ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9

K990689 · Zcv ,Inc. · LJE · Sep 3, 1999 · GU

Device Facts

• Record ID: K990689
• Device Name: ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
• Applicant: Zcv ,Inc.
• Product Code: LJE · GU
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Zynergy Loc-Sure Single Pass Drainage Set is a minimally invasive device for percutaneous drainage of cysts, abcesses and fluid collections such as renal cysts; renal, hepatic and other abcesses; pleural effusions; ascitic/thoracic collections and nephrostomies.

Device Story

The Zynergy Loc-Sure Single Pass Drainage Set is a minimally invasive, sterile, single-use device designed for percutaneous fluid drainage. It consists of a radiopaque, semi-coiled drainage catheter with internal drainage holes, a trocar stylet for puncture and placement, a proximal connector cannula flange (male luer lock) for insertion guidance and connection to ancillary drainage devices, and a suture button for securing the catheter to the skin during extended drainage. The device is used by clinicians in a clinical setting to drain cysts, abscesses, and fluid collections. By providing a secure, localized drainage path, the device facilitates the removal of fluid from body cavities, potentially reducing patient discomfort and the need for more invasive surgical interventions.

Clinical Evidence

Bench testing only. Performance testing was successfully completed per BS/EN1617:1997. Biocompatibility testing, including cytotoxicity, systemic injection, intracutaneous injection, pyrogenicity, sensitization, and implantation, was successfully completed per ISO10993 and FDA guidelines.

Technological Characteristics

Materials: Polyethylene catheter, stainless steel cannula/trocar. Design: Radiopaque, semi-coiled catheter with internal drainage holes, male luer lock connector, suture button. Sterilization: ETO per ANSI/AAMI/ISO 11135, EN550:1994, EN556:1994. Biocompatibility: ISO10993 compliant. Performance: BS/EN1617:1997 compliant.

Indications for Use

Indicated for percutaneous drainage of cysts, abscesses, and fluid collections including renal cysts, renal/hepatic/other abscesses, pleural effusions, ascitic/thoracic collections, and nephrostomies in patients requiring minimally invasive fluid drainage.

Predicate Devices

• Elecath One-Step Fluid Drain Assembly (Electro-Catheter Corporation)
• Dawson Mueller Drainage Catheter with Slip-Coat Hydrophillic Coating (Cook)

Submission Summary (Full Text)

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SEP 3 1999

K990689

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Image /page/0/Picture/3 description: The image shows the letters ZCV in a bold, sans-serif font. The letters are large and take up most of the frame. A horizontal line is present underneath the letters.

Zynergy CardioVascular, Inc.
298 Fernwood Avenue Edison, NJ 08837-6803 USA Tel: [phone]
Fax: [phone]

| Safety & Effectiveness | Zynergy Loc-Sure Single Pass Drainage Set | | |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Summary: | | | |
| Classification Name: | 74DQY Catheter, Percutaneous | | |
| Common / Usual Name: | Fluid Drainage Catheter | | |
| Contact: | Priscilla Whitehead Cox, Regulatory Affairs Manager | | |
| Prepared: | Tuesday, March 02, 1999 | | |
| | Zynergy Loc-Sure Single Pass Drainage Set is a minimally invasive device for percutaneous drainage of<br>cysts, abcesses and fluid collections such as renal cysts; renal, hepatic and other abcesses; pleural<br>effusions; ascitic/thoracic collections and nephrostomies. | | |
| | Zynergy Loc-Sure Single Pass Drainage Set is a minimally invasive device for percutaneous drainage of<br>cysts, abcesses and fluid collections such as renal cysts; renal, hepatic and other abcesses; pleural<br>effusions; ascitic/thoracic collections and nephrostomies. | | |
| | The Zynergy Loc-Sure Single Pass Drainage Set comprised of four components: | | |
| | 1. A radiopaque, semi-coiled, drainage catheter. The distal segment of the catheter has drainage holes on<br>the inside radius to facilitate the draining of fluid from the selected body cavity. | | |
| | 2. The proximal connector cannula flange is comprised of a standard male luer lock. This is inserted into the catheter tubing and is used as an insertion guide for a trocar stylet and may be attached directly to ancillary drainage devices. | | |
| | 3. The trocar stylet is a needle used as a puncture trocar for placing the drainage catheter in the precise location required for the drainage procedure. | | |
| | 4. A suture button is included which may be sutured to the skin for safe extended drainage.<br>Zynergy Loc-Sure Single Pass Drainage Set is supplied sterile in single use pouches. Qualification is based on the overkill method with a sterility assurance level of 106. The packaged product will be ETO sterilised in accordance with ANSI/AAMI/ISO 11135, Medical Devices - Validation & Routine Control Of Ethylene Oxide Sterilisation; EN550:1994, Sterilisation of Medical Devices - Validation And Routine Control Of Sterilisation By Ethylene Oxide; EN556:1994, Sterilisation of Medical Devices - Requirements For Terminally Sterilised Devices To Be Labelled "Sterile". ETO residuals are within ISO10993-7 guidelines fo rprolonged exposure. Lal testing is done for each sterilzation lot to assure non-pyrogenicity. Performance testing was successfully completed per BS/ EN1617: 1997. Biocompatibility testing, including cytotoxicity, systemic injection, intracutaneous injection, pyrogenicity, sensitisation and implantation has been successfully completed per ISO10993 and FDA guidelines. | | |
| | Zynergy Loc-Sure Single Pass Drainage Set is similar in design, composition and function to the Elecath One-Step Fluid Drain Assembly manufactured by Electro-Catheter Corporation and the Dawson Mueller Drainage Catheter with Slip-Coat Hydrophillic Coating manufactured by Cook. | | |
| COMPARATIVE FEATURES | | | |
| Characteristics | ZCV, Inc<br>Zynergy Loc-sure Single Pass<br>Drainage Set | Electro-Catheter Co.<br>Elecath One Step Fluid Drain<br>Assembly | Cook<br>Dawson-Mueller Drainage Catheter with<br>Slip-Coat Hydrophilic Coating |

| Characteristics | ZCV, Inc<br>Zynergy Loc-sure Single Pass<br>Drainage Set | Electro-Catheter Co.<br>Elecath One Step Fluid Drain<br>Assembly | Cook<br>Dawson-Mueller Drainage Catheter with<br>Slip-Coat Hydrophilic Coating |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Polyethylene | Polyethylene | Polyurethane with hydrophillic coating |
| Components | Catheter, SS cannula, trocar<br>stylet, suture button, locking<br>hub | Catheter, SS cannula, trocar<br>stylet, retention flange, locking<br>hub | Catheter, SS cannula, flexible cannula,<br>trocar stylet, locking hub |
| Indications For Use | Renal cysts; renal, hepatic and<br>other abcesses; pleural<br>effusions; ascitic / thoracic<br>collections and nephrostomies | Abcesses, cysts, other localised<br>fluid collection; pleural effusions,<br>ascitic fluid collections, renal<br>cysts; renal, hepatic, subhepatic<br>and subdiaphragmatic abcesses | Abcesses, cysts, other localised fluid<br>collection; pleural effusions, ascitic fluid<br>collections, renal cysts; renal, hepatic,<br>subhepatic and subdiaphragmatic<br>abcesses |
| Packaging | Poly/Tyvek | Poly/Tyvek | Poly/Tyvek |
| Sterilisation Method | ETO | ETO | ETO |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 SEP

Ms. Priscilla Whitehead Cox Manager, Regulatory Affairs Zynergy CardioVascular, Inc. 298 Fernwood Avenue Edison, NJ 08837-3839

Re: K990689 Zynergy Loc-Sure Single Pass Drainage Set Dated: June 7, 1999 Received: June 8, 1999 Requlatory Class: II 21 CFR §876.5130/Procode: 78 LJE

Dear Ms. Cox:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Page 1 of 1

# 510(k) Number (if known): K990689

Device name: Zynergy Loc-Sure Single Pass Drainage Set

#### Indications For Use:

Zynergy Loc-Sure Single Pass Drainage Assembly is a minimally invasive device for percutaneous drainage of cysts, abcesses and fluid collections such as:

- Renal cysts .
- Renal, hepatic and other abcesses .
- Pleural effusions .
- Ascitic collections .
- Thoracic collections .
- Nephrostomies .

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

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over The Counter Use OR

(Optional Format 1-2-96)

Zynergy CardioVascular, Inc

Zynergy L.oc-Sure Single Pass Drainage Set

510(k) Submission