(27 days)
Not Found
No
The summary describes a physical medical device (PICC catheter) and its performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and physical integrity.
No
The device is a peripherally inserted central venous catheter (PICC) used for diagnostic and fluid/drug administration purposes, including venous pressure monitoring, blood sampling, and delivery of contrast in CT studies. While it has an antimicrobial impregnation to prevent infections, its primary function is not to treat a disease or condition but to provide access to the venous system for other medical procedures.
No
The device is a peripherally inserted central venous catheter (PICC) used for administration of drugs and fluids, blood sampling, venous pressure monitoring, and contrast delivery for CT studies. While it is involved in obtaining blood samples and venous pressure data, its primary function is not to diagnose_a_disease or condition but to provide a means for delivery and monitoring.
No
The device description clearly outlines physical components such as catheters, introducers, needles, and wire guides, and the performance studies focus on physical properties like tensile strength, pressure resistance, and leakage. There is no mention of software as the primary or sole component.
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 for CT scans. These are all direct medical interventions on a patient.
- Device Description: The device is described as a catheter inserted into a vein. This is a medical device used for accessing the circulatory system, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body, outside of the body. This device is designed to be inserted into the body for therapeutic and diagnostic procedures performed on the patient.
N/A
Intended Use / Indications for Use
Spectrum 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 catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum 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 proposed Spectrum 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 proposed devices are minimally tapered 4.0 Fr and 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
Central Venous
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
The following tests were performed to demonstrate that the proposed Spectrum 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 catheters 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 catheters did not leak liquid.
- Air Leakage Testing – Testing demonstrated that the catheters did not exhibit air leakage.
- Antimicrobial Testing - Testing demonstrated that the catheters met the predetermined acceptance criteria.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of these tests provide reasonable assurance that the Spectrum Turbo-Ject® PICC Set is as safe and effective as the predicate devices and support a determination of substantial equivalence.
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.
K081690, K072625, K132334, K132885
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.”
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Image /page/0/Picture/0 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.
DEC 2 3 2013
510(k) SUMMARY - K133634 Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set 21 CFR $807.92 Date Prepared: December 09, 2013
Submitted By:
Applicant: Contact: Applicant Address: Cook Incorporated Sean Spence, RAC Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x105127 (812) 332-0281
Device Information:
Contact Fax Number:
Contact Phone Number:
| Trade name: | Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter Set |
|---|---|
| Common name: | PICC Set |
| Classification Name: | Percutaneous, Implanted, Long-Term Intravascular Catheter |
| Regulation: | 21 CFR §880.5970 |
| Product Code: | LJS |
Intended Use:
Spectrum 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 catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSIs). The Spectrum 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 Spectrum Turbo-Ject® PICC Sets, subject of this submission, are modifications to the following Cook Incorporated PICCs:
- K081690, Spectrum Turbo-Ject® Peripherally Inserted Central Venous Catheter �
1
Image /page/1/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters on a black background. Below the word "COOK" is the word "MEDICAL" in smaller, white letters.
COOK INCORPORATED 750 DANIELS WAY. P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 1. 012.339.2235 rou firer 800.457.4500 WWW.COOKMEDICAL.COM
Comparison to Predicate Devices:
The scope of this submission is to first add a minimal taper design modification to the 4.0 Fr single and 5.0 Fr single and double lumen antimicrobial (Spectrum) PICCs cleared in the primary predicate, K081690. Second, this submission will add a Spectrum 4.0 Fr double lumen configuration not found in the primary predicate. Complete performance testing, including power injection, was reviewed for a 4.0 Fr double lumen PICC without Spectrum under K072625. Subsequently, the design was modified under K132334 to a minimal taper. Due to market demand, the Spectrum technology from K081690 is being added to the 4.0 Fr double lumen device design cleared under K132334. Lastly, this submission is also meant to standardize the labeling (IFU) format with the non-Spectrum minimally tapered PICCs as amended during K132334 (4.0 Fr) and K132885 (5.0 Fr).
| | Cook Spectrum Turbo-Ject PICC
K081690! | Cook Spectrum Turbo-Ject PICC Set
SUBJECT OF THIS SUBMISSION |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number/
Product Code | 21 CFR 880.5970, LJS | Identical |
| Classification Name | Intravascular Catheter | Identical |
| Class | II | Identical |
| Intended Use | 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 catheter is impregnated with
the antimicrobials minocycline and rifampin to
help provide protection against catheter-related
bloodstream infections (CRBSIs). The Spectrum 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 Spectrum Turbo- Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rated indicated. | Identical |
| Catheter Shaft Material. | Polyurethane | Identical |
| French Size /
Length (cm) | 4.0 and 5.0 / 60 | Identical |
| Taper | 2 Fr sizes | 1 Fr size |
| Number of Lumens. | 4.0 Fr - Single lumen
4.0 Fr - Double lumen (K132334)
5.0 Fr - Single lumen
5.0 Fr - Double lumen | 4.0 Fr - Single lumen
4.0 Fr - Double lumen
5.0 Fr - Single lumen
5.0 Fr - Double lumen |
| Flow Rate. | 4.0 Fr Single lumen - 4 mL/sec
4.0 Fr Double lumen - 3 mL/sec (K132334)
5.0 Fr Single lumen - 7mL/sec
5.0 Fr Double lumen - 5mL/sec | 4.0 Fr Single lumen - 5 mL/sec
4.0 Fr Double lumen - 3 mL/sec
5.0 Fr Single lumen - 7mL/sec
5.0 Fr Double lumen - 5mL/sec |
| Maximum Pressure
Rating | 325 psi | Identical |
Table 1: Comparison Table
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Image /page/2/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, sans-serif font at the top. Below it, the word "MEDICAL" is in a smaller, sans-serif font. The background is black, and the text is white.
| | Cook Spectrum Turbo-Ject PICC K081690' | Cook Spectrum Turbo-Ject PICC Set
SUBJECT OF THIS SUBMISSION |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Antimicrobial Agents | Minocycline
• Synonym: Minocin
• Chemical family : Tetracycline
• Formula : C23 H27 N3 O7 · HCl
Rifampin
• Synonym: Rifampicin
• Chemical family : Macrolide antibiotic
• Formula : C43H58N4O12 | Identical |
| Antimicrobial Activity
Specification | Minimum zone of inhibition of 15 mm | |
| Method of
antimicrobial
application | Impregnation | Identical |
| Inside Diameter (inch) | 4.0 Fr Single lumen - 0.030
4.0 Fr Double lumen - 0.022/0.038* (K132334)
5.0 Fr Single lumen - 0.037
5.0 Fr Double lumen - 0.022/0.044* | 4.0 Fr Single lumen - 0.037
4.0 Fr Double lumen - 0.022/0.038*
5.0 Fr Single lumen - 0.048
5.0 Fr Double lumen - 0.024/0.048* |
| Outside Diameter (inch) | 4.0 Fr Single lumen - 0.053
4.0 Fr Double lumen - 0.055 (K132334)
5.0 Fr Single lumen - 0.066
5.0 Fr Double lumen - 0.066 | 4.0 Fr Single lumen - 0.055
4.0 Fr Double lumen - 0.055
5.0 Fr Single lumen - 0.066
5.0 Fr Double lumen - 0.066 |
| Primary set components | Obturator, Peel-Away introducer, entry needles,
wire guide, injection caps, syringe, scalpel, and
securement device | Identical |
1K 132334 is referenced where appropriate for the 4.0 Fr double lumen device *height/width
Device Description:
The proposed Spectrum 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 proposed devices are minimally tapered 4.0 Fr and 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 proposed Spectrum 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.
3
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is in black and white, with the word "COOK" in large, bold letters on the top line. Below the word "COOK" is the word "MEDICAL" in smaller letters. The logo is simple and professional.
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489
- Dynamic Pressure Testing Testing demonstrated that the catheters did not fail during . simulated use.
- Static Failure Pressure Testing demonstrated that static failure pressure was at or above the . acceptance criterion.
- 트 Liquid Leakage Testing - Testing demonstrated that the catheters did not leak liquid.
- l Air Leakage Testing – Testing demonstrated that the catheters did not exhibit air leakage.
- . Antimicrobial Testing - Testing demonstrated that the catheters met the predetermined acceptance criteria.
Conclusions Drawn from the Tests:
The results of these tests provide reasonable assurance that the Spectrum Turbo-Ject® PICC Set is as safe and effective as the predicate devices and support a determination of substantial equivalence.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol that resembles a stylized human figure embracing a globe. The image is black and white and appears to be a scan of a document.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2013
Cook. Incorporated C/O Mr. Sean Spence. RAC 750 Daniels Way BLOOMINGTON IN 47404
Re: K133634
Trade/Device Name: Spectrum Turbo-Jet Peripherally Inserted Central Venous Catheter Set Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: November 25, 2013 Received: November 26, 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.
5
· 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 YowIndustry/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 yours.
Kwame O Ulmer
-s FDA
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
*** : : ... . ...
Indications for Use
510(k) Number (if known) K133634
Device Name
Spectrum (antimicrobial) Turbo-Ject PICCs
Indications for Use (Describe)
Spectrum Turbo-Ject Peripherally Inserted Central Venous Catherer (PICC) Sets and Trays are intended for short-or long-term use for venous pressure monitoring, blood sampling, administration of drugs and for use with power injectors for delivery of contrast in CT studies. The catheter is impregnated with the antimicrobials minocycline and rifampin to help protection against catherer-related bloodstream infections (CRBSIs). The Spectrum Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure liniectors used with the Spectrum 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)
[ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013
See PRA Statement on last page.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CONTRACTORIE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
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Digitally signed by Richard C. Chapman Date: 2013.12.23 14:21:50 -05'00'
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