(99 days)
The SYNERGY™ CT PICC is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. The intended use has not changed from that of the predicate devices. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The SYNERGY™ CT PICC is indicated for short or long term (less than or greater than 30 days) peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec.
The SYNERGY™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each SYNERGY™ CT PICC has a kink resistant, reverse tapered catheter design. The SYNERGY™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The SYNERGY™ CT PICC is indicated for dwell times shorter or greater than 30 days. The SYNERGY™ CT PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.
The SYNERGY™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen, 5 Fr and 6 Fr dual lumen and 6 Fr triple lumen. All catheters are approximately 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment. All SYNERGY™ CT PICC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The provided text describes a 510(k) premarket notification for the SYNERGY™ CT PICC device. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than providing detailed standalone performance studies with specific statistical metrics against predefined acceptance criteria for novel clinical claims.
Based on the information provided, here's a breakdown of the requested elements:
1. Table of Acceptance Criteria and Reported Device Performance
The submission indicates that "The SYNERGY™ CT PICC met all established acceptance criteria for performance testing and design verification testing." However, the specific quantitative acceptance criteria or the detailed reported device performance values related to infusion rates, pressure, or other functional aspects are not explicitly listed in the provided text in a table format.
What is mentioned as a performance characteristic is:
"The SYNERGY™ CT PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi."
And, "All SYNERGY™ CT PICC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi."
This implies that the acceptance criteria for power injection performance were to withstand 5 ml/sec and 300 psi without failure. The reported performance is that the device "met all established acceptance criteria" for this.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Verification testing was performed according to protocols based on the above-referenced vicince document recommendations and additional standards." It also states, "Performance data gathered in design verification testing demonstrated that the SYNERGY™ CT PICC is substantially equivalent to the noted predicate devices."
However, the specific sample size used for performance testing (test set) is not provided in the given text.
The data provenance is from "Health Line International Corporation," the manufacturer, which implies the testing was conducted by or for the manufacturer. The location is Centerville, Utah, USA. The data would be considered prospective in the sense that the tests were performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (expert consensus for a test set) is typically relevant for interpretative diagnostic devices or those involving subjective assessments. For a medical device like a Percutaneously Inserted Central Catheter (PICC) that focuses on mechanical and functional performance (e.g., ability to withstand pressure and flow rates), expert opinion is not usually used to establish "ground truth" for the device's technical specifications. Instead, performance is measured objectively through engineering tests.
Therefore, this information is not applicable and not provided in the text.
4. Adjudication Method for the Test Set
As explained above, adjudication methods (like 2+1, 3+1) are usually for situations requiring human interpretation or subjective assessment to establish ground truth or resolve discrepancies. For the performance testing of a PICC, where objective measurements of pressure, flow, and material integrity are key, adjudication methods are not applicable and not mentioned in the text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where different readers interpret cases, and the AI's impact on their performance is evaluated. For a catheter, this is not a relevant study design.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance assessment was done. The entire 510(k) submission is dedicated to demonstrating the standalone performance of the SYNERGY™ CT PICC device itself through "performance testing and design verification testing" against established standards and predicate devices. There is no mention of an algorithm or human-in-the-loop component for this device. The device is a physical medical instrument.
7. The Type of Ground Truth Used
For the performance and design verification testing of the SYNERGY™ CT PICC, the "ground truth" is established by objective engineering measurements and adherence to recognized industry standards (e.g., ISO 11135:2007 for sterilization, ISO-10993 for biocompatibility, and FDA Guidance for Intravascular Catheters). The device's ability to withstand specific pressures and flow rates without failure constitutes its "performance ground truth" for these technical aspects.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm that requires a training set. It is a physical medical device (PICC catheter). Therefore, this information is not applicable and not provided.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device with a training set, this information is not applicable and not provided.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for SYNERGY™ CT PICC
SUBMITTER:
Health Line International Corporation 803 N. 1250 W. - STE 1 Centerville, Utah 84014
AUG 1 9 2010
ESTABLISHMENT REGISTRATION NUMBER: 3006097687
CONTACT:
Nola L. Benstog QA/RA Director Telephone: 801-773-7798 Fax: 801-820-8007 Email: nbenstog@hlic.net
DATE PREPARED:
Proprietary Name:
Regulation Name:
Common/Usual Name:
May 11, 2010
NAME OF MEDICAL DEVICE:
SYNERGY™ CT PICC
Percutaneous, implanted, long-term intravascular catheter Peripherally Inserted Central Catheter (PICC), single, double and triple lumen
DEVICE CLASSIFICATION:
Classification Panel: Regulatory Class: Product Code: Regulation Number: General Hospital Class II ાર 21 CFR 880.5970
PREDICATE DEVICES:
Proprietary Name: Regulation Name: Common/Usual Name: Classification Panel: Regulatory Class: Product Code: Regulation Number:
PICC (CT Rated and Non-Rated) (K083873)
Percutaneous, Implanted, Long-term Intravascular Catheter Catheter, Intravascular, Therapeutic, Long Term General Hospital Class II ।।
21 CFR 880.5970
CUNFIDENTIAL
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| Proprietary Name: | OmniPICC P.I. (K051102) |
|---|---|
| Regulation Name: | Percutaneous, implanted, long-term intravascular catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC), single anddouble lumen |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Regulation Number: | 21 CFR 880.5970 |
| Proprietary Name: | OmniPICC P.I. (K062579) |
| Regulation Name: | Percutaneous, implanted, long-term intravascular catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC), 4 French singleand 5 French double lumen |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Regulation Number: | 21 CFR 880.5970 |
| Proprietary Name: | PRO-LINE CT Pressure Injectable CVC (K093309) |
| Regulation Name: | Percutaneous, Implanted, Long-Term intravascular Catheter |
| Common/Usual Name: | Percutaneous, implanted, long-term intravascular catheter |
| Classification Panel: | General Hospital |
| Regulatory Class: | Class II |
| Product Code: | LJS |
| Regulation Number: | 21 CFR 880.5970 |
DEVICE DESCRIPTION:
The SYNERGY™ CT PICC is a family of peripherally inserted central venous catheters designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each SYNERGY™ CT PICC has a kink resistant, reverse tapered catheter design. The SYNERGY™ CT PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The SYNERGY™ CT PICC is indicated for dwell times shorter or greater than 30 days. The SYNERGY™ CT PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi.
The SYNERGY™ CT PICC product line has catheters in 4 Fr and 5 Fr single lumen, 5 Fr and 6 Fr dual lumen and 6 Fr triple lumen. All catheters are approximately 60 cm long. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer
CONFIDENTIAL
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lock fittings for access attachment. All SYNERGY™ CT PICC products have a maximum recommended infusion rating is 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
CONFIDENTIAL
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INTENDED USE:
The SYNERGY™ CT PICC is intended to be used by medical professionals for short-term or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and for power injection of contrast media. The intended use has not changed from that of the predicate devices. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
INDICATIONS FOR USE:
The SYNERGY™ CT PICC is indicated for short or long term (less than or greater than 30 days) peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates.
Does the new device have the same indication statements? Yes.
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.
Does the new device have the same technological characteristics, e.g. design, material, etc.? Yes. The PICC device of this submission, the SYNERGY™ CT PICC, is identical to that of (K083873), PICC (CT Rated and Non-Rated). In fact, the SYNERGY™ CT PICC and the PICC (CT Rated and Non-Rated) are manufactured by the same company, Health Line International Corporation, the submitter of this submission. In addition, the SYNERGY™ CT PICC is substantially equivalent to predicate devices, OmniPICC P.I. (K051102) and (K062579) and PRO-LINE CT Pressure Injectable CVC (K093309). The basic fundamental scientific technology of the device has not changed. There may be minor variations in the contents of the introduction kit components.
Could the new characteristics affect safety or effectiveness? No.
Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
CONFIDENTIAL
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The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 was used to determine the appropriate methods for evaluating the device's performance.
Sterilization requirements of ISO 11135:2007, Sterilization of Health Care Products -Requirements for Validation and Routine Control -- Ethylene Oxide Sterilization.
Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Test profiles for externally communication of Irences contacting, long-term devices will be met.
These and other standards were used to determine the appropriate methods for evaluating the device's performance.
Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced vicince document recommendations and additional standards.
Do performance data demonstrate equivalence? Yes. Performance data gathered in design verification testing demonstrated that the SYNERGY™ CT PICC is substantially equivalent to the noted predicate devices.
CONCLUSION
The SYNERGY™ CT PICC met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the SYNERGY™ CT PICC is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices: PICC (CT Rated and Non-Rated)(K083873), OmniPICC P.I. (K051102) and (K062579) and PRO-LINE CT Pressure Injectable CVC (K093309).
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Nola Benstog Ouality Assurance/ Regulatory Affairs Director Health Line International Corporation 803 N. 1250 W street, Suite 1 Centerville, Utah 84014
AUG 1 9 2010
Re: K101329
Trade/Device Name: SYNERGY™ CT PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Pertaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 26, 2010 Received: July 27, 2010
Dear Ms. Benstog:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2- Ms. Benstog
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Lumore
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 14 of 169
Indications For Use
510(k) Number (if known):
Device Name: SYNERGY™ CT PICC
Indications For Use:
The SYNERGY™ CT PICC is indicated for short or long term (less than or greater than 30 days) peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. All SYNERGY™ CT PICC products have a maximum recommended infusion rating of 5 ml/sec.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Uid C. Ch 8/19/10
Division Sign-Off) (Division Sign=ON)
Division of Anesthesiology, General Hospital
Division of Anest Dantal Devices infection Control, Dental Devices
510(k) Number: K101329
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”