(29 days)
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
The 3.0, 4.0, 5.0, and 6.0 Fr Turbo-Ject PICC Sets with various lumen configurations are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer or over-the-wire. The set components may include the PICC, obturator, Peel-Away introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.
This document is a 510(k) summary for the Cook Incorporated Turbo-Ject PICC Sets, indicating substantial equivalence to previously marketed predicate devices. It describes the device's intended use and technological characteristics but does not contain information regarding the acceptance criteria, study that proves the device meets the acceptance criteria, or any of the other specific details requested in the prompt (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) relevant to the evaluation of a medical device’s performance against acceptance criteria.
The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices through various standard tests (ISO 10555-1, ISO 10993-1) for physical properties and biocompatibility.
Therefore, I cannot provide the requested information based on the provided text. The document states that "Testing demonstrated the proposed device met the predetermined acceptance criteria following accelerated aging" for several tests, but it does not specify what those acceptance criteria were or describe the detailed results of a study to prove they were met.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Cook Incorporated Mr. Sean Spence, RAC 750 Daniels Way Bloomington, IN 47404
Re: K141818
Trade/Device Name: Turbo-Ject PICC Sets Regulation Number: 21 CFR 880.5970 Regulation Name: PICC Sets Regulatory Class: II Product Code: LJS Dated: July 3, 2014 Received: July 7, 2014
Dear Mr. Spence:
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 - Mr. Spence
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) TBD K141818
Device Name
Turbo-Ject® Peripherally Inserted Central Venous Catheter (PICC)
Indications for Use (Describe)
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, stacked above the word "MEDICAL" in a smaller, white, sans-serif font. Both words are set against a red background. The "COOK" has a trademark symbol next to it.
10.0 510(k) SUMMARY
Turbo-Ject® PICC Sets 21 CFR §807.92 Date Prepared: 3 July 2014
Cook Incorporated
Sean Spence, RAC
Cook Incorporated 750 Daniels Way
(812) 332-0281
Bloomington, IN 47404
(812) 335-3575 x105127
Submitted By:
Applicant: Contact: Applicant Address:
Contact Phone Number: Contact Fax Number:
Device Information:
Trade Name: Common Name: Classification Name: Regulation: Product Code
Turbo-Ject® PICC Sets PICC Sets Catheter, intravascular, therapeutic, long-term greater than 30 days 21 CFR §880.5970 LIS
Predicate Devices:
- K072625, Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) ●
- K111244, Turbo-Ject® PICC Set ●
- K132334, Turbo-Ject® Peripherally Inserted Central Venous Catheter Set 0
- K132885, Turbo-Ject® Peripherally Inserted Central Venous Catheter Set 0
Device Description:
The 3.0, 4.0, 5.0, and 6.0 Fr Turbo-Ject PICC Sets with various lumen configurations are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer or over-the-wire. The set components may include the PICC, obturator, Peel-Away introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.
Intended Use:
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for power injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.
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Image /page/4/Picture/18 description: The image features the logo for Cook Medical. The word "COOK" is displayed in large, bold, white letters against a red background. Below "COOK", the word "MEDICAL" is written in white letters on a red banner. The logo is simple and clean, with a focus on the company name.
Comparison to Predicates:
It has been demonstrated that the subject Turbo-Ject® PICC Sets are comparable to the predicates. Both are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. In addition, the subject devices and predicate are substantially equivalent in terms of design.
Technological Characteristics:
The following tests were performed to demonstrate that the subject Turbo-Ject® PICC Set met applicable design and performance requirements and support a determination of substantial equivalence.
- . ISO 10555-1:2013, Force at Break - Testing demonstrated the proposed device met the predetermined acceptance criteria following accelerated aging
- ISO 10555-1:2013, Liquid Leakage Testing demonstrated the proposed device met the ● predetermined acceptance criteria following accelerated aging
- ISO 10555-1:2013. Air Leakage Testing demonstrated the proposed device met the ● predetermined acceptance criteria following accelerated aging
- Static Burst Testing Testing demonstrated the proposed device met the predetermined ● acceptance criteria following accelerated aging
- ISO 10993-1:2009, Biocompatibility Testing demonstrated the proposed device met the ● predetermined acceptance criteria. The following test results were considered:
- o Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (Acute), Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility
- In addition to those required tests, SC5b-9 and C3a Complement Activation, ASTM о Partial Thromboplastin Time, and Materials Mediated Rabbit Pyrogen were preformed
Conclusion:
The results of these tests provide reasonable assurance that the Turbo-Ject® PICC Sets are as safe and effective as the predicate devices and support a determination of substantial equivalence.
§ 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.”