(77 days)
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 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.
The CliniCath® PolyFlow® Polyurethane Peripherally Inserted Catheters are compared to two predicate devices: the CliniCath® Peripherally Inserted Catheters and the BIOVUE Peripherally Inserted Catheters. The study conducted was a functional in-vitro testing and biocompatibility testing to demonstrate that the new device performs according to specification and uses biocompatible materials.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices and the “Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters.” The reported device performance is presented through the various specifications shown in the "DEVICE COMPARISON" table, implying that these align with or are superior to the predicate devices, and that the functional testing confirmed these specifications.
| Acceptance Criteria (Implied) | Reported Device Performance (CliniCath® PolyFlow®) |
|---|---|
| Intended Use Equivalence: Repeated venous access for IV injection/infusion and/or blood sampling. | Met (Identical to predicate devices) |
| Catheter Insertion: Peripheral vein | Met (Identical to predicate devices) |
| Catheter Tip Placement: Peripheral/Central | Met (Identical to predicate devices) |
| Catheter Material: Radiopaque Polyurethane | Met (Similar to BIOVUE, different from original CliniCath which was silicone) |
| Available Catheter Sizes: Range of single and dual-lumen sizes. | Met (Offers a wide range, generally comparable to or expanding upon predicate sizes) |
| Catheter O.D. and I.D. (Nominal): Specific dimensions for various sizes. | Met (Detailed dimensions provided, indicating performance within expected ranges for the designated French sizes) |
| Catheter Length (Nominal): Various lengths available. | Met (Offers 20cm, 30cm, 50cm, and 65cm, greater range than original CliniCath) |
| Flow Rate (Nominal): Specific flow rates for various configurations. | Met (Detailed flow rates provided, demonstrating functionality consistent with or exceeding predicate devices where applicable) |
| Functional Performance: Functions according to specifications. | Met (In-vitro testing conducted confirms this performance) |
| Biocompatibility: Materials used are biocompatible. | Met (Biocompatibility testing conducted confirms this) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided text. The document mentions "In-vitro testing was conducted" and "Biocompatibility testing was conducted on the device" but does not specify the number of units or tests performed.
- Data Provenance: Not explicitly stated, however, the testing was "in accordance with the FDA 'Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters,' dated March 1995." This implies the testing was likely conducted in a controlled laboratory environment. It is prospective testing, as it was performed specifically for this 510(k) submission. No country of origin for the data is specified, but given the applicant's location (St. Paul, MN) and FDA submission, it's highly probable the testing was done in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study did not involve expert-based ground truth establishment for a test set in the conventional sense (e.g., image interpretation). The evaluation relied on functional performance metrics and biocompatibility standards rather than human expert opinion on a clinical outcome.
4. Adjudication Method for the Test Set
This information is not applicable as the study involved objective functional and biocompatibility testing, not an assessment requiring adjudication of human-derived observations or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "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." The assessment of effectiveness was based on similarity to predicate devices and in-vitro testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The concept of "standalone performance" typically applies to AI algorithms. This device is a physical medical device (catheter), not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The functional and biocompatibility tests are inherent "standalone" assessments of the device's physical properties and performance.
7. The type of ground truth used
The "ground truth" for the device's performance was established via objective physical and chemical testing standards and specifications. This includes:
- In-vitro functional testing to verify flow rates, catheter dimensions (O.D. and I.D.), and other design specifications.
- Biocompatibility testing to ensure the materials meet established safety standards for human contact.
These are based on established engineering and biological standards, not clinical outcomes or expert consensus on a subjective measure.
8. The sample size for the training set
This information is not applicable. This device is a physical medical device, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for this physical medical device.
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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 RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Lisa StoneManager, Regulatory AffairsTel. (612) 628-7224 |
| Common/Usual Name: | Peripherally Inserted Venous Catheters |
| Proprietary Name: | CliniCath® PolyFlow® Polyurethane PeripherallyInserted 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.
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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 PeripherallyInserted Catheters | CliniCath® PeripherallyInserted Catheters | BIOVUE PeripherallyInserted Catheters | |
|---|---|---|---|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Johnson & Johnson MedicalInc. |
| INDICATION FOR USE | The CliniCath® PolyFlow®Polyurethane PeripherallyInserted Catheter is usedwhen therapy requiresrepeated venous access forintravenous injection orinfusion and/or venous bloodsampling. | The CliniCath® PeripherallyInserted Catheter is usedwhen therapy requiresrepeated venous access forintravenous injection orinfusion and/or venous bloodsampling. | BIOVUE PeripherallyInserted Catheters aredesigned for prolongedperipheral venous access forthe infusion of IV therapysolutions and blood sampling. |
| CATHETER INSERTION | Peripheral vein | Peripheral vein | Peripheral vein |
| CATHETER TIPPLACEMENT | Peripheral/Central | Peripheral/Central | Peripheral/Central |
| CATHETER MATERIAL | Radiopaque Polyurethane | Radiopaque Silicone | Radiopaque Polyurethane |
| AVAILABLE CATHETERSIZES | Single-Lumen2 French (24 Gauge)3 French (20 Gauge)4 French (18 Gauge)5 French (16 Gauge)Dual-Lumen4 French (18 Gauge)5 French (16 Gauge) | Single-Lumen---3 French (20 Gauge)4 French (18 Gauge)5 French (16 Gauge)--- | Single-Lumen2 French (24 Gauge)3 French (20 Gauge)4 French (18 Gauge)---Dual-Lumen4 French (18 Gauge)5 French (16 Gauge) |
| CliniCath® PolyFlow®Polyurethane PeripherallyInserted Catheters | CliniCath® PeripherallyInserted Catheters | BIOVUE PeripherallyInserted 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 1METER | DELTEC FLOW RATES:GRAVITY FLOW AT 1METER | J&J FLOW RATES:GRAVITY FLOW AT 48INCHES |
| 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
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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.
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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
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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 ___________
§ 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).