and Urology Product Code: KOG

- Identification of Predicate or Legally Marketed Device 3. Endogator Endoscopy Irrigation Pump - K060962, K031773
#### Device Description 4.

Spyglass is an irrigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures.

The system is compromised of a pump, foot pedal, and a sterile single use disposable tubing set. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.

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K06 3700

Page 2 of 2

- Intended Use રું. To provide irrigation during endoscopic surgical procedures
- Comparison of Technological Characteristics б. The comparison of Intended Use, System Components, Flow rate adjustments, The comparison of Min/max Pressures, and Pump Type indicate the device is substantially equivalent to its predicate.
- Performance Testing 7 I crormation resumed to demonstrate that the Spyglass Irrigation would perform as intended.
- Statement of Equivalency 8. The Spyglass Irrigation System is substantially equivalent to the predicate devices. The intended use, technological characteristics of the materials and processes used in the application and safety characteristics of the Spyglass Irrigation System support the concept of substantial equivalence

000079

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Paul Nardella, Jr. President Medical Scientific, Inc. Taunton Corporate Center 125 John Hancock Road TAUNTON MA 02780

FEB 8 2007

Re: K063700

Trade/Device Name: SpyGlass™ Irrigation System Regulation Number: None Regulatory Class: Unclassified Product Code: LJH Dated: December 1, 2006 Received: December 13, 2006

Dear Mr. Nardella:

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 seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. The seal is surrounded by text that reads "U.S. FOOD & DRUG ADMINISTRATION PROTECTING YOUR HEALTH".

Protecting and Promoting Public Health

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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. 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 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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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

K06 3700

510(k) Number (if known): K063700 -

Spyglass Irrigation System Device Name:

Indications For Use:

To provide irrigation during endoscopic surgical procedures

Prescription Use X (Part 21 CFR 801 Subpart D) OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Wyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_