The ONECATH Catheter System is designed for use when patient therapy requires repeated venous access or prolonged intravenous administration of fluids, medications, and/or nutritional solutions as prescribed. The catheter is designed to be inserted in a peripheral vein. While any vessel suitable for insertion may be used; the basilic vein is the most commonly used vein.

Device Description

The ONECATH Catheter System consists of a SafeSide DEVICE DESCRIPTION: II® introducer and a radiopaque single lumen polyurethane catheter with a clear tip. The SafeSideII introducer consists of a stainless steel needle and a two-part locking needle protection device with a flashback chamber and introducer protector. The 60, 50 and 20 cm catheters are marked in 5cm increments, in a linear tear protective sleeve. For the 60, 50 and 20 cm catheters a stylet is pre-inserted through the Y-site injection port that is connected to the catheter. A vent plug is inserted in the side port of the Y-site. The SafeSide II introducer is pre-inserted in the catheter through an aperture approximately 2cm from the tip. The ONECATH catheter system is available in various lengths of 60. 50 and 20 cm and is packaged in a two-part tray in a pouch. The ONECATH 5cm catheter is packaged in a pouch with a hemostasis valve. The product contains no DEHP or latex. The female luer is lipid resistant. Non serrated forceps are included.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a medical device (ONECATH® Catheter System), indicating that the manufacturer believes their modified device is "substantially equivalent" to a previously marketed device. In such a submission, the acceptance criteria and a detailed study proving the device meets those criteria, as typically requested in your prompt for AI/algorithm performance, are generally not provided in the same way.

Instead, the submission focuses on demonstrating that the modified device is equivalent to a predicate device and that the modification poses no additional risks or potential questions of efficacy. The "study" isn't a comprehensive clinical trial with ground truth and expert adjudication, but rather a comparison of specifications and an affirmation that existing literature addresses potential complications.

Therefore, many of your requested fields will be filled with "Not Applicable" or explanations based on the context of a 510(k) submission for a physical medical device modification.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission for a physical device modification, "acceptance criteria" are typically met by demonstrating substantial equivalence to a predicate device through material, design, and intended use comparisons, and by showing that the modification does not introduce new risks.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Efficacy Equivalence to Predicate Device	The modification (minor tip configuration change) poses "no additional risks or potential questions of efficacy." (Statement from summary)
Material Equivalence to Predicate Device	"Manufactured using essentially the same materials" (Conclusion) - Radiopaque Polyurethane.
Design Equivalence to Predicate Device	The basic device is "essentially the same as the original ONECATH with a minor change in tip configuration." (Summary) Design elements like introducer, catheter markings, proximal end configuration are the same. Catheter gauge size and length have minor differences from the predicate, but are accepted.
Intended Use Equivalence to Predicate Device	"There is no change in intended use." (Summary) - I.V. Administration, Blood Therapy, Blood Sampling.
Operational Equivalence to Predicate Device	Mode of operation described as "Catheter Insertion Over the Needle Introducer with protected needle" and recommended sites are identical to the predicate device.
Historical Safety Record of Predicate Device	The ONECATH (predicate device) has been marketed since 1994 "with no reported adverse effects." (Substantial Equivalence section)
Known Complications are Documented and Understood	"Extensive studies are available in the scientific literature to address the known complications from the insertion of Catheters." (Potential Complications section)
No DEHP or Latex (for Modified and Predicate)	"The product contains no DEHP or latex." (Device Description)
Lipid Resistance of Female Luer (for Modified and Predicate)	"The female luer is lipid resistant." (Device Description)

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable. This is not a study involving a "test set" of data in the AI/algorithm sense. The evaluation is based on a comparison of device specifications and the historical performance of its predicate.
Data Provenance: Not applicable in the context of an AI test set. The submission relies on the existing market history of the predicate device (ONECATH, marketed since 1994) and general scientific literature on catheter complications. This would be considered retrospective in the sense of reviewing past performance and existing knowledge. The country of origin of this historical data is not specified but would be global, primarily originating from clinical use of the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. No "ground truth" was established based on expert review of a test set in this context. The "ground truth" for a medical device such as this is defined by its mechanical and material properties, and its safe and effective performance in a clinical setting over time, usually through post-market surveillance.
Qualifications of Experts: Not applicable for establishing ground truth of a test set.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring adjudication was used.

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

MRMC Study Done: No. This is a submission for a physical medical catheter, not an AI or imaging device with "human readers."
Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance Study: No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

Type of Ground Truth: For a physical medical device like a catheter, "ground truth" refers to its physical specifications, material composition, functional performance (e.g., flow rates, tensile strength, sterility), and clinical safety and efficacy.
- In this submission, the ground truth is implicitly established by:
  - Material specifications (Radiopaque Polyurethane, no DEHP or latex, lipid-resistant luer).
  - Design specifications (tip configuration, introducer type, markings, lengths, gauges).
  - Intended use and anatomical locations.
  - The historical safety record of the predicate device ("no reported adverse effects" since 1994).
  - General scientific literature on known complications of similar devices.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/algorithm development. Device design and manufacturing processes are iteratively refined (which could be considered a form of "training" in a very broad sense), but there isn't a quantifiable "training set" of data as understood in AI.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. There is no training set in the AI sense. The design and manufacturing processes of medical devices are established through engineering principles, material science, regulatory standards (e.g., ISO, FDA guidance), bench testing, and potentially pre-clinical studies, rather than a "ground truth" for a training set.

Summary

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LUTHER MEDICAL PRODUCTS, INC.

14332 CHAMBERS ROAD TUSTIN, CALIFORNIA 92780-6912

(714) 544-3002 FAX (714) 544-7273

K9800090

MAR 2 4 1998

510(k) SUMMAR Y

GENERAL INFORMATION:

Applicant's Name and Address

Luther Medical Products, Inc. 14332 Chambers Road Tustin, CA 92780-6912 Phone: (714) 544-3002 (714) 544-7273 FAX:

September 4, 1997

Contact Person:

George Brdlik Voice Mail: (714) 544-3002 Ext. 224 FAX: (714) 544-7273

Date of Summary:

Peripherally Inserted Catheter

Common/Usual Name:

Proprietary Name:

Classification Name:

ONECATH® Catheter System an L-Cath® Catheter, Intravascular, Long Term 80FOZ Classification Number: E880.5200 Class II Catheter, Long Term, Implanted 80LJS Classification Number: None

COMPARISON TO A LEGALLY MARKETED DEVICE;

ONECATH (K930743)

Luther Medical Products, Inc. 510(k) Substantially Equivalent Catheter 09/04/97 Page 1 of 4

Class II

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60, 50 and 20 cm catheters a stylet is pre-inserted through the Y-site injection port that is connected to the catheter. A vent plug is inserted in the side port of the Y-site. The SafeSide II introducer is pre-inserted in the catheter through an aperture approximately 2cm from the tip. The ONECATH catheter system is available in various lengths of 60. 50 and 20 cm and is packaged in a two-part tray in a pouch. The ONECATH 5cm catheter is packaged in a pouch with a hemostasis valve. The product contains no DEHP or latex. The female luer is lipid resistant. Non serrated forceps are included.

The basic device is essentially the same as the original SUMMARY: ONECATH with a minor change in tip configuration. There is no change in intended use.

SUBSTANTIAL EQUIVALENCE: The ONECATH has been marketed since 1994 with no reported adverse effects.

The modification poses no additional risks or potential questions of efficacy.

The results of use of this catheter system indicates that it is acceptable for human implant.

Based on the proposed modification and the device similarity to the original in material, design and intended use the device is considered to be substantially equivalent.

Extensive studies are available in the scientific literature to POTENTIAL COMPLICATIONS: address the known complications from the insertion of The types and causes of safety and/or catheters. effectiveness problems that have been reported in use of infusion catheters are well known.

The potential exists for serious complications, some of which are as follows:

AIR EMBOLUS ARRHYTHMA

HYDROTHORAX INFECTION AND CATHETER RELATED SEPSIS

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POTENTIAL COMPLICATIONS:

ARTERIAL PUNCTURE BLEEDING CARDIAC TAMPONADE CATHETER FRAGMENT EMBOLUS CATHETER OCCLUSION DAMAGE TO CATHETER DRUG EXTRAVASATION EROSION/PERFORATIO N OF VESSEL/HEART HEMATOMA HEMOTHORAX

IMPLANT REJECTION MIGRATION OF CATHETER MYOCARDIAL DAMAGE NERVE DAMAGE

PHLEBITIS, CHEMICAL AND MECHANICAL PNEUMOTHORAX

PULMONARY ARTERY RUPTURE THROMBOEMBOLISM

THROMBOSIS VALVULAR DAMAGE ALONG VEIN

CONCLUSION:

Based on the evidence presented the device is manufactured using essentially the same materials.

The intended use is the same and therefore the device is considered substantially equivalent.

A comparison of the subject device to the claimed device follows on the next page.

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Element of Comparison	Subject DeviceModified ONECATH	Claimed DeviceLegally Marketed ONECATHK930473
Catheter TypeFOZ – IntravascularCatheterAndLJS – Long-termIntravascular Catheter	Long-Term IntravascularCatheter, Adult andNeonate/PediatricPeripheral, Midline, Midclavicularand CVC (PICC)	Long-Term IntravascularCatheter, Adult andNeonate/PediatricPeripheral, Midline, Midclavicularand CVC (PICC)
Intended Use	I.V. AdministrationBlood TherapyBlood Sampling	I.V. AdministrationBlood TherapyBlood Sampling
Mode of Operation	Catheter Insertion Over the NeedleIntroducer with protected needle.Recommended Site, AnticubitalPeripheral Vein. Additional siteselection may be at the direction ofthe practitioner when used on theneonatal and pediatric population.	Catheter Insertion Over the NeedleIntroducer with protected needle.Recommended Site, AnticubitalPeripheral Vein. Additional siteselection may be at the direction ofthe practitioner when used on theneonatal and pediatric population.
Intended AnatomicalLocation of Distal End	Peripheral – Distal portion of theextremityMidline –Proximal portion of theextremityMidclavicular –Proximal axillary or subclavianveins.Central – (PICC) within theSuperior Vena CavaThis is not a Right Atrium Catheter	Peripheral – Distal portion of theextremityMidline –Proximal portion of theextremityMidclavicular –Proximal axillary or subclavianveins.Central – (PICC)Superior Vena CavaThis is not a Right Atrium Catheter
Cannula Introducer	Stainless Steel Over the Needle	Stainless Steel Over the Needle
Catheter Markings	5 cm intervals from distal end ofstrain relief.	5 cm intervals from distal end ofstrain relief.
Catheter Material	Radiopaque Polyurethane	Radiopaque Polyurethane
Distal End Configuration	Tapered on Over the NeedleCannula Introducer	Tapered on Over the NeedleCannula Introducer
Proximal EndConfiguration	Strain relief, standard luer lock,with pre-inserted stylet through aY-site.	Strain relief, standard luer lock,with pre-inserted stylet through aY-site.
Catheter Gauge Size	16, 18, 20, 22	16, 18, 20, 24
Catheter Length	5 – 60 cm	10 – 60 cm

Luther Medical Products, Inc. 510(k) Substantially Equivalent Catheter 09/04/97 Page 4 of 4

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1998

Ms. Barbara C. Luther ·Requlatory Affairs Luther Medical Products, Incorporated 530 Kings Road Newport Beach, California 92663-5710

K980090 Re : Onecath®, L-Cath Catheter System, Model OC-Trade Name: (16-22 ga., 5cm - 60 cm) Regulatory Class: Unclassified Product Code: LJS Dated: January 4, 1998 Received: January 9 1998

Dear Ms. Luther:

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, Drug, 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) regulation (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. Luther

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 labelinq 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 qeneral 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.qov/cdrh/dsmamain.html".

Sincerely yours

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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510(k) Number : _ | 980090

Name of Device: ONECATH CATHETER SYSTEM PERIPHERALLY INSERTED CATHETERS

INDICATIONS FOR USE:

"Statement of Indications for Use"

The ONECATH Catheter System is designed for use when patient therapy

requires repeated venous access or prolonged intravenous administration of

fluids, medications, and/or nutritional solutions as prescribed. The catheter is

designed to be inserted in a peripheral vein. While any vessel suitable for

insertion may be used; the basilic vein is the most commonly used vein.

Note: This product may be used in pediatric as well as adult patients. Vascular cannulation is an important Procedure in the management of ill infants and children. The indications for use in children are the same as adults; however, insertion techniques are often modified according to the age and size of a child. If the practitioner is inexperienced in utilizing this product in a child, appropriate consultation should be sought.

Patricio Cucendie
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital, Intection of

\X Prescription Use

510(k) Number ________________________________________________________________________________________________________________________________________________________________

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.”