(58 days)
“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.”
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.
- 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.
The provided document is a 510(k) premarket notification for a medical device, specifically a Urethane PICC Line. It describes the device, its intended use, and its substantial equivalence to predicate devices. It also lists the types of tests performed to assure its design and performance. However, this document does not contain explicit acceptance criteria with numerical targets or detailed study results that "prove" the device meets them in the way modern AI/ML medical devices are assessed.
This document is from 1999 and reflects the regulatory landscape of that time for a relatively simple medical device. The "studies" mentioned are primarily engineering and performance tests, not clinical efficacy trials with human subjects or complex statistical analyses often associated with AI/ML device evaluations.
Here's a breakdown of the requested information based on the provided text, with notes on what is not present in this type of submission for this device:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (as stated or implied) |
|---|---|
| Not explicitly listed as quantitative pass/fail criteria in the provided text for individual tests. | "The Urethane PICC Line has been subjected to the following tests to assure reliable design and performance under the specified testing parameters." |
| Implied Acceptance: Device demonstrates reliable design and performance under specified testing parameters for each test below. | Tests Performed: |
| - Tensile strength of junctions meets specifications | - Tensile testing of junctions performed |
| - Flow rate meets specifications | - Flow testing performed |
| - Burst pressure meets specifications | - Burst testing performed |
| - Absence of leakage | - Leakage testing performed |
| - Absence of air leakage during aspiration | - Air leakage during aspiration performed |
| - Hub maintains durability | - Hub durability performed |
| - Extension tube maintains durability | - Extension Tube Durability performed |
| - Device maintains stability over time | - Stability Testing performed |
Study Details (Based on the document's content)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The tests are industrial/engineering in nature (tensile, flow, burst, etc.), and the sample sizes would typically be determined by internal quality control protocols, but these numbers are not disclosed in this 510(k) summary.
- Data Provenance: Not specified. These are laboratory-based engineering tests, likely conducted by COOK INCORPORATED internally or by an accredited testing lab. Country of origin not mentioned but generally implied to be within the US, as COOK INCORPORATED is based in Bloomington, IN.
- Retrospective or Prospective: These would be considered prospective tests performed on newly manufactured devices or device components as part of the design validation process.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. For a medical device like a PICC line, "ground truth" typically refers to objective physical measurements or established engineering standards. There are no clinical images or diagnostic interpretations requiring expert consensus in these types of performance tests. The "experts" would be engineers and quality control personnel following standardized test methods.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation (e.g., image reading) where disagreement among observers needs a resolution process. The tests listed are objective physical measurements or functional tests of the device.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a traditional medical device (a PICC line), not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a hardware medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Specifications/Standards and Physical Measurements. The "ground truth" for each test would be the predetermined engineering specifications (e.g., minimum tensile strength, maximum leak rate, acceptable flow rate) derived from industry standards (e.g., ISO, ASTM, or internal validated standards) or predicate device performance. Device samples are then tested against these objective criteria.
-
The sample size for the training set:
- Not Applicable. This is a hardware medical device, not an AI/ML device. There is no "training set" in the context of machine learning.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
In summary: The provided document is a 510(k) notification for a conventional medical device. It successfully demonstrates "substantial equivalence" based on materials, intended use, and a series of engineering performance tests against predicate devices. However, it does not involve AI/ML technology or clinical studies with human image interpretation, so many of the requested elements regarding acceptance criteria and study design for AI/ML devices are not present or applicable.
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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.
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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.
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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
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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
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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
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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
§ 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).