PIGGYBACK IRRIGATING SYSTEM

K040094 · Kosin Technologies, LLC · LJH · Apr 15, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040094
• Device Name: PIGGYBACK IRRIGATING SYSTEM
• Applicant: Kosin Technologies, LLC
• Product Code: LJH · Gastroenterology, Urology
• Decision Date: Apr 15, 2004
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Indications for Use

The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

Device Story

Piggyback Irrigating System is a modular endoscope valve assembly for controlled irrigation during urological/endoscopic procedures. Device mounts to endoscope; allows physician to control irrigation flow between thumb and finger of hand holding endoscope. Leaves other hand free for stone extraction, lithotripsy, or biopsy. Supports continuous gravity-fed irrigation or intermittent irrigation via plunger depression. Used in hospitals, clinics, and laboratories by physicians. Benefits include improved procedural efficiency and manual control of fluid delivery.

Clinical Evidence

Bench testing only. Comparative performance testing evaluated flow rates at various head heights (4-6 feet) and plunger activation force. Biocompatibility assessment included cytotoxicity, sensitization, irritation, and systemic toxicity testing with satisfactory results.

Technological Characteristics

Modular endoscope valve assembly. Materials: polycarbonate, nylon, PVC, thermoplastic elastomer, silicone rubber, stainless steel. Lubricant: medical grade silicone. Modes: continuous gravity or intermittent plunger-activated. Sterilization: Gamma radiation. Single-use. Form factor: handheld, releasably mounted to endoscope.

Indications for Use

Indicated for irrigation of ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures in patients undergoing urological interventions.

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

• C.R. Bard Syringe Assist Irrigation (K905102)

Submission Summary (Full Text)

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Confidential Kosin Technologies, LLC Piggyback Irrigating System Abbreviated 510(k)

## APR 1 5 2004

K040094
Page 1 of 2

### Section II

#### 510(k) SUMMARY

| Submitted by: | Kosin Technologies, LLC.<br>3305 Greyfox Drive<br>Valparaiso, IN 46383<br>Phone: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------|
| | Small Business Decision No.: SBD047023 |
| | Expires: Sep, 30, 2004 |
| | Payment Identification No.: 012216-956733 |
| Contact Person: | Avtar S. Dhindsa, M.D. |
| Date Prepared: | January 14, 2004 |
| Proprietary Name: | Piggyback Irrigating System |
| Common Name: | Endoscope Irrigation Tubing Set |
| Classification Name: | Endoscope And/Or Accessories |
| Predicate Device: | C.R. Bard Syringe Assist Irrigation<br>510(k) #K905102 |

#### Description of the Device:

The I.V. Piggyback Irrigating System is designed with a releasably mounted modular endoscope valve assembly. It is designed for controlled irrigation through an endoscope during urological and/or endoscopic procedures. The design of the valve allows the irrigation to be controlled between the finger and the thumb of the hand holding the endoscope, leaving the other hand completely froe for stone extraction, lithotripsy, or biopsy.

#### Intended Use of the Device:

The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

#### Technological Characteristics:

The Piggyback Irrigating System is substantially equivalent to the Bard Syringe Assist Irrigation under 510(k) number K905102. It has the same intended use, and is manufactured from similar biocompatible materials as the predicate device.

#### Performance Data:

Comparative performance testing was done, between the proposed Piggyback Irrigating System and the current C.R. Bard Syringe Assist Irrigation System. Data summaries and results from the testing are included in Table 1.

A biocompatibility assessment was performed on the materials with satisfactory results. Test results are included in Appendix B.

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K04 oc 94
Page 2 of 2

## Section II continued

| | Kosin<br>Piggyback Irrigating System | C.R. Bard<br>Syringe Assist Irrigation<br>System |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Uses | This device is intended for use in<br>the irrigation of the ureter and<br>renal pelvis during the<br>therapeutic and diagnostic<br>ureteroscopy/ureteropyescopy.<br>Once the valve assembly is<br>mounted to the endoscope, the<br>physician can manually control<br>the flow of irrigation fluid during<br>urological and/or endoscopic<br>procedures. | This device is intended for use in<br>the irrigation of the ureter and<br>renal pelvis during the<br>therapeutic and diagnostic<br>ureteroscopy/ureteropyescopy. It<br>is connected to the endoscope<br>with standard luer adapters. |
| Users | Hospitals, clinics, laboratories | Hospitals, clinics, laboratories |
| Materials | Polycarbonate, nylon, PVC,<br>thermoplastic elastomer, silicone<br>rubber, stainless steel | Natural Rubber Latex,<br>polycarbonate, PVC, lubricant |
| Lubricant<br>composition | Medical grade silicone | Medical grade silicone |
| Sterility Assurance<br>Level | 10-6 SAL | 10-6 SAL |
| Packaging material | Tyvek pouch | Tyvek pouch |
| Modes of irrigation | 1. Continuous by gravity<br>2. Intermittent by depressing<br>plunger | 1. Continuous by gravity<br>2. Intermittent by depressing<br>plunger |
| Flow Rate | - 4 foot head height = 9.8 L/hr<br>- 6 foot head height = 12.0 L/hr<br>- 6 foot head height = 14.4 L/hr<br>(with pressure cuff) | - 4 foot head height = 14.7 L/hr<br>- 6 foot head height = 17.8 L/hr<br>- 6 foot head height = 22.9 L/hr<br>(with pressure cuff) |
| Plunger activation | 0.76 lbf | 3.99 lbf |
| Single Use Only | Single Use | Single Use |
| Biocompatibility | Cytotoxicity<br>Sensitization<br>Irritation<br>Systemic Toxicity | Same |
| Sterilization method | Gamma | EtO |

:

# Table 1. Device Comparison Information - Similarities and Differences

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2004

Avtar S. Dhindsa, M.D. Kosin Technologies, LLC 3305 Greyfox Drive VALPARAISO IN 46383

Re: K040094

Trade/Device Name: Piggyback Irrigating System Regulation Number: None Regulatory Class: Unclassified Product Code: 78 LJH Dated: January 14, 2004 Received: January 16, 2004

Dear Dr. Dhindsa:

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 (PMA), it may be subject to 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.

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.

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Page 2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonitiation. The I Dry intelligence 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 rr you the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.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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K0400094

Confidential Kosin Technologies, LLC Piggyback Irrigating System Abbreviated 510(k)

#### Section V

## INDICATIONS FOR USE STATEMENT

510(k) Number:

K040094

Piggyback Irrigating System

Device Name:

Indications For Use:

The device is intended for use in the irrigation of the ureter and renal pelvis during therapeutic and diagnostic ureteroscopy and/or endoscopic procedures.

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

Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Use
*(Per 21 CFR §801.109)*

Over-The-Counter Use__

Nancy C. Hogdon

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