(87 days)
K/DEN: Not Found
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No
The document describes a physical medical device (PICC catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for administering drugs and fluids, which are therapeutic interventions.
No
Explanation: The device is a Peripherally Inserted Central Venous Catheter (PICC) used for administration of drugs and fluids, blood sampling, and venous pressure monitoring, as well as for delivery of contrast in CT studies. While it can be used for "venous pressure monitoring" and "blood sampling," these are not sufficient to classify it as a diagnostic device on its own. It facilitates diagnostic procedures (like CT studies with contrast, or blood tests) but does not itself provide a diagnosis or process diagnostic information.
No
The device description clearly outlines physical components like catheters, needles, wire guides, syringes, and other medical supplies, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Turbo-Ject PICC is a catheter inserted into a vein for various medical procedures like administering drugs, fluids, and contrast media, as well as blood sampling and pressure monitoring. These are all procedures performed within the body (in vivo).
- Intended Use: The stated intended use clearly describes procedures performed directly on the patient's circulatory system, not on samples taken from the patient.
Therefore, the function and intended use of the Turbo-Ject PICC align with a medical device used for direct patient care, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Turbo-Ject Peripherally Inserted Central Venous Catheters (PICC) are indicated 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 rated indicated, as shown on the following table.
| Catheter Size | Maximum Flow Rate* | Injection Pressure Limit Setting |
|---|---|---|
| 4 Fr Single Lumen | 4 ml/sec | 325 psi |
| 4 Fr Double Lumen | 3 ml/sec | 325 psi |
| 5 Fr Single Lumen | 7 ml/sec | 325 psi |
| 5 Fr Double Lumen | 5 ml/sec | 325 psi |
*Flow rates achieved using room temperature Omnipaque 3000 contrast and veriffed using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.
Product codes
LJS
Device Description
The Turbo-Ject PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters for short or long-term use. The Turbo-Ject PICC catheters are 60 cm in length and available in 4 and 5 Fr single lumen and 4 and 5 Fr double lumen.
The set components include an introducer needle, wire guide, locking Peel-Away sheath introducer, 12cc syringe and hydrophilic-coated wire guide obturator for non-over-thewire versions. The tray components include all set items in addition to 22 and 25 gauge needles, lidocaine, antiseptic sponges, drape, gauze, 3 cc syringe, suture with needle and needle holder. The set components will be the same for the single and double lumen Turbo-Ject PICC catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Turbo-Ject PICC Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Flow rate tests
-
- Static burst failure pressure tests
-
- Cyclic fatigue test
-
- Liquid leakage under pressure test
-
- Air leakage during aspiration test
- Tensile strength tests 6.
- Bond strength test 7.
-
- Shelf life testing
-
- Biocompatibility tests
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PICC catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Image /page/0/Picture/0 description: The image shows a date that appears to be stamped on a document. The date reads "DEC 1 3 2007". The text is in a sans-serif font and is slightly skewed. The image is a close-up of the date stamp.
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510(k) Summary
Submitted By:
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
Device:
Trade Name: Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Proposed Classification: Percutaneous, Implanted, Long-Term Intravascular Catheter (LJS)
Indications for Use:
Turbo-Ject Peripherally Inserted Central Venous Catheters (PICC) are indicated 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 rated indicated, as shown on the following table.
| Catheter Size | Maximum Flow Rate* | Injection Pressure
Limit Setting |
|-------------------|--------------------|-------------------------------------|
| 4 Fr Single Lumen | 4 ml/sec | 325 psi |
| 4 Fr Double Lumen | 3 ml/sec | 325 psi |
| 5 Fr Single Lumen | 7 ml/sec | 325 psi |
| 5 Fr Double Lumen | 5 ml/sec | 325 psi |
*Flow rates achieved using room temperature Omnipaque 3000 contrast and veriffed using a Medrad Stellant® CT injector system. Omnipaque 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosity of the contrast medium used will result in a change in achievable flow rates. Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.
Predicate Devices:
The Turbo-Ject PICC Catheter is similar in terms of intended use, materials of construction and technological characteristics to predicate devices,
1
Device Description:
The Turbo-Ject PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters for short or long-term use. The Turbo-Ject PICC catheters are 60 cm in length and available in 4 and 5 Fr single lumen and 4 and 5 Fr double lumen.
The set components include an introducer needle, wire guide, locking Peel-Away sheath introducer, 12cc syringe and hydrophilic-coated wire guide obturator for non-over-thewire versions. The tray components include all set items in addition to 22 and 25 gauge needles, lidocaine, antiseptic sponges, drape, gauze, 3 cc syringe, suture with needle and needle holder. The set components will be the same for the single and double lumen Turbo-Ject PICC catheter.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
Test Data:
The Turbo-Ject PICC Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Flow rate tests ﺴﻬ
-
- Static burst failure pressure tests
-
- Cyclic fatigue test
-
- Liquid leakage under pressure test
-
- Air leakage during aspiration test
- Tensile strength tests 6.
- Bond strength test 7.
-
- Shelf life testing
-
- Biocompatibility tests
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PICC catheter.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 3 2007
Ms. Karen Bradburn Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
Re: K072625
Trade/Device Name: Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 14, 2007 Received: September 18, 2007
Dear Ms. Bradburn:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Ms. Bradburn
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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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510(k) Number (if known):
Device Name: Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC)
Kora675
Indications for Use:
Turbo-Ject Peripherally Inserted Central Venous Catheters (PICC) are indicated 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 rated indicated, as shown on the following table.
| Catheter Size | Maximum Flow Rate* | Injection Pressure
Limit Setting |
|-------------------|--------------------|-------------------------------------|
| 4 Fr Single Lumen | 4 ml/sec | 325 psi |
| 4 Fr Double Lumen | 3 ml/sec | 325 psi |
| 5 Fr Single Lumen | 7 ml/sec | 325 psi |
| 5 Fr Double Lumen | 5 ml/sec | 325 psi |
*Flow rates achieved using room temperature Omnipague 300® contrast and vertified using a Medrad Stellant® CT injector system. Omnipage 300 has a viscosity of 11.8 centipoise at room temperature (20 degrees C). A change in temperature or viscosìty of the contrast medium used will result in a change in achievable flow rates. Omnipaque 300€ is a registered trademark of Amersham Health, New Jersey.
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)
Cuma Vm
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _ 麻雀门26고S