I.V. Catheter

• K Number: K142797
• Device Name: I.V. Catheter
• Manufacturer: Jiangxi Sanxin Medtec Co., Ltd
• Date Cleared: 2015-06-18 ( 262 days)
• Product Code: FOZ
• Regulation Number: 880.5200

Intended Use

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.

Predicate Devices

K083429

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard I.V. catheter and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

Yes
The device is used to administer fluid intravenously, which is a therapeutic intervention.

Diagnostic

No
The device is described as an I.V. Catheter intended to withdraw blood samples or administer fluid, which are procedures, not diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical I.V. Catheter, a sterile, single-use hardware device intended for insertion into the vascular system. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is 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." This describes a device used on the patient for direct medical intervention (administering fluids) and sample collection from the patient.
• IVD Definition: In vitro diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. They are used outside the body (in vitro).

While the device is used to collect blood samples, the device itself is not used to examine those samples or provide diagnostic information. The examination of the blood samples would be performed using separate IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FOZ

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 10^6, and packed in a sterility maintenance package. The shelf life of the product is three years.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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
• 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
• 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 Bacterial Endotoxin Limit
• ISO 10993-3:2003, Biological evaluation of medical devices- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
• ISO 10993-4:2002 A1:2006, Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood.
• ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
• 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;
• 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;
• ISO10555-5: 1996/AMD.1:1999(E), Sterile, single-use intravascular catheters- Part 5: Over-needle peripheral catheters;
• 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

Key Metrics

Not Found

Predicate Device(s)

K083429

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stylized to resemble a bird.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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
• 2. 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: [phone] Fax: [phone] Email: [e-mail]

• 3. Submission Correspondent
     Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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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:

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.

• 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

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.

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• 7. 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 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, 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.	I.V. Catheter for Single Use, including Type
I, Type Y and Type Straight, is intended to be
inserted in to a patient's vascular system for
short term use to withdraw blood samples,
administer fluid intravenously or through
which to place monitoring equipment such as
blood pressure monitors.
Features	Closed System, Radio Detectable, Color
Coding, Single Use	Closed System, Radio Detectable, Color
Coding, Single Use
Configuration	Catheter tube, Catheter hub, Needle, Needle
handle, Flexible tube and Infusion joint	Catheter tube, Catheter hub, Needle, Needle
handle, 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.
2:2004
ISO10555-5: 1996/AMD.1:1999(E)
ISO 9626: 1991/AMD-1:2006
ISO 594-2:1998	Comply with:
ISO 10555-1:1995/AMD.1:1999/ AMD.
2:2004
ISO10555-5: 1996/AMD.1:1999(E)
ISO 9626: 1991/AMD-1:2006
ISO 594-2:1998
Biocompatibility	Conforms to the requirement of ISO 10993
series Standards	Conforms to the requirement of ISO 10993
series
Standards

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).