A vascular access catheter used for, infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring (CVP), acute hyperalimentation, continuous or intermittent drug infusion.

Device Description

The Triple Lumen Central Venous consists of a three-lumen, silicone shaft and manifold hub. With three separate lumens, it is possible to infuse/withdraw several different medications simultaneously. The catheter will be available in 12.5 Fr. The catheter will be part of a set which contains a percutaneous entry needle, peel-away sheath, curved wire guide, introducer and Luer-slip syringe. This set will be supplied sterile, packaged in trays.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Triple Lumen Central Venous Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific performance metrics against those criteria, and detailed study designs (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance) would generally not be found in such a document for this type of medical device.

The study described is more akin to verification and validation testing to ensure the device performs as intended and is safe, rather than a clinical effectiveness study.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Reported Device Performance (Implied)
Tensile Strength	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an intravascular catheter."
Flow Rate	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an intravascular catheter."
Leak/Pressure Integrity	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an intravascular catheter."
Catheter Occlusion	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an intravascular catheter."
Biocompatibility	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an intravascular catheter."

Note: The document states that the test results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific quantitative performance values achieved by the device. This level of detail is typically found in the full submission, not the summary.

2. Sample sized used for the test set and the data provenance:

Sample Size for Test Set: Not specified in the provided text.
Data Provenance: The tests are "Testing conducted on the Triple Lumen Central Venous Catheter," implying bench testing rather than clinical data from a specific geographical origin. It's likely prospective in the sense that the device was manufactured and then tested according to a plan, but it's not a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This type of information is not applicable as the "tests" described are engineering and material performance tests (tensile, flow, leak, occlusion, biocompatibility), not diagnostic or interpretative tasks requiring expert consensus for ground truth.

4. Adjudication method for the test set:

Not applicable for the type of engineering and material performance tests described. Adjudication typically applies to expert review of diagnostic images or clinical outcomes.

5. 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, an MRMC comparative effectiveness study was not done. This device is a physical medical catheter, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This pertains to AI algorithms, which this device is not. The "standalone" performance here would refer to the device's physical performance in isolation, which is what the "Test Data" section addresses.

7. The type of ground truth used:

The "ground truth" for these tests would be established through scientific and engineering standards and specifications. For example:
- Tensile: Material strength specifications (e.g., ISO standards for medical devices).
- Flow: Fluid dynamics principles and medical requirements for infusion rates.
- Leak/Pressure: Pressure holding capacity standards for catheters.
- Catheter Occlusion: Functional criteria to ensure patency.
- Biocompatibility: ISO 10993 standards for biological evaluation of medical devices.

8. The sample size for the training set:

Not applicable. This typically refers to training data for AI/machine learning models. The development of this physical medical device would involve engineering design and iterative prototyping, not a "training set" in the AI sense.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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Ko13/82 13

Triple Lumen Central Venous Catheter 510 (k) Premarket Notification Cook Incorporated

ਰੇ 510K Summary

Submitted By:

Lisa Hopkins Regulatory Affairs Coordinator COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235

Device:

Trade Name: Triple Lumen Central Venous Catheter Central Venous Catheter Common/Usual Name:

Proposed Classification Name:	Intravascular Catheter
	21 CFR Part 880.5200, FOZ

Intended Use:

The Triple Lumen Central Venous Catheter is intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring (CVP), plasma pheresis, acute hyperalimentation, continuous or intermittent drug infusion.

The device will be supplied sterile and is intended for one-time use.

Predicate Devices:

Cook Double Lumen Catheters	Marketed & Distributed byCook Incorporated(Preamendment)
Arrow-Howes Large BoreMulti-lumen CentralVenous Catheter	Marketed & Distributed byArrow InternationalK970864

Device Description

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Triple Lumen Central Venous Catheter 510 (k) Premarket Notification Cook Incorporated

Substantial Equivalence:

The device will be manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to currently marketed devices. This device is similar with respect to intended use, and physical characteristics to predicate devices in terms of section 510(k) substantial equivalency.

Test Data:

Testing conducted on the Triple Lumen Central Venous Catheter includes:

Tensile �
� Flow
� Leak /Pressure
Catheter Occlusion �
� Biocompatibility

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an intravascular catheter.

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Image /page/2/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is listed as 9200 Corporate Boulevard, Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.

1 2002 JUL

Ms. Lisa Hopkins Cook, Incorporated Regulatory Affairs Coordinator P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K013182/S2

Trade/Device Name: Triple Lumen Central Venous Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Central Venous Catheter Regulatory Class: II Product Code: FOZ Dated: April 24, 2002 Received: April 25, 2002

Dear Ms. Hopkins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 - Ms. Hopkins

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely,

Timothy A. Ulatowski

Timothy Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K013182

Triple Lumen Central Venous Catheter Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V Use (Per 21 CFR 801.109) OR

Over-the-Counter

Patric Cucenitz
Division Sign Off

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

Hospital Devices

510(k) Number K013182/52

Regulation Number and Section

§ 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).