(25 days)
Not Found
No
The document describes a physical medical device (a PICC catheter) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies focus on the physical properties and function of the catheter.
No
The device is a peripherally inserted central venous catheter (PICC) used for administration of drugs and fluids, blood sampling, and contrast delivery, which are methods of treatment or diagnosis, but the device itself is not described as having an intrinsic therapeutic effect.
No
Explanation: The device, a Peripherally Inserted Central Venous Catheter (PICC), is used for administering drugs and fluids, blood sampling, and pressure monitoring. While it can be used for "venous pressure monitoring" and "blood sampling," these actions are part of patient management and therapy delivery, not solely for diagnosing a medical condition or disease. It does not perform any analysis or interpretation of data to provide a diagnosis.
No
The device description clearly indicates it is a physical catheter made of radiopaque polyurethane, along with various hardware components like introducers, needles, and wire guides. The performance studies also focus on physical properties like tensile strength and pressure resistance.
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 used in vivo (within the body) for procedures like venous pressure monitoring, blood sampling, drug/fluid administration, and contrast delivery during CT scans. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to provide information about a person's health.
- Device Description: The description details a catheter designed for insertion into a vein, which is an in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) is a medical device used for therapeutic and diagnostic procedures performed directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for shortor 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The subject Turbo-Ject® PICCs 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 subject devices are minimally tapered 5.0 Fr single and double lumen catheters. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- . Tensile Testing - In conformance with ISO 10555-1:1995, testing demonstrated that the peak load value was greater than 10 N.
- . Dynamic Pressure Testing - Testing demonstrated that the catheter did not fail during simulated use.
- . Static Failure Pressure - Testing demonstrated that static failure pressure was at or above the acceptance criterion.
- . Liquid Leakage Testing - Testing demonstrated that the catheter did not leak liquid.
- 들 Air Leakage Testing - Testing demonstrated that the catheter did not exhibit air leakage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below "COOK" is the word "MEDICAL" in smaller, white letters. The logo is simple and professional.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
MONE: 812.339.2235 TOU PREF: 800.457.4500
WWW.COOKMEDICAL.COM
24
510(k) SUMMARY Turbo-Ject® Peripherally Inserted Central Venous Catheter Set 21 CFR $807.92 Date Prepared: September 13, 2013
Submitted By:
Applicant: Contact: Applicant Address:
Contact Phone Number: Contact Fax Number:
Cook Incorporated Sean Spence, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x105127 (812) 332-0281
OCT 1 1 2013
Device Information:
Turbo-Ject® Peripherally Inserted Central Venous Catheter Set Trade name: Common name: PICC Set Classification Name: Percutaneous, implanted, long-term intravascular catheter 21 CFR §880.5970 Regulation: Product Code: ાં રાજ
Intended Use:
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for shortor 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.
Predicate Devices:
The Turbo-Ject" PICC Sets, subject of this submission, are a modification to the Cook Incorporated Turbo-Ject® PICC (K072625), which was cleared for commercial distribution on December 13, 2007.
Comparison to Predicate Device:
It has been demonstrated that the subject Turbo-Ject® PICC Sets are comparable to the predicate. Both are intended for short- or long-term use for venous pressure monitoring, 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.
1
Device Description:
The subject Turbo-Ject® PICCs 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-thewire. The subject devices are minimally tapered 5.0 Fr single and double lumen catheters. 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.
Test Data:
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.
- . Tensile Testing - In conformance with ISO 10555-1:1995, testing demonstrated that the peak load value was greater than 10 N.
- . Dynamic Pressure Testing - Testing demonstrated that the catheter did not fail during simulated use.
- . Static Failure Pressure - Testing demonstrated that static failure pressure was at or above the acceptance criterion.
- . Liquid Leakage Testing - Testing demonstrated that the catheter did not leak liquid.
- 들 Air Leakage Testing - Testing demonstrated that the catheter did not exhibit air leakage.
Conclusions Drawn from the Tests:
The results of these tests provide reasonable assurance that the Turbo-Ject® PICC Set is as safe and effective as the predicate devices and support a determination of substantial equivalence.
COMPANY CONFIDENTIAL
2
Image /page/2/Picture/1 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 wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
October 11, 2013
Cook, Incorporated C/O Mr. Sean Spence, RAC 750 Daniels Way BLOOMINGTON IN 47404
Re: K132885
Trade/Device Name: Turbo-Jet® PICC Set Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 13, 2013 Received: September 16, 2013
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.
3
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/ResourcesforYou/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/ReportalProblem/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 vours.
Mary S. Runner -S
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Cook Incorporated Special 510(k) Premarket Notification Turbo-Ject® PICC Set September 2013
K 132885 510(k) Number (if known):
Device Name: Turbo-Ject® PICC Set
Indications for Use:
Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for shortor 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 Iimit 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.
Prescription Use X (Per 21 CFR 801 Subpart D)
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)
Image /page/4/Picture/10 description: The image shows the logo of the Food and Drug Administration (FDA). The logo is a stylized version of the letters "FDA". The letters are made up of small, geometric shapes, giving the logo a textured appearance. The logo is black and white.
Richard C. Chapman 2013.10.11 15:56:55 -04'00'