(154 days)
Not Found
Not Found
No
The summary describes a physical medical device (catheter) and its accessories, with no mention of software, algorithms, or any terms related to AI or ML.
No.
The device is described as a catheter for venous access and delivery/sampling, which is a diagnostic/delivery tool, not a therapeutic device in itself.
No
The device is a catheter designed for repeated venous access for infusions, injections, and blood sampling, not for diagnosing conditions.
No
The device description clearly outlines physical components like a silicone catheter, stiffening wire, flushing assembly, and various accessories (needle, guidewire, etc.), indicating it is a hardware medical device.
Based on the provided information, the CliniCath™ IR Peripherally Inserted Central Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for providing venous access for intravenous injection, infusion therapy, and blood sampling. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes on the patient, not for testing samples outside the body.
- Device Description: The description details a catheter designed to be inserted into a vein. This is a medical device used for direct patient care.
- 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.) for the purpose of providing information about a physiological state, health, disease, or congenital abnormality.
IVD devices are used to perform tests on samples taken from the body, such as blood glucose meters, pregnancy tests, or laboratory analyzers. The CliniCath™ is a device used to access the body for treatment and sample collection, not to analyze those samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Venous system (Peripheral vein, Central)
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:
- Study Type: In-vitro testing
- Methodology: Conducted in accordance with the FDA "Guidance on Premarket Notification [510(k)] Submissions for Short- and Long-term Intravascular Catheters," dated March 1995.
- Key Results: The results of the testing indicated that the CliniCath™ IR Peripherally Inserted Central Catheter functions according to specification.
Biocompatibility Testing:
- Study Type: Biocompatibility testing
- Methodology: Conducted on the device.
- Key Results: The materials used in the device are biocompatible.
Clinical Studies:
- Study Type: Not deemed necessary.
- Reasoning: Due to its similarity in materials; design and function to current commercially available CliniCath™ Peripherally Inserted Venous Catheters.
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.
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
§ 880.5970 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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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™ IR
Peripherally Inserted
Central Catheters | CliniCath™
Peripherally Inserted
Catheters | Cook Peripherally
Inserted Central Venous
Catheter Sets |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Cook, Inc. |
| INDICATION 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. | The CliniCath™ Peripherally
Inserted Central Catheter is used
when therapy requires repeated
venous access for intravenous
injection or infusion and/or
venous blood sampling. | Peripherally Inserted Central
Venous Catheter is suggested for:
(1) Delivery of whole blood or
blood products; (2) Drug
administration; and (3) Blood
sampling. |
| CATHETER INSERTION | Peripheral vein | Peripheral vein | Peripheral vein |
| CATHETER TIP
PLACEMENT | Central | Peripheral/Central | Central |
| CATHETER MATERIAL | Radiopaque Silicone | Radiopaque Silicone | Radiopaque Silicone |
| AVAILABLE CATHETER
SIZES | 4 French (18 Gauge)
5 French (16 Gauge) | 3 French (20 Gauge)
4 French (18 Gauge)
5 French (16 Gauge) | 3 French
4 French
5 French |
| CATHETER O.D. AND I.D.
(Nominal)
4 French
5 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 for
testing. |
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