Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
Device Facts
| Record ID | K252513 |
|---|---|
| Device Name | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) |
| Applicant | Poly Medicure Limited |
| Product Code | FOZ · General Hospital |
| Decision Date | Apr 1, 2026 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Polywin Safety and Polywin Safety Adva IV Catheters 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.
Device Story
Over-the-needle peripheral passive safety IV catheter; incorporates safety clip to prevent needle-stick injuries. Two models: Polywin Safety (standard) and Polywin Safety Adva (includes quick flashback technology for instant blood flow confirmation). Indwelling catheter made of polyurethane with barium sulfate for radiopacity; hub/slip ring are non-conductive, non-metallic polymers. Used by clinicians in clinical settings for vascular access. Input: manual insertion into patient vein. Output: venous access for fluid/drug administration or blood sampling. Passive safety mechanism engages automatically upon needle withdrawal. Benefits: reduces needle-stick risk; provides reliable vascular access; Adva model improves success rate via visual confirmation. Subject device expands length range (14mm-64mm) of predicate device.
Clinical Evidence
Bench testing only. Testing included dimensional verification (ISO 10555-1), biocompatibility (ISO 10993-1/7), fluid path integrity (ISO 80369-7), mechanical strength (ISO 9626), flow dynamics, and sharps protection functionality. All tests met specifications. Sterilization validation confirmed SAL 10^-6.
Technological Characteristics
Materials: Polyurethane + Barium Sulfate (catheter), Stainless Steel 304 (needle). Passive safety clip mechanism. Dimensions: 14G-26G, 14mm-64mm lengths. Connectivity: None. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 10555-1/5, ISO 80369-7, ISO 9626, ISO 11607-1, ASTM F2503-23.
Indications for Use
Indicated for short-term ( <30 days) vascular access for blood sampling or fluid/drug/parenteral nutrition administration in any patient population, considering patient size, therapy duration, and solution appropriateness. 14G-24G catheters are compatible with power injectors up to 300psi.
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
- Polywin Safety and Polywin Safety Adva IV Catheter (K231401)
Submission Summary (Full Text)
{0}
FDA U.S. FOOD & DRUG ADMINISTRATION
April 1, 2026
Poly Medicure Limited
% Sunita Teekasingh
Regulatory Consultant
GSA2 Group LLC
8049 Hayes Street North East
Spring Lake Park, Minnesota 55432
Re: K252513
Trade/Device Name: Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
Regulation Number: 21 CFR 880.5200
Regulation Name: Intravascular Catheter
Regulatory Class: Class II
Product Code: FOZ
Dated: March 1, 2026
Received: March 2, 2026
Dear Sunita Teekasingh:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K252513 - Sunita Teekasingh
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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
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K252513 - Sunita Teekasingh
Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 WOLLOSCHECK -S
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
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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252513 | |
| Device Name Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | |
| Indications for Use (Describe) The Polywin Safety and Polywin Safety Adva IV Catheters 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) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| 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." | |
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POLY MEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 - Special 510(k) Summary
POLYMED
# K252513 - 510(K) SUMMARY PER 807.92(C)
## 1 ADMINISTRATIVE INFORMATION
| Device Name | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm). |
| --- | --- |
| Type of 510(k) submission | Special 510(k) |
| Manufacturer | Poly Medicare 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 |
| Date | April 1, 2026 |
| 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 |
| Predicate | |
| Predicate Manufacturer: | Poly Medicare Ltd |
| Predicate Trade Name: | Polywin Safety and Polywin Safety Adva IV Catheter |
| Predicate 510(k) Number: | K231401 |
| Class | II |
| Predicate Product Code | FOZ |
| FDA Classification Name: | 21 CFR 880.5200 |
## 2 DEVICE DESCRIPTION
The Polywin Safety (thereafter, called Polywin Safety) is an over-the-needle, peripheral passive safety IV catheter that incorporates a safety clip to help prevent needle-stick injuries. There are two models of the device, one with quick flashback technology (Polywin Safety Adva) and one without quick flashback (Polywin Safety). The quick flash back provides instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein. All models of the Polywin Safety IV Catheter have a passive safety clip to help prevent needle-stick injuries. This is a passive safety mechanism that does not require the user to operate safety feature. The indwelling catheter is composed of medical-grade polyurethane (PUR) with Barium Sulfate $(\mathrm{BaSO}_4)$ for radiopacity. All indwelling components, including the catheter hub and slip ring, are composed of non-conductive, non-metallic, and non-magnetic polymers.
{5}
POLY MEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 - Special 510(k) Summary
POLYMED
# 3 SUBMISSION SCOPE
Poly Medicare Ltd. (PolyMed) is submitting this Special 510(k) to obtain market clearance for the Polywin Safety and Polywin Safety Adva IV catheters. The predicate devices were previously cleared under K231401 on September 21, 2023. The only modification in this submission is the addition of new length options for the existing gauge sizes, expanding the original length range of 19mm-45mm to 14mm-64mm.
This modification is being made in response to customer feedback and clinical needs, providing healthcare professionals with expanded options for catheter selection based on specific patient and procedural requirements. The new lengths complement the existing product portfolio while maintaining the same safety features, quality standards, and performance characteristics as the predicate devices.
Like the predicate device, the 26G catheter cannot be used with power injectors. Design control activities were conducted in accordance with 21CFR820.30 to ensure that the new lengths meet all performance requirements and maintain the safety and effectiveness of the devices.
# 4 INDICATIONS FOR USE
The Polywin Safety and Polywin Safety Adva IV Catheters 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.
Page 2 of 8
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POLY MEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 Special 510(k) Summary
POLYMED MEDICAL DEVICES
We Care As We Cure
Table 1: Predicate Comparison
| Feature | Predicate Device
Polywin Safety and Polywin Safety Adva | Subject Device
Polywin Safety and Polywin Safety Adva | Comparison |
| --- | --- | --- | --- |
| Device Manufacturer | Poly Medicare, India | Poly Medicare, India | Same |
| 510(k) Reference | K231401 | K252513 | N/A |
| FDA Product Code | FOZ | FOZ | Same |
| Trade Name | Polywin Safety and Polywin Safety Adva | Polywin Safety and Polywin Safety Adva | Same |
| Common Name | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Same |
| FDA Classification Name | Intravascular catheter | Intravascular catheter | Same |
| FDA Regulation Number | 880.5200 | 880.5200 | Same |
| 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 provides quick flashback features. | 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 provides quick flashback features. | Same |
| 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-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. | The Polywin Safety and Polywin Safety Adva IV Catheters 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. | Same |
| 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’, | Yes – passive, tested in accordance with ISO 23908 and FDA ‘Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features’, | Same |
| Catheter tube material | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Same |
| X-ray visible | Yes | Yes | Same |
| Needle material | Stainless steel-304 | Stainless steel-304 | Same |
| Needle distal end configuration | Back cut ground beveled needle | Back cut ground beveled needle | Same |
| Flashback visualization Adva feature | Yes | Yes | Same |
| Gauge sizes and Lengths | Polywin Safety and Polywin Safety Adva: | Additional Polywin Safety and Polywin Safety Adva gauge lengths | Similar |
Page 3 of 8
{7}
POLYMEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 Special 510(k) Summary
POLYMED
MEDICAL CENTER
We Care As We Cure
| Feature | Predicate Device Polywin Safety and Polywin Safety Adva | | | Subject Device Polywin Safety and Polywin Safety Adva | | | Comparison |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Cleared Models | | | | | | Additional lengths to existing gauges. |
| | Polywin Safety Gauges and Lengths | | Flashback Chamber | Polywin Safety Gauges and Lengths | | Flashback Chamber | |
| | 26G | 0.6mm x19mm | Square | 26G | 0.6mm x 14mm | Square | |
| | 24G | 0.7mm x 19mm | Square /Standard | 24G | 0.7mm x 32mm | Square | |
| | | | | | 0.7mm x 14mm | Square | |
| | 22G | 0.9 mm x 25mm | Square/Standard | 22G | 0.9mm x 64mm | Square | |
| | | | | | 0.9mm x 45mm | Square | |
| | 20G | 1.1mm x 32mm | Square/Standard | 20G | 1.1mm x 64mm | Square | |
| | | 1.1mm x 25mm | Square/Standard | | 1.1mm x 45mm | Square | |
| | 18G | 1.3mm x 45mm | Square/Standard | 18G | 1.3mm x 64mm | Square | |
| | | 1.3mm x 32 mm | Square/Standard | 16G | 1.7mm x 51 mm | Square | |
| | 16G | 1.7mm x 45mm | Square/Standard | 14G | 2.1mm x 51 mm | Square | |
| | 14G | 2.1mm x 45mm | Square/Standard | | | | |
| | Polywin Safety Adva | | Flashback Chamber | Polywin Safety Adva | | Flashback Chamber | |
| | 26G | 0.6mm x19mm | Square/Standard | 26G | 0.6mm x 14mm | Square | |
| | | | | 24G | 0.7mm x 32 mm | Square | |
| | | | | 24G | 0.7mm x 14mm | Square | |
| | 22G | 0.9mm x 25mm | Square/Standard | 22G | 0.9mm x 64mm | Square | |
| | 20G | 1.1mm x 32mm | Square/Standard | | 0.9mm x 45mm | Square | |
| | | 1.1mm x 25mm | Square/Standard | 20G | 1.1mm x 64mm | Square | |
| | | 1.3mm x 45mm | Square/Standard | | 1.1mm x 45mm | Square | |
| | 18G | 1.3mm x 32 mm | Square/Standard | 18G | 1.3mm x 64mm | Square | |
| | | 1.7mm x 45mm | Square/Standard | 16 G | 1.7mm x 51 mm | Square | |
| | 14G | 2.1mm x 45mm | Square/Standard | 14 G | 2.1mm x 51mm | Square | |
| Flow Rate | Polywin Safety and Polywin Safety Adva | | | Polywin Safety and Polywin Safety Adva | | | Meets specification |
| | Gauge | Length | Flow Rate | Gauge | Length | Flow Rate | |
| | 26G | 19 ± 1 | 17 ml/min | 26G | 14 ± 1 | 20 ml/min | |
| | 24G | 19 ± 1 | 23 ml/min | 24G | 32± 1 | 17 ml/min | |
| | 22G | 25 ± 1 | 36 ml/min | 24G | 14± 1 | 24 ml/min | |
| | 20G | 32± 1 | 61 ml/min | 22G | 64± 1 | 25 ml/min | |
| | 20G | 25 ± 1 | 65 ml/min | 22G | 45± 1 | 28 ml/min | |
| | 18G | 45 ± 1 | 100 ml/min | 20G | 64± 1 | 52 ml/min | |
| | 18G | 32± 1 | 105 ml/min | 20G | 45± 1 | 55 ml/min | |
Page 4 of 8
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POLYMEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 Special 510(k) Summary
POLYMED MEDICAL CENTER
We Care As We Cure
| Feature | Predicate Device
Polywin Safety and Polywin Safety Adva | | | Subject Device
Polywin Safety and Polywin Safety Adva | | | Comparison |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 16G | 45 ± 1 | 200 ml/min | 18G | 64 ± 1 | 90 ml/min | |
| | 16G | 32± 1 | 210 ml/min | 16G | 51 ± 1 | 190 ml/min | |
| | 14G | 32 ± 1 | 305 ml/min | 14G | 51 ± 1 | 305 ml/min | |
| | 14G | 45 ± 1 | 305 ml/min | | | | |
| 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 | 5 years | | | 5 years | | | Same |
| Physical properties | According to ISO 10555-1, ISO 10555-5 | | | According to ISO 10555-1, ISO 10555-5 | | | Same |
| Power injection usage? | Yes, 14 - 24G catheters up to 300 psi. | | | Yes, 14 - 24G catheters up to 300 psi. | | | Same |
| Biocompatibility | Biocompatible in accordance with ISO 10993 series and FDA guidance | | | Biocompatible in accordance with ISO 10993 series and FDA guidance | | | Same |
| Environment of use | Rx only | | | Rx only | | | Same |
| MRI Safety | MR Safe | | | MR Safe without needle | | | Same |
Page 5 of 8
{9}
POLY MEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 Special 510(k) Summary
Polyweb
M E D I C A C H E T T E R S
We Care As We Cure
# 5 SUBSTANTIAL EQUIVALENCE DISCUSSION
This section provides a comprehensive analysis of substantial equivalence between the proposed device modifications and the predicate device (Polywin Safety and Polywin Safety Adva, K231401). The Polywin Safety and Polywin Safety Adva IV catheters with expanded length ranges (14mm-64mm) maintain identical intended use and technological characteristics as the predicate devices.
The only modification is the addition of new length options to the previously cleared gauge sizes. The original length range of 19mm-45mm is being expanded to 14mm-64mm, while maintaining all other device characteristics including design, materials, chemical composition, manufacturing processes, sterilization methods, packaging configuration and fundamental technology. This modification responds directly to clinical needs while preserving the established safety and effectiveness profile of predicate devices.
The new models meet all specifications for gauge dimensions and have been thoroughly validated to ensure safety and effectiveness of the new lengths. Product labeling has been updated accordingly to reflect the new models.
## 5.1 Design Control Activities
In accordance with 21CFR 820.30, Poly Medicare Ltd. has completed comprehensive design control activities for the new length configurations ensuring that the expanded catheter lengths maintain the same level of safety and effectiveness as the predicate devices.
## 5.2 Design Control Assessment
### 5.2.1 Verification and Validation Activities
- Comprehensive verification and validation activities have been completed for all new catheter lengths:
- Dimensional Verification conducted according to ISO 10555-1:2023, confirming precise adherence to specifications.
- Biocompatibility & Sterilant Residuals: Subject-specific residual testing per ISO 10993-7 was performed. Results demonstrated compliance with allowable limits for limited exposure devices. Biocompatibility device Categorization as per ISO 10993-1:2018 :
- Contact Duration: B (Prolonged)
- Nature of Body Contact: External communicating device
- Area of contact: Circulating Blood
- Performance Testing executed using identical protocols and standards as the predicate device
- Sterilization Validation confirming achievement of SAL 10⁻⁶ for all new configurations using the same EtO sterilization process as the predicate.
Page 6 of 8
{10}
POLY MEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 Special 510(k) Summary
POLYMED MEDICATE LTD
We Care As We Cure
# 5.3 Testing and Performance Data
Comprehensive bench testing was conducted on final, finished, sterile devices subjected to worst-case preconditioning, including 2x sterilization cycles, distribution simulation (ASTM D4169), and accelerated aging (ASTM F1980).
# 5.3.1 Standards Compliance
Testing protocols were identical to those used for the predicate devices, ensuring direct comparability. Verification confirmed compliance with the following FDA-recognized standards:
Table 2: FDA Recognized Standards
| Standard | FDA Recognition Number |
| --- | --- |
| ISO 10555-1: 2023 Intravascular catheters- Sterile and single use catheters – Part 1: General requirements | 6-408 |
| ISO 10555-5:2013 – Intravascular catheters – Sterile and single use catheters- Part 5: Over the needle peripheral catheters | 6-303 |
| ISO 80369-7:2021 Small bore connectors for liquids and gases in healthcare application – Part 7: Connectors for intravascular or hypodermic applications | 5-115 |
| ISO 9626:2016 Stainless steel needle tubing for medical devices- Requirements and test methods | 6-455 |
| ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems | 14-530 |
| Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods. | 14-531 |
| ASTM F2503-23 Marking Medical Devices for Safety in the MR Environment | 8-544 |
# 5.3.2 Performance Results Summary
Quantitative statistical analysis was performed for all mechanical tests. Testing was conducted on final, finished, sterile. The results demonstrate:
- Fluid Path Integrity: 100% pass rate for liquid and air leakage testing (ISO 80369-7 / ISO 10555-1), mitigating risks of infection and sepsis.
- Mechanical Strength: Tensile strength of the hub-to-tube bond and needle resistance to breakage (ISO 9626) met all requirements.
- Flow Dynamics: Flow rates and burst pressures meet specifications across all gauges and new lengths.
- Sharps Protection: Safety mechanism functionality is identical to the predicate, providing consistent sharps injury protection.
- Power Injection: Verification confirmed that 14G to 24G configurations safely withstand power injection at a maximum pressure of 300 psi. In accordance with the predicate device labeling, the 26G configuration is excluded from power injection use.
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POLY MEDICURE LTD.
Polywin Safety and Polywin Safety Adva IV Catheters
K252513 Special 510(k) Summary
PolyMED MEDICATE
- Equivalence: All other performance characteristics remain equivalent to those documented in K231401.
## 5.4 Material and Manufacturing
The subject devices are composed of the same materials as the predicate; a biocompatibility assessment per ISO 10993-1 confirmed that the expanded surface area of the 64 mm configurations does not alter the biological safety profile of the device.
- Material Identity: No changes to the catheter material (Polyurethane + Barium Sulfate), needle material (Stainless Steel 304), or hub polymers. PolyMed confirms that no metallic slip ring is present in the subject or predicate configurations.
- Manufacturing Consistency: Devices are produced using the same validated processes, equipment, and facilities as the predicate.
- Sterilization: Achievement of SAL 10⁻⁶ is confirmed using the same validated Ethylene Oxide process.
- Shelf Life: Validated to maintain a 5-year shelf life post-aging.
## 5.5 MRI Safety Status
In accordance with ASTM F2503-23, the MRI safety status has been standardized based on the clinical configuration:
- Complete Device Assembly: MR Unsafe due to the transient metallic introducer needle.
- In-Situ Device (Post-Needle Removal): MR Safe. The indwelling catheter contains no metallic, magnetic, or conductive materials, posing no risk of RF-induced heating or significant image artifacts.
## 5.6 Conclusion
Based on the comprehensive design controls, performance testing, and Polywin Safety and Polywin Safety Adva IV catheters with expanded length range (14mm-64mm) are substantially equivalent to the predicate device (K231401). The subject devices raise no new questions of safety or effectiveness and perform as safely and effectively as the cleared predicate.
