(28 days)
Not Found
No
The summary describes a physical medical device (a PICC catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is used for administration of drugs, blood sampling, and contrast delivery, and venous pressure monitoring, but it is not intended to treat or prevent a disease or condition itself.
No
The device is a peripherally inserted central venous catheter (PICC) used for administration of drugs, blood sampling, and monitoring, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter made of radiopaque polyurethane, impregnated with antimicrobials, and available in various lumen configurations. This is a hardware medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for direct patient care procedures like venous pressure monitoring, blood sampling, drug administration, and contrast delivery during CT scans. These are all in-vivo procedures performed directly on the patient.
- Device Description: The device is a catheter, which is a medical device inserted into 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.) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not for direct intervention or administration within the body.
N/A
Intended Use / Indications for Use
The Spectrum Turbo-JeCT PICC is 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 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 rate indicated.
Product codes (comma separated list FDA assigned to the subject device)
FOZ, LJS
Device Description
The Spectrum Turbo-JeCT PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters impregnated with the antimicrobials minocycline and rifampin for short- or long-term use. The devices are currently available in the following configurations: 4 Fr single lumen, 5 Fr single lumen, 5 Fr double lumen. The proposed devices add two additional configurations, more specifically, a 3 Fr single lumen catheter and a 6 Fr triple lumen catheter.
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 presented to demonstrate that the Spectrum Turbo-JeCT PICC Set meets applicable design and performance requirements.
- Tensile Testing .
- Flow Rate .
- Cyclic Bending .
- Zone of Inhibition .
- Elution Profile
- Air and Liquid Leakage .
- Burst Pressure .
- Cyclic Pinch Clamping .
- . HPLC Analysis
- Stability Testing ●
The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Special 510(k): Device Modification Spectrum® TurboJeCT™ PICC Set COOK INCORPORATED 07 April 2010
KIO0974
510(k) SUMMARY
Submitted By:
Susanne Galin, RAC Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x 2296 April 2, 2010
Device:
| Trade Name: | Spectrum® Turbo-JeCT™ PICC Set |
|---|---|
| Proposed Classification Name: | Percutaneous, Implanted, Short- and Long-Term |
| Intravascular Catheter | |
| 21 CFR §880.5200, Product Code FOZ, LJS |
Indications for Use:
The Spectrum Turbo-JeCT PICC is indicated for short- or long-term use for yenous 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 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 rate indicated.
| Catheter Size | Maximum Flow Rate* | Injection Pressure
Limit Setting |
|----------------------|--------------------|-------------------------------------|
| 3 Fr Single Lumen | 2 mL/sec | 325 psi |
| 4 Fr Single Lumen | 4 mL/sec | 325 psi |
| 5 Fr Single Lumen | 7 mL/sec | 325 psi |
| 5 Fr Double Lumen | 5 mL/sec | 325 psi |
| 6 Fr Triple Lumen ** | 7 mL/sec | 325 psi |
*Flow rates achieved using room temperature Omnipaque 300® contrast and verified 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. **Lumen #1 only.
Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.
MAY - 6 2010
1
Special 510(k): Device Modification Spectrum® TurboJeCTTM PICC Set COOK INCORPORATED 07 April 2010
Predicate Devices:
Spectrum® Turbo-JeCT™ PICC Set, 510(k) number K081690
Device Description:
The Spectrum Turbo-JeCT PICC catheters are radiopaque polyurethane peripherally inserted central venous catheters impregnated with the antimicrobials minocycline and rifampin for short- or long-term use. The devices are currently available in the following configurations: 4 Fr single lumen, 5 Fr single lumen, 5 Fr double lumen. The proposed devices add two additional configurations, more specifically, a 3 Fr single lumen catheter and a 6 Fr triple lumen catheter.
Substantial Equivalence:
The Spectrum Turbo-JeCT PICC Sets in 3 Fr and 6 Fr sizes are identical to the predicate Spectrum Turbo-JeCT PICC Sets in 4 Fr and 5 Fr sizes (cleared under premarket notification 510(k) number K081680) in terms of intended use, technological characteristics, drugs used for impregnation, impregnation process, and material which support a determination of substantial equivalence.
Test Data:
The following tests were presented to demonstrate that the Spectrum Turbo-JeCT PICC Set meets applicable design and performance requirements.
- Tensile Testing .
- Flow Rate .
- Cyclic Bending .
- Zone of Inhibition .
- Elution Profile �
- Air and Liquid Leakage .
- Burst Pressure .
- Cyclic Pinch Clamping .
- . HPLC Analysis
- Stability Testing ●
The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Susanne Galin, RAC Regulatory Affairs Specialist Cook, Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402
MAY - 6 2010
Re: K100974
Trade/Device Name: Spectrum® Turbo-JeCT™ Peripherally Inserted Central Venous Catheter (PICC) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ, LJS Dated: April 7, 2010 Received: April 8, 2010
Dear Ms. Galin:
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
Page 2- Ms. Galin
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 (OS) 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 Rurres
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
4
Special 510(k): Device Modification Spectrum® TurboJeCTTM PICC Set COOK INCORPORATED 07 April 2010
Indications for Use
510(k) Number (if known):
Device Name:
Spectrum® Turbo-JeCT™ Peripherally Inserted Central Venous Catheter (PICC)
Indications for Use:
The Spectrum Turbo-JeCT PICC is 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 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 rate indicated.
| Catheter Size | Maximum Flow Rate* | Injection Pressure
Limit Setting |
|---------------------|--------------------|-------------------------------------|
| 3 Fr Single Lumen | 2 mL/sec | 325 psi |
| 4 Fr Single Lumen | 4 mL/sec | 325 psi |
| 5 Fr Single Lumen | 7 mL/sec | 325 psi |
| 5 Fr Double Lumen | 5 mL/sec | 325 psi |
| 6 Fr Triple Lumen** | 7 mL/sec | 325 psi |
*Flow rates achieved using room temperature Omnipaque 300® contrast and verified using a Medrad Stellant® CT injector system. Omnipague 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.
**Lumen #1 only.
Omnipaque 300® is a registered trademark of Amersham Health, New Jersey.
Prescription Use XX (Per 21 CFR 801.109)
Over-the-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
OR
| PAGE IF NEEDED) | |
|---|---|
| I |
Sumalatha
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
| 510(k) Number: | K1004 |
|---|---|
| ---------------- | ------- |