(194 days)
Not Found
No
The 510(k) summary describes a physical medical device (catheter system) with a passive safety mechanism. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on bench testing and compliance with physical and biological standards.
No
The device is a catheter used for administering fluids and collecting blood samples, which are diagnostic and procedural functions, not therapeutic treatments.
No
This device is an I.V. catheter system used for peripheral venous access and fluid administration, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of polyurethane and other materials, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "short-term peripheral venous access that allow the collection of blood samples and administration of fluids intravascularly." This describes a device used for accessing the bloodstream for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description details an "over-the-needle, peripheral intravascular catheter" and associated components for accessing veins. This aligns with an in-vivo medical device, not an in-vitro diagnostic device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, etc.) to provide information about a patient's health status, disease, or condition. IVDs are designed for testing samples in vitro (in a lab setting).
Therefore, the Deltaven Fast Flash Closed I.V. Catheter system is a medical device used for accessing the peripheral venous system, not an in-vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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).
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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous
Indicated Patient Age Range
any patient population
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench/Performance/Non-Clinical Testing:
- Accelerated aging: 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 Particulates test — evaluation of particulates 10 microns in size and greater according to USP 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.
- 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).
- 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)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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.
| 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)
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3
K200373 510(K) SUMMARY
| Submitter: | Delta Med S.p.A
Via Guido Rossa, 20
I-46019 Viadana, Mantova
Italy |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Phone: +39 03 757 85915
Fax: +39 03 757 85201 |
| Application Correspondent: | Mr. Roger Gray
Vice President Quality and Regulatory
Donawa Lifescience Consulting
Piazza Albania 10
00153 Rome Italy |
| | Phone: +39 03 757 85915
Email: 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:
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).
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.
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.
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 DEVICE
Deltaven Fast Flash Closed I.V. Catheter
systems | PREDICATE DEVICE
Deltaven Closed IV Catheter Fast Flash | EQUIVALENCE |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Device name | Deltaven Fast Flash Closed I.V. Catheter
systems:
• 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 new
models added
plus design
changes to all
models, as
listed 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. 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 26 gauge are not suitable for
administration at high pressure. | Deltaven 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 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
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 Closed I.V. Catheter systems 26
gauge are not suitable for administration at
high pressure. | Same |
| Sharps injury prevention
feature | Yes | Yes | Same |
| Safety mechanism | Passive activation | Passive activation | Same |
| CHARACTERISTIC | SUBJECT DEVICE
Deltaven Fast Flash Closed I.V. Catheter
systems | PREDICATE DEVICE
Deltaven Closed IV Catheter Fast Flash | EQUIVALENCE |
| Safety mechanism
activation | After the device is inserted in the vein, the
introducer needle can be completely
withdrawn until safety device activation.
The introducer needle engages with the
safety finger that closes its arms and hides
the needle point within itself. The needle
point is completely encased within the
safety device. | After the device is inserted in the vein, the
introducer needle can be completely
withdrawn until safety device activation.
The introducer needle engages with the
safety finger that closes its arms and hides
the needle point within itself. The needle
point is completely encased within the
safety device. | Same |
| Sharps injury prevention
features remains
activated during disposal | Yes | Yes | Same |
| Mode of
operation | Conventional venipuncture technique | Conventional venipuncture technique | Same |
| Insertion technique | 1-handed or 2-handed | 1-handed or 2-handed | Same |
| Tubing extension line
dimension | 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 catheter
tubing? | Yes | Yes | Same |
| Needle material | Stainless steel | Stainless steel | Same |
| Needle distal end
configuration | 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 end
configuration | Conforms to ISO 80369-7 | Conforms to ISO 594-1, ISO 594-2,
ISO 80369-7 | Same |
| Material
biocompatibility | 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 bonding
strength | 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 Particulates test — evaluation of particulates 10 microns in size and greater according to USP 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.