The L-Cath Modified Seldinger Technique Accessory Kit is designed for placement and/or exchange of the L-Cath Peripherally Inserted Catheter System in 16 ga. (5Fr.), 18 ga. (4Fr.), 20 ga. (3Fr.), 24 ga. (2.6 Fr.) and the L-Cath Dual Lumen 16 and 18 ga.

Utilization of a Modified Seldinger Technique for catheter placement has been demonstrated to be effective for the placement of peripherally inserted central catheters in patients, pediatric and adult, with difficult to access veins.

Device Description

The L-Cath Modified Seldinger Technique Kit consists of over-the-needle insertion catheters, a scalpel, measuring tape, sterile drapes, scissors, needle holder, syringe, with a sheath dilator and guide wire, in appropriate sizes to accommodate the Luther Medical line of Peripherally Inserted Catheters, the "parent devices". Included in the kit are appropriate accessories to aid in this technique.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device from 1997. It describes the L-Cath® Modified Seldinger Technique (MST) Kit. The primary purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove safety and effectiveness through extensive clinical trials as would be required for a novel device. Therefore, the "study" described is focused on this comparison and functional testing, not a comprehensive efficacy or diagnostic accuracy study typical of AI/ML device submissions.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for a kit of basic medical components, the "acceptance criteria" are implied to be functional compatibility with the L-Cath catheters and demonstration that the components are similar or identical to those in predicate devices. The "performance" is the successful physical fit and biocompatibility.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Compatibility with L-Cath Catheters:
Guide wire Outer Diameter (OD) must accommodate Inner Diameter (ID) of existing Luther Medical catheters (specifically for neonate/pediatric tubing).	"Testing of the OD of the guide wire through the ID of existing Luther Medical catheters has proven to be accurate and appropriate for this application." (This implies the guide wire successfully passed through the catheters without issue). The kit offers .010", .012", and .018" guide wire diameters to accommodate various catheter sizes.
Biocompatibility:
Guide wire material must be biocompatible.	"Biocompatibility testing was completed on the guide wire of similar size in another 510(k) for Silicone catheters." (This references previous testing for a similar component, implying the guide wire material is safe for its intended use).
Substantial Equivalence:
Device components must be similar or identical to legally marketed predicate devices.	The document provides a detailed comparison table (Section 2) listing components (scalpel, introducer, syringe, etc.) included in the Luther Medical kit and those found in kits from Arrow International, HDC, and Cook Critical Care. The summary states: "The contents of the kit are either similar or identical to those devices, with the same intended use, on the market." and "Based on the evidence presented the devices are either essentially similar/or identical materials. The intended use is the same and therefore the devices are considered substantially equivalent."
Kit must contain appropriate accessories to aid in the Modified Seldinger Technique.	The device description lists components such as over-the-needle insertion catheters, scalpel, measuring tape, sterile drapes, scissors, needle holder, syringe, sheath dilator, and guide wire, all "in appropriate sizes to accommodate the Luther Medical line of Peripherally Inserted Catheters."

2. Sample size used for the test set and the data provenance

Sample Size:
- For the functional compatibility (guide wire OD through catheter ID): The document states "Testing of the OD of the guide wire through the ID of existing Luther Medical catheters has proven to be accurate and appropriate for this application." It does not specify the number of catheters or guide wires tested.
- For biocompatibility: No specific sample size is mentioned for this submission; it references "biocompatibility testing was completed on the guide wire of similar size in another 510(k)".
Data Provenance: The document does not specify the country of origin. The testing would have been conducted by or on behalf of Luther Medical Products, Inc. (USA). The testing appears to be prospective in nature, as it describes a specific test performed for this submission.

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

Not applicable. This device is a sterile kit of common medical components. "Ground truth" in the diagnostic sense is not a concept applied here. The assessment primarily relies on engineering specifications (e.g., guide wire OD, catheter ID) and material biocompatibility, confirmed through direct measurement and laboratory testing, not expert interpretation of diagnostic data.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication in the context of expert consensus. The assessment was based on physical measurements, material properties, and comparison to existing products.

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

Not applicable. This is a medical device kit, not a diagnostic AI/ML algorithm. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical medical device kit, not an algorithm.

7. The type of ground truth used

For functional compatibility: Engineering specifications (e.g., precise measurements of guide wire outer diameter and catheter inner diameter) and successful physical passage.
For biocompatibility: Laboratory test results (implied from the reference to previous 510(k) submission).
For substantial equivalence: Direct comparison of physical components, materials, and intended use to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. As above, this is not an AI/ML device.

Summary

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LUTHER MEDICAL PRODUCTS, INC.

14332 CHAMBERS ROAD TUSTIN, CALIFORNIA 92780-6912

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

K97 4543

Page 1 of 3

FEB 1 0 1998

GENERAL INFORMATION:

Applicant's Name andAddress	Luther Medical Products, Inc.14332 Chambers RoadTustin, CA 92780-6912Phone: (714) 544-3002FAX: (714) 544-7273
Contact Person:	Barbara C. LutherVoice Mail: (714) 544-3002 Ext. 227Phone: (714) 646-5183FAX: (714) 650-1492
Date of Summary:	August 24, 1997
Common/Usual Name:	Catheter Guide Wire Kit
Proprietary Name:	L-Cath® Modified Seldinger Technique (MST) Kit
Classification Name:	Catheter Guide Wire, KitClassification Number: 79KGZClass II§848.4200
COMPARISON TO LEGALLYMARKETED DEVICES:	Arrow, InternationalHDC, CorporationCook Critical Care
DEVICE DESCRIPTION:	The L-Cath Modified Seldinger Technique Kit consists ofover-the-needle insertion catheters, a scalpel, measuringtape, sterile drapes, scissors, needle holder, syringe, with asheath dilator and guide wire, in appropriate sizes toaccommodate the Luther Medical line of PeripherallyInserted Catheters, the "parent devices". Included in the kitare appropriate accessories to aid in this technique.

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SUMMARY:

The contents of the kit are either similar or identical to those devices, with the same intended use, on the market. Luther Medical has smaller neonate/pediatric tubing then the competitors and therefore requires a special guide wire OD to accommodate these catheters. A detail comparison is found on the last page of this summary.

SUBSTANTIAL EQUIVALENCE: The guide wire insertion and/or exchange technique has been available to the medical community for over 17 years. The .018" guide wire is too large for the Luther line of catheters specifically used in pediatric and neonatal care.

Testing of the OD of the guide wire through the ID of existing Luther Medical catheters has proven to be accurate and appropriate for this application.

Biocompatibility testing was completed on the guide wire of similar size in another 510(k) for Silicone catheters.

POTENTIAL COMPLICATIONS:

Extensive studies are available in the scientific literature to address the known complications from an insertion, or exchange, of catheters using the modified Seldinger technique. They include but are not limited to:

Infection Damage to the Intima of the Vein Veno Spasm

Arterial Placement

CONCLUSION:

Difficulty Threading Catheter Bleeding from Site.

Discomfort

Air Emboli

Arrythmias Catheter Emboli

Difficulty Removing Guide Wire Thrombosis

Based on the evidence presented the devices are either essentially similar/or identical materials.

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

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Contents in MST KIT	Luther MedicalProducts, Inc.	ArrowInternational	HDC	Cook CriticalCare
Wire Guide Diameter ininches	.018" X 45 , 50, 60,80 cm.012" X 45, 50 cm.010" X 45 cm	.018" X 25 , 33,85 cm.025" X 25, 68cm.035" X 45, 60,68 cm	.018" X 80 cm	.018" X 50 cm.021" X 60 cm.025" X 60 cm
Scalpel	Yes	Yes	Yes	Yes
Intravenous OTNIntroducer/Catheter	20 ga. X 2"22 ga. X 1"24 ga. X ¾"	No	No	25 ga.22 ga.
Hypodermic Needle	22 ga. X 1"	No	No	No
Syringe	5cc	Yes	Yes	Yes
Introducer Needle	21 X 2.75"w/echogenic tip		21 gaw/echogenic tip	3.5 Fr.4.0 Fr.4.5 Fr.5.0 Fr.
Measuring Tape	Yes	Yes	Yes	Yes
Iris scissor	Yes	No	No	No
Catheter Clamp/NeedleHolder	Yes	Yes	No	Yes
Sheath/Dilator	3, 4, & 5 Fr.	5, 5.5, & 7 Fr.	5 Fr.	4 Fr.5 Fr.7 Fr.
Sterile Drape	Yes	Yes	No	No
MST Introducer Kit	All of the above.Catheters andProcedural items areprovided separatelyas L-Cath, Singleand DuaL-CathPICC Catheters.	All of the aboveplus catheters andproceduralaccessories anddrugs.	One 21 gaintroducerneedle withechogenic tip,One 0.18"floppy guidewire (80cm) andOneSheath/Dilatorassembly	All of the aboveplus catheters andproceduralaccessories anddrugs.
Labeling and Directionsfor Use	Available UponRequest	Submittedw/510(k)	Submittedw/510(k)	Submittedw/510(k)

Components of Luther Medical Products, Inc. MST Kits and Companies w/ Legally Marketed MST Kit Devices

Luther Medical Products, Inc. 510(k) Modified Seldinger Technique Kit 08/24/97

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

FEB 1 0 1998

K974543 Re : L-CATH Modified Seldinger Technique Trade Name: Insertion/Catheter Exchange Kit Regulatory Class: II Product Code: FOZ Dated: August 4, 1997 Received: December 3, 1997

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. However, you are responsible to determine that the medical devices you use as components in the L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your ...... L-CATH Modified Seldinger Technique Insertion/Catheter Exchange Kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, and 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 Page 2 - Ms. Luther

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regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗ 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. 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 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 the labeling requlation (21 CFR Part 801 and additionally 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 requlation 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 "dsmo@fdadr.cdrh.fda.gov".

Sincerely yours,

My Anturat

Timot W A. Ulatowski 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: K974543

L-CATH MODIFIED SELDINGER TECHNIQUE Device Name: INSERTION/CATHETER EXCHANGE KIT

INDICATIONS FOR USE:

"Statement of Indications for Use"

Patricin Cusack

X Prescription Use

Section D

Additional Page 2A

December, 1997

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).