(129 days)
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 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.
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.
The provided text describes a 510(k) premarket notification for Poly Medicure Limited's Polysafety BC, Polysafety BC Adva, Polywin Safety, and Polywin Safety Adva Intravascular Catheters. The submission aims to demonstrate substantial equivalence to existing predicate devices.
Crucially, this document is a 510(k) submission, not a study report detailing acceptance criteria for an AI/ML medical device. It describes the safety and effectiveness testing for intravascular catheters, which are physical medical devices, and does not involve an AI/ML component. Therefore, the questions related to AI/ML device performance (like sensitivity, specificity, MRMC studies, training/test sets, expert adjudication, or ground truth for AI models) are not applicable to this document.
The document discusses the physical and functional characteristics of the catheters and compares them to predicate devices based on non-clinical (bench) testing against recognized standards.
Here's an attempt to answer the questions based on the provided document, noting that many AI-specific questions are inapplicable:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of "acceptance criteria" against "reported device performance" in the way an AI/ML device evaluation would for clinical metrics. Instead, it demonstrates compliance with a series of recognized standards and guidances through bench testing to establish substantial equivalence.
The "acceptance criteria" are implied by successful compliance with these standards. The "reported device performance" is a statement of successful adherence to these standards.
Here's a summary of the standards the devices were tested against:
Summary of Tested Standards (Acceptance Criteria are implied by successful compliance)
| Test Category | Standards / Guidances | Reported Performance (Implied) |
|---|---|---|
| General Catheter | - ISO 10555-1:2013/AMD 1:2017 (Intravascular Catheters - General Requirements) | Compliant |
| - ISO 10555-5:2013 (Intravascular Catheters - Sterile single-use, over-needle peripheral intravascular catheters) | Compliant | |
| Connectors | - ISO 80369-7:2016 (Small-bore connectors for liquids and gases) | Compliant |
| Particulate Matter | - USP <788> Method 1 (Particulate matter Analysis) | Compliant |
| Sharps Injury | - ISO 23908:2011 (Sharps injury protection) | Compliant |
| - FDA 'Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features', August 2005 (Simulated Clinical Use Testing) | Compliant | |
| Biocompatibility | - ISO 10993-5:2009 (Cytotoxicity) | Biocompatible |
| - ISO 10993-10:2010 (Skin Sensitization, Irritation or intracutaneous reactivity) | Biocompatible | |
| - ISO 10993-11:2017 (Acute systemic toxicity, Subacute/subchronic toxicity, Material-mediated pyrogenicity) | Biocompatible | |
| - ISO 10993-4:2017 (Hemocompatibility) | Biocompatible | |
| - ISO 10993-6:2016 (Implantation) | Biocompatible | |
| - ISO 10993-3:2014 (Genotoxicity) | Biocompatible | |
| - Annex A of ISO 10993-1:2018; relevant FDA guidances | Biocompatible | |
| Sterilization | - ISO 11135:2014/Amd 1:2018 (Ethylene Oxide Sterilization Validation) | Achieved SAL 10-6 |
| ETO Residuals | - ISO 10993-7:2008/Amd 1:2019 | Within acceptable limits |
| Endotoxins | - USP <85> (Bacterial Endotoxins tests) | Less than 20 EU/device |
| Packaging | - ISO 11607-2:2019 (Packaging Validation) | Compliant |
| - ASTM F-1929 (Packaging Leak test) | Compliant | |
| - ASTM F-2096 (Packaging Leak test) | Compliant | |
| - ASTM F-88 / F-88M (Packaging Seal Test) | Compliant | |
| Shelf Life | - ASTM F1980-16 (Accelerated aging for shelf life) | Polysafety BC: 3 years. |
| Polywin Safety: 5 years. | ||
| Transit Testing | - ISTA 3A:2018 (Vibration Packaging Testing) | Successfully carried out |
| Final Batch Testing | - ISO 10555-1:2013/AMD 1:2017, ISO 10555-5:2013, ISO 80369-7:2016, USP <788> Method 1 | Samples tested for compliance |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in a way that is typically presented for AI/ML device testing. The tests are bench tests of physical devices to demonstrate compliance with standards. The document does not specify "sample size for the test set" in terms of patient data or clinical images. The data provenance is related to the manufacturing location (India) and the performance of tests according to international and FDA-recognized standards. The testing is non-clinical (bench testing), not clinical or involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device that requires expert-established ground truth from images or other patient data. The "ground truth" for these physical devices is conformity to engineering and biological standards validated through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device and does not involve adjudication of expert readings or interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device. No MRMC study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for demonstrating substantial equivalence of these physical devices is adherence to established international and national (FDA) standards for medical devices (e.g., ISO, ASTM, USP). This is verified through engineering bench testing and biocompatibility assessments, not clinical "ground truth" from patient outcomes or expert consensus on medical images.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set or AI-specific ground truth establishment for this physical device.
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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
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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 LtdPlot No. 115-117, Sector- 59HSIIDC Industrial Area, Ballabgarh Faridabad-121004, HaryanaINDIA |
| 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 ConsultantGSA2 Group LLC 8049 Hayes St NEMinneapolis, MN 55432 |
| 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 devicePolysafety BCPolysafety BC Adva | Predicate deviceIntrocan Safety® 2 IV Catheter | Comparison |
|---|---|---|---|
| DeviceManufacturer | Poly Medicure, India | B. Braun Medical Inc,Pennsylvania | N/A |
| 510(k) Reference | This submission | K192676 | N/A |
| DeviceDescription: | The Polysafety-BC safety IV Catheter is anover-the-needle blood control. Peripheralpassive Safety IV Catheter incorporates asafety clip to help prevent needle-stickinjuries & blood control valve to reduceblood exposure during initial catheterplacement, blood sampling, withdrawal ofthe needle, and connection of the luer. ThePolysafety BC Safety IV Catheter isprovided with a detachable or integrated,flexible perforated soft wing for providingventilation & skin maceration. The devicealso incorporates a 'quick flash back'. | The Introcan Safety® 2 IV Catheterconsists of an over-the-needle, peripheralcatheter made of radiopaquepolyurethane, an integrated onedirectional septum that controls the flowof blood during and after cannulation, anda passive safety needle-shieldingmechanism. Introcan Safety® 2 isdesigned to reduce blood exposure atinsertion until first connection of aninfusion line or luer device to protectclinicians and patients from bloodexposure. During needle withdrawal, theneedle is withdrawn through a septum thatseals after the needle has been removed,blood is thus contained within theIntrocan Safety® 2 device. The pressureexerted on the needle as it passes throughthe septum wipes blood from the needlefurther reducing potential bloodexposure. The passive safety needleshielding mechanism of the IntrocanSafety® 2 is located inside the catheterhub. Upon withdrawal of the needle, thesafety shield engages as the needle passesthrough the catheter hub and deploysautomatically to shield the needle tip. Thesafety shield protects during disposal,aiding in the prevention of needlestickinjuries. Once the safety shield engagesand shields the needle tip, the user isunable to re-insert the needle which aidsin the prevention of catheter shearing.This device may be used for any patientpopulation with consideration given toadequacy of vascular anatomy andappropriateness for the solution beinginfused and duration of therapy. Thecatheters may be used intravascularlywith power injectors for which themaximum pressure setting is 300 psi witha luer lock connection only. The deviceswill be available in 18, 20, 22, and 24- | Different see2.1.1(Substantialequivalent) |
| Feature | Subject devicePolysafety BCPolysafety BC Adva | Predicate deviceIntrocan Safety® 2 IV Catheter | Comparison |
| gauge versions with and without astabilization platform. | |||
| Indications foruse | The Polysafety BC IV Catheter are indicatedfor short-term use (less than 30 days) forinsertion into a patient's vascular system tosample blood or administer fluids such assolutions, parenteral nutrition, andadministration of other drugs. The cathetersmay be used for any patient population withconsideration given to patient size,appropriateness for the solution beinginfused and duration of therapy. The 18G-24G catheters may be used intravascularlywith power injectors at a maximum pressureof 300psi.The Polysafety BC Adva IV Catheter areindicated for short-term use (less than 30 days) for insertion into a patient's vascularsystem to sample blood or administer fluidssuch as solutions, parenteral nutrition, andadministration of other drugs. The cathetersmay be used for any patient population withconsideration given to patient size,appropriateness for the solution beinginfused and duration of therapy. The 18G-24G catheters may be used intravascularlywith power injectors at a maximum pressureof 300psi. | The Introcan Safety® 2 IV Catheteris inserted into a patient's vascularsystem for short term use to sampleblood, monitor blood pressure, oradminister fluids and bloodintravascularly. The catheters may beused intravascularly with power injectorsat a maximum pressure of 300 psi with aluer lock connection only. | Different see2.1.2(Substantialequivalent) |
| Sharps injuryprotectionfeature? | Yes - passive, tested in accordance with ISO23908 and FDA 'Guidance for Industry andFDA Staff Medical Devices with SharpsInjury Prevention Features', August 2005. | Yes - passive | Same |
| Wings | With, without and Detachable wings with | Yes- and without wings | Same |
| Catheter tubematerial | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Same |
| X-ray visible | Yes | Yes | Same |
| Needle material | Stainless steel | Stainless steel | Same |
| Needle distal endconfiguration | Back cut ground beveled needle | Back cut ground beveled needle | Same |
| Flashbackvisualization | 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 endconfiguration | Female 6 % Luer | Female 6 % Luer | Same |
| Single use | Yes | Yes | Same |
| Sterile | Yes, SAL 10-6 | Yes, SAL 10-6 | Same |
| Sterilizationmethod | Ethylene oxide | Ethylene oxide | Same |
| Shelf life | 3 years | 1 years | DifferentTesting onsubject devicesupports 3years shelflife, |
| Feature | Subject devicePolysafety BCPolysafety BC Adva | Predicate deviceIntrocan Safety® 2 IV Catheter | Comparison |
| Physicalproperties | According to ISO 10555-1, ISO 10555-5 | According to ISO 10555-1, ISO 10555-5 | Same |
| Power injectionusage? | Yes, 18-24G catheters up to 300 psi. | The 18-24 G devices are suitable for usewith power injectors up to 300 psi | Same |
| Biocompatibility | Biocompatible in accordance with ISO10993 series and FDA guidance | Biocompatible in accordance with ISO10993 series. | Same |
| Environment ofuse | 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 <788> 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<85> |
| 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 <71> |
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 <788> 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 <85> (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 devicePolywin SafetyPolywin Safety AdvaPoly Medicure, India | Predicate deviceIntrocan Safety® IV Catheter | Comparison |
|---|---|---|---|
| DeviceManufacturer | Poly Medicure, India | B. Braun Medical Inc,Pennsylvania | N/A |
| 510(k) Reference | This submission | K020785 | N/A |
| DeviceDescription: | The Polywin safety IV Catheter is an over theneedle, Peripheral passive Safety IV Catheterthat incorporates a safety clip to help preventneedle- stick injuries. The Polywin SafetyAdva IV Catheter provided with quick flashback features. | B. Braun Medical's Introcan Safety IVCatheter is a passive needle stickprevention device used for arterial andvenous access for the infusion of fluids,drugs and/or blood components. 14 - 22-gauge catheters may be used with powerinjectors for which the maximum pressuresetting is 300 psi. The Introcan Safety IVCatheter is available in 14 - 24-components. 14 - 22-gauge catheters maybe used with power injectors for which themaximum pressure setting is 300 psi. TheIntrocan Safety IV gauge sizes, and bothwinged and non-winged versions. | Different see3.1.1(Substantialequivalent) |
| Indications for use | The Polywin Safety IV Catheter are indicatedfor short term use (less than 30 days) forinsertion into a patient's vascular system tosample blood or administer fluids such assolutions, parenteral nutrition andadministration of other drugs. The cathetersmay be used for any patient population withconsideration given to patient size,appropriateness for the solution beinginfused and duration of therapy. The 14G- | Passive anti-needle stick device forvenous or arterial access for the infusionof fluids, drugs, and/or bloodcomponents. 14 - 22-gauge catheters maybe used with powerinjectors for which the maximum pressuresetting is 300 psi | Different see3.1.2(Substantialequivalent) |
| Feature | Subject devicePolywin SafetyPolywin Safety Adva | Predicate deviceIntrocan Safety® IV Catheter | Comparison |
| 24G catheters may be used intravascularlywith power injectors at a maximum pressureof 300psi.The Polywin Safety Adva IV Catheter areindicated for short term use (less than 30days) for insertion into a patient's vascularsystem to sample blood or administer fluidssuch as solutions, parenteral nutrition andadministration of other drugs. The cathetersmay be used for any patient population withconsideration given to patient size,appropriateness for the solution beinginfused and duration of therapy. The 14G-24G catheters may be used intravascularlywith power injectors at a maximum pressureof 300psi. | |||
| Sharps injuryprotectionfeature? | Yes - passive, tested in accordance with ISO23908 and FDA 'Guidance for Industry andFDA Staff Medical Devices with SharpsInjury Prevention Features', August 2005. | Yes - passive | Same |
| Wings | Does not have wings | Available with/without wings | Different see3.1.1.2(Substantialequivalent) |
| Catheter tubematerial | Polyurethane + Barium Sulfate | Polyurethane + Barium Sulfate | Same |
| X-ray visible | Yes | Yes | Same |
| Needle material | Stainless steel | Stainless steel | Same |
| Needle distal endconfiguration | Back cut ground beveled needle | Back cut ground beveled needle | Same |
| Flashbackvisualization | Yes | Yes | Same |
| Blood control | Yes | Yes | Same |
| Gauge sizes | 14 - 26G | 14- 24G | Different see3.1.1(SubstantialEquivalent) |
| 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 endconfiguration | Female 6 % Luer | Female 6 % Luer | Same |
| Single use | Yes | Yes | Same |
| Sterile | Yes, SAL 10-6 | Yes, SAL 10-6 | Same |
| Sterilizationmethod | Ethylene oxide | Ethylene oxide | Same |
| Shelf life | 5 years | 5 years | Same |
| Physicalproperties | According to ISO 10555-1, ISO 10555-5 | According to ISO 10555-1, ISO 10555-5 | Same |
| Power injectionusage? | Yes, 18-24G catheters up to 300 psi. | The 18-24 G devices are suitable for usewith power injectors up to 300 psi | Same |
| Biocompatibility | Biocompatible in accordance with ISO10993 series and FDA guidance | Biocompatible in accordance with ISO10993 series. | Same |
| Environment ofuse | Rx only | Rx only | Same |
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".
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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 <788> 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<85> |
| 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 <71> |
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 <788> 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 <85> (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 <788> 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.
§ 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).