(77 days)
Not Found
Not Found
No
The 510(k) summary describes a standard medical device (a catheter) and makes no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on functional testing and biocompatibility, not algorithmic performance.
No
The device is described as a catheter used for venous access for injections, infusions, and blood sampling. It facilitates therapy but is not a therapeutic device itself.
No
The device is a peripherally inserted catheter used for venous access for injections, infusions, and blood sampling. While it facilitates blood sampling (which can be used for diagnostic purposes), the device itself does not perform any diagnostic function such as analyzing the blood or interpreting results. Its primary role is therapeutic access.
No
The device description clearly states it is a physical catheter made of polyurethane with accessories like needles and clamps, and the performance studies involve in-vitro functional testing and biocompatibility, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for repeated venous access for intravenous injection or infusion and/or venous blood sampling. This describes a device used in vivo (within the body) for delivering substances or collecting samples, not for performing tests in vitro (outside the body) on those samples.
- Device Description: The description details a catheter designed to be inserted into a vein. This is a medical device used for direct patient interaction and treatment/sampling, not for analyzing biological samples in a lab setting.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analytical methods, or any other components or processes typically associated with in vitro diagnostic testing.
The device is clearly a medical device used for patient care and sample collection, not for performing diagnostic tests on those collected samples.
N/A
Intended Use / Indications for Use
"The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter is used when therapy requires repeated venous access for intravenous injection or infusion and/or venous blood sampling."
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The modified CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters are similar in design and function to the current commercially available CliniCath® Peripherally Inserted Catheters.
The catheters are designed to permit repeated venous access for intravenous injection or infusion and/or venous blood sampling
The product consists of single- and dual-lumen, radiopaque polyurethane catheters with preinserted stylets, clamps, and attached stylet/flushing assemblies. Catheters will be made available with and without the following accessories: introducer needle, injection cap and procedural tray. Catheters will be provided in single- and multi-unit package configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral vein
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)
Functional Testing: In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters," dated March 1995.
Biocompatibility testing was conducted on the device.
Clinical Studies: Clinical studies were not deemed necessary regarding the CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter due to its similarity in design and function to current commercially available peripherally inserted catheters.
Conclusion: The results of the testing indicated that the CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters function according to specification and the materials used in the device are biocompatible. Therefore, the device is considered acceptable for human 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.
Not Found
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
510(k) SUMMARY OF SAFETY AND EFFECTIVEN
CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters
November 12, 1998
I. GENERAL INFORMATION
| Applicant's Name and Address: | SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa Stone
Manager, Regulatory Affairs
Tel. (612) 628-7224 |
| Common/Usual Name: | Peripherally Inserted Venous Catheters |
| Proprietary Name: | CliniCath® PolyFlow® Polyurethane Peripherally
Inserted Catheters |
| Equivalence Device Comparison: | CliniCath® Peripherally Inserted Catheters
(manufactured by SIMS Deltec, Inc.)
BIOVUE Peripherally Inserted Catheters
(manufactured by Johnson & Johnson Medical Inc.) |
II. DEVICE DESCRIPTION
The modified CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters are similar in design and function to the current commercially available CliniCath® Peripherally Inserted Catheters.
The catheters are designed to permit repeated venous access for intravenous injection or infusion and/or venous blood sampling
The product consists of single- and dual-lumen, radiopaque polyurethane catheters with preinserted stylets, clamps, and attached stylet/flushing assemblies. Catheters will be made available with and without the following accessories: introducer needle, injection cap and procedural tray. Catheters will be provided in single- and multi-unit package configurations.
1
INTENDED USE OF DEVICE III.
The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter is used when therapy requires repeated venous access for intravenous injection or infusion and/or venous blood sampling.
DEVICE COMPARISON IV.
| | CliniCath® PolyFlow®
Polyurethane Peripherally
Inserted Catheters | CliniCath® Peripherally
Inserted Catheters | BIOVUE Peripherally
Inserted Catheters |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Johnson & Johnson Medical
Inc. |
| INDICATION FOR USE | The CliniCath® PolyFlow®
Polyurethane Peripherally
Inserted Catheter is used
when therapy requires
repeated venous access for
intravenous injection or
infusion and/or venous blood
sampling. | The CliniCath® Peripherally
Inserted Catheter is used
when therapy requires
repeated venous access for
intravenous injection or
infusion and/or venous blood
sampling. | BIOVUE Peripherally
Inserted Catheters are
designed for prolonged
peripheral venous access for
the infusion of IV therapy
solutions and blood sampling. |
| CATHETER INSERTION | Peripheral vein | Peripheral vein | Peripheral vein |
| CATHETER TIP
PLACEMENT | Peripheral/Central | Peripheral/Central | Peripheral/Central |
| CATHETER MATERIAL | Radiopaque Polyurethane | Radiopaque Silicone | Radiopaque Polyurethane |
| AVAILABLE CATHETER
SIZES | Single-Lumen
2 French (24 Gauge)
3 French (20 Gauge)
4 French (18 Gauge)
5 French (16 Gauge)
Dual-Lumen
4 French (18 Gauge)
5 French (16 Gauge) | Single-Lumen
3 French (20 Gauge)
4 French (18 Gauge)
5 French (16 Gauge)
--- | Single-Lumen
2 French (24 Gauge)
3 French (20 Gauge)
4 French (18 Gauge)
Dual-Lumen
4 French (18 Gauge)
5 French (16 Gauge) |
| | CliniCath® PolyFlow®
Polyurethane Peripherally
Inserted Catheters | CliniCath® Peripherally
Inserted Catheters | BIOVUE Peripherally
Inserted Catheters |
| CATHETER O.D. AND I.D.
(Nominal) | | | |
| Single-Lumen | | | |
| 2 French | 0.7 mm O.D. x 0.4 mm I.D. | - | 0.7 mm O.D. x 0.4 mm I.D. |
| 3 French | 1.0 mm O.D. x 0.5 mm I.D. | 0.9 mm O.D. x 0.5 mm I.D. | 1.0 mm O.D. x 0.6 mm I.D. |
| 4 French | 1.4 mm O.D. x 0.8 mm I.D. | 1.3 mm O.D. x 0.8 mm I.D. | 1.2 mm O.D. x 0.8 mm I.D. |
| 5 French | 1.7 mm O.D. x 1.0 mm I.D. | 1.7 mm O.D. x 1.0 mm I.D. | - |
| Dual-Lumen | | | |
| 4 French | 1.4 mm O.D. x 0.8/0.6 mm I.D. | - | 1.3 mm O.D. x I.D. not noted |
| 5 French | 1.7 mm O.D. x 0.9/0.8 mm I.D. | - | 1.7 mm O.D. x I.D. not noted |
| CATHETER LENGTH
(Nominal) | 20 cm, 30 cm, 50 cm, and 65 cm | 20 cm and 65 cm | 20 cm, 30 cm, and 60 cm |
| FLOW RATE (Nominal) | DELTEC FLOW RATES:
GRAVITY FLOW AT 1
METER | DELTEC FLOW RATES:
GRAVITY FLOW AT 1
METER | J&J FLOW RATES:
GRAVITY FLOW AT 48
INCHES |
| Single-Lumen | | | |
| 2 French, 50 cm | 37 ml/hr | - | - |
| 2 French, 30 cm | 62 ml/hr | - | 66 ml/hr |
| 2 French, 20 cm | 89 ml/hr | - | - |
| 3 French, 65 cm | 123 ml/hr | 68 ml/hr | - |
| 3 French, 60 cm | - | - | 150 ml/hr |
| 3 French, 20 cm | 362 ml/hr | 227 ml/hr | 270 ml/hr |
| 4 French, 65 cm | 659 ml/hr | 479 ml/hr | - |
| 4 French, 60 cm | - | - | 570 ml/hr |
| 4 French, 20 cm | 1505 ml/hr | >999 ml/hr | 960 ml/hr |
| 5 French, 65 cm | 1444 ml/hr | >999 ml/hr | - |
| 5 French, 20 cm | 3020 ml/hr | >999 ml/hr | - |
| Dual-Lumen | | | |
| 4 French, 60 cm | - | - | 150 ml/hr (each lumen) |
| 4 French, 65 cm | 224 ml/hr (lg lumen)
123 ml/hr (sm lumen) | - | - |
| 4 French, 20 cm | 611 ml/hr (lg lumen)
322 ml/hr (sm lumen) | - | 240 ml/hr (each lumen) |
| 5 French, 60 cm | 660 ml/hr (lg lumen)
424 ml/hr (sm lumen) | - | 540 ml/hr (each lumen) |
| 5 French, 65 cm | - | - | - |
| 5 French, 20 cm | 1606 ml/hr (lg lumen)
1096 ml/hr (sm lumen) | - | - |
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510(k) Summary of Safety and Effectiveness Page 3 of 4
3
510(k) Summary of Safety and Effectiveness Page 4 of 4
SUMMARY OF STUDIES V.
Functional Testing A.
In-vitro testing was conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters," dated March 1995.
Biocompatibility testing was conducted on the device.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter due to its similarity in design and function to current commercially available peripherally inserted catheters.
C. Conclusion Drawn from the Studies
The results of the testing indicated that the CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters function according to specification and the materials used in the device are biocompatible. Therefore, the device is considered acceptable for human use.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 29 1999
Ms. Lisa J. Stone Manager, Requlatory Affairs SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
K984055 Re : Trade Name: CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters Regulatory Class: II Product Code: FOZ Dated: November 12, 1998 November 13, 1998 Received:
Dear Ms. Stone:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Ms. Stone
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA acinding 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation chercica) hisbidian's by Solorigeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
6
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters
Indications for Use:
"The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheter is used when therapy requires repeated venous access for intravenous injection or infusion and/or venous blood sampling."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) | Brenk Bolster |
---|---|
Division of Dental, Infection Control, and General Hospital Devices | |
510(k) Number | K984055 |
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The Counter Use ___________