Deltaven Fast Flash Closed I.V. Catheter Systems

K200373 · Delta Med Spa · FOZ · Aug 26, 2020 · General Hospital

Device Facts

• Record ID: K200373
• Device Name: Deltaven Fast Flash Closed I.V. Catheter Systems
• Applicant: Delta Med Spa
• Product Code: FOZ · General Hospital
• Decision Date: Aug 26, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended 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.

Device Story

Over-the-needle peripheral intravascular catheter; includes integrated extension tubing, Luer lock adaptor, and slide/pinch clamp. Passive safety mechanism encases needle point upon withdrawal to prevent needlestick injuries. Blood containment feature prevents exposure during insertion. Used for short-term venous access, blood sampling, and fluid administration. 16-24G models support power injection up to 330 psi. Operated by clinicians via conventional venipuncture technique. Design changes include modified extension line closure, hub wing geometry, extension line diameters, safety housing, and needle sheath. Benefits include reduced risk of blood exposure and needlestick injury for healthcare providers.

Clinical Evidence

Bench testing only. Performance verified via ISO 10555-1/5 (catheter requirements), ISO 80369-7 (connectors), ISO 23908 (sharps protection), and USP <788> (particulates). Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, haemocompatibility, and genotoxicity. Accelerated aging performed per ASTM F1980. Sterilization validated per ISO 11135.

Technological Characteristics

Polyurethane catheter; stainless steel needle with back-cut configuration. Passive safety mechanism. Extension tubing with pinch clamp. Luer lock connectors per ISO 80369-7. Sterilized via ethylene oxide (EO) per ISO 11135. Biocompatible per ISO 10993. Available in 16G-26G sizes.

Indications for Use

Indicated for short-term peripheral venous access in any patient population, subject to vascular anatomy and procedure appropriateness. Used for blood collection and fluid administration. Contraindicated for high-pressure administration in 26G models.

Regulatory Classification

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.

Predicate Devices

• Deltaven Closed I.V. Catheter Systems (K171530)

Submission Summary (Full Text)

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 ([e-mail]) or phone [phone] 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

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

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

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# K200373 510(K) SUMMARY

| Submitter: | Delta Med S.p.A<br>Via Guido Rossa, 20<br>I-46019 Viadana, Mantova<br>Italy |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone]<br>Fax: [phone] |
| Application Correspondent: | Mr. Roger Gray<br>Vice President Quality and Regulatory<br>Donawa Lifescience Consulting<br>Piazza Albania 10<br>00153 Rome Italy |
| | Phone: [phone]<br>Email: [e-mail] |
| 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

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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

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# Predicate device comparison:

| CHARACTERISTIC | SUBJECT DEVICE<br>Deltaven Fast Flash Closed I.V. Catheter<br>systems | PREDICATE DEVICE<br>Deltaven Closed IV Catheter Fast Flash | EQUIVALENCE |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Device name | Deltaven Fast Flash Closed I.V. Catheter<br>systems:<br>• Deltaven Fast Flash<br>• Deltaven Y Fast Flash<br>• Deltaven SC Fast Flash<br>• Deltaven Y- NL Fast Flash<br>• Deltaven SC-NL Fast Flash<br>• Deltaven NPL Fast Flash<br>• Deltaven Y-DNL Fast Flash | Deltaven Closed IV Catheter System:<br>• Deltaven XiV Max Fast Flash<br>• Deltaven XiV Max Y Fast Flash<br>• Deltaven XiV Max SC Fast Flash<br>• Deltaven XiV Max Y- NL Fast Flash<br>• Deltaven XiV Max SC-NL Fast Flash | Two new<br>models added<br>plus design<br>changes to all<br>models, as<br>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<br>systems are catheters for short-term<br>peripheral venous access that allow the<br>collection of blood samples and<br>administration of fluids intravascularly.<br>Deltaven Fast Flash Closed I.V. Catheter<br>systems are equipped with a passive system<br>for the prevention of accidental needlestick<br>injuries. Blood is contained within the<br>device during the catheter insertion<br>process, aiding the prevention of blood<br>exposure. The device can be used for any<br>patient population with consideration given<br>to adequacy of vascular anatomy and<br>appropriateness of procedure. Deltaven<br>Fast Flash Closed I.V. Catheter systems 16-<br>24 gauge catheters are suitable for use with<br>pressure injectors rated for a maximum of<br>330 psi when the access ports and<br>stopcocks are removed and a direct<br>connection is made with the proximal luer<br>lock connector.<br>Deltaven Fast Flash Closed I.V. Catheter<br>systems 26 gauge are not suitable for<br>administration at high pressure. | Deltaven Closed I.V. Catheter systems are<br>catheters for short-term peripheral venous<br>access that allow the collection of blood<br>samples and administration of fluids<br>intravascularly.<br>Deltaven Closed I.V. Catheter systems are<br>equipped with a passive system for the<br>prevention of accidental needlestick<br>injuries. Blood is contained within the<br>device during the catheter insertion<br>process, aiding the prevention of blood<br>exposure. The device can be used for any<br>patient population with consideration given<br>to adequacy of vascular anatomy and<br>appropriateness of procedure. Deltaven<br>Closed I.V. Catheter systems 16-24 gauge<br>catheters are suitable for use with pressure<br>injectors rated for a maximum of 330 psi<br>when the access ports and stopcocks are<br>removed and a direct connection is made<br>with the proximal luer lock connector.<br>Deltaven Closed I.V. Catheter systems 26<br>gauge are not suitable for administration at<br>high pressure. | Same |
| Sharps injury prevention<br>feature | Yes | Yes | Same |
| Safety mechanism | Passive activation | Passive activation | Same |
| CHARACTERISTIC | SUBJECT DEVICE<br>Deltaven Fast Flash Closed I.V. Catheter<br>systems | PREDICATE DEVICE<br>Deltaven Closed IV Catheter Fast Flash | EQUIVALENCE |
| Safety mechanism<br>activation | After the device is inserted in the vein, the<br>introducer needle can be completely<br>withdrawn until safety device activation.<br>The introducer needle engages with the<br>safety finger that closes its arms and hides<br>the needle point within itself. The needle<br>point is completely encased within the<br>safety device. | After the device is inserted in the vein, the<br>introducer needle can be completely<br>withdrawn until safety device activation.<br>The introducer needle engages with the<br>safety finger that closes its arms and hides<br>the needle point within itself. The needle<br>point is completely encased within the<br>safety device. | Same |
| Sharps injury prevention<br>features remains<br>activated during disposal | Yes | Yes | Same |
| Mode of<br>operation | Conventional venipuncture technique | Conventional venipuncture technique | Same |
| Insertion technique | 1-handed or 2-handed | 1-handed or 2-handed | Same |
| Tubing extension line<br>dimension | For 26G up to 22G: ID 1.2mm,<br>For 20G up to 16G: ID 1.6mm | For 26G up to 18G: ID 1.2mm,<br>For 16G: ID 1.6mm | Different |
| Catheter tube material | Polyurethane | Polyurethane | Same |
| Radio-opaque catheter<br>tubing? | Yes | Yes | Same |
| Needle material | Stainless steel | Stainless steel | Same |
| Needle distal end<br>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<br>configuration | Conforms to ISO 80369-7 | Conforms to ISO 594-1, ISO 594-2,<br>ISO 80369-7 | Same |
| Material<br>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…