Disposable IV catheter is intended to be inserted into a Patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA devices are suitable for use with power injectors set to a maximum pressure of 300 psi when access ports not suitable for use with power injectors are removed.

Device Description

The Safety Straight IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needle stick injury. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, needle hub, vent fitting, safety clip, lid, valve tube, actuator, anti-reflux valve.
Straight IV Catheter System is the same as The Safety Straight IV Catheter System except for the safety device designed to minimize blood exposure.
Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, heparin plug, needleless connector, Luer adapter with dual port.
Closed IV Catheter System is the same as Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.
Needleless Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, needleless connector, Luer adapter with dual port.
Needleless Closed IV Catheter System is the same as Needleless Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.

AI/ML Overview

The provided text is a 510(k) summary for a Disposable IV catheter. It outlines the device's features, intended use, and a comparison to a predicate device (K183399, Nexiva IV Catheter System) to establish substantial equivalence.

However, the document does not describe a study in the context typically expected for acceptance criteria for an AI/ML powered medical device, such as a multi-reader, multi-case study, or standalone algorithm performance. This document is for a traditional medical device (IV catheter) and focuses on engineering and biocompatibility testing against recognized standards.

Therefore, many of the requested categories related to AI/ML device studies (like sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance for an algorithm, and ground truth types) are not applicable to the information contained in this 510(k) summary for an IV catheter.

I will attempt to extract the relevant "acceptance criteria" and "device performance" based on the provided engineering and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with the referenced ISO and ASTM standards. The reported device performance is that it met these standards.

Acceptance Criteria (Defined by Standard Compliance)	Reported Device Performance
Mechanical/Physical Performance:
Compliance with ISO 594-1:1986 (Conical fittings for syringes, needles, etc. - General requirements)	Bench test results meet requirements of the recognized standards.
Compliance with ISO 594-2:1998 (Conical fittings for syringes, needles, etc. - Lock fittings)	Bench test results meet requirements of the recognized standards, specifically for ease of assembly performance testing for the plunger.
Compliance with ISO 9626:2016 (Stainless steel needle tubing - Requirements and test methods)	Bench test results meet requirements of the recognized standards.
Compliance with ISO 10555-1: 2013 (Intravascular catheters - General requirements)	Bench test results meet requirements of the recognized standards for different gauge sizes. Catheter burst pressure exceeds peak pressure at maximum flow, and flow rate meets allowable limits. Test results meet standard requirements for extension tubing.
Compliance with ISO 10555-5: 2013 (Intravascular catheters - Over-needle peripheral catheters)	Bench test results meet requirements of the recognized standards, specifically for vent fitting test for the needle hub.
Compliance with ISO 23908: 2011 (Sharps injury protection - Requirements and test methods)	Bench test results meet requirements of the recognized standards for needlestick injury prevention feature.
Compliance with ISO 80369-7: 2016 (Small-bore connectors for liquids and gases - Intravascular/hypodermic applications)	Bench test results meet requirements of the recognized standards.
Biocompatibility:
Compliance with ISO 10993-1:2009 and FDA guidance (Biological evaluation of medical devices - General)	Biological evaluation and testing with the final device, including all materials, showed no biological risk. This implicitly covers specific tests for genotoxicity, carcinogenicity, reproductive toxicity, blood interactions, cytotoxicity, local effects, irritation, skin sensitization, and systemic toxicity as per ISO 10993-3, -4, -5, -6, -10, -11.
Compliance with ISO 10993-7:2009 (Biological Evaluation of Medical Device - Ethylene Oxide Sterilization residuals)	Bench test results meet requirements of the recognized standards.
Sterility/Packaging:
Compliance with ASTM F1980-07 (Accelerated aging of sterile barrier systems)	Bench test results meet requirements of the recognized standards.
Sterilization by Ethylene oxide (consistency with predicate)	Yes, sterilized by Ethylene oxide.
Packaging (consistency with predicate)	Blister packaging.
Single Sterile Wrapped (consistency with predicate)	Yes.
Power Injector Compatibility:
22-18 GA devices suitable for use with power injectors set to max pressure of 300 psi (when access ports not suitable for power injectors are removed)	Catheter burst pressure exceeds peak pressure at maximum flow conditions when tested according to ISO 10555-1:2013. Identified as capable with 18G, 20G, 22G.
Injection Port Functionality (for models with this feature):	Bench tests (ISO 10555-1, Leakage Test) conducted; results meet requirements.

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

The document does not specify exact sample sizes for each test mentioned (e.g., how many catheters were burst tested, how many were put through flow rate tests, etc.). The phrase "bench testing" is used, implying laboratory tests on manufactured samples.
Data provenance is not provided geographically, but it is implied to be from the manufacturer's (Shinva Ande Healthcare Apparatus Co., Ltd.) testing facilities, which are based in China.
The tests are "non-clinical," meaning they are not conducted on human subjects. They are prospective in the sense that they are performed on device samples to verify compliance.

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

Not applicable as this is not an AI/ML-powered device or a study involving expert consensus on images/data. The "ground truth" here is compliance with engineering and biological standards, determined through validated test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are typically for subjective assessments, primarily in clinical or image-based studies. These are objective engineering and biological tests against established standards.

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 as this is not an AI/ML-powered device. No human reader studies (with or without AI assistance) were performed or are relevant for this type of medical device's 510(k) submission.

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

Not applicable as this is not an AI/ML-powered device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For this traditional medical device, the "ground truth" is defined by compliance with internationally recognized engineering performance standards (ISO, ASTM) and biocompatibility standards (ISO 10993 series), and that test results meet the specified requirements of these standards.

8. The sample size for the training set:

Not applicable as this is not an AI/ML-powered device. There is no "training set."

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

Not applicable as this is not an AI/ML-powered device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 23, 2021

Shinva Ande Healthcare Apparatus Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District, BeiJing 102401 China

Re: K202060

Trade/Device Name: Disposable IV catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: June 17, 2021 Received: June 22, 2021

Dear Ray Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202060

Device Name Disposable IV catheter

Indications for Use (Describe)

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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K202060 510(k) Summary

Date of Preparation: 7/19/2021

Sponsor Identification

Shinva Ande Healthcare Apparatus Co., Ltd.

No.77 Development Zone North Road, Zibo, Shandong 255086, China Contact Person: Liang wanjie Position: Registrar Tel: +86-533-3917816 Fax: +86-533-3917815 Email: liangwanjie@andemed.com

Designated Submission Correspondent

Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

Tel: +86-18910677558 Fax: +86-10-52214696 Email: ray.wang@believe-med.com

Subject Device

Trade Name:	Disposable IV Catheter
Regulation Name:	Catheter, Intravascular, Therapeutic, Short-term less than 30 day
Regulation Name:	21 CFR 880.5200
Product Code:	FOZ
Device Class:	Class II

Predicate Device: K183399, Nexiva IV Catheter System

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Device Description

a. The Safety Straight IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needle stick injury. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, needle hub, vent fitting, safety clip, lid, valve tube, actuator, anti-reflux valve.
Straight IV Catheter System is the same as The Safety Straight IV Catheter System except b. for the safety device designed to minimize blood exposure.
c. Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, heparin plug, needleless connector, Luer adapter with dual port.
Closed IV Catheter System is the same as Safety Closed IV Catheter System except for the d. safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.
e. Needleless Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, needleless connector, Luer adapter with dual port.
f. Needleless Closed IV Catheter System is the same as Needleless Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.

Categories	Model	Model mark
Straight IV Catheter System	Type with wings but without injection port	IVC01
	Type without wings and injection port	IVC03
	Type with wings and injection port	IVC04
	Pen type	IVC05
Safety Straight IV Catheter System	Safety type with wings but without injection port	IVC06
	Safety type without wings and injection port	IVC07
	Safety type with wings and injection port	IVC08

Model(s):

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	Safety pen type	IVC09
	Safety anti-reflux type	IVC02
Closed IV Catheter System	Closed type with single port	IVC10
	Closed type with dual port	IVC11
	Safety closed type with single port	IVC12
Safety Closed IV CatheterSystem	Safety closed type with dual port for Heparin plug andNeedleless connector	IVC13
	Safety closed type with dual port for two Heparin plug	IVC14
	Needleless Closed IVCatheter System	Needleless closed type with single port
Needleless closed type with dual port		IVC16
Needleless Safety ClosedIV Catheter System	Needleless safety closed type with single port	IVC17
	Needleless safety closed type with dual port	IVC18

Indications for Use Statement:

Disposable IV catheter is intended to be inserted into a Patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA devices are suitable for use with power injectors set to a maximum pressure of 300 psi when access ports not suitable for use with power injectors are removed.

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Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device K183399	Remark
Indications forUse Statement	Disposable IV catheter is intended to beinserted into a Patient's peripheral vascularsystem for short term use to sample blood,monitor blood pressure, or administer fluids.These devices may be used for any patientpopulation with consideration given toadequacy of vascular anatomy, procedurebeing performed, fluids being infused, andduration of therapy. The 22-18 GA devicesare suitable for use with power injectors setto a maximum pressure of 300 psi whenaccess ports not suitable for use with powerinjectors are removed.	BD Nexiva closed IV catheter systems areintended to be inserted into a Patient'speripheral vascular system for short term useto sample blood, monitor blood pressure, oradminister fluids. These devices may be usedfor any patient population with considerationgiven to adequacy of vascular anatomy,procedure being performed, fluids beinginfused, and duration of therapy. The 22-18GA (0.9-1.3 mm) devices are suitable for usewith power injectors set to a maximumpressure of 300 psi (2068 kPa) when accessports not suitable for use with powerinjectors are removed.	SAME
Classification	21CFR § 880.5200Class IIFOZ -Catheter, intravascular, therapeutic,short-term less than 30 days	21CFR § 880.5200Class IIFOZ -Catheter, intravascular, therapeutic,short-term less than 30 days (primary)	SAME
gauge sizes	14G,16G,18G,20G,22G, 24G,26G	18G, 20G, 22G, 24G,	Analysis
Use with PowerInjectors	Yes(18G, 20G, 22G)	Yes(18G, 20G, 22G)	SAME
Flashbackvisualization	Yes	Yes	SAME
Packaging	Blister	Blister	SAME
Single SterileWrapped	Yes	Yes	SAME
Sterilization	Ethylene oxide	Ethylene oxide	SAME

		Table 1 General Comparison Table
--	--	----------------------------------	--	--	--

Analysis

The proposed device is different than the predicate device in Gauge Size, the proposed device has more specification of gauge size available than predicate device (14G, 16G, 26G). The difference gauge sizes is used for different clinical situations and for more choices to the physician. We have conducted bench testing to each gauge size, and the tests results meet the requirements of the recognized standards. This difference does not raise concerns of safety and effectiveness.

ITEM	Proposed Device	Predicate Device K183399	Remark
Needle	Stainless Steel	Stainless Steel	SAME
Catheter	Polyurethane	Polyurethane	SAME
Catheter hubwings	TPE/PP	TPE	Analysis
Pinch Clam	Polyoxymethylene	Acetal	Analysis
ExtensionTubing	PVC/Polyurethane	Polyurethane	Analysis
Luer Adapter	Copolyester	Copolyester	SAME

Table 2 Device Materials Comparison Table

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Needlelessconnector	Polycarbonate/ Silicone elastomer	Polycarbonate/ Silicone (Q-Syte/ MaxZero)	SAME
Heparin plugbody	Copolyester	N/A	Analysis
Heparin plugInjection Port	Polyisoprene rubber(Rubber pad)	N/A	Analysis

Analysis

The proposed device and the predicate device have different materials used for the Catheter hub wings, Pinch Clam, Extension tubing, heparin plug body and heparin plug. This difference may cause a biological risk. We have conducted biological evaluation and testing with the final device, which included whole materials of proposed device, and the results shown that there is no biological risk. This difference does not raise concerns of safety and effectiveness than the predicate device.

ITEM	Proposed Device		Predicate Device K183399	Remark
Needlestickinjurypreventionfeature	Safety Straight IV Catheter System	Yes	NA	Analysis
	Safety Closed IV Catheter System
	Needleless Safety Closed IVCatheter System
	Straight IV Catheter System
	Closed IV Catheter System	NA	NA	SAME
	Needleless Closed IV CatheterSystem
Extensiontubing (closed)	Straight IV Catheter System	NA	Yes	Analysis
	Safety Straight IV Catheter System
	Closed IV Catheter System	Yes	Yes	SAME
	Safety Closed IV Catheter System
	Needleless Closed IV CatheterSystem
	Needleless Safety Closed IVCatheter System
Port	Safety closed type with single port	Single port	Single Port with MaxZero	SAME
	Needleless closed type with singleport
	Needleless safety closed type withdual port	Dual Port	Dual Port with Q-Syte	SAME
	Safety closed type with dual port forHeparin plug and Needlelessconnector
	Needleless closed type with dualport
	Safety closed type with dual port fortwo Heparin plug	Y Connection(dual port) withtwo PRNadapters	Y Connection (dual port) with twoPRN adapters	SAME
	Closed type with dual port
	Safety closed type with single port	Single port	Single port	SAME
	Closed type with single port
	Type with wings but withoutinjection port	Single port	Single port	SAME
	Type without wings and injectionport	Single port	Single port	SAME
	Type with wings and injection port	Single port +Injection Port	Single port	Analysis
	Pen type	Single port	Single port	SAME
	Safety type with wings but without	Single port	Single port	SAME

Table 3 Primary Device Components Comparison Table

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injection port
Safety type without wings andinjection port	Single port	Single port	SAME
Safety type with wings andinjection port	Single port +Injection Port	Single port	Analysis
Safety pen type	Single port	Single port	SAME
Safety anti-reflux type	Single port +Injection Port	Single port	Analysis

Analysis

The proposed device has a slightly different passive Needlestick injury prevention feature than the predicate device. We have conducted bench testing per ISO 23908 and the tests results meet the requirements of the recognized standards. This difference does not raise concerns of safety and effectiveness.

The proposed device is different than the predicate device in that it is available with and without Extension tubing, it will not affect the normal use of the product and does not change the intended use. Testing has been conducted in accordance with ISO 10555-1:2013, and the test results meet the standard requirements, so this difference does not raise concerns of safety and effectiveness.

The proposed device has an Injection Port, the predicate device does not have Injection port, this port is used for dosing during infusion, it will provide more choices to the physician for different clinical situations. We have conducted bench tests to this port (ISO 10555-1, Leakage Test). This difference does not raise concerns of safety and effectiveness.

ITEM	Proposed Device	Predicate Device K183399	Remark
Bio	Accordance with ISO 10993 -1:2009 andreferencing FDA guidance entitled "Use ofInternational Standard ISO 10993- 1,Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process".	Accordance with ISO 10993 -1:2009 andreferencing FDA guidance entitled "Use ofInternational Standard ISO 10993- 1,Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process".	SAME
Power injectiontest	Catheter burst pressure exceeds the peakpressure present in the catheter at maximumflow conditions when tested according to ISO10555-1:2013	No detail test information	Analysis
Flow rate test	The flow rate through catheter meets allowablelimits when tested according to ISO10555-1:2013	No detail test information	Analysis
Vent fitting testfor the needlehub	The needle hub with the packing part isimpervious to liquid infiltration whensubjected to positive pressure in accordancewith ISO 10555 - 5: 2013.	No detail test information	Analysis
Ease ofassemblyperformancetesting for theplunger	The plunger passes through the check valvewhen tested according to ISO 594-2:1998	No detail test information	Analysis

Table 4 Performance Comparison Table

Analysis

Information about testing of predicate device performance is not available, so these tests are considered as different. We have conducted bench tests (ISO 10555-5, ISO 594-2), and the tests results meet the requirements of the recognized standards. These differences do not raise concerns of safety and effectiveness.

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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:

ISO 594-1:1986: Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements.
A ISO 594-2:1998: Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
♪ ISO 9626:2016: Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
ISO 10555-1: 2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
A ISO 10555-5: 2013 Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral catheters
ISO23908: 2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
A ISO 80369-7: 2016 Small-bore connectors for liquids and gases in healthcare applications -Part 7 : Connectors for intravascular or hypodermic applications
ASTM F1980-07 Standard guide for accelerated aging of sterile barrier systems for medical device.
ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
A ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity.
ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
ISO 10993-7:2009 Biological Evaluation of Medical Device Part 7: Ethylene Oxide > Sterilization residuals.
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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).