Nouvo Safety Set

K232234 · Poly Medicure Limited · FOZ · Mar 15, 2024 · General Hospital

Device Facts

• Record ID: K232234
• Device Name: Nouvo Safety Set
• Applicant: Poly Medicure Limited
• Product Code: FOZ · General Hospital
• Decision Date: Mar 15, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood. Infusion of fluids such as solutions, parenteral nutrition of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

Device Story

The Nouvo Safety Set is an over-the-needle peripheral intravascular catheter system designed for vascular access; it incorporates a passive safety clip to prevent needle stick injuries. The device includes a radiopaque polyurethane catheter, needle cover, introducer needle, stabilization platform, integrated extension tubing, C-clamp, and needle-free connector. It is used in clinical settings by healthcare professionals for blood sampling and fluid/drug infusion. The device features an immediate flashback system to confirm vessel entry. Upon needle removal, the passive safety clip automatically engages to shield the needle tip. The system is provided sterile and non-pyrogenic for single use. It is compatible with power injectors for specific gauges. The device benefits patients by providing secure vascular access while reducing the risk of sharps injuries to clinicians.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including compliance with ISO 10555-1, ISO 10555-5, ISO 80369-7, and ISO 23908. Biocompatibility was established per ISO 10993 series. Sterilization and shelf-life (5 years) were validated via ETO cycle validation and accelerated aging (ASTM F1980).

Technological Characteristics

Materials: Polyurethane (catheter/tubing), Cellulose Acetate Propionate/ABS (adapter), ABS (grip/luer), Polycarbonate (tip shield), Polyacetal (clamp). Sensing: Flashback visualization. Energy: None (manual). Connectivity: None. Sterilization: Ethylene oxide. Standards: ISO 10555-1/5, ISO 80369-7, ISO 23908, ISO 10993, ASTM F1980.

Indications for Use

Indicated for insertion into patient's vascular system for blood sampling, fluid infusion, parenteral nutrition, and drug administration. Suitable for any patient population based on size, solution appropriateness, and therapy duration. 18G-22G catheters compatible with power injectors up to 300 psi.

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

• BD Nexiva™ Closed IV Catheter System (K183399)

Submission Summary (Full Text)

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March 15, 2024

Poly Medicure Limited % Sunita Teekasingh Regulatory Consulatant GSA 2 Group LLC 8049 Haves Street North East Spring Lake Park, Minnesota 55432

Re: K232234

Trade/Device Name: Nouvo Safety Set Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: February 15, 2024 Received: February 16, 2024

Dear Sunita Teekasingh:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,

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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) K232234

Device Name Nouvo Safety Set

# Indications for Use (Describe)

The Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood. Infusion of fluids such as solutions, parenteral nutrition of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/4/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a yellow circle containing a red cross in place of the "O". Below "POLYMED" are the words "MEDICAL DEVICES" in a smaller, gray font. Underneath that is the phrase "We Care As We Cure" in teal.

# K232234- 510(k) Summary Complies with 21CFR 807.92

# SUBMITTER I.

Poly Medicure Limited Plot No. 115-117, Sector- 59 HSIIDC Industrial Area, Ballabgarh Faridabad-121004, Haryana INDIA

Contact Person: Sunita Teekasingh, RN, BSN, CCRN Consultant, GSA2 Group LLC Phone: [phone] Email: [e-mail]

Date Prepared: March 15, 2024

# II. DEVICE

| Name of Device: | Nouvo Safety Set |
|----------------------------|------------------------------------------------------------------------------------------|
| Common Name or Usual Name: | Intravascular Catheter |
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than<br>30 Days 21 (CFR §880.5200) |
| Regulatory Class: | II |
| Primary Product Code | FOZ |

# III. PREDICATE DEVICE

| 510(k) Number: | K183399 |
|----------------------------|------------------------------------------------------------------------------------------|
| Name of Device: | BD Nexiva™ Closed IV Catheter System |
| Common Name or Usual Name: | Intravascular Catheter |
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30<br>Days 21 (CFR §880.5200) |
| Regulatory Class: | II |
| Primary Product Code | FOZ |

There are no reference devices used in this submission.

# DEVICE DESCRIPTION IV.

The Nouvo Safety Set is an over the Needle Intravascular Catheter, peripheral, it incorporates the passive safety clip to help prevent needle stick injuries. The catheter is made from a radio-opaque polyurethane (PUR) material. The devices have a septum, stabilization platform, integrated extension tubing, c-clamp, single luer, needle free connector, safety clip, access split septum with site luer and vent plug. The needle cover protects the needle and catheter.

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Image /page/5/Picture/0 description: The image shows the logo for "POLYMED MEDICAL DEVICES". The word "POLYMED" is in large teal letters, with a red cross inside a yellow circle in place of the "O". Below the company name is the slogan "We Care As We Cure" in a smaller teal font.

The color of the catheter hub identifies the gauge size, the catheter gauge size and length are identified on the product packaging. The Nouvo safety set IV catheter is provided sterile and non-pyrogenic for single use only. The Nouvo safety set IV catheter is not made with natural rubber latex or PVC.

The subject device shares the similar technological characteristics, principles of operation and the same fundamental scientific technology as the predicate device. Both devices have needleless adaptors and passive safety features. The Needleless adaptor used in the subject device is FDA cleared.

The Nouvo Safety Set has the following features: needle cover, introducer needle, needle hub, radiopaque catheter, colored wings, catheter hub, C-clamp, extension tube with or without the N-Pules needles connection (single port, single port with needle free valve, dual port with needle free valve) cleared under K220288 (NP Medical). The immediate flashback system has a plug that prevents leaking and seepage. Upon removal, the safety clip is engaged to prevent needle sticks.

There are no additional accessories included with the Nouvo Safety Set.

| Gauge | Safety I.V Cannula | Extension Tube | Wing | PUR-Catheter | Y-site, | C-Clamp | SQ FB chamber with filter | N-Pulse1 | Tyvek Pack |
|----------|--------------------------|-------------------|------|------------------|---------|---------|---------------------------------|----------|------------|
| 18Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 18Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | |
| 18Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 24Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 24Gx14mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 26Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | , Yes |
| 18Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 18Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 18Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 20Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 20Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 20Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 20Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 22Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 22Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 22Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 22Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 24Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 24Gx14mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 26Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2- Yes | Yes |
| 18Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 18Gx64mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 18Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 24Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Gauge | Safety<br>I.V<br>Cannula | Extension<br>Tube | Wing | PUR-<br>Catheter | Y-site, | C-Clamp | SQ FB<br>chamber<br>with filter | N-Pulse¹ | Tyvek Pack |
| 24Gx14mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 26Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 18Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 18Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 18Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 20Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 20Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 20Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 20Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 22Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 22Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 22Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 22Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 24Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 24Gx14mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes |
| 26Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | 2-Yes | Yes, |
| 18Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 18Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx32mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 20Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx64mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx45mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx25mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 22Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 24Gx19mm | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| 24Gx14mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 26Gx19mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 18Gx45mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 18Gx32mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes, |
| 18Gx64mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes, |
| 20Gx64mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 20Gx45mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 20Gx32mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 20Gx25mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 22Gx64mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 22Gx45mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 22Gx25mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 22Gx19mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 24Gx19mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 24Gx14mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 26Gx19mm | Yes | Yes | Yes | Yes | No | Yes | Yes | Yes | Yes |
| 18Gx45mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 18Gx64mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 18Gx32mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 20Gx64mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 20Gx45mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 20Gx32mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 20Gx25mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 22Gx64mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 22Gx45mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 22Gx25mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 22Gx19mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 24Gx19mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 24Gx14mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |
| 26Gx19mm | Yes | Yes | Yes | Yes | No | Yes | Yes | No | Yes |

The subject device has the following models/configurations:

¹N-Pulse is a subcomponent cleared under K220288

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Image /page/6/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and gray, with a yellow circle and red cross in the upper left. Below the logo is the tagline "We Care As We Cure".

# V. INDICATIONS FOR USE

The Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood, Infusion of fluids such as solutions, parenteral nutrition and administration of other drugs. The

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Image /page/7/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a red cross inside a yellow circle replacing the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller, gray font. Underneath that, the phrase "We Care As We Cure" is written in teal.

catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

| FEATURE | SUBJECT DEVICE | PREDICATE<br>DEVICE | COMPARISION |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | Nouvo Safety Set | BD NexivaTM Closed<br>IV Catheter System | |
| Device Manufacturer | Poly Medicure<br>Limited | Becton Dickson | N/A |
| 510(k) Reference | K232234 | K183399 | N/A |
| Indications For Use | The Nouvo Safety Set<br>IV Catheter are<br>indicated for insertion<br>into a patient's<br>vascular system to<br>sample blood,<br>Infusion of fluids<br>such as solutions,<br>parenteral nutrition,<br>and administration of<br>other drugs. The<br>catheters may be used<br>for any patient<br>population with<br>consideration given to<br>patient size,<br>appropriateness for<br>the solution being<br>infused, and duration<br>of therapy.<br>The 18G-22G<br>catheters may be used<br>intravascularly with<br>power injectors at a<br>maximum pressure of<br>300 psi. | BD Nexiva closed IV<br>catheter systems are<br>intended to be inserted<br>into a patient's<br>peripheral vascular<br>system for short term<br>use to sample blood,<br>monitor blood pressure,<br>or administer fluids.<br>These devices may be<br>used for any patient<br>population with<br>consideration given to<br>adequacy of vascular<br>anatomy, procedure<br>being performed, fluids<br>being infused, and<br>duration of therapy. The<br>22- 18 GA (0.9-1.3 mm)<br>devices are suitable for<br>use with power injectors<br>set to a maximum<br>pressure of 300 psi<br>(2068 kPa) when access<br>ports not suitable for use<br>with power injectors are<br>removed. | Similar, Refer to<br>comment a |
| Models | Extension tube- with<br>and without access<br>port | Extension tube with and<br>without access port | Same |
| Product configurations | • Single port,<br>• Dual port,<br>• Single port with<br>needle free valve,<br>Dual port with<br>needle free valve | • Single Port,<br>• Single Port with<br>MaxZero,<br>• Dual Port,<br>• Dual Port with Q-<br>Syte,<br>• Dual Port with Q-<br>Syte and End Cap,<br>Dual Port with MaxZero | Similar, Refer to<br>comment b |
| FEATURE | SUBJECT DEVICE<br>Nouvo Safety Set | PREDICATE DEVICE<br>BD Nexiva ™ Closed IV Catheter System | COMPARISION |
| Fundamental Scientific<br>Technology | Closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port or Y (dual)-port injection site. Incorporates flashback visualization. | Closed peripheral intravascular catheter system designed with an integrated extension set incorporating a single port or Y (dual)-port injection site. Incorporates BD Instaflash™ technology to assist with flashback visualization. | Same |
| Sharps Injury Protection<br>Feature | Yes- passive | Yes - passive | Same |
| X-Ray Visible | Yes | Yes | Same |
| Needle Material | Stainless steel | Stainless steel | Same |
| Needle Distal End<br>Configuration | Back cut ground beveled needle | Back cut ground beveled needle | Same |
| Flashback Visualization | Yes | Yes | Same |
| Catheter Tube Material | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Same |
| Catheter Adapter Wings | TPE + Gauge-specific colorant | TPE + Gauge-Specific Colorant | Same |
| Catheter Adapter | Cellulose Acetate Propionate / Polycarbonate / Acrylonitrile Butadiene Styrene | Copolyester | Different, Refer to comment c |
| Tip Shield | Polycarbonate | Polycarbonate + Grey Colorant | Similar, Refer to comment d |
| Grip/Needle Hub | Acrylonitrile Butadiene<br>Styrene (exel white) | Polycarbonate + White Colorant | Different, Refer to comment e |
| Pinch Clamp | Polyacetal | Polyacetal | Same |
| Extension Tubing | Polyurethane | Polyurethane | Same |
| Luer Adapter | Acrylonitrile Butadiene Styrene | Copolyester | Different, refer to comment f |
| Needleless Adapter | Yes (FDA cleared K220288) | Yes- MaxZero | Similar, refer to comment g |
| Blood control | Yes | Yes | Same |
| Gauge sizes | 18 - 26G | 18- 24G | Same |
| Catheter Lengths (inch) | 0.55 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.77 IN, 2.52 IN | 0.56 IN, 0.75 IN, 1.00 IN, 1.25 IN, 1.75 IN | Similar, refer to comment h |
| Color-Coding | Yes, according to ISO. 10555-5 | Yes, according to ISO. 10555-5 | Same |
| Proximal End<br>Configuration | Female 6 % Luer | Female 6 % Luer | Same |
| Single Use | Yes | Yes | Same |
| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE | COMPARISION |
| | Nouvo Safety Set | BD Nexiva TM Closed IV Catheter System | |
| Sterilization Method | Ethylene oxide | Ethylene oxide | Same |
| Shelf Life | 5 years | 3 years | Different, refer to comment i |
| Physical Properties | According to ISO 10555-1, ISO 10555-5 | According to ISO 10555-1, ISO 10555-5 | Same |
| Power Injection Usage? | Yes, 18-22 G catheters up to 300 psi. | The 18-22 G devices are suitable for use with power injectors up to 300 psi | Same |
| Biocompatibility | Biocompatible in accordance with ISO 10993 series and FDA guidance | Biocompatible in accordance with ISO 10993 series | Same |
| Prescription or Rx Only | Rx only | Rx only | Same |
| MRI Safety | MR Conditional | Unknown…