(232 days)
No
The description focuses on the mechanical and material properties of the IV catheter and its safety features. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
The device is used for infusion of fluids and drugs, which is a therapeutic purpose.
No
Explanation: The device is an IV catheter used for sampling blood and infusing fluids, not for diagnosing conditions.
No
The device description clearly outlines a physical medical device (intravascular catheter) with various hardware components and materials. There is no mention of software as the primary or sole component.
Based on the provided information, the Nouvo Safety Set IV Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into a patient's vascular system to sample blood and infuse fluids. This is an in vivo (within a living organism) application.
- Device Description: The description details a catheter designed for direct insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to analyze samples like blood, urine, or tissue in a laboratory setting to provide diagnostic information. The Nouvo Safety Set is a medical device used for direct patient care involving the vascular system.
N/A
Intended Use / 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 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.
Product codes
FOZ
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population with consideration given to patient size
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 testing has been successfully conducted to ensure the safety and effectiveness of the Nouvo Safety Set, to verify conformity to specification, and demonstrate substantial equivalence to the predicate device cited in this submission.
Testing has included a demonstration of compliance testing with the following standards:
ISO 10555-1:2013/AMD 1:2017
ISO 10555-5:2013
ISO 80369-7:2021
USP Method 1 (not FDA recognized)
The Nouvo Safety Sets have been subjected to testing in accordance with FDA 'Guide for Industry and staff - Medical Devices with Sharp injury Prevention Features' and ISO 23908:2011 'Sharps injury protection. Requirements and Test method. Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Biocompatibility of components in direct or indirect contact with the patient has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018, while taking into consideration relevant FDA guidance's and, including the following tests:
Cytotoxicity (ISO 10993-5:2009)
Sensitization (ISO 10993-10:2010)
Irritation or intracutaneous reactivity (ISO 10993-10:2010)
Acute systemic toxicity (ISO 10993-11:2017)
Subacute/sub chronic toxicity (ISO 10993-11:2017)
Material-mediated pyrogenicity (ISO 10993-11:2017)
Hemocompatibility (ISO 10993-4:2017)
Implantation (ISO 10993-6:2016)
Genotoxicity (ISO 10993-3:2014)
All tests were successfully completed.
Sterile packaging is performed at Polymed in accordance with internal documentation (drawings and work instructions). The sterile packaging materials use Tyvek / MG Paper supplied by Amcor or Oingdao Medlight Trade Co Ltd or Anhui Harmony Medical + PVC Film supplied by Rainbow Industries / Soft blister film.
The subject devices are packed for transport in 5 ply corrugated boxes. A transit test has been successfully conducted in accordance with ISTA 3A:2018.
Sterilization is conducted on-site by Polymed by means of ethylene oxide (ETO) gas, resulting in a sterility assurance level (SAL) of 10-6. The cycle has been validated in accordance with ISO 11135:2014/Amd 1:2018. ETO residuals have been assessed in accordance with ISO 10993-7:2008/Amd 1:2019 and found to be within acceptable limits. Bacterial endotoxin levels of 'ready for release' devices have been assessed by means of a Limulus amebocyte lysate (LAL) test in accordance with USP and found to be less than the allowable limit of ≤ 20 EU/device.
The shelf life for the subject devices has been assessed by subjecting them to accelerated aging per ASTM F1980-16 and then by evaluating them to confirm compliance with specifications at the end of their designated shelf lives. These tests have resulted in the establishment of a shelf life of 5 years.
Final testing is performed on each batch before release, testing samples for compliance with:
ISO 10555-1:2013/AMD 1:2017
ISO 10555-5:2013
ISO 80369-7:2021
USP Method 1 (Not FDA recognized)
Risk analysis, including human factors, was performed taking into consideration the requirements of ISO 14971:2019 to demonstrate that all reasonably foreseeable risks have been identified and, where necessary, mitigated, such that the benefits of use outweigh any residual risks of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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,
2
General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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: 612-814-7999 Email: gsa2groupllc@gmail.com
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 |
| 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 |
| 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 | ||||||||
| I.V | |||||||||
| Cannula | Extension | ||||||||
| Tube | Wing | PUR- | |||||||
| Catheter | Y-site, | C-Clamp | SQ FB | ||||||
| chamber | |||||||||
| 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
DEVICE | COMPARISION |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | Nouvo Safety Set | BD NexivaTM Closed
IV Catheter System | |
| Device Manufacturer | Poly Medicure
Limited | Becton Dickson | N/A |
| 510(k) Reference | K232234 | K183399 | N/A |
| 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
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. | BD Nexiva closed IV
catheter systems are
intended to be inserted
into a patient's
peripheral vascular
system for short term
use to sample blood,
monitor blood pressure,
or administer fluids.
These devices may be
used for any patient
population with
consideration given to
adequacy of vascular
anatomy, procedure
being performed, fluids
being infused, and
duration of therapy. The
22- 18 GA (0.9-1.3 mm)
devices are suitable for
use with power injectors
set to a maximum
pressure of 300 psi
(2068 kPa) when access
ports not suitable for use
with power injectors are
removed. | Similar, Refer to
comment a |
| Models | Extension tube- with
and without access
port | Extension tube with and
without access port | Same |
| Product configurations | • Single port,
• Dual port,
• Single port with
needle free valve,
Dual port with
needle free valve | • Single Port,
• Single Port with
MaxZero,
• Dual Port,
• Dual Port with Q-
Syte,
• Dual Port with Q-
Syte and End Cap,
Dual Port with MaxZero | Similar, Refer to
comment b |
| FEATURE | SUBJECT DEVICE
Nouvo Safety Set | PREDICATE DEVICE
BD Nexiva ™ Closed IV Catheter System | COMPARISION |
| Fundamental Scientific
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
Feature | Yes- passive | Yes - passive | Same |
| X-Ray Visible | Yes | Yes | Same |
| Needle Material | Stainless steel | Stainless steel | Same |
| Needle Distal End
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
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
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 | Different, refer to comment j |
Table 1: Subject and Predicate Device Comparison
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Image /page/8/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 the middle of the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller, gray font. Underneath that is the slogan "We Care As We Cure".
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Image /page/9/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 gray. Below that is the text "We Care As We Cure".
The following section describes the differences between the subject and the predicate device:
Indications for Use a.
The predicate and the subject devices have minor differences between the statements within the IFU. The differences do not raise different questions of safety and effectiveness.
b. Product Configurations
The subject and predicate device have different product configurations. Biocompatibility, sterility, performance, shipping, and shelf-life testing of the subject device demonstrates that the differences do not raise different questions of safety and effectiveness.
Catheter Adapter c.
The catheter adapter of the subject device is made of Cellulose Acetate Propionate / Acrylonitrile Butadiene Styrene while the catheter adapter provided in the predicate device is made of Copolyester. The safety and performance of catheter adapter has been proven with stability study and biocompatibility of the subject device. The differences do not raise different questions of safety and effectiveness.
d. Tip Sheild
The tip shield of the subject and predicate device is of the same material; however, the predicate device has a colorant. The subject device biocompatibility testing demonstrates the difference does not raise different questions of safety and effectiveness.
Grip/Needle Hub e.
The Grip/needle hub of the subject device is made of Acrylonitrile Butadiene Styrene (exel white) while the Grip/needle hub provided in the predicate device is made of Polycarbonate + white colorant. The safety
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Image /page/10/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 the word "POLYMED" are the words "MEDICAL DEVICES" in gray. Underneath that is the text "We Care As We Cure" in teal.
and performance of Grip/needle hub has been proven with stability study and biocompatibility of the subject device. The differences do not raise different questions of safety and effectiveness.
f. Luer Adapter.
The Luer adapter of the subject device is made of ABS while the Luer adapter provided in predicate device is made of Copolyester. The safety and performance of luer adapter has been proven with stability study and biocompatibility of subject device. The differences do not raise different questions of safety and effectiveness.
Needless Adapter g.
Both devices have a needleless system with similar technology. The needleless adaptor used in subject device is FDA cleared (K220288), additional validation was conducted with the Nouvo Safety Set. The differences do not raise different questions of safety and effectiveness.
h. Catheter Lengths
The subject device is available in a long length and has been evaluated for the same safety and performance requirements and performs the same as the predicate shorter lengths. The differences do not raise different questions of safety and effectiveness.
i. Shelf Life
The subject device has a shelf of 5 years while the predicate device has a shelf life of 3 years. Shelf life for the subject devices has been assessed by means of subjecting devices to accelerated aging in accordance with ASTM F1980 (FDA recognition # 14-497) and then by testing them to confirm compliance with specifications at the end of their designated shelf lives. These tests have resulted in the establishment of a shelf life of 5 years. The differences do not raise different questions of safety and effectiveness.
MR Safety J.
The subject device is MR conditional and related information provided in IFU. However, predicate device is unknown with respect to MR safety. The predicate device is not labelled with respect to its compatibility with magnetic resonance (MR) systems. The differences do not raise different questions of safety and effectiveness.
VII. PERFORMANCE DATA
Bench testing has been successfully conducted to ensure the safety and effectiveness of the Nouvo Safety Set, to verify conformity to specification, and demonstrate substantial equivalence to the predicate device cited in this submission.
Testing has included a demonstration of compliance testing with the following standards:
| Standard | FDA Recognition Number |
|---|---|
| ISO 10555-1:2013/AMD 1:2017 | FDA recognition # 6-408 |
| ISO 10555-5:2013 | FDA recognition # 6-303 |
| ISO 80369-7:2021 | FDA recognition # 5-115 |
| USP Method 1 | not FDA recognized |
Table 2: FDA Recognized Standards
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Image /page/11/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 the middle of the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in gray, and below that is the phrase "We Care As We Cure" in teal.
The Nouvo Safety Sets have been subjected to testing in accordance with FDA 'Guide for Industry and staff - Medical Devices with Sharp injury Prevention Features' and ISO 23908:2011 'Sharps injury protection. Requirements and Test method. Sharp protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Biocompatibility a.
Biocompatibility of components in direct or indirect contact with the patient has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018, while taking into consideration relevant FDA guidance's and, including the following tests:
| Tests | FDA Recognition number |
|---|---|
| Cytotoxicity | ISO 10993-5:2009, FDA recognition # 2-245 |
| Sensitization | ISO 10993-10:2010, FDA recognition # 2-174 |
| Irritation or intracutaneous reactivity | ISO 10993-10:2010, FDA recognition # 2-174 |
| Acute systemic toxicity | ISO 10993-11:2017, FDA recognition # 2-255 |
| Subacute/sub chronic toxicity | ISO 10993-11:2017, FDA recognition # 2-255 |
| Material-mediated pyrogenicity | ISO 10993-11:2017, FDA recognition # 2-255 |
| Hemocompatibility | ISO 10993-4:2017, FDA recognition # 2-248 |
| Implantation | ISO 10993-6:2016, FDA recognition # 2-247 |
| Genotoxicity | ISO 10993-3:2014, FDA recognition # 2-228 |
| Table 3: Biocompatibility Recognized Standards | |||
|---|---|---|---|
| -- | ------------------------------------------------ | -- | -- |
All tests were successfully completed.
b. Packaging
Sterile packaging is performed at Polymed in accordance with internal documentation (drawings and work instructions).
The sterile packaging materials use Tyvek / MG Paper supplied by Amcor or Oingdao Medlight Trade Co Ltd or Anhui Harmony Medical + PVC Film supplied by Rainbow Industries / Soft blister film.
c. Shipping Packaging
The subject devices are packed for transport in 5 ply corrugated boxes. A transit test has been successfully conducted in accordance with ISTA 3A:2018 (FDA recognition # 5-126).
Sterilization d.
Sterilization is conducted on-site by Polymed by means of ethylene oxide (ETO) gas, resulting in a sterility assurance level (SAL) of 10°. The cycle has been validated in accordance with ISO 11135:2014/Amd 1:2018 (FDA recognition # 14-529).
ETO residuals have been assessed in accordance with ISO 10993-7:2008/Amd 1:2019 and found to be within acceptable limits.
Bacterial endotoxin levels of 'ready for release' devices have been assessed by means of a Limulus amebocyte lysate (LAL) test in accordance with USP (FDA recognition # 14-561) and found to be less than the allowable limit of ≤ 20 EU/device.
e. Shelf Life
The shelf life for the subject devices has been assessed by subjecting them to accelerated aging per ASTM F1980-16 (FDA recognition #14-497) and then by evaluating them to confirm compliance with specifications at the end of their designated shelf lives. These tests have resulted in the establishment of a shelf life of 5 years.
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Image /page/12/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 the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller, gray font. Below that is the phrase "We Care As We Cure" in teal.
f. Final Testing and Batch Release
Final testing is performed on each batch before release, testing samples for compliance with: Table 4 Batch testing FDA Recognized Standards
| Standard | FDA Recognition number |
|---|---|
| ISO 10555-1:2013/AMD 1:2017 | FDA recognition # 6-408 |
| ISO 10555-5:2013 | FDA recognition # 6-303 |
| ISO 80369-7:2021 | FDA recognition # 5-115 |
| USP Method 1 | Not FDA recognized |
Risk Analysis g.
This submission includes the risk analysis, including human factors. The analysis was performed taking into consideration the requirements of ISO 14971:2019 to demonstrate that all reasonably foreseeable risks have been identified and, where necessary, mitigated, such that the benefits of use outweigh any residual risks of use.
h. Labeling
Labeling has been developed considering FDA requirements and guidance, relevant international standards, predicate device labeling, and usability testing results.
i. Clinical Testing:
Not Applicable
CONCLUSIONS VIII.
The subject and predicate devices have similar indications for use and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices are addressed. All variations between the predicate device and subject devices have been tested for device safety and performance. These differences do not raise different questions of safety and effectiveness. The performance data demonstrates that the subject device is substantially equivalent to the predicate device.