Who is the manufacturer of Polyguard and Polyshield Safety IV Catheters?

Poly Medicure Limited filed the 510(k) submission for Polyguard and Polyshield Safety IV Catheters (K230616).

What is the FDA product code for Polyguard and Polyshield Safety IV Catheters?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Polyguard and Polyshield Safety IV Catheters?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Polyguard and Polyshield Safety IV Catheters?

BD Insyte Autoguard BC (K110443).

Who can help prepare an FDA 510(k) submission like Polyguard and Polyshield Safety IV Catheters?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Polyguard and Polyshield Safety IV Catheters

K230616 · Poly Medicure Limited · FOZ · May 5, 2023 · General Hospital

Device Facts

Record ID	K230616
Device Name	Polyguard and Polyshield Safety IV Catheters
Applicant	Poly Medicure Limited
Product Code	FOZ · General Hospital
Decision Date	May 5, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. 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 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

Device Story

Over-the-needle peripheral safety IV catheters; used for vascular access (blood sampling, pressure monitoring, fluid infusion). Features active sharps injury prevention (spring-activated or push-back needle shields); some models include blood control (prevents flow until distal connection) and 'quick flash back' technology for vein access confirmation. Used in clinical settings by healthcare professionals. Catheter hub color-coded per ISO 10555-5. Power injection capability (14-24G) up to 300 psi. Benefits include reduced needle-stick injury risk, improved vein access success, and controlled blood flow.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), sterility, packaging integrity (ASTM F-1980, F-1929, F-2096, F-88), and clinical simulation studies per ISO 23908.

Technological Characteristics

Polyurethane catheter; stainless steel needle; female 6% Luer connector. Active safety mechanisms (spring-activated or push-back). Sterile (EO gas, SAL 10-6). MR Conditional. Complies with ISO 10555-1/5, ISO 80369-7, ISO 10993, USP <788>.

Indications for Use

Indicated for short-term (<30 days) vascular access for blood sampling, blood pressure monitoring, or fluid administration in any patient population, considering patient size, solution appropriateness, and therapy duration. 14-24G catheters are indicated for power injection 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 Insyte Autoguard BC (K110443)

Reference Devices

ViaValve Safety IV Catheter (K160235)

Related Devices

K252677 — Polyshield Safety IV Catheters · Poly Medicure Limited · Nov 5, 2025
K113700 — VIAVALVE SAFETY IV CATHETER · Smiths Medical Asd, Inc. · Mar 14, 2012
K171530 — Deltaven XiV Max, Deltaven XiV Max FF · Delta Med Spa · Dec 21, 2017
K220626 — Introcan Safety IV Catheter · B.Braun Medical, Inc. · May 14, 2022
K192493 — BD Cathena (TM) Safety IV Catheter · Becton Dickinson Infusion Therapy Systems, Inc. · Jan 24, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 5, 2023 Poly Medicure Limited % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 Italy Re: K230616 Trade/Device Name: Polyguard and Polyshield Safety IV Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: March 1, 2023 Received: March 7, 2023 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. 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 {1}------------------------------------------------ 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 (QS) 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 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, David Walloschek David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230616 Device Name Polyguard and Polyshield Safety IV Catheters #### Indications for Use (Describe) The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood pressure, or administer fluids. 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 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 ps. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a stylized "P" with a red cross inside a yellow circle. Below the logo is the tagline "We Care As We Cure". # K230616 - 510(k) Summary | Type of 510(k) submission: | Traditional | |-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date of Preparation: | 3 May 2023 | | Manufacturer: | Poly Medicure Ltd Plot No. 115-117, Sector- 59 HSIIDC Industrial Area, Ballabgarh Faridabad-121004, Haryana, INDIA | | Phone: | +91-129-3355070 | | 510(k) Owner and Submitter: | Poly Medicure Ltd Plot No. 115-117, Sector- 59 HSIIDC Industrial Area, Ballabgarh Faridabad-121004, Haryana, INDIA | | 510(k) Contact: | Mr. Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 00153 Rome, ITALY | | Phone: Email: | +39 06 578 2665 rgray@donawa.com | | Subject Device Trade Name: | Polyguard and Polyshield Safety IV Catheters | | Common Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | | Requlation Number: | 21 CFR 880.5200 | | Regulation Name: | Intravascular catheter | | Product Code: | FOZ | | Classification Panel: | General Hospital | | Predicate Device: Sponsor 510(k) Number Clearance Date: FDA Product Code Regulation No: Regulation Name Class: | BD Insyte Autoguard BC Becton Dickinson Infusion Therapy Systems Inc K110443 19 July 2011 FOZ 21 CFR 880.5200 Intravascular catheter II . | A reference device has been identified as being relevant to this submission, this being: | Reference Device: | ViaValve Safety IV Catheter | |-------------------|-----------------------------| | Sponsor | Smiths Medical ASD, Inc. | | 510(k) Number | K160235 | | Clearance Date: | 30 June 2016 | | FDA Product Code | FOZ | | Regulation No: | 21 CFR 880.5200 | | Regulation Name: | Intravascular catheter | | Class: | II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for "POLYMED MEDICAL DEVICES". The word "POLYMED" is in large, teal letters, with a yellow circle containing a red cross in the middle of the "O". Below "POLYMED" is the phrase "MEDICAL DEVICES" in smaller, teal letters. Underneath that, the slogan "We Care As We Cure" is written in a slightly smaller, teal font. #### Indications for Use: The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. 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 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi. #### Device Description: The Polyshield and Polyguard Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths. In more detail: - Polyshield: An over-the-needle, peripheral active safety IV catheter that incorporates a springactivated needle shield to help prevent needle-stick injuries - Polyshield Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a springactivated needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein. - Polyshield BC: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. - An over-the-needle, peripheral active safety IV catheter with wings that incorporates Polyshield BC Adva: a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle). Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein. - An over-the-needle, peripheral active safety IV catheter that incorporates a push-Polyquard+: back needle shield to help prevent needle-stick injuries. - Polyguard+ Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a pushback needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein. - An over-the-needle, peripheral active safety IV catheter with wings that incorporates Polyguard BC: a push-back needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made - Polyguard BC Adva: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a push-back needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein. Color-coding of the catheter hub (and wings, where fitted) is used to help identify the catheter gauge size, in accordance with ISO 10555-5. The major features of the available models are indicated in Table 1. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a 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 "POLYMED" is the text "MEDICAL DEVICES" in a smaller, gray font. Underneath that, the text "We Care As We Cure" is written in teal. | Table 1: Polyshield and Polyguard major design features | | | | | | | | | |---------------------------------------------------------|------------|--------------------|------------------|-----------------------|------------|--------------------|-----------------|----------------------| | Feature | Polyshield | Polyshield Adva | Polyshield BC | Polyshield BC Adva | Polyguard+ | Polyguard+ Adva | Polyguard BC | Polyguard BC Adva | | Safety mechanism type | Active | Active | Active | Active | Active | Active | Active | Active | | Spring activated by button | Yes | Yes | Yes | Yes | No | No | No | No | | Push-back mechanism | No | No | No | No | Yes | Yes | Yes | Yes | | Blood control mechanism | No | No | Yes | Yes | No | No | Yes | Yes | | Quick flash back | No | Yes | No | Yes | No | Yes | No | Yes | | Hub wings | Optional | Optional | Optional | Optional | Optional | Optional | Optional | Optional | | Shelf life of device | 3 yrs | 3 yrs | 3 yrs | 3 yrs | 5 yrs | 5 yrs | 3 yrs | 3 yrs | Polyshield and Polyguard Safety IV Catheters are labeled for prescription use only (Rx only) and supplied sterile for single use with a sterility assurance level (SAL) of 10-6. Sterilization is achieved by ethylene oxide gas exposure. ## Technological Characteristics: comparison with Predicate Device: The following Table 2 provides evidence of substantial equivalence of the subject device with the selected predicate device, while taking into account certain specific features of the reference devices: | Feature | Subject device K230616 | Predicate device K110443 | Similarity | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Polyguard and Polyshield Safety IV Catheters | BD Insyte Autoguard BC IV Catheter | N/A | | Device Manufacturer | Poly Medicure, India | Becton Dickinson Infusion Therapy Systems Inc, USA | N/A | | FDA Product Code | FOZ | FOZ | Same | | FDA Classification Name | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Same | | FDA Regulation Number | 880.5200 | 880.5200 | Same | | Device description: | Polyshield: Over-the-needle, peripheral safety IV catheter that incorporates a spring- activated needle shield Polyguard: Over-the-needle, peripheral safety IV catheter that incorporates a push-back needle shield 'BC' models: Incorporate a blood control feature | Over-the-needle, peripheral safety IV catheter that incorporates a spring-activated needle shield and blood control feature | Substantially equivalent but without the blood control feature Note 1 Substantially equivalent to predicate, but without the blood control feature and with a push back safety mechanism instead of spring-activated safety mechanism Polyshield BC identical to predicate; Polyguard model substantially equivalent to predicate but with push back safety mechanism | | Table 2: Predicate device comparison table | | | | | Feature | Subject device K230616 | Predicate device K110443 | Similarity | | | 'Adva' models: Incorporate a 'quick flash back' feature | | 'Adva' models identical to predicate which includes a 'quick flash back' feature (BD Instaflash™ needle technology) on 20, 22 and 24G needles | | Indications for use | The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. 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 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi. | The BD Insyte Autoguard BC catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. | Substantially equivalent, but with the addition of patient population details and power injector use for the subject device Note 5 | | Sharps injury protection feature? | Yes - active, tested in accordance with ISO 23908 and FDA 'Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features', August 2005. | Yes - active | Same | | Sharps injury prevention mechanism | Polyshield and Polyshield BC: User-activated button initiates needle retraction into the needle-shielding barrel. Once the button has been pushed and the needle retracted, the user cannot override the shielding mechanism to re- expose the needle tip. | User-activated button initiates needle retraction into the needle-shielding barrel. Once the button has been pushed and the needle retracted, the user cannot override the shielding mechanism to re- expose the needle tip. | Same | | | Polyguard and Polyguard BC: User-activated push-back mechanism retracts the needle into the needle-shielding barrel. Once activated, the user cannot override the shielding mechanism to re- expose the needle tip. | | Different. Push-back mechanism on subject device instead of push button-activated spring mechanism on predicate Note 2 | | Catheter tube material | Polyurethane | Polyurethane | 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 | Adva models | Yes | Same for Adva models | | Blood control | Yes, in BC models | Yes | Same | | Table 2: Predicate device comparison table | | | | | Feature | Subject device K230616 | Predicate device K110443 | Similarity | | Gauge sizes | 14 - 26G | 16 - 24G | Similar Note 3 | | 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 | | Sterile | Yes, SAL 10-6 | Yes, SAL 10-6 | Same | | Sterilization method | Ethylene oxide | Ethylene oxide | Same | | Shelf life | 3 or 5 years, depending on model | 3 years | Similar Note 4 | | Physical properties | According to ISO 10555-1, ISO 10555-5 | Unknown | N/A | | Power injection usage? | Yes, 14 - 24G catheters up to 300 psi. | No | Different Note 5 | | Biocompatibility | Biocompatible in accordance with ISO 10993 series and FDA guidance | Biocompatible in accordance with ISO 10993 series | Same | | Particulates | Complies with USP <788> | Not indicated | Different Note 6 | | Environment of use | Rx only | Rx only | Same | | Hub wings? | Yes, as an option | Yes, as an option | Same | | MR compatibility | MR Conditional | Not indicated | Different Note 7 | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for a company called "Polymed Medical Devices". The logo features the company name in teal letters, with a yellow circle containing a red cross in the center of the "O" in "Polymed". Below the company name is the tagline "We Care As We Cure" in a smaller, teal font. The logo is simple and professional, and the colors are eye-catching. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a yellow circle with a red cross in the center. Below the logo, the text "MEDICAL DEVICES" is written in a smaller font. Below that, the text "We Care As We Cure" is written in a smaller font. The subject device and the predicate device have many identical, similar or substantially equivalent properties or features. The differences that exist and are identified in the above table are explained in further detail in the following paragraphs. Note 1: Blood control feature: The subject device does not include a 'blood contro' feature in the range, whereas the predicate device does offer this in all models in the range. The non-availability of a blood control feature on some models in the subject device range does not raise new questions of safety or efficacy. Note 2: Safety mechanism: The subject device range offers both a 'click to close' and a 'push back to close' option, depending on the model type, whereas the predicate device offers only a 'click to close' option. The reference device, however, offers the 'push back to close' option, and the subject device has been subjected to the same simulated clinical use test regime, in accordance with FDA 'Guide for Industry and staff – Medical Devices with Sharp injury Prevention Features' and ISO 23908:2011. Use of the 'push back to close' mechanism on certain models of the subject device range does not raise new questions of safety or efficacy. Note 3: Gauge sizes in range: The subject device includes a wider range of gauge sizes than the predicate device. "Worst case' samples from the subject device range have been tested and found to be in compliance with ISO 80369-7, ISO 10555-1 and ISO 10555-5. On the basis of these tests, no new questions of safety or efficacy are raised by the inclusion of additional gauge sizes in the subject device range. Note 4: Shelf life: Certain models of the subject device range have a different shelf life from the devices in the predicate device range. Packaging samples from the subject device range with a longer labeled shelf life (5 years) than the predicate device range (3 years) have been successfully subjected to testing in accordance with ASTM F-1929, ASTM F-2096, and ASTM F-88/F-88M, with no new questions of safety or efficacy being raised. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a red cross inside of a yellow circle. Below the logo is the tagline "We Care As We Cure". Note 5: Power injection usage: The subject device catheters in the range 14 - 24G have been verified for use with power injectors up to 300 psi, similar to the reference device, which has been verified for the same power injector pressure for catheters in the 18 - 24G range. Verification of subject device and reference device suitability for power injection was established by successful testing in accordance with ISO 10555-1, with no new questions of safety or efficacy being raised. Note 6: Particulates: The predicate device was not tested for particulates in accordance with USP <788>, but the subject device has been tested and meets the requirements of this test protocol. The subject device therefore has a lower risk associated with particulate inclusion than the predicate device. Note 7: Metal slip ring material / MR compatibility: The predicate device is not labelled with respect to its compatibility with magnetic resonance (MR) systems. The reference device includes a similarly sized stainless steel type 305 insert (identified as an 'eyelet actuator') as a slip ring in the subject device. The reference device is identified on www.mrisafety.com as being suitable for labeling as an 'MR Conditional' device, so the subject device has also been labeled 'MR Conditional' as a result of the similarity between the components of interest in each device, thus no new questions of safety or efficacy are raised. #### Performance data: Non-clinical testing of the Polyshield and Polyguard Safety IV Catheters has included successful compliance testing with the following standards, most of which are FDA-recognized: - 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 - ISO 11135:2014/AMD 1:2019, FDA recognition #14-529 ● - ISO 11607-2:2019, FDA recognition # 14-531 - ISTA 3A transportation test ● - ASTM 640-20, FDA recognition # 8-556 . - USP <788> Method 1 - Blood sample collection times, for applicable devices . Biocompatibility of components in direct 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 quidance, according to which the subject device components are externally communicating items in either prolonged direct contact with circulating blood or indirect contact with the blood path. The tests undertaken were: - 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/subchronic 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) . A shelf life of 3 or 5 years, depending on the specific model, has been established by testing the integrity of the sterile packaging following accelerated aging (per ASTM F 1980-16) in accordance with the following standards: - . ISO 10555-1:2013/AMD 1:2017. FDA recognition # 6-408 - ISO 10555-5:2013, FDA recognition # 6-303 ● - ISO 80369-7:2016, FDA recognition # 5-115 ● - USP <788> Method 1 - USP <71> ● - USP <85> ● - ASTM F-1929, FDA recognition # 14-484 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a yellow circle with a red cross in the center. Below the logo is the tagline "We Care As We Cure". - ASTM F-2096, FDA recognition # 14-359 ● - ASTM F-88 / F-88M, FDA recognition # 14-573 ● A clinical simulation study has also been carried out in accordance with ISO 23908:2011, while taking into consideration relevant FDA guidance. # Clinical Data: Not applicable. #### Conclusion: The subject and predicate devices have similar indications for use and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.