(184 days)
K-NUMBER: Not Found
Not Found
No
The device description focuses on mechanical components for drainage and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes
The device is described as a "minimally invasive device for percutaneous drainage of cysts, abcesses and fluid collections," which directly addresses and treats medical conditions.
No
Explanation: The device is described as a "minimally invasive device for percutaneous drainage" and its components are for facilitating fluid removal, not for diagnosing conditions.
No
The device description clearly outlines multiple physical components (catheter, connector cannula, trocar stylet, suture button) which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for percutaneous drainage of fluid collections from within the body. This is a therapeutic or interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The components (catheter, connector, trocar stylet, suture button) are all designed for physically accessing and draining fluid from a patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used to detect, measure, or identify substances or characteristics in these samples to aid in diagnosis or monitoring.
Therefore, the Zynergy Loc-Sure Single Pass Drainage Assembly is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / 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 .
Product codes
78 LJE
Device Description
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.
The Zynergy Loc-Sure Single Pass Drainage Set comprised of four components:
- A radiopaque, semi-coiled, drainage catheter. The distal segment of the catheter has drainage holes on the inside radius to facilitate the draining of fluid from the selected body cavity.
- 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.
- 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.
- A suture button is included which may be sutured to the skin for safe extended drainage.
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 1E-6. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Renal, hepatic, pleural, ascitic/thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
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.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
SEP 3 1999
Page 1 of 1
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: (732) 225-3800
Fax: (732) 225-4454
| 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 | |||
| cysts, abcesses and fluid collections such as renal cysts; renal, hepatic and other abcesses; pleural | |||
| effusions; ascitic/thoracic collections and nephrostomies. | |||
| 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. | |||
| 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 | |||
| 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. | |||
| 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 | ||
| Zynergy Loc-sure Single Pass | |||
| Drainage Set | Electro-Catheter Co. | ||
| Elecath One Step Fluid Drain | |||
| Assembly | Cook | ||
| Dawson-Mueller Drainage Catheter with | |||
| Slip-Coat Hydrophilic Coating |
| Characteristics | ZCV, Inc
Zynergy Loc-sure Single Pass
Drainage Set | Electro-Catheter Co.
Elecath One Step Fluid Drain
Assembly | Cook
Dawson-Mueller Drainage Catheter with
Slip-Coat Hydrophilic Coating |
|----------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Polyethylene | Polyethylene | Polyurethane with hydrophillic coating |
| Components | Catheter, SS cannula, trocar
stylet, suture button, locking
hub | Catheter, SS cannula, trocar
stylet, retention flange, locking
hub | Catheter, SS cannula, flexible cannula,
trocar stylet, locking hub |
| Indications For Use | Renal cysts; renal, hepatic and
other abcesses; pleural
effusions; ascitic / thoracic
collections and nephrostomies | Abcesses, cysts, other localised
fluid collection; pleural effusions,
ascitic fluid collections, renal
cysts; renal, hepatic, subhepatic
and subdiaphragmatic abcesses | Abcesses, cysts, other localised fluid
collection; pleural effusions, ascitic fluid
collections, renal cysts; renal, hepatic,
subhepatic and subdiaphragmatic
abcesses |
| Packaging | Poly/Tyvek | Poly/Tyvek | Poly/Tyvek |
| Sterilisation Method | ETO | ETO | ETO |
1
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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
2
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