(154 days)
The CliniCath™ IR Peripherally Inserted Central Catheter is used when patient therapy requires repeated venous access for intravenous injection or infusion therapy and/or venous blood sampling.
The modified CliniCath™ IR Peripherally Inserted Central Catheters are similar in design and function to the current commercially available CliniCath™ Peripherally Inserted Venous Catheters.
The catheters are designed to permit repeated access to the venous system for the delivery of medications, fluids, and nutritional solutions, and for blood therapy and/or sampling.
The product consists of a single-lumen, radiopaque silicone catheter with preinserted catheter stiffening wire and attached flushing assembly. Catheters will be made available with and without the following accessories: introducer needle, guidewire, dilator/sheath assembly, syringe, tape measure, mini-scalpel and injection cap. Catheters will be provided in single- and multi-unit package configurations.
Device Acceptance Criteria and Study Details: CliniCath™ IR Peripherally Inserted Central Catheters (K970269)
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Function according to specification (based on in-vitro testing) | The results of the testing indicated that the CliniCath™ IR Peripherally Inserted Central Catheter functions according to specification. |
| Materials are biocompatible | The materials used in the device are biocompatible. |
2. Sample Size and Data Provenance for Test Set
There was no specific "test set" in the context of a clinical study. The device's performance was evaluated through in-vitro functional testing and biocompatibility testing. Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. Ground truth for functional testing and biocompatibility testing does not typically rely on "experts" in the same way clinical imaging studies do. Functional tests are typically evaluated against established engineering specifications, and biocompatibility tests follow specific standardized protocols.
4. Adjudication Method for Test Set
Not applicable. As there was no clinical test set requiring ground truth establishment through expert review, no adjudication method was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical studies were not deemed necessary regarding the CliniCath™ IR Peripherally Inserted Central Catheter due to its similarity in materials; design and function to current commercially available CliniCath™ Peripherally Inserted Venous Catheters."
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical device (catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the device's acceptable performance was based on:
- Engineering specifications for functional performance (evaluated through in-vitro testing).
- Standardized biocompatibility test results against established safety limits for medical device materials.
8. Sample Size for Training Set
Not applicable. This a physical medical device, not an AI/machine learning model, so there is no "training set."
9. How Ground Truth for Training Set Was Established
Not applicable. As there is no training set for an AI/machine learning model, no ground truth was established for it.
{0}------------------------------------------------
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CliniCath™ IR Peripherally Inserted Central Catheters - K970269
January 22, 1997
JUN 26 B97
GENERAL INFORMATION I.
Applicant's Name and Address:
Contact Person:
St. Paul, MN 55112 Lisa Stone Manager, Regulatory Affairs
SIMS Deltec, Inc.
1265 Grey Fox Road
Tel. (612) 628-7224
Common/Usual Name:
Proprietary Name:
Equivalence Device Comparison:
Peripherally Inserted Venous Catheters
CliniCath™ IR Peripherally Inserted Central Catheters
CliniCath™ Peripherally Inserted Venous Catheters (manufactured by SIMS Deltec, Inc.)
Peripherally Inserted Central Venous Catheter Sets (manufactured by Cook, Inc.)
II. DEVICE DESCRIPTION
The modified CliniCath™ IR Peripherally Inserted Central Catheters are similar in design and function to the current commercially available CliniCath™ Peripherally Inserted Venous Catheters.
The catheters are designed to permit repeated access to the venous system for the delivery of medications, fluids, and nutritional solutions, and for blood therapy and/or sampling.
The product consists of a single-lumen, radiopaque silicone catheter with preinserted catheter stiffening wire and attached flushing assembly. Catheters will be made available with and without the following accessories: introducer needle, guidewire, dilator/sheath assembly, syringe, tape measure, mini-scalpel and injection cap. Catheters will be provided in single- and multi-unit package configurations.
{1}------------------------------------------------
III. INTENDED USE OF DEVICE
The CliniCath™ IR Peripherally Inserted Central Catheter is used when patient therapy requires repeated venous access for intravenous injection or infusion therapy and/or venous blood sampling.
IV. DEVICE COMPARISON
| CliniCath™ IRPeripherally InsertedCentral Catheters | CliniCath™Peripherally InsertedCatheters | Cook PeripherallyInserted Central VenousCatheter Sets | |
|---|---|---|---|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Cook, Inc. |
| INDICATION FOR USE | The CliniCath™ IR PeripherallyInserted Central Catheter is usedwhen therapy requires repeatedvenous access for intravenousinjection or infusion and/orvenous blood sampling. | The CliniCath™ PeripherallyInserted Central Catheter is usedwhen therapy requires repeatedvenous access for intravenousinjection or infusion and/orvenous blood sampling. | Peripherally Inserted CentralVenous Catheter is suggested for:(1) Delivery of whole blood orblood products; (2) Drugadministration; and (3) Bloodsampling. |
| CATHETER INSERTION | Peripheral vein | Peripheral vein | Peripheral vein |
| CATHETER TIPPLACEMENT | Central | Peripheral/Central | Central |
| CATHETER MATERIAL | Radiopaque Silicone | Radiopaque Silicone | Radiopaque Silicone |
| AVAILABLE CATHETERSIZES | 4 French (18 Gauge)5 French (16 Gauge) | 3 French (20 Gauge)4 French (18 Gauge)5 French (16 Gauge) | 3 French4 French5 French |
| CATHETER O.D. AND I.D.(Nominal)4 French5 French | 1.4 mm O.D. x 0.7 mm I.D.1.7 mm O.D. x 1.0 mm I.D. | 1.3 mm O.D. x 0.8 mm I.D.1.7 mm O.D. x 1.0 mm I.D. | 1.4 mm O.D. x 0.6 mm I.D.1.7 mm O.D. x 0.9 mm I.D. |
| CATHETER LENGTH(Nominal) | 65 cm | 20 cm and 65 cm | 50 cm and 60 cm |
| FLOW RATE (Nominal)(1 METER GRAVITY FLOW) | 4 French (65 cm)$7 ml/min. \pm 0.7 ml/min.$ | 4 French (65 cm)479 ml/hr | 4 French (60 cm)270 ml/hr |
| 5 French (65 cm)$20 ml/min. \pm 1.2 ml/min.$ | 5 French (65 cm)1420 ml/hr | 5 French (60 cm)Sample not available fortesting. |
{2}------------------------------------------------
SUMMARY OF STUDIES V.
Functional Testing A.
- 人 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™ IR Peripherally Inserted Central Catheter due to its similarity in materials; design and function to current commercially available CliniCath™ Peripherally Inserted Venous Catheters.
C. Conclusion Drawn from the Studies
The results of the testing indicated that the CliniCath™ IR Peripherally Inserted Central Catheter functions according to specification and the materials used in the device are biocompatible. Therefore, the device is considered acceptable for human use.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Stone Manager, Regulatory Affairs SIMS Deltec, Incorporated . 1265 Grey Fox Road St. Paul, Minnesota 55112
JUN 2 6 1997
K970269 Re : Clini-Cath™ IR Peripherally Inserted Trade Name: Catheter Requlatory Class: Unclassified Product Code: LJS Dated: June 17, 1997 Received: June 18, 1997
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that of the Act. the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510 (k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your The general controls provisions of the Act include kit. requirements for annual registration, listing of devices, good manufacturing practice, and 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General
{4}------------------------------------------------
(GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please_note: this response to your 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.
This letter will allow you to begin marketing your device as described in your 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 the labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 63/8-2041 or at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known): j 97 C269
Device Name: CliniCath™ IR Peripherally Inserted Central Catheters
Indications for Use:
*The CliniCath™ IR Peripherally Inserted Central 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)
Patrici Guernitz
(Division Sign-Off) X970269
Division of Dental, Infection O and General Hospital Devices 510(k) Number _ 4
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
§ 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.”