Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical IV catheter with safety features and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.

Therapeutic

Yes
The device is used to administer fluids, parenteral nutrition, and other drugs, which are all therapeutic interventions for a patient's health.

Diagnostic

No
The device is an IV catheter used for administering fluids and sampling blood, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical, over-the-needle IV catheter with mechanical components like a safety clip and blood control valve. The performance studies also focus on bench testing and simulated clinical use of this physical device. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the catheters are for insertion into the vascular system to sample blood or administer fluids and drugs. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo (within the living organism).
Device Description: The description details the physical components of the catheter and its safety features for insertion and fluid management. It does not describe any components or processes related to analyzing samples in vitro (outside the living organism).
Lack of IVD Characteristics: There is no mention of analyzing biological samples to provide diagnostic information about a patient's condition. IVDs are typically used to test blood, urine, tissue, or other samples to detect diseases, conditions, or markers.

The device is a medical device used for accessing the vascular system, which is a different category than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Polysafety BC IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer 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-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

The Polysafety BC Adva IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer 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-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

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

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

Product codes (comma separated list FDA assigned to the subject device)

FOZ

Device Description

The Polysafety-BC safety IV Catheter is an over-the-needle blood control. Peripheral passive Safety IV Catheter incorporates a safety clip to help prevent needle-stick injuries & blood control valve to reduce blood exposure during initial catheter placement, blood sampling, withdrawal of the needle, and connection of the luer. The Polysafety BC Safety IV Catheter is provided with a detachable or integrated, flexible perforated soft wing for providing ventilation & skin maceration. The device also incorporates a 'quick flash back'.

The Polywin safety IV Catheter is an over the needle, Peripheral passive Safety IV Catheter that incorporates a safety clip to help prevent needle- stick injuries. The Polywin Safety Adva IV Catheter provided with quick flash back features.

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

Not Found

Intended User / Care Setting

Rx only

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 carried out to ensure the safety and effectiveness of the Polysafety BC to verify conformity to specification and demonstrate substantial equivalence to the predicate cited in this submission. testing has included a demonstration of compliance testing with the standards and FDA guidance's.

The Polysafety BC and Polysafety BC Adva IV Catheters have been subjected to simulated clinical use 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'.

Bench testing has been carried out to ensure the safety and effectiveness of the Polywin safety catheter variants, to verify conformity to specification, and demonstrate substantial equivalence to the predicate cited in this submission. testing has included a demonstration of compliance testing with the following standards:

The Polywin Safety IV Catheter variants have been subjected to simulated clinical use 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'.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K192676, K020785

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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 & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. Food & Drug Administration".

September 21, 2023

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

Re: K231401

Trade/Device Name: Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: August 18, 2023 Received: August 22, 2023

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 (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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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,

Danil Walloschek

David Wolloscheck, Ph.D. 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) K231401

Device Name

Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva

Indications for Use (Describe)

The Polysafety BC IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer 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-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. maniliani probat v o r vopsi

The Polysafety BC Adva IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer 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 180-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

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

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 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 in place of the "O". Below the word "POLYMED" are the words "MEDICAL DEVICES" in a smaller font. Below that is the slogan "We Care As We Cure".

K 231401 - 510(K) SUMMARY

SUBMISSION ADMINISTRATIVE INFORMATION 1

Device Name:	Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva IV Catheters
Type of 510(k) submission:	Traditional Bundled 510(k)
Manufacturer:	Poly Medicure Ltd
Plot No. 115-117, Sector- 59
HSIIDC Industrial Area, Ballabgarh Faridabad-121004, Haryana
INDIA
Phone:	+91-129-3355070
FDA Establishment Reg. Number:	9616991
Subject Device
FDA Product Code:	FOZ
FDA Regulation Number:	21 CFR 880.5200
FDA Classification Name:	Intravascular catheter
Classification Panel:	General Hospital
Common Name:	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
FDA Classification:	Class II
Submission Type:	510(k)
Date	September 19, 2023
Official Primary Correspondent	Sunita Teekasingh RN, BSN, CCRN, MSc Regulatory Consultant
GSA2 Group LLC 8049 Hayes St NE
Minneapolis, MN 55432
Email	GSA2Groupllc@gmail.com
Phone:	612-814-7999
Polysafety Blood Control (BC) Predicate
Predicate Manufacturer:	B. Braun Medical Inc.
Predicate Trade Name:	Introcan Safety® 2 IV Catheter
Predicate 510(k) Number:	K192676
Class	II
Predicate Product Code	FOZ
FDA Classification Name:	21 CFR 880.5200
Classification Panel:	General Hospital
Common Name:	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Polywin Safety IV Catheter Predicate
Predicate Manufacturer:	B. Braun Medical Inc
Predicate Trade Name:	Introcan Safety® IV Catheter
Predicate 510(k) Number:	K020785
Class	II
Predicate Product Code	FOZ
FDA Classification Name:	21 CFR 880.5200
Classification Panel:	General Hospital
Common Name:	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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Image /page/4/Picture/1 description: The image shows the logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a red plus sign inside a yellow circle in place of the "O". Below the company name, the text "MEDICAL DEVICES" is written in a smaller font. The slogan "We Care As We Cure" is written in a smaller font below the company name.

2 POLYSAFETY BLOOD CONTROL SUBSTANTIAL EQUIVALANCE

The Polysafety BC predicate is B. Braun Medical Inc, Introcan Safety® 2 IV Catheter (K192676). Both devices are under the same product code FOZ and classification (880.5200) and intended for short term use less than 30 days.

| Feature | Subject device
Polysafety BC
Polysafety BC Adva | Predicate device
Introcan Safety® 2 IV Catheter | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Device
Manufacturer | Poly Medicure, India | B. Braun Medical Inc,
Pennsylvania | N/A |
| 510(k) Reference | This submission | K192676 | N/A |
| Device
Description: | The Polysafety-BC safety IV Catheter is an
over-the-needle blood control. Peripheral
passive Safety IV Catheter incorporates a
safety clip to help prevent needle-stick
injuries & blood control valve to reduce
blood exposure during initial catheter
placement, blood sampling, withdrawal of
the needle, and connection of the luer. The
Polysafety BC Safety IV Catheter is
provided with a detachable or integrated,
flexible perforated soft wing for providing
ventilation & skin maceration. The device
also incorporates a 'quick flash back'. | The Introcan Safety® 2 IV Catheter
consists of an over-the-needle, peripheral
catheter made of radiopaque
polyurethane, an integrated one
directional septum that controls the flow
of blood during and after cannulation, and
a passive safety needle-shielding
mechanism. Introcan Safety® 2 is
designed to reduce blood exposure at
insertion until first connection of an
infusion line or luer device to protect
clinicians and patients from blood
exposure. During needle withdrawal, the
needle is withdrawn through a septum that
seals after the needle has been removed,
blood is thus contained within the
Introcan Safety® 2 device. The pressure
exerted on the needle as it passes through
the septum wipes blood from the needle
further reducing potential blood
exposure. The passive safety needle
shielding mechanism of the Introcan
Safety® 2 is located inside the catheter
hub. Upon withdrawal of the needle, the
safety shield engages as the needle passes
through the catheter hub and deploys
automatically to shield the needle tip. The
safety shield protects during disposal,
aiding in the prevention of needlestick
injuries. Once the safety shield engages
and shields the needle tip, the user is
unable to re-insert the needle which aids
in the prevention of catheter shearing.
This device may be used for any patient
population with consideration given to
adequacy of vascular anatomy and
appropriateness for the solution being
infused and duration of therapy. The
catheters may be used intravascularly
with power injectors for which the
maximum pressure setting is 300 psi with
a luer lock connection only. The devices
will be available in 18, 20, 22, and 24- | Different see
2.1.1
(Substantial
equivalent) |
| Feature | Subject device
Polysafety BC
Polysafety BC Adva | Predicate device
Introcan Safety® 2 IV Catheter | Comparison |
| | | gauge versions with and without a
stabilization platform. | |
| Indications for
use | The Polysafety BC IV Catheter are indicated
for short-term use (less than 30 days) for
insertion into a patient's vascular system to
sample blood or administer 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-
24G catheters may be used intravascularly
with power injectors at a maximum pressure
of 300psi.
The Polysafety BC Adva IV Catheter are
indicated for short-term use (less than 30 days) for insertion into a patient's vascular
system to sample blood or administer 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-
24G catheters may be used intravascularly
with power injectors at a maximum pressure
of 300psi. | The Introcan Safety® 2 IV Catheter
is inserted into a patient's vascular
system for short term use to sample
blood, monitor blood pressure, or
administer fluids and blood
intravascularly. The catheters may be
used intravascularly with power injectors
at a maximum pressure of 300 psi with a
luer lock connection only. | Different see
2.1.2
(Substantial
equivalent) |
| Sharps injury
protection
feature? | Yes - passive, tested in accordance with ISO
23908 and FDA 'Guidance for Industry and
FDA Staff Medical Devices with Sharps
Injury Prevention Features', August 2005. | Yes - passive | Same |
| Wings | With, without and Detachable wings with | Yes- and without wings | Same |
| Catheter tube
material | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | 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 |
| Blood control | Yes | Yes | Same |
| Gauge sizes | 18 - 24G | 18- 24G | Same |
| Needle lengths | 19-45 mm | 19-45 mm | Same |
| 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 years | 1 years | Different
Testing on
subject device
supports 3
years shelf
life, |
| Feature | Subject device
Polysafety BC
Polysafety BC Adva | Predicate device
Introcan Safety® 2 IV Catheter | Comparison |
| Physical
properties | According to ISO 10555-1, ISO 10555-5 | According to ISO 10555-1, ISO 10555-5 | Same |
| Power injection
usage? | Yes, 18-24G catheters up to 300 psi. | The 18-24 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 |
| Environment of
use | Rx only | Rx only | Same |
| MR Safety | MR Conditional | MR Conditional | Same |

Table 2-1 Polysafety BC Predicate Comparison

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Image /page/5/Picture/1 description: The image is a 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" are the words "MEDICAL DEVICES" in a smaller font. The tagline "We Care As We Cure" is located below the company name.

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Image /page/6/Picture/1 description: The image shows the logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a yellow circle and red cross in the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller font. Underneath that is the phrase "We Care As We Cure".

POLYSAFETY SUBSTANTIAL EQUIVALENCE DISCUSSION 2.1

2.1.1 DEVICE Description

The subject device shares the same technological characteristics, principles of operation and the same fundamental scientific technology as the predicate device. The predicate device description wording is more extensive than the subject devices have the same features. The predicate device uses the Introcan Safety 2 system, the Polymed system uses the same concepts for a safety clip system. Both the devices can be used with power injectors. The differences are minor and stylistic in nature and do not raise new questions about safety and effectiveness.

INDICATIONS FOR USE 2.1.2

The predicates are intended for the same patient population and are available in the same gauge sizes and needle lengths. The subject intended use is more descriptive than the intended use of the predicate, this difference is minor and stylistic in nature and does not raise new questions about safety and effectiveness.

The are no differences between the proposed Polysafety BC IV Catheter variants and predicate Introcan Safety® 3 Closed IV Catheter devices are listed below. These differences do not raise new issues of safety and effectiveness.

DEVICE FEATURES 2.1.3

2.1.3.1 Blood Control Feature

The subject and predicate devices both have a one directional septum used for "blood control' feature in all models in all gauge sizes. The septum maintains a closed catheter system, before and after use.

2.1.3.2 Safety Mechanism

The subject and predicate both devices are provided with a safety mechanism i.e., passive safety tip clip to help prevent needle stick injuries.

2.1.3.3 Power Injection Usage

The subject and predicate device catheters in the range 18 - 24G have been verified for use with power injectors up to 300 psi.

2.1.3.4 Hub Wings

The predicate device offers the choice of having or not having hub wings on all models within the device family. Polysafety BC also offers integrated or detachable wings or without wings depending on customer requirement. The detachable wings do not introduce any new concerns about safety and effectiveness.

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Image /page/7/Picture/1 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 the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller font. Underneath that, the phrase "We Care As We Cure" is written in a slightly larger font.

NON-CLINICAL TESTING 2.1.4

Bench testing has been carried out to ensure the safety and effectiveness of the Polysafety BC to verify conformity to specification and demonstrate substantial equivalence to the predicate cited in this submission. testing has included a demonstration of compliance testing with the standards and FDA guidance's.

Table 2-2 Standards
Tests	Standard
Intravascular Catheters- General Requirements-
single sterile	ISO 10555-1:2013/AMD 1:2017
	ISO 10555-5:2013
Small -bore connectors for liquids and gases	ISO 80369-7:2016
Particulate matter Analysis	USP Method 1
Sharps injury protection	ISO 23908:2011
Cytotoxicity	ISO 10993-5:2009
Skin Sensitization	ISO 10993-10:2010
Irritation or intracutaneous reactivity	ISO 10993-10:2010
Packaging Validation	ISO 11607-2:2019
Ethylene Oxide Sterilization Validation	ISO 11135:2014/Amd 1:2018
EO sterilization residuals	10993-7:2008/Amd 1:2019
Bacterial Endotoxins tests	USP
Vibration Packaging Testing	ISTA 3A:2018
Packaging Leak test	ASTM F-1929
Packaging Leak Test	ASTM F-2096
Packaging Seal Test	ASTM F-88 / F-88M
Sterility Testing	USP

To establish substantial equivalence and the safety and effectiveness of the Polysafety BC Safety IV catheter variants to bench testing was successfully conducted to verify conformity to specification to the predicate device.

The Polysafety BC and Polysafety BC Adva IV Catheters have been subjected to simulated clinical use 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 2.1.5

Biocompatibility of finished device 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 test to support the contact category.

The contact category of the device is:

. External Communicating Device. Contact duration - B-
Prolonged Exposure
Area of Contact Circulating Blood ●

Table 2-3 Biocompatibility Standards

Test	FDA Recognition number
------	------------------------

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Image /page/8/Picture/1 description: The image is a logo for Polymed Medical Devices. The logo features the word "POLYMED" in large, teal, sans-serif font. The "O" in "POLYMED" is replaced by a yellow circle with a red cross inside. Below "POLYMED" are the words "MEDICAL DEVICES" in a smaller, gray, sans-serif font, and below that is the phrase "We Care As We Cure" in a smaller, teal, sans-serif font.

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 # 2-24
Genotoxicity	ISO 10993-3:2014, FDA recognition # 2-228
USP Method 1	Not FDA recognized

2.1.6 STERILIZATION, PACKAGING AND SHELF-LIFE

Sterilization was conducted as per standards ISO 11135:2014/Amd 1:2018 (FDA recognition # 14- 529);

2.1.6.1 Sterile packaging

Sterile packaging is performed at Polymed in accordance with internal documentation (drawings and work instructions)

The sterile packaging materials used are: -

Medical grade paper (80+10 GSM) supplied by Qingdao Medlight Trade Co Ltd or Anhui Harmony Medical
Thermoforming PP+PE film (120 um) supplied by Anhui Harmony . Medical, Reliant Packaging Films, or Qingdao Medlight Trade Co

2.1.6.2 Sterilization

Sterilization is carried out on-site by Polymed by means of ethylene oxide (ETO) gas, resulting in a sterility assurance level (SAL) of 10-6. The ETO cycle parameters are provided in Section 14 of this submission. 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 # 14-570) and found to be less than the allowable limit of 20 EU/device. Further details regarding the sterilization of the subject devices are provided in Section 14 of this submission.

2.1.6.3 Shelf Life

Testing on subject device supports 3 years' shelf life. The subject device has a longer shelf life than the predicate, materials and sterilization methods have the same standards and performance specifications. The difference does not impact the safety and effectiveness of the device.

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 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 3 years.

The subject devices are packed for transport in 5 ply corrugated boxes. A transit test has been successfully carried out in accordance with ISTA 3A:2018 (FDA recognition # 5-126).

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Image /page/9/Picture/1 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 to the left of the word. Below the word "POLYMED" are the words "MEDICAL DEVICES" in a smaller, gray font. Below that is the text "We Care As We Cure" in a teal, italicized font.

Final testing is performed on each batch before release, testing samples for compliance with:

Standard	FDA Recognition number
ISO 10555-1:2013/AMD 1:2017	FDA recognition # 6-408
ISO 10555-5:2013	FDA recognition # 6-303
ISO 80369-7:2016	FDA recognition # 5-115

Table 2-4 Batch testing FDA Recognized Standards

CLINICAL TESTING 2.1.7

Not applicable

2.1.8 CONCLUSION

The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Polysafety BC and Polysafety BC Adva IV Catheter is substantially equivalent to the Introcan® Safety 2 IV Catheter with respect to the indications for use and the fundamental technological characteristics.

POLYWIN SAFETY SUBSTANTIAL EQUIVALANCE 3

The Polywin Safety predicted to the B. Braun Introcan Safety® IV Catheter (K020785). Both devices are under the same product code (FOZ) and regulation number (880.5200) classification and intended for short term use less than 30 days.

| Feature | Subject device
Polywin Safety
Polywin Safety Adva
Poly Medicure, India | Predicate device
Introcan Safety® IV Catheter | Comparison |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Device
Manufacturer | Poly Medicure, India | B. Braun Medical Inc,
Pennsylvania | N/A |
| 510(k) Reference | This submission | K020785 | N/A |
| Device
Description: | The Polywin safety IV Catheter is an over the
needle, Peripheral passive Safety IV Catheter
that incorporates a safety clip to help prevent
needle- stick injuries. The Polywin Safety
Adva IV Catheter provided with quick flash
back features. | B. Braun Medical's Introcan Safety IV
Catheter is a passive needle stick
prevention device used for arterial and
venous access for the infusion of fluids,
drugs and/or blood components. 14 - 22-
gauge catheters may be used with power
injectors for which the maximum pressure
setting is 300 psi. The Introcan Safety IV
Catheter is available in 14 - 24-
components. 14 - 22-gauge catheters may
be used with power injectors for which the
maximum pressure setting is 300 psi. The
Introcan Safety IV gauge sizes, and both
winged and non-winged versions. | Different see
3.1.1
(Substantial
equivalent) |
| Indications for use | The Polywin Safety IV Catheter are indicated
for short term use (less than 30 days) for
insertion into a patient's vascular system to
sample blood or administer 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 14G- | Passive anti-needle stick device for
venous or arterial access for the infusion
of fluids, drugs, and/or blood
components. 14 - 22-gauge catheters may
be used with power
injectors for which the maximum pressure
setting is 300 psi | Different see
3.1.2
(Substantial
equivalent) |
| Feature | Subject device
Polywin Safety
Polywin Safety Adva | Predicate device
Introcan Safety® IV Catheter | Comparison |
| | 24G catheters may be used intravascularly
with power injectors at a maximum pressure
of 300psi.

Table 3-1 Polywin Safety Predicate Comparison

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Image /page/10/Picture/1 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 in place of the "O". Below the company name is the slogan "We Care As We Cure".

11

Image /page/11/Picture/1 description: The image is a 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 text "We Care As We Cure" in a teal, sans-serif font.

3.1 POLYWIN SAFETY SUBSTANTIAL EQUIVALENCE DISCUSSION

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.

DEVICE DESCRIPTION 3.1.1

The subject device shares the same technological characteristics, principles of operation and the same fundamental scientific technology as the predicate device. The predicate wording for predicate device description is more expansive than the subject device. The systems are similar. Both the devices can be used with power injectors, the predicate has a range 14-22G and the subject has the range of 14-24 G. Performance testing was conducted to establish the safety profile of the 24 G no new concerns for safety and effectiveness were found.

3.1.1.2 HUB WINGS

The subject device does not contain wings, the predicate device is available with or without wings.

INDICATIONS FOR USE 3.1.2

The predicates are intended for the same patient population and are available in the same gauge sizes and needle lengths for the same intended purpose. The subject intended use is more descriptive than the intended use of the predicate, this difference is minor and stylistic in nature and does not raise new questions about safety and effectiveness.

3.1.3 DEVICE FEATURES:

The subject and predicate both devices are provided with the same safety mechanism i.e., passive safety tip clip to help prevent needle stick injuries.

The subject device catheters are available in gauge sizes 14 to 26 however the14 - 24G have been verified for use with power injectors up to 300 PSI. Both the predicate and subject devices are compatible for power injections.

NON-CLINICAL TESTING 3.1.4

Tests	Standard
Intravascular Catheters- General Requirements-
single sterile	ISO 10555-1:2013/AMD 1:2017
	ISO 10555-5:2013
Small -bore connectors for liquids and gases	ISO 80369-7:2016
Particulate matter Analysis	USP Method 1
Sharps injury protection	ISO 23908:2011
Cytotoxicity	ISO 10993-5:2009
Skin Sensitization	ISO 10993-10:2010
Irritation or intracutaneous reactivity	ISO 10993-10:2010
Acute systemic toxicity	ISO 10993-11:2017
Subacute/subchronic toxicity	ISO 10993-11:2017
Material-mediated pyrogenicity	ISO 10993-11:2017
Hemocompatibility	ISO 10993-4:2017
Implantation	ISO 10993-6:2016

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Image /page/12/Picture/1 description: The image shows the logo for Polymed Medical Devices. The logo features the word "POLYMED" in teal, with a yellow circle and red cross in the center of the "O". Below the word "POLYMED" is the phrase "MEDICAL DEVICES" in a smaller font, and below that is the phrase "We Care As We Cure".

Tests	Standard
Genotoxicity	ISO 10993-3:2014
Packaging Validation	ISO 11607-2:2019
Ethylene Oxide Sterilization Validation	ISO 11135:2014/Amd 1:2018
EO sterilization residuals	10993-7:2008/Amd 1:2019
Bacterial Endotoxins tests	USP
Vibration Packaging Testing	ISTA 3A:2018
Packaging Leak test	ASTM F-1929
Packaging Leak Test	ASTM F-2096
Packaging Seal Test	ASTM F-88 / F-88M
Sterility Testing	USP

Bench testing has been carried out to ensure the safety and effectiveness of the Polywin safety catheter variants, to verify conformity to specification, and demonstrate substantial equivalence to the predicate cited in this submission. testing has included a demonstration of compliance testing with the following standards:

To establish substantial equivalence and the safety and effectiveness of the Polywin Safety IV catheter variants to bench testing was successfully conducted to verify conformity to specification to the predicate device.

The Polywin Safety IV Catheter variants have been subjected to simulated clinical use 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 3.1.5

Biocompatibility of finished device 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 test: to support the contact duration.

The contact category of the device is:

External Communicating Device. Contact duration - B-
Prolonged Exposure
Area of Contact Circulating Blood ●

Biocompatibility Recognized Standards
---------------------------------------	--	--

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/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
USP Method 1	Not FDA recognized

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Image /page/13/Picture/1 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 in place of the "O". Below the word "POLYMED" are the words "MEDICAL DEVICES" in a smaller, gray font. Underneath that, the words "We Care As We Cure" are written in a teal, cursive font.

3.1.6 STERILIZATION, PACKAGING AND SHELF-LIFE

Sterilization was conducted as per standards ISO 11135:2014/Amd 1:2018 (FDA recognition # 14-529):

Sterile packaging is performed at Polymed in accordance with internal documentation (drawings and work instructions).

The sterile packaging materials used are:

Medical grade paper (80+10 GSM) supplied by Qingdao Medlight Trade Co Ltd or . Anhui Harmony Medical
Thermoforming PP+PE film (120 um) supplied by Anhui Harmony Medical, . Reliant Packaging Films, or Qingdao Medlight Trade Co Ltd.

3.1.6.1 Sterilization

Sterilization is carried out on-site by Polymed by means of ethylene oxide (ETO) gas, resulting in a sterility assurance level (SAL) of 10-6. The ETO cycle parameters are provided in Section 14 of this submission. 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 # 14-570) and found to be less than the allowable limit of 20 EU/device.

Further details regarding the sterilization of the subject devices are provided in Section 14 of this submission.

3.1.6.2 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 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, depending on the specific catheter model.

The subject devices are packed for transport in 5 ply corrugated boxes. A transit test has been successfully carried out in accordance with ISTA 3A:2018 (FDA recognition # 5-126).

Final testing is performed on each batch before release, testing samples for compliance with:

Standard	FDA Recognition number
ISO 10555-1:2013/AMD 1:2017	FDA recognition # 6-408
ISO 10555-5:2013	FDA recognition # 6-303
ISO 80369-7:2016	FDA recognition # 5-115
USP Method 1	Not FDA recognized.

	1		Table Batch testing FDA Recognized Standards
--	---	--	----------------------------------------------	--

CLINICAL TESTING 3.1.7

Not applicable

3.1.8 Conclusion

The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Polywin Safety and Polywin Safety Adva

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Image /page/14/Picture/1 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 in place of the "O". Below the word "POLYMED" are the words "MEDICAL DEVICES" in a smaller font. Underneath that, the slogan "We Care As We Cure" is written in a similar font.

IV Catheter is substantially equivalent to the Introcan® Safety IV Catheter with respect to indications for use and fundamental technological characteristics.