The proposed device, I.V. Catheter, is intended to be inserted in to a patient's vascular system for short term use (no more than 72 hours) to withdraw blood samples or administer fluid intravenously.

Device Description

The proposed devices, I.V. Catheters, are sterile, single use devices intended to be inserted in to a patient's vascular system for short term use to withdraw blood samples or administer fluid intravenously.

The I.V. Catheter is a closed system, and further available in two combinations of configurations. All of them are sterilized by Ethylene Oxide to achieve a SAL of 106, and packed in a sterility maintenance package. The shelf life of the product is three years.

AI/ML Overview

This document is a 510(k) summary for an I.V. Catheter (K142797) submitted by Jiangxi Sanxin Medtec Co., Ltd. It declares substantial equivalence (SE) to a predicate device (K083429).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with recognized international and ASTM standards. The reported device performance is that it complies with these standards.

Acceptance Criteria (Standard)	Reported Device Performance
ASTM F88-09 (Seal Strength of Flexible Barrier Materials)	Device complies
ASTM F 1140-07 (Internal Pressurization Failure Resistance of Unrestrained Package)	Device complies
ASTM F1929-98(2004) (Detecting Seal Leaks by Dye Penetration)	Device complies
ISO 11135-1:2007 (Ethylene Oxide Sterilization)	Device complies (achieves SAL of 10^-6)
USP <85> (Bacterial Endotoxin Limit)	Device complies
ISO 10993-3:2003 (Biological evaluation - Genotoxicity, carcinogenicity, reproductive toxicity)	Device complies (conforms to the requirements of ISO 10993 series Standards)
ISO 10993-4:2002 A1:2006 (Biological evaluation - Interactions with blood)	Device complies (conforms to the requirements of ISO 10993 series Standards)
ISO 10993-5:2009 (Biological Evaluation - In Vitro Cytotoxicity)	Device complies (conforms to the requirements of ISO 10993 series Standards)
ISO 10993-6:2007 (Biological evaluation - Local effects after implantation)	Device complies (conforms to the requirements of ISO 10993 series Standards)
ISO 10993-7:2008 (Biological evaluation - Ethylene Oxide Residues)	Device complies (conforms to the requirements of ISO 10993 series Standards)
ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization)	Device complies (conforms to the requirements of ISO 10993 series Standards)
ISO 10993-11:2006 (Biological evaluation - Systemic toxicity)	Device complies (conforms to the requirements of ISO 10993 series Standards)
ASTM F756-08 (Assessment of hemolytic properties of material)	Device complies
ISO 10555-1:1995/AMD.1:1999/AMD.2:2004(E) (Sterile, single-use intravascular catheters - General requirements)	Device complies
ISO10555-5: 1996/AMD.1:1999(E) (Sterile, single-use intravascular catheters - Over-needle peripheral catheters)	Device complies
ISO594-2:1998 (Conical fittings with 6 % (Luer) taper for syringes, needles)	Device complies
ISO9626:1991/AMD-1:2001 (Stainless steel needle tubing)	Device complies

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

The document does not specify the sample size used for each non-clinical test. The data provenance is indicated as "Non clinical tests were conducted to verify that the proposed device met all design specifications" (Page 5), suggesting these were performed by the manufacturer, Jiangxi Sanxin Medtec Co., Ltd. The country of origin for the device itself is China, and the tests were likely conducted there or by affiliated entities. The tests are prospective with respect to the submission, performed specifically to demonstrate compliance.

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

This document describes a 510(k) submission for a medical device (I.V. Catheter). The "tests" here are primarily engineering and biocompatibility evaluations against recognized standards, not diagnostic performance assessments requiring expert ground truth establishment in a clinical sense. Therefore, this information is not applicable and not provided in the document. The standards themselves represent expert consensus on performance requirements.

4. Adjudication method for the test set

Similarly to point 3, adjudication methods like 2+1 or 3+1 are typically for diagnostic studies where there's variability in interpretation or a need to resolve discrepancies. For the non-clinical tests listed (e.g., seal strength, sterilization, biocompatibility), the results are generally objective measurements against predefined criteria in the standards. Therefore, an adjudication method is not applicable and not provided.

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

This document is for an I.V. Catheter, which is a physical medical device, not an AI software or a diagnostic imaging system. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not applicable and not mentioned.

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

As this is a physical medical device and not an algorithm, a standalone performance study in the context of an algorithm is not applicable and not discussed in the document. The non-clinical tests represent the standalone performance of the physical device.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specifications and limits set forth in the referenced ASTM and ISO international standards. For example, for sterility, the ground truth is "achieve a SAL of 10^-6". For biocompatibility, it's "conforms to the requirement of ISO 10993 series Standards." This is based on established scientific and engineering principles for medical device safety and performance.

8. The sample size for the training set

This document describes non-clinical testing of a physical medical device, not a machine learning algorithm. Therefore, the concept of a "training set" is not applicable and no information is provided.

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

As there is no training set for a machine learning algorithm, this question is not applicable.

Summary

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

June 18, 2015

Jiangxi Sanxin Medtec Co., Ltd c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 China

Re: K142797

Trade/Device Name: I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 13, 2015 Received: May 18, 2015

Dear Ms. Hong:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

for Erin I. Keith, M.S. 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) K142797

Device Name I.V. Catheter

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CER 801 Subpart D)

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

PLEASE DO NOT WRITE BECOW THIS LINE - CONTINUE ON A SEPARATE PAGE IE NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 3 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K142797

1. Date of prepare the summary: June 18, 2015
1. Sponsor Identification

Jiangxi Sanxin Medtec Co., Ltd. No. 999, Fushan Road, Xiaolan Economic Development, Nanchang, Jiangxi, 330200, China

Establishment Registration Number: Not yet registered

Contact Person: Bingrong Liu Position: Technical Department Manager Tel: +86-791-85950238 Fax: +86-791-85988030 Email: tengyun2005@163.com

1. Submission Correspondent
  Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Proposed Device Identification 4.
Proposed Device Name: I.V. Catheter Proposed Device Common Name: Intravascular Catheter

Regulatory Information for I.V. Catheter Classification Name: Intravascular Catheter; Classification: II; Product Code: FOZ; Regulation Number: CFR 880.5200; Review Panel: General Hospital;

Intended Use Statement:

રું. Predicate Device Identification
Predicate Device 510(k) Number: K083429 Product Name: I.V. Catheter for Single Use Manufacturer: Weihai Jierui Medical Products Co., Ltd.

6. Device Description

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1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ASTM F88-09, Standard Test Method for Seal Strength of Flexible Barrier Materials
A ASTM F 1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Package for Medical Applications
ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
A ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices;
USP <85> Bacterial Endotoxin Limit >
A ISO 10993-3:2003, Biological evaluation of medical devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
A ISO 10993-4:2002 A1:2006, Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood.
A ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
A ISO 10993-6:2007, Biological evaluation of medical devices- Part 6: Tests for local effects after implantation:
ISO 10993-7:2008, Biological evaluation of medical devices- Part 7: Test of Ethylene Oxide Residues;
A 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;
ASTM F756-08. Standard practice for assessment of hemolytic properties of material: ▲
ISO 10555-1:1995/AMD.1:1999/AMD.2:2004(E), Sterile, single-use intravascular catheters-Part 1: General requirements;
A ISO10555-5: 1996/AMD.1:1999(E), Sterile, single-use intravascular catheters- Part 5: Over-needle peripheral catheters;
A ISO594-2:1998. Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock fittings
ISO9626:1991/AMD-1:2001, Stainless steel needle tubing for the manufacture of medical devices

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8. Substantially Equivalent (SE) Comparison

Item	Proposed device	Predicate Device K083429
Product Code	FOZ	FOZ
Regulation Number	CFR 880.5200	CFR 880.5200
Intended Use	The proposed device, I.V. Catheter, isintended to be inserted in to a patient'svascular system for short term use (no morethan 72 hours) to withdraw blood samples oradminister fluid intravenously.	I.V. Catheter for Single Use, including TypeI, Type Y and Type Straight, is intended to beinserted in to a patient's vascular system forshort term use to withdraw blood samples,administer fluid intravenously or throughwhich to place monitoring equipment such asblood pressure monitors.
Features	Closed System, Radio Detectable, ColorCoding, Single Use	Closed System, Radio Detectable, ColorCoding, Single Use
Configuration	Catheter tube, Catheter hub, Needle, Needlehandle, Flexible tube and Infusion joint	Catheter tube, Catheter hub, Needle, Needlehandle, Flexible tube and Infusion joint
Principle of Operation	Manual	Manual
Sterility	EO Sterilized	EO Sterilized
Performance	Comply with:ISO 10555-1:1995/AMD.1:1999/ AMD.2:2004ISO10555-5: 1996/AMD.1:1999(E)ISO 9626: 1991/AMD-1:2006ISO 594-2:1998	Comply with:ISO 10555-1:1995/AMD.1:1999/ AMD.2:2004ISO10555-5: 1996/AMD.1:1999(E)ISO 9626: 1991/AMD-1:2006ISO 594-2:1998
Biocompatibility	Conforms to the requirement of ISO 10993series Standards	Conforms to the requirement of ISO 10993seriesStandards

Table 1 Product Comparison

Substantially Equivalent (SE) Conclusion 9.

The propose device has the same intended use with the predicate device, except that the proposed device is not intended for placing monitoring equipment. The proposed device has less indication compared with the propose device, and the indications are provided on the label and user manual, therefore, this difference is not considered to affect the substantially equivalent between the proposed and predicate device.

The features, configurations, principle of operation, sterility of the proposed are the same as those of the predicate device.

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In addition, the results of performance tests performed on the proposed device can also demonstrate the proposed device is complied with FDA recognized standards, which the proposed device was also complied with. The results of biocompatibility studies performed on the proposed device demonstrate that the patient materials used in proposed device are biocompatibile.

Based on the comparison above, the proposed device, I.V. Catheter, is determined to be Substantially Equivalent (SE) to the predicate devices, I.V. Catheter for Single Use (K083429).

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).