Plastimed's Seldiflex® central venous catheter is intended for long-term vascular access and is indicated for use with patients who require central venous pressure monitoring, I.V. fluids, blood products, drugs, or parenteral nutrition solutions.

Device Description

The Seldiflex® is a single lumen, radiopaque polyurethane, long-term central venous catheter. Its accessories include a protective adapter female cap, introducer needle, needle obturator, double-ended J guidewire, scalpel, catheter clamp, rigid fastener, a vessel dilator, and silver Dacron® cuff.

AI/ML Overview

The provided 510(k) summary for the Seldiflex® central venous catheter describes a device that is exempt from a clinical study to prove acceptance criteria because it focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing, rather than an AI/ML-driven device requiring performance metrics. Therefore, many of the requested categories related to AI/ML device performance studies are not applicable to this submission.

Here's the information that can be extracted or deduced from the provided document:

Acceptance Criteria and Device Performance (Not Applicable for AI/ML performance)

This submission focuses on demonstrating substantial equivalence to predicate devices based on functional design, materials, and indications for use, rather than meeting specific quantifiable performance metrics typically associated with AI/ML devices. The "acceptance criteria" are implied by successful functional and safety testing and similarity to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Functional operation under normal usage conditions	"The results of the examination and testing were successful."
Conformance to product specifications	"The results of the examination and testing were successful."
No new issues of safety and effectiveness compared to predicates	"did not raise any issues of safety and effectiveness."
Substantial equivalence to predicate catheters	"substantially equivalent to the Hickman/Broviac central venous catheters..." and "ONECATH® long-term intravascular catheters..."

Study Information (Relevant to the provided document)

Since this is for a medical device (central venous catheter) that is not an AI/ML device, many of the requested study details (sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, training set details) are not applicable in the context of this 510(k) submission.

Sample size used for the test set and the data provenance: Not specified. The document states "Functional and safety testing... consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications." This implies in-house testing, likely with a sample size determined by internal quality standards for mechanical and material properties, rather than a clinical trial. Data provenance is not described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a central venous catheter, "ground truth" would relate to its physical properties, biocompatibility, and functional integrity, which are assessed through engineering and material science testing, not typically by clinical experts establishing ground truth in the way it's done for diagnostic AI/ML.
Adjudication method for the test set: Not applicable. The testing described (functional and safety) would involve objective measurements and observations against pre-defined specifications without the need for an adjudication process.
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: Not applicable. This is not an AI/ML device, so no MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: For this type of device, the "ground truth" for the functional and safety testing would be based on engineering specifications, material standards, and established performance benchmarks for similar medical devices. For example, testing for tensile strength (material property), flow rates (functional property), or biocompatibility (safety).
The sample size for the training set: Not applicable. There is no AI/ML component, therefore no training set.
How the ground truth for the training set was established: Not applicable. There is no AI/ML component or training set.

Summary

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K992424

A. 510(k) Summary

SUBMITTER:

CONTACT PERSON:

Plastimed Laboratoire Pharmaceutique

Dr. Jean Daniel Nury B.P. 20 2 Rue Loues Armand Saint-Leu-La-Forêt Cédex 95321 France Ph: 011 33 134 44 15 15 Fax: 011 33 1 30 72 22 08

DATE PREPARED:

TRADE NAME:

NAME

& NUMBER

PREDICATE

DEVICE(S):

CLASSIFICATION

PRODUCT CODE:

June 11, 1999

DEC 2 9 2000

Seldiflex® central venous catheter

Long-term intravascular catheter Unclassified Lis

The Seldiflex® central venous catheter is substantially equivalent to the Hickman/Broviac central venous catheters manufactured by Bard Access Systems (K823553) and the ONECATH® long-term intravascular catheters manufactured by Luther Medical Products, Inc. (K980090), and other similar devices made by other manufacturers.

DEVICE DESCRIPTION:

INTENDED USE:

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nutrition solutions.

FUNCTIONAL & SAFETY TESTING:

Functional and safety testing of the Seldiflex® central venous catheter consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results of the examination and testing were successful, and did not raise any issues of safety and effectiveness of the device.

CONCLUSION:

B. Truthful and Accurate Statement

The Truthful and Accurate Statement is on the following page.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 9 2000

Mr. Jean-Daniel Nury General Manager Plastimed Laboratoire Pharmaceutiqu 95321 Saint-Lue-La-Foret Cedex, FRANCE

K992424 Re :

Seldiflex® Central Catheter Trade Name: Requlatory Class: II Product Code: LJS Dated: October 6, 2000 October 10, 2000 Received:

Dear Mr. Nury:

We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we have determined the marker 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, devices markees& In f 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). provibions or cho, 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. ਚੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Nury

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 Additionally, for questions on Compliance at (301) 594-4692. 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 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/dsma/dsmamain.html".

Sincerely yours,

Herald W. Sharp

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital DEvices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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INDICATIONS FOR USE PAGE

510(k) Number (if known): K992424

Device Name: Seldiflex® Central Venous Catheter

INDICATIONS FOR USE:

Concurrence of CDRH, Office of Device Evaluation (ODE)

< Prescription Device

Hevel W. Sheppard

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device F (Cik) Mumber .

510(k) Notification - Plastimed SELDIFLEX® Catheter June 1999

Page 1

Regulation Number and Section

§ 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.”