(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 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 (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 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.
§ 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).