Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly.

Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries.

Blood is contained within the device during the catheter insertion process, aiding the prevention of blood exposure. The device can be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Deltaven Fast Flash Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use with pressure injectors rated for a maximum of 330 psi when the access ports and stopcocks are removed and a direct connection is made with the proximal luer lock connector.

Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.

Device Description

The devices consist of an over-the-needle, peripheral intravascular catheter made of polyurethane, integrated extension tubing with Luer lock adaptor and slide clamp. The devices are also equipped with a Luer lock final adaptor (single entry version) or a Y Luer lock final adapter (dual entry version).

AI/ML Overview

The provided text describes a 510(k) summary for the Delta Med S.p.A Deltaven Fast Flash Closed I.V. Catheter Systems. This document pertains to a medical device (intravascular catheter) and not an AI/ML-driven device or an imaging device. Therefore, a study proving an AI device meets acceptance criteria, including elements like expert consensus, MRMC studies, or training/test set details, is not applicable to this document.

The document discusses acceptance criteria and the study that proves the device meets them in the context of a physical medical device (intravenous catheter), not an AI/ML system. The "acceptance criteria" here refer to the performance standards, regulatory requirements, and safety benchmarks for this type of medical device.

Here's a breakdown of the acceptance criteria and the study as described in the document, tailored to a medical device:

Acceptance Criteria for Deltaven Fast Flash Closed I.V. Catheter Systems

The acceptance criteria for the Deltaven Fast Flash Closed I.V. Catheter Systems are primarily based on established international and FDA-recognized standards for intravascular catheters, and proving substantial equivalence to a predicate device.

Table of Acceptance Criteria and Reported Device Performance

Characteristic / Test	Acceptance Criteria (Standard / Requirement)	Reported Device Performance
Functional Performance	- Maintain intended function throughout shelf-life. - Meet specifications for various components (e.g., extension line closure, catheter hub wings, needle sheath).	Functional tests were carried out on all material versions of the new designs. All tests were performed on finished sample devices after a standard ethylene oxide sterilization cycle. The test protocols and acceptance criteria were the same as those used in the predicate submission, indicating the device performed to the established specifications. Specific design changes and their impact were verified.
Material Biocompatibility	- Meet biological safety standards for patient contact. - Compliance with ISO 10993 series and FDA guidance on biocompatibility.- Specific tests: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Haemocompatibility (ASTM hemolysis, Complement Activation, Thromboresistance), Genotoxicity (Bacterial Mutagenicity, In Vitro Mouse Lymphoma), Material Mediated Rabbit Pyrogen, EO residuals.	Biocompatibility tests were carried out on new, sterile, complete devices with the new materials, in accordance with ISO 10993-1:2018 and FDA guidance. All listed specific tests were performed: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Subacute/Subchronic Toxicity, Haemocompatibility (ASTM hemolysis, Complement Activation Sc5b-9, Thromboresistance), Genotoxicity (Bacterial Mutagenicity Test (Ames Assay), In Vitro Mouse Lymphoma), ISO Material Mediated Rabbit Pyrogen, and EO residuals. The results were deemed acceptable.
Sterility	- Achieve a Sterilization Assurance Level (SAL) of 10-6. - Compliance with ISO 11135:2014 for ethylene oxide sterilization validation.	The devices are sterilized by ethylene oxide (EO) to an SAL of 10-6. The sterilization process was validated according to ISO 11135:2014, using the half cycle overkill approach. The sterile packaging is unchanged from the predicate device and found acceptable.
Pyrogenicity	- Endotoxin levels within acceptable limits via Limulus Amebocyte Lysate (LAL) test.	Sample devices produced with the new materials were tested for bacterial endotoxins using the LAL test and found to be within limits.
Physical/Mechanical Performance (Bench Tests)	- Compliance with ISO 10555-1:2013 (General requirements for intravascular catheters). - Compliance with ISO 10555-5:2013 (Over-needle peripheral catheters). - Compliance with ISO 80369-7:2016 (Small-bore connectors for intravascular/hypodermic applications). - Compliance with ISO 23908:2011 (Sharps injury protection features). - Compliance with USP <788> for particulate evaluation (no more than 10 microns and greater). - Catheter Force at break: Conforms to ISO 10555-1. - Cannula bonding strength: Conforms to ISO 10555-5. - Flow rate: Conforms to ISO 10555-1. - Pressure resistance: 330 psi (for 16-24 gauge).	Bench tests were carried out, and the results demonstrate that the devices meet the applicable technical requirements of the listed FDA-recognized standards. This includes satisfactory performance related to catheter force at break, cannula bonding strength, flow rate, and pressure resistance (330 psi for indicated gauges). Particulate testing per USP <788> was also performed, and the devices met the acceptance criteria.
Material/Shelf-life Stability	- Maintain performance after accelerated aging equivalent to 5 years shelf-life. - Compliance with ASTM F 1980:2007.	Accelerated aging tests were conducted at 60 ℃ for 19 weeks, which is equivalent to 5 years of real-time shelf-life, in accordance with ASTM F 1980:2007. Functional tests were then performed on these aged samples and found acceptable.
Indications for Use / Intended Use Equivalence	- Maintain the same indications for use as the predicate device (K171530). - Not raise new or different questions of safety and effectiveness compared to the predicate device.	The Indications for Use statement for the subject device is unchanged from the predicate, K171530. The conclusion states that "The modified device does not raise new or different questions of safety and effectiveness and this conclusion is supported by non-clinical testing," confirming substantial equivalence.

Study Details (Non-AI Device)

Sample Size Used for the Test Set and Data Provenance:
- The document does not explicitly state the specific number of units used for each test (e.g., functional, biocompatibility, sterility) as a "sample size" in the way one would for a clinical trial or AI test set.
- Instead, for medical devices, testing is performed on representative samples of the device, often according to guidelines within the referenced ISO standards (e.g., ISO 10993 specifies sample preparation, ISO 11135 specifies sample sizes for sterility validation).
- Data provenance: The testing was performed by Delta Med S.p.A (Italy) through their various testing procedures and subcontractors. The tests are "non-clinical" (bench and lab-based), not from patient data.
Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable as this is a physical medical device, not an AI/ML system requiring expert labeling or ground truth establishment from medical images/data. The "ground truth" is defined by the physical and chemical properties of the device and its performance against engineering and biological standards.
Adjudication Method:
- Not applicable. This concept pertains to resolving discrepancies in expert labeling for AI ground truth, which is not relevant here.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This type of study is used for diagnostic AI systems where human readers interpret medical images. This document describes a physical medical device.
Standalone (Algorithm Only) Performance:
- Not applicable. This device is not an algorithm. The performance evaluation is of the physical catheter and its components.
Type of Ground Truth Used:
- The "ground truth" for this device is based on:
  - Standard Compliance: Adherence to internationally recognized standards (ISO, ASTM, USP) for materials, design, manufacturing, sterility, and performance.
  - Bench Test Results: Direct measurements and observations from laboratory testing (e.g., flow rate, force at break, particulate counts, endotoxin levels).
  - Biocompatibility Assay Results: Laboratory tests on biological interactions.
  - Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (K171530).
Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device. The device itself is manufactured. The manufacturing process ensures consistency, and the testing evaluates that consistency and adherence to design specifications.
How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons mentioned above. The design and manufacturing specifications are based on engineering principles, regulatory requirements, and historical data from similar devices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.

August 26, 2020

Delta Med S.p.A % Roger Gray VP, Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 Roma, 00153 Italy

Re: K200373

Trade/Device Name: Deltaven Fast Flash Closed I.V. Catheter Systems Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: July 22, 2020 Received: July 27, 2020

Dear Roger Gray:

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.

{1}------------------------------------------------

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 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 medical devices and radiation-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.

for 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200373

Device Name

Deltaven Fast Flash Closed I.V. Catheter Systems

Indications for Use (Describe)

Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly.

Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries.

Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.

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

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K200373 510(K) SUMMARY

Submitter:	Delta Med S.p.AVia Guido Rossa, 20I-46019 Viadana, MantovaItaly
	Phone: +39 03 757 85915Fax: +39 03 757 85201
Application Correspondent:	Mr. Roger GrayVice President Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 Rome Italy
	Phone: +39 03 757 85915Email: rgray@donawa.com
Preparation Date:	August 24, 2020
Trade Name:	Deltaven Fast Flash Closed I.V. Catheter systems
Common or Usual Name:	Intravascular Catheter
Regulation Name:	Intravascular Catheter
Regulation Number:	21 CFR 880.5200
Product Code:	FOZ
Device Class:	Class II
Predicate Device:	K171530: Deltaven Closed I.V. Catheter Systems

Device Description:

Deltaven Closed I.V. Catheter systems cleared under K171530 included the following five versions:

o Deltaven XiV Max Fast Flash
Deltaven XiV Y Max Fast Flash
Deltaven XiV SC Max Fast Flash ●
Deltaven XiV Y-NL Max Fast Flash
Deltaven XiV SC-NL Max Fast Flash

{4}------------------------------------------------

To the existing five models are added two new models by means of this 510(k):

. Deltaven NLP Fast Flash
Deltaven Y-DNL Fast Flash 0

The devices provided with single entry Luer lock adaptors are also equipped with:

Luer lock white cap
3 way stopcock
. 3 way stopcock and needleless valve

The devices provided with dual entry Luer lock adaptors are also equipped with:

Luer lock white cap
O Needleless valve connector

This 'Fast Flash' range was previously cleared under K171530 with the generic name Deltaven XiV Max Fast Flash Closed I.V. Catheter systems, but the words 'XiV Max' have now been deleted from the model names.

Indications for Use:

Deltaven Fast Flash Closed I.V. Catheter systems are catheters for short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly.

Deltaven Fast Flash Closed I.V. Catheter systems are equipped with a passive system for the prevention of accidental needlestick injuries.

Deltaven Fast Flash Closed I.V. Catheter systems 26G are not suitable for the administration at high pressure.

Description of design changes:

This 510(k) addresses the following design changes to the Deltaven Fast Flash Closed I.V. Catheter systems range:

Detail design changes:

O Extension line closure system: original slide clamp replaced with a pinch clamp
Catheter hub wings: knurls were replaced with grooves on the bottom of the wings
20G and 18G extension lines: increased internal and external diameter
Safety housing/container: increased length and push tap on the surface
Needle sheath: new hooking of the needle sheath onto white finger grip and wings
Introduction of alternative materials
Change on the final connector dimension as consequence of the extension line changed dimensions for 20G and 18G Catheters
Change on the catheter hub dimension as consequence of the extension line changed dimensions for 20G and 18G Catheters
Change in sterilization subcontractor

{5}------------------------------------------------

Predicate device comparison:

CHARACTERISTIC	SUBJECT DEVICEDeltaven Fast Flash Closed I.V. Cathetersystems	PREDICATE DEVICEDeltaven Closed IV Catheter Fast Flash	EQUIVALENCE
Device name	Deltaven Fast Flash Closed I.V. Cathetersystems:• Deltaven Fast Flash• Deltaven Y Fast Flash• Deltaven SC Fast Flash• Deltaven Y- NL Fast Flash• Deltaven SC-NL Fast Flash• Deltaven NPL Fast Flash• Deltaven Y-DNL Fast Flash	Deltaven Closed IV Catheter System:• Deltaven XiV Max Fast Flash• Deltaven XiV Max Y Fast Flash• Deltaven XiV Max SC Fast Flash• Deltaven XiV Max Y- NL Fast Flash• Deltaven XiV Max SC-NL Fast Flash	Two newmodels addedplus designchanges to allmodels, aslisted above
Manufacturer	Tipromed Srl for Delta Med SpA, Italy	Tipromed Srl for Delta Med SpA, Italy	Same
510(k) reference	K200373	K171530	N/A
Regulation name	Intravascular catheter	Intravascular catheter	Same
IV Catheter type	Over the needle peripheral catheter	Over the needle peripheral catheter	Same
Regulation no	21 CFR 880.5200	21 CFR 880.5200	Same
Product Code	FOZ	FOZ	Same
Indications for use	Deltaven Fast Flash Closed I.V. Cathetersystems are catheters for short-termperipheral venous access that allow thecollection of blood samples andadministration of fluids intravascularly.Deltaven Fast Flash Closed I.V. Cathetersystems are equipped with a passive systemfor the prevention of accidental needlestickinjuries. Blood is contained within thedevice during the catheter insertionprocess, aiding the prevention of bloodexposure. The device can be used for anypatient population with consideration givento adequacy of vascular anatomy andappropriateness of procedure. DeltavenFast Flash Closed I.V. Catheter systems 16-24 gauge catheters are suitable for use withpressure injectors rated for a maximum of330 psi when the access ports andstopcocks are removed and a directconnection is made with the proximal luerlock connector.Deltaven Fast Flash Closed I.V. Cathetersystems 26 gauge are not suitable foradministration at high pressure.	Deltaven Closed I.V. Catheter systems arecatheters for short-term peripheral venousaccess that allow the collection of bloodsamples and administration of fluidsintravascularly.Deltaven Closed I.V. Catheter systems areequipped with a passive system for theprevention of accidental needlestickinjuries. Blood is contained within thedevice during the catheter insertionprocess, aiding the prevention of bloodexposure. The device can be used for anypatient population with consideration givento adequacy of vascular anatomy andappropriateness of procedure. DeltavenClosed I.V. Catheter systems 16-24 gaugecatheters are suitable for use with pressureinjectors rated for a maximum of 330 psiwhen the access ports and stopcocks areremoved and a direct connection is madewith the proximal luer lock connector.Deltaven Closed I.V. Catheter systems 26gauge are not suitable for administration athigh pressure.	Same
Sharps injury preventionfeature	Yes	Yes	Same
Safety mechanism	Passive activation	Passive activation	Same
CHARACTERISTIC	SUBJECT DEVICEDeltaven Fast Flash Closed I.V. Cathetersystems	PREDICATE DEVICEDeltaven Closed IV Catheter Fast Flash	EQUIVALENCE
Safety mechanismactivation	After the device is inserted in the vein, theintroducer needle can be completelywithdrawn until safety device activation.The introducer needle engages with thesafety finger that closes its arms and hidesthe needle point within itself. The needlepoint is completely encased within thesafety device.	After the device is inserted in the vein, theintroducer needle can be completelywithdrawn until safety device activation.The introducer needle engages with thesafety finger that closes its arms and hidesthe needle point within itself. The needlepoint is completely encased within thesafety device.	Same
Sharps injury preventionfeatures remainsactivated during disposal	Yes	Yes	Same
Mode ofoperation	Conventional venipuncture technique	Conventional venipuncture technique	Same
Insertion technique	1-handed or 2-handed	1-handed or 2-handed	Same
Tubing extension linedimension	For 26G up to 22G: ID 1.2mm,For 20G up to 16G: ID 1.6mm	For 26G up to 18G: ID 1.2mm,For 16G: ID 1.6mm	Different
Catheter tube material	Polyurethane	Polyurethane	Same
Radio-opaque cathetertubing?	Yes	Yes	Same
Needle material	Stainless steel	Stainless steel	Same
Needle distal endconfiguration	Back cut configuration	Back cut configuration	Same
Gauge sizes available	From 26G up to 16G	From 26G up to 16G	Same
Color-coded?	Yes, according to ISO 10555-5	Yes, according to ISO 10555-5	Same
Tubing proximal endconfiguration	Conforms to ISO 80369-7	Conforms to ISO 594-1, ISO 594-2,ISO 80369-7	Same
Materialbiocompatibility	Biocompatible per ISO 10993	Biocompatible per ISO 10993	Same
Single use?	Yes	Yes	Same
Supplied sterile?	Yes	Yes	Same
Sterilization method	EO	EO	Same
Catheter Force at break	Conforms to ISO 10555-1	Conforms to ISO 10555-1	Same
Cannula bondingstrength	Conforms to ISO 10555-5	Conforms to ISO 10555-5	Same
Flow rate	Conforms to ISO 10555-1	Conforms to ISO 10555-1	Same
Power injection usage?	Yes	Yes	Same
Pressure resistance?	330 psi	330 psi	Same
Prescription use only?	Yes	Yes	Same

{6}------------------------------------------------

{7}------------------------------------------------

Substantial Equivalence Discussion

The only differences between the predicate and subject devices are those identified earlier in this Summary. Specific bench tests have been completed to ensure the new models and modified devices perform to specification.

In addition, new materials have been introduced to the device range, and finished, sterile devices with these new materials have been subjected to biocompatibility tests in accordance with the applicable parts of ISO 10993 for the appropriate nature of patient contact and duration of contact.

The Indications for Use statement for the Deltaven Fast Flash Closed I.V. Catheter systems is unchanged from the predicate, K171530.

Based on the above similarities and differences, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.

Bench/Performance/Non-Clinical Testing

Accelerated aging: For tests at end of shelf life, Items were exposed to 60 ℃ for 19 weeks for an equivalent of 5 years real time shelf life, in accordance with ASTM F 1980:2007, 'Standard Guide for Accelerated Aging of Sterile Medical Device Packages'.

Functional Tests: Verification/validation tests were carried out on all material versions of the new designs. All tests were carried out on finished sample devices that had been subjected to a standard ethylene oxide sterilization cycle. The test protocols and acceptance criteria used were the same as those used in the predicate submission.

Bench Tests: The following tests have been carried out and the results demonstrate that the devices to meet the applicable technical requirements of the following FDA-recognized standards:

. ISO 10555-1:2013, 'Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements'
. ISO 10555-5:2013, 'Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle peripheral catheters'
ISO 80369-7:2016, 'Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications'
ISO 23908:2011, 'Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling'
USP <788> Particulates test — evaluation of particulates 10 microns in size and greater according to USP <788> acceptance criteria

Sterility: The subject devices are sterilized by ethylene a sterilization assurance level (SAL) of 10 °. The sterilization process has been validated according to ISO 11135:2014, 'Sterilization of healthcare products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices', using the half cycle overkill approach. The sterile packaging is unchanged in materials or methods from the predicate device.

Pyrogenicity: Sample subject devices produced with the new materials were tested for bacterial endotoxins by means of the limulus amebocyte lysate (LAL) test and found to be within limits.

{8}------------------------------------------------

Biocompatibility: Biocompatibility tests have been carried out based on criteria defined in ISO 10993-1.2018 Biological evaluation of medical devices – Part 1: evaluation and testing within a risk management process and FDA guidance on Use of the international Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: evaluation and testing within a risk management" (2016).

Biocompatibility tests have been carried out as follows on new, sterile, complete devices:

Cytotoxicity (ISO 10993-5:2009)
o Sensitization (ISO 10993-10:2010)
o Irritation or intracutaneous reactivity (ISO 10993-10:2010)
Acute Systemic toxicity (ISO 10993-11:2006)
o Subacute/Subchronic Toxicity (ISO 10993-11:2006)
Haemocompatibility (ISO 10993-4:2002 and Amend. 1 2006)
- O ASTM hemolysis Assay – Direct contact and extract method
- Complement Activation Sc5b-9 Assay O
- Thromboresistance evaluation O
. Genotoxicity (ISO 10993-3:2014)
- Bacterial Mutagenicity Test (Ames Assay) o
- In Vitro Mouse Lymphoma o
ISO Material Mediated Rabbit Pyrogen (ISO 10993-11:2006) .
EO residuals (ISO 10993-7:2008) ●

FDA Guidance: In addition, the following FDA guidance documents were considered during verification and validation of the design changes described in this submission:

Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
o Guidance for Industry and FDA Staff - Medical Devices with Sharps Injury Prevention Features -August 9, 2005

Conclusion

The modified device does not raise new or different questions of safety and effectiveness and this conclusion is supported by non-clinical testing. Deltaven Fast Flash Closed I.V. Catheter systems as modified are substantially equivalent to the predicate catheter systems cleared under K171530.

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).