The CATHTONG™ I PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 1mL/sec for 3F and 3.5mL/sec for 4F single-lumen catheters. The maximum pressure of power injection with the CATHTONG™ I PICC Catheter may not exceed 325 psi. The CATHTONG™ I PICC Catheter is indicated for adult patients.

Device Description

CATHTONG™ I PICC Catheters are radiopaque polyurethane-based peripherally inserted central venous catheters for short or long-term use. The CATHTONG™ I PICC Catheters are 55 cm in length with markings in 5 cm increments and available in 3 Fr and 4 Fr single lumen. The catheter is packaged as a kit with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique.

AI/ML Overview

The provided text is a 510(k) summary for the CATHTONG™ I PICC Catheter. It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not describe an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format of a clinical study assessing diagnostic performance as implied by the request (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size).

Instead, this document focuses on non-clinical testing to demonstrate the device's functional performance, safety, and biocompatibility compared to a predicate device. The acceptance criteria here are typically established by reference to a predicate device and relevant industry standards.

Here's an attempt to extract and reframe the information based on the provided document and the prompt's requirements, acknowledging the difference in the type of study presented:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CATHTONG™ I PICC Catheter are primarily defined by its substantial equivalence to the predicate device (NMI PICC IV, K140266) regarding its intended use, design, and performance characteristics, as well as by adherence to recognized industry standards for intravascular catheters. The document doesn't provide a direct table of numerical "acceptance criteria" and "reported performance" like a diagnostic device study would. Instead, it states that the non-clinical tests demonstrate the device meets "expected performance requirements."

Below is a table summarizing key performance characteristics and how they are addressed, based on the provided text's comparison to the predicate:

Feature/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (CATHTONG™ I PICC Catheter)
Intended Use	Identical to predicate (NMI PICC IV) for central venous access.	Identical to predicate, including infusion, IV therapy, blood sampling, power injection, fluid/medication/nutrient administration, CVP monitoring for adult patients.
Maximum Flow Rate (Power Injection)	3F SL: 1 mL/sec; 4F SL: 3.5 mL/sec (same as predicate)	3F SL: 1 mL/sec; 4F SL: 3.5 mL/sec
Injection Pressure Limit Setting	325 psi (same as predicate)	325 psi
Catheter Material	Radiopaque polyurethane (same as predicate)	Radiopaque polyurethane (Carbothane)
Length	55 cm (3F, 4F) (same as predicate)	55 cm (3F, 4F)
# Lumens	Single lumen (explicit difference from predicate, but flow rates identical)	One (3F, 4F)
Catheter Design	Demonstrate equivalent performance despite design difference (standard vs. reverse tapered).	Standard tapered catheter. (Demonstrated to maintain identical maximum flow rates to predicate).
Sterilization Method	EO sterilization with acceptable low EO residues (same as predicate)	Provided sterile using EO sterilization method.
Biocompatibility	Compliance with ISO 10993 series for medical devices.	All specified biocompatibility tests (Cytotoxicity, Hemolysis, PTT, Systemic Toxicity, Irritation/Intracutaneous Reactivity, Sensitization, Implantation, Genotoxicity, Complement Activation) were performed and results are implied to be acceptable for substantial equivalence.
Mechanical Performance	Compliance with relevant ISO standards and predicate performance for: Flexural fatigue, peak tensile force, liquid/air leakage, flow rate, burst pressure, catheter collapse, radiopacity, gauging, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking.	Non-clinical tests listed for all these aspects were performed and demonstrate that the device "meets the expected performance requirements for a PICC device."
Regulatory Standards Compliance	Adherence to ISO 10551-1, ISO 10551-3, ISO 594-1, ISO 594-2, and FDA Guidance (1995).	The device was tested according to these standards, implying compliance, and deemed substantially equivalent.

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

The document specifies "Non-clinical Testing" including a list of tests. For these types of tests (e.g., mechanical, biocompatibility), the sample sizes are typically determined by relevant ISO standards or internal quality procedures. The document does not explicitly state the sample size for each non-clinical test performed on the device.

Regarding data provenance: These are laboratory tests performed on the device itself, not clinical data from patients. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" as applied to patient data are not directly relevant here. The tests are performed in a controlled laboratory environment.

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

This question is not applicable to the type of testing described. The "ground truth" for non-clinical performance and safety tests is established by:

Industry standards: e.g., ISO 10551, ISO 594, ISO 10993 series. These standards define the acceptable methodologies and performance thresholds.
Predicate device performance: The "ground truth" for substantial equivalence is that the new device performs at least as safely and effectively as the legally marketed predicate device.
Regulatory requirements: FDA guidance documents.

These tests do not involve expert consensus on clinical images or patient outcomes.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretation of clinical data. The non-clinical tests described follow standardized protocols with objective measurements.

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 device is a physical medical device (PICC catheter), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithmic performance is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:

Compliance with recognized voluntary standards: As listed in the document (e.g., ISO 10551, ISO 10993 series). These standards define objective test methods and acceptable performance limits for various physical, mechanical, and biological properties.
Comparative performance to the legally marketed predicate device: The new device must demonstrate that it is as safe and effective as the predicate, often by showing equivalent performance in relevant non-clinical tests.
Established scientific principles: Underlying the safety and performance evaluation of medical devices.

No clinical "outcomes data" or "pathology" as ground truth is described in this non-clinical submission.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning or AI algorithm involved, so there is no "training set."

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

Not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2016

L&Z US, Inc. Ms. Jenella Coutts Director of Regulatory Affairs 6 Horizon Road, #2301 Fort Lee. New Jersey 07024

Re: K153469

Trade/Device Name: CATHTONG™ I PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: July 29, 2016 Received: August 3. 2016

Dear Ms. Coutts:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153469

Device Name CATHTONGTM I PICC Catheter

Indications for Use (Describe)

The CATHTONG™ I PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is ImL/sec for 3F and 3.5mL/sec for 4F single-lumen catheters. The maximum pressure of power injection with the CATHTONG™ I PICC Catheter may not exceed 325 psi. The CATHTONG™ I PICC Catheter is indicated for adult patients.

Catheter Size Maximum Flow Rate Injection Limit Setting 3 Fr Single Lumen 1 ml/sec 325 psi

4 Fr Single Lumen 3.5 ml/sec 325 psi

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter Information:	L&Z US, Inc.6 Horizon Road, #2301Fort Lee, NJ 07024
Contact Person:	Jenella CouttsDirector of Regulatory Affairs
Email Address:	jcoutts@lingzeus.com
Phone Number:	(718) 601-0889 ext. 1
Fax Number:	(718) 228-2441
Date of Submission:	August 31, 2016
Trade Name:	CATHTONG™ I PICC Catheter
Common Name:	Peripherally Inserted Central Catheter (PICC)
Regulation Number:	21 CFR 880.5970
Regulation Name:	Percutaneous, implanted, long-term intravascular catheter
Regulatory Class:	II
Product Code:	LJS
Classification Panel:	General Hospital
Primary Predicate:	NMI PICC IVCommon Name: Peripherally Inserted Central Catheter (PICC)Regulation Number: 21 CFR 880.5970Regulation Name: Percutaneous, implanted, long-termintravascular catheterRegulatory Class: IIProduct Code: LJSClassification Panel: General Hospital510(K) #: K140266Manufacturer: Navilyst Medical, Inc.

Device Description:

CATHTONG™ I PICC Catheters are radiopaque polyurethane-based peripherally inserted central venous catheters for short or long-term use. The CATHTONG™ I PICC

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Catheters are 55 cm in length with markings in 5 cm increments and available in 3 Fr and 4 Fr single lumen. The catheter is packaged as a kit with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique.

Intended Use/Indications for Use:

Catheter Size	Maximum Flow Rate	Injection Limit Setting
3 Fr Single Lumen	1 mL/sec	325 psi
4 Fr Single Lumen	3.5 mL/sec	325 psi

Table E-1 Device comparisons table

Characteristics	Subject Device:	Primary Predicate :
	CATHTONG™ I PICC Catheter	NMI PICC IVK140266SE 03.05.2014
Indications for UseStatement	The CATHTONG™ I PICC Catheter isintended for short or long-termperipheral access to the central venoussystem for infusion, intravenoustherapy, blood sampling, powerinjection of contrast media, theadministration of fluids, medicationsand nutrients, and allows for centralvenous pressure monitoring. Themaximum recommended infusion rate is1mL/sec for 3F and 3.5mL/sec for 4Fsingle-lumen catheters. The maximumpressure of power injection with theCATHTONG™ I PICC Catheter maynot exceed 325 psi. TheCATHTONG™ I PICC Catheter isindicated for adult patients.Catheter Size: 3 Fr Single LumenMaximum Flow Rate 1 mL/sec,Injection Limit Setting 325 psi.Catheter Size 4 Fr Single Lumen,Maximum Flow Rate 3.5 mL/sec,Injection Limit Setting 325 psi.	The NMI PICC IV is indicated for shortor long-term peripheral access to thecentral venous system for intravenoustherapy, including but not limited to, theadministration of fluids, medicationsand nutrients, the sampling of blood, forcentral venous pressure monitoring andfor power injection of contrast media.The maximum recommended flow rateis 1mL/sec for 3F and 3.5mL/sec for 4F.The maximum pressure of injectionwith the NMI IV PICC catheter may notexceed 325 psi.
Dwell Time	Short or long-term (Less than or greaterthan 30 days)	Short or long-term (Less than or greaterthan 30 days)
Regulation	21CFR880.5970 Percutaneous,implanted, long-term intravascularcatheter	Same
Product Code	LJS	LJS
Target Population	Adults	Adults
Catheter Materials	Radiopaque polyurethane (Carbothane)	Radiopaque polyurethane
Length	55 cm (3F), 55cm (4F)	55 cm (3F), 55cm(4F)
# Lumens and catheter size	One (3F, 4F)	One (3F, 4F, 5F), Two (5F, 6F), Three(6F)
Markings	Every 5 cm	Every 5 cm
Catheter Design	Standard tapered catheter	Reverse tapered catheter
Contrast Injectables	Yes	Yes
Supplied Sterile(Sterilization Method)	Provided sterile using EO sterilizationMethod	Provided sterile using EO sterilizationMethod

Labeling Shelf-Life	16 Months	6 Months
Accessories in Package	Guidewire Straight Tip, Guidewire,Multi Compartment Tray, Micro Accesswith Dilator, Introducer Needle, NeedleReceptacle, Safety Scalpel, Syringe,Scissors, Instructions For Use,SorbaView® Ultimate Dressing,Universal Tape Strip, Wingguard®Xtra, Tape Measure, Fenestrated Drape	"Available kitted with a range ofprocedural accessories for userconvenience"






Maximum recommendedinfusion rating for powerinjection	3F SL: 1mL/sec4F SL: 3.5mL/sec	3F SL: 1mL/sec4F SL: 3.5mL/sec
Injection Pressure LimitSetting	325 psi	325 psi

Available performance datato support SE determination	Yes	Yes

Special labeling performanceclaim	None	"Demonstrate resistance to bloodcomponents (platelet and thrombus)accumulation"

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Similarity to the Predicate

The proposed device, CATHTONG™ I PICC Catheter, has the same intended use, intended function, catheter length, maximum recommended infusion rating, pressure limit for power injection of contrast media and are also made of the same materials as the primary predicate device, NMI PICC IV. They both are intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring in adult patients. There are no changes in the fundamental clinical indications for both PICC catheters. There are no

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additional contra-indications or warnings. Both devices are sterilized by ethylene oxide with acceptable low EO residues.

Difference to the Predicate

The only differences between the proposed device and the predicate are the number of the lumen, the catheter size, the taper design, the accessories in the kit package, and special functional performance claim. The proposed device has only one single lumen configuration with 3F and 4F sizes, while the predicate device has single, double and triple lumen configurations with 3F, 4F, 5F and 6F sizes. The proposed device and the predicate do differ in that the predicate has a reverse tapered catheter design while the proposed device is the standard tapered design. However, upon testing both proposed and the predicate devices maintained identical maximum flow rates, therefore this different design feature does not dispute equivalence. In terms of kit package content, the proposed PICC device contains Guidewire Straight Tip, Guidewire, Multi Compartment Tray, Micro Access with Dilator, Introducer Needle, Needle Receptacle, Safety Scalpel, Syringe, Scissors, Instructions For Use, SorbaView® Ultimate Dressing, Universal Tape Strip, Wingguard® Xtra, Tape Measure, Fenestrated Drape in its kit package, while the predicate contains "a range of procedural accessories for user convenience". In addition, the predicate device makes "resistance to blood components (platelet and thrombus) accumulation" labeling claim, while the proposed device does not make any functional performance claim.

Non-clinical Testing:

. Flexural fatigue and flexibility
. Peak tensile force
Liquid leakage under pressure .
. Air leakage

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Flow rate ●
Power injection - Burst pressure
Power injection Flow rate ●
Catheter collapse
Radiopacity
Gauging
Irritation/Intracutaneous Reactivity ●
Cytotoxicity Test (MEM Elution) ●
Partial Thromboplastin Time (PTT)
Material Mediated Pyrogen Test ●
Kligman Maximization Test
Intramuscular Implantation Test 13 ● Week Implantation
28-Day Systemic Toxicity in Rats via Intramuscular Implantation
Systemic Injection Test ●
Liquid Leakage ●
Separation Force ●
Unscrewing Torque ●
Ease of Assembly
Resistance to Overriding .
Stress Cracking .
Salmonella Typhirmurium and ● Escherichia Coli Reverse Mutation Assay
C3A and SCB-9 Complement . Activation Test (Direct Contact)
Rabbit Blood Hemolysis Test .
Thrombogenicity Study in Swine .
Mouse Lymphoma Mutagenesis ● Assay with Confirmation
. Rodent Blood Micronucleus Assay
LAL Testing for Pyrogenicity ●

Standards:

ISO 10551 -1:2013 Sterile, single-use intravascular catheters Part 1: General Requirements ISO 10551 -3: 2013 Sterile, single-use intravascular catheters Part 3: Central venous catheters ISO 594-1: 1986 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 1: General Requirements.

ISO 594-2: 1998 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 2: Lock Fittings

FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-term and Long-term Intravascular Catheters, dated March 16, 1995.

ISO 10993-3, 2014 Biological Evaluation of Medical Devices- Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity

ISO/TR 10993-33, 2015 Biological Evaluation of Medical Devices- Part 33: Guidance on Tests to Evaluate Genotoxicity - Supplement to ISO 10993-3

ISO 10993-4, 2006 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, as amended 2006

ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5; Tests for In Vitro Cytotoxicity

ISO 10993-6, 2007 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects after Implantation

ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization

ISO 10993-11:2006 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity

ISO 11135-1:2007 Sterilization of health care products – Ethylene oxide Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices

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Substantial Equivalence Rationale:

Intended Use

The intended use of the proposed device, CATHTONG™ I PICC Catheter, is identical to the primary predicate, NMI PICC IV (K140266). There are no changes in the fundamental clinical indications. There are no additional contraindications or warnings.

Design and Technological Characteristics

The CATHTONG™ I PICC Catheter has the same catheter material (polyurethane), dimensions, configuration, and device properties as the predicate. The only minor design difference is the standard tapered catheter design for the proposed device versus reverse tapered catheter design for the predicate. However, this does not impact the effectiveness or safety of the proposed device as upon testing both devices safely maintained identical maximum flow rates.

Non-clinical Test Results

The non-clinical test results in this submission demonstrate that CATHTONG™ I PICC Catheter meets the expected performance requirements for a PICC device, and is therefore substantially equivalent to the predicate relative to safety and mechanical properties as a PICC.

Conclusion

Based upon the indications for use, technological characteristics, and non-clinical testing the CATHTONG™ I PICC Catheter has demonstrated to be Substantially Equivalent to the predicate device, NMI PICC IV (K140266).

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.”