(58 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a standard medical catheter, with no mention of AI or ML components or capabilities.
No.
The device is used for monitoring, sampling, and administration of drugs and fluids, rather than for diagnosing, treating, or preventing disease, which are typical functions of a therapeutic device.
No
The device is described as being used for venous pressure monitoring, blood sampling, and administration of drugs and fluids, which are primarily interventional and therapeutic functions, not diagnostic ones.
No
The device description clearly outlines multiple physical components made of polyurethane and plastic, such as the catheter, manifold, tubing, clamp, and hub. There is no mention of software as a component or the primary function of the 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 "venous pressure monitoring, blood sampling and administration of drugs and fluids." This describes a device used in vivo (within the body) for direct patient care and treatment.
- Device Description: The description details a catheter and associated components designed for insertion into a vein. This is consistent with a medical device used for accessing the circulatory system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve reagents, analyzers, or other components used to test biological samples like blood, urine, or tissue.
Therefore, the Urethane PICC Line is a medical device used for direct patient intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
“The Urethane PICC Lines will be indicated for intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy.”
“Used for venous pressure monitoring, blood sampling and administration of drugs and fluids.”
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
“The Urethane PICC Line is comprised of five components which can be further described as follows:
- Catheter: The catheter is constructed of polyurethane and is available in 4 Fr and 5 Fr single lumen configurations. The catheter is 60 cm in length.
- The distal end of the catheter tubing has depth distance markers in 5 cm increments.
- The final 5 cm (from the 55 cm mark to the winged manifold) are designed as a bump tubing.
- The proximal end configuration is composed of a winged manifold, extension tubing, and a luer lock hub which are discussed below.
- Winged Manifold: The winged manifold is constructed of polyurethane.
- Extension Tubing: The extension tube is constructed of polyurethane.
- Clamp: A plastic clamp is provided around the external surface of the extension tube.
- Luer Lock Hub: The luer lock hub is constructed of polyurethane and is stamped on either side with the following information: 1) COOK® 4 FR/.9 CC LUM VOL, or 2) COOK® 5 FR/1.3 CC LUM VOL.
The Urethane PICC Line will also be available in a set or tray that incorporates legally marketed accessories. These accessories are identical to those currently sold in COOK®'s Silicone PICC Line sets and trays.”
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
“The Urethane PICC Line has been subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Tensile testing of junctions
- Flow testing
- Burst testing
- Leakage testing
- Air leakage during aspiration
- Hub durability
- Extension Tube Durability
- Stability Testing”
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
AUG 27 1999
Special 510(k) Premarket Notification: Modified Device Urethane PICC Line COOK INCORPORATED
K 992198
Safety and Effectiveness Information
Lisa Webb, RAC Submitted By: Regulatory Affairs Coordinator COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 June 29, 1999
| Device: | Trade Name: | Urethane PICC Line |
|---|---|---|
| Proposed Classification Name: | Intravascular Catheter |
Predicate Devices:
The Urethane PICC Line is similar in terms of intended use, materials of construction, and technological characteristics as the predicate devices reviewed: COOK® Silicone PICC Lines, Arrow International PICC Lines, and Vaxcel™ PICC Lines.
Device Description:
The Urethane PICC Line is comprised of five components which can be further described as follows:
- O Catheter: The catheter is constructed of polyurethane and is available in 4 Fr and 5 Fr single lumen configurations. The catheter is 60 cm in length.
- The distal end of the catheter tubing has depth distance markers in 5 cm increments. o
- The final 5 cm (from the 55 cm mark to the winged manifold) are designed as a bump tubing.
- The proximal end configuration is composed of a winged manifold, extension tubing, and a luer lock hub which are discussed below.
- Winged Manifold: The winged manifold is constructed of polyurethane. o
- Extension Tubing: The extension tube is constructed of polyurethane.
- Clamp: A plastic clamp is provided around the external surface of the extension tube. ට
- Luer Lock Hub: The luer lock hub is constructed of polyurethane and is stamped on either side with the following information: 1) COOK® 4 FR/.9 CC LUM VOL, or 2) COOK® 5 FR/1.3 CC LUM VOL.
The Urethane PICC Line will also be available in a set or tray that incorporates legally marketed accessories. These accessories are identical to those currently sold in COOK®'s Silicone PICC Line sets and trays.
1
Substantial Equivalence:
Three devices are currently marketed which are believed to be substantially equivalent to the Urethane PICC Line, subject of this submission. These devices include Silicone PICC Lines (COOK® Inc.), Peripherally Inserted Central Catheters (Arrow International), and Vaxcel™ PICC Lines (Boston Scientific/Medi-Tech®).
Silicone PICC Lines (COOK® Inc.) are legally marketed as Preamendment Devices under the document registration number A137605 and have not been the subject of premarket notification clearance. These Silicone PICC Lines are indicated for intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy. The device is constructed of silicone and is manufactured in single and double lumen configuration. The catheter is available in sizes of 3, Fr, 4 Fr, 5 Fr, 6 Fr, and in lengths ranging from 50 to 60 cm.
Peripherally Inserted Central Catheters (Arrow International) were reviewed as substantially equivalent under K862056 and are indicated for venous access to the central circulation through a peripheral vein for an alternative method of intravenous therapy for select adult and pediatric patients. The device is constructed of Urethane and is manufactured in single or double lumen configurations. The catheter is available in sizes of 16 gage, 3 Fr, 4 Fr, and 5 Fr and in lengths ranging from 50 to 70 cm.
Vaxcel™ PICC Lines (Boston Scientific/Medi-Tech®) are currently in commercial distribution. The Vaxcel™ PICC Lines are indicated for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. The device is constructed of Urethane and is manufactured in single or double lumen configurations. The catheter is available in sizes of 4 Fr and 5 Fr and in a length of 60 cm.
The Urethane PICC Lines will be indicated for intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy. The device will be constructed of polyurethane and will be manufactured in a single lumen configuration. The catheter will be available in sizes of 4 Fr and in a length of 60 cm. The fundamental scientific technology of the modified device has not been changed by the requested modifications of this submission.
2
Test Data
The Urethane PICC Line has been subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Tensile testing of junctions 0
- Flow testing ロ
- Burst testing ם
- Leakage testing
- Air leakage during aspiration
- Hub durability
- Extension Tube Durability 0
- Stability Testing o
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines beneath them, resembling a bird or a wave. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Ms. Lisa Webb Regulatory Affairs Coordinator Cook®, Incorporated 925 South Curry Pike P.O. Box 489 Bloomington, Indiana 47402
Re : K992198 Urethane PICC Line Model UPICS-Trade Name: Requlatory Class: II Product Code: FOZ August 5, 1999 Dated: Received: August 6, 1999
Dear Ms. Webb
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 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.
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 regulation may result in regulatory action. In addition, FDA 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
4
Page 2 - Ms. Webb
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 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 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
thy A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) Premarket Notification: Modified Device Urethane PICC Line COOK INCORPORATED
4992198 510(k) Number (if known):
Urethane PICC Line Device Name:
Indications for Use:
Used for venous pressure monitoring, blood sampling and administration of drugs and fluids.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 CFR 801.109) OR
Over-the-Counter
Palioan Cuenta
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K993148