(184 days)
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 .
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.
The provided text describes a medical device, the "Zynergy Loc-Sure Single Pass Drainage Set," and its clearance by the FDA based on substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies (beyond basic certifications and biocompatibility), training sets, test sets, expert consensus, or any metrics typically associated with AI/algorithm performance studies.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with acceptance criteria in the context of an AI/algorithm.
Therefore, I cannot fulfill your request for the specific points related to AI/algorithm performance. I can only extract information related to the device itself and its regulatory clearance process as present in the provided text.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
- No acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) are present in this document. The document primarily focuses on demonstrating that the device is "substantially equivalent" to predicate devices and has successfully completed standard certifications and biocompatibility testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This document does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This document does not describe a performance study with a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document does not describe a performance study with adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document does not mention an MRMC study or any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. This document does not describe a performance study requiring ground truth.
8. The sample size for the training set
- Not applicable. This document does not describe an algorithm or a training set.
9. How the ground truth for the training set was established
- Not applicable. This document does not describe an algorithm or a training set.
Additional information from the document regarding device validation/testing:
- Sterilization: Qualified based on the overkill method with a sterility assurance level of 10^-6. ETO sterilized in accordance with ANSI/AAMI/ISO 11135, EN550:1994, EN556:1994. ETO residuals are within ISO10993-7 guidelines.
- Pyrogenicity: LAL testing done for each sterilization lot to assure non-pyrogenicity.
- Performance Testing: Successfully completed per BS/EN1617:1997.
- Biocompatibility Testing: Successfully completed per ISO10993 and FDA guidelines, including cytotoxicity, systemic injection, intracutaneous injection, pyrogenicity, sensitization, and implantation.
Study described to meet acceptance criteria:
The "study" referenced in this document is primarily the demonstration of substantial equivalence to existing predicate devices (ELECATH One-Step Fluid Drain Assembly and Cook Dawson-Mueller Drainage Catheter with Slip-Coat Hydrophilic Coating). The manufacturer compared the design, composition, and function of the Zynergy Loc-Sure Single Pass Drainage Set to these predicates. The successful completion of standard certification tests (sterilization, biocompatibility, performance) supports this claim of equivalence. The FDA letter confirms that the device was deemed "substantially equivalent" for its stated indications for use.
In summary, this document is a regulatory submission for a physical medical device and does not contain the kind of detailed performance study information you would expect for an AI/algorithm-based device as outlined in your request.
{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 ofcysts, abcesses and fluid collections such as renal cysts; renal, hepatic and other abcesses; pleuraleffusions; ascitic/thoracic collections and nephrostomies. | |||
| Zynergy Loc-Sure Single Pass Drainage Set is a minimally invasive device for percutaneous drainage ofcysts, abcesses and fluid collections such as renal cysts; renal, hepatic and other abcesses; pleuraleffusions; 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 onthe 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, IncZynergy Loc-sure Single PassDrainage Set | Electro-Catheter Co.Elecath One Step Fluid DrainAssembly | CookDawson-Mueller Drainage Catheter withSlip-Coat Hydrophilic Coating |
| Characteristics | ZCV, IncZynergy Loc-sure Single PassDrainage Set | Electro-Catheter Co.Elecath One Step Fluid DrainAssembly | CookDawson-Mueller Drainage Catheter withSlip-Coat Hydrophilic Coating |
|---|---|---|---|
| Composition | Polyethylene | Polyethylene | Polyurethane with hydrophillic coating |
| Components | Catheter, SS cannula, trocarstylet, suture button, lockinghub | Catheter, SS cannula, trocarstylet, retention flange, lockinghub | Catheter, SS cannula, flexible cannula,trocar stylet, locking hub |
| Indications For Use | Renal cysts; renal, hepatic andother abcesses; pleuraleffusions; ascitic / thoraciccollections and nephrostomies | Abcesses, cysts, other localisedfluid collection; pleural effusions,ascitic fluid collections, renalcysts; renal, hepatic, subhepaticand subdiaphragmatic abcesses | Abcesses, cysts, other localised fluidcollection; pleural effusions, ascitic fluidcollections, renal cysts; renal, hepatic,subhepatic and subdiaphragmaticabcesses |
| 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
N/A