Who is the manufacturer of Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

Poly Medicure Limited filed the 510(k) submission for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva (K231401).

What is the FDA product code for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

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

What is the regulatory pathway for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

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

What are the predicate devices for Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

Introcan Safety® 2 IV Catheter (K192676); Introcan Safety® IV Catheter (K020785).

Who can help prepare an FDA 510(k) submission like Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva?

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

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

K231401 · Poly Medicure Limited · FOZ · Sep 21, 2023 · General Hospital

Device Facts

Record ID	K231401
Device Name	Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva
Applicant	Poly Medicure Limited
Product Code	FOZ · General Hospital
Decision Date	Sep 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic, Pediatric

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.

Device Story

Peripheral passive safety IV catheters for vascular access; includes blood control valve to reduce exposure during placement/sampling; features passive safety clip to prevent needlestick injuries. Input: vascular access; Output: fluid administration/blood sampling. Used in clinical settings by healthcare providers. Includes quick flashback visualization. Passive safety mechanism deploys automatically upon needle withdrawal; prevents re-insertion and catheter shearing. Benefits: reduced blood exposure, prevention of needlestick injuries, and safe power injection capability.

Clinical Evidence

No clinical data. Bench testing only. Compliance demonstrated via ISO 10555-1/5, ISO 80369-7, ISO 23908, and biocompatibility testing per ISO 10993 series. Simulated clinical use testing performed per FDA guidance for sharps injury prevention.

Technological Characteristics

Materials: Polyurethane + Barium Sulfate; Stainless steel needle. Passive safety tip clip. Female 6% Luer connection. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: None. Dimensions: 14-26G, 19-45mm lengths. Power injection: 18-24G (up to 300 psi).

Indications for Use

Indicated for short-term ( <30 days) vascular access for blood sampling or fluid/drug/parenteral nutrition administration. Suitable for all patient populations based on size, therapy duration, and solution appropriateness. 14G-24G models compatible with power injectors up to 300 psi.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

Introcan Safety® 2 IV Catheter (K192676)
Introcan Safety® IV Catheter (K020785)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/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 | {4}------------------------------------------------ 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…

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

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Device Story

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

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Submission Summary (Full Text)

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