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.

AI/ML Overview

The provided text does not describe an AI medical device or a study involving AI assistance. Therefore, I cannot provide information on acceptance criteria, reported device performance, sample size for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as requested in the prompt.

The document describes the regulatory submission for Polyguard and Polyshield Safety IV Catheters, which are traditional medical devices, not AI-powered. The submission focuses on demonstrating substantial equivalence to a predicate device (BD Insyte Autoguard BC IV Catheter) through non-clinical performance testing and biocompatibility assessments, rather than AI performance metrics.

Summary

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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

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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

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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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K230616 - 510(k) Summary

Type of 510(k) submission:	Traditional
Date of Preparation:	3 May 2023
Manufacturer:	Poly Medicure LtdPlot No. 115-117, Sector- 59HSIIDC Industrial Area, BallabgarhFaridabad-121004, Haryana, INDIA
Phone:	+91-129-3355070
510(k) Owner and Submitter:	Poly Medicure LtdPlot No. 115-117, Sector- 59HSIIDC Industrial Area, BallabgarhFaridabad-121004, Haryana, INDIA
510(k) Contact:	Mr. Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 Rome, ITALY
Phone:Email:	+39 06 578 2665rgray@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:Sponsor510(k) NumberClearance Date:FDA Product CodeRegulation No:Regulation NameClass:	BD Insyte Autoguard BCBecton Dickinson Infusion Therapy Systems IncK11044319 July 2011FOZ21 CFR 880.5200Intravascular catheterII.

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

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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:

Device Description:

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.

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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	PolyshieldAdva	PolyshieldBC	PolyshieldBC Adva	Polyguard+	Polyguard+Adva	PolyguardBC	PolyguardBC Adva
Safetymechanismtype	Active	Active	Active	Active	Active	Active	Active	Active
Springactivated bybutton	Yes	Yes	Yes	Yes	No	No	No	No
Push-backmechanism	No	No	No	No	Yes	Yes	Yes	Yes
Bloodcontrolmechanism	No	No	Yes	Yes	No	No	Yes	Yes
Quick flashback	No	Yes	No	Yes	No	Yes	No	Yes
Hub wings	Optional	Optional	Optional	Optional	Optional	Optional	Optional	Optional
Shelf life ofdevice	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 deviceK230616	Predicate deviceK110443	Similarity
Device name	Polyguard and PolyshieldSafety IV Catheters	BD Insyte Autoguard BC IVCatheter	N/A
DeviceManufacturer	Poly Medicure, India	Becton Dickinson InfusionTherapy Systems Inc, USA	N/A
FDA ProductCode	FOZ	FOZ	Same
FDAClassificationName	Catheter, Intravascular,Therapeutic, Short-Term LessThan 30 Days	Catheter, Intravascular,Therapeutic, Short-Term LessThan 30 Days	Same
FDA RegulationNumber	880.5200	880.5200	Same
Devicedescription:	Polyshield: Over-the-needle,peripheral safety IV catheterthat incorporates a spring-activated needle shieldPolyguard: Over-the-needle,peripheral safety IV catheterthat incorporates a push-backneedle shield'BC' models: Incorporate ablood control feature	Over-the-needle, peripheralsafety IV catheter thatincorporates a spring-activatedneedle shield and blood controlfeature	Substantially equivalent butwithout the blood controlfeature Note 1Substantially equivalent topredicate, but without the bloodcontrol feature and with a pushback safety mechanism insteadof spring-activated safetymechanismPolyshield BC identical topredicate; Polyguard modelsubstantially equivalent topredicate but with push backsafety mechanism
Table 2: Predicate device comparison table
Feature	Subject deviceK230616	Predicate deviceK110443	Similarity
	'Adva' models: Incorporate a'quick flash back' feature		'Adva' models identical topredicate which includes a'quick flash back' feature (BDInstaflash™ needle technology)on 20, 22 and 24G needles
Indications foruse	The Polyshield and PolyguardSafety IV Catheters areindicated for short term use(less than 30 days) forinsertion into a patient'svascular system to sampleblood, monitor blood pressure,or administer fluids. Thecatheters may be used for anypatient population withconsideration given to patientsize, appropriateness for thesolution being infused, andduration of therapy. The 14 -24G catheters may be usedintravascularly with powerinjectors at a maximumpressure of 300 psi.	The BD Insyte Autoguard BCcatheter is inserted into apatient's vascular system tosample blood, monitor bloodpressure, or administer fluids.	Substantially equivalent, butwith the addition of patientpopulation details and powerinjector use for the subjectdevice Note 5
Sharps injuryprotectionfeature?	Yes - active, tested inaccordance with ISO 23908and FDA 'Guidance forIndustry and FDA StaffMedical Devices with SharpsInjury Prevention Features',August 2005.	Yes - active	Same
Sharps injurypreventionmechanism	Polyshield and Polyshield BC:User-activated button initiatesneedle retraction into theneedle-shielding barrel. Oncethe button has been pushedand the needle retracted, theuser cannot override theshielding mechanism to re-expose the needle tip.	User-activated button initiatesneedle retraction into theneedle-shielding barrel. Oncethe button has been pushedand the needle retracted, theuser cannot override theshielding mechanism to re-expose the needle tip.	Same
	Polyguard and Polyguard BC:User-activated push-backmechanism retracts the needleinto the needle-shieldingbarrel. Once activated, theuser cannot override theshielding mechanism to re-expose the needle tip.		Different.Push-back mechanism onsubject device instead of pushbutton-activated springmechanism on predicate Note 2
Catheter tubematerial	Polyurethane	Polyurethane	Same
X-ray visible	Yes	Yes	Same
Needle material	Stainless steel	Stainless steel	Same
Needle distal endconfiguration	Back cut ground beveledneedle	Back cut ground beveledneedle	Same
Flashbackvisualization	Adva models	Yes	Same for Adva models
Blood control	Yes, in BC models	Yes	Same
Table 2: Predicate device comparison table
Feature	Subject deviceK230616	Predicate deviceK110443	Similarity
Gauge sizes	14 - 26G	16 - 24G	Similar Note 3
Color-coding	Yes, according to ISO10555-5	Yes, according to ISO10555-5	Same
Proximal endconfiguration	Female 6 % Luer	Female 6 % Luer	Same
Single use	Yes	Yes	Same
Sterile	Yes, SAL 10-6	Yes, SAL 10-6	Same
Sterilizationmethod	Ethylene oxide	Ethylene oxide	Same
Shelf life	3 or 5 years, depending onmodel	3 years	Similar Note 4
Physicalproperties	According to ISO 10555-1, ISO10555-5	Unknown	N/A
Power injectionusage?	Yes, 14 - 24G catheters up to300 psi.	No	Different Note 5
Biocompatibility	Biocompatible in accordancewith ISO 10993 series andFDA guidance	Biocompatible in accordancewith ISO 10993 series	Same
Particulates	Complies with USP <788>	Not indicated	Different Note 6
Environment ofuse	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

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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.

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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.

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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

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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.

Regulation Number and Section

§ 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).