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510(k) Data Aggregation
(60 days)
The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "MedSource Selectable IV Set." This document confirms the device's substantial equivalence to legally marketed predicate devices.
However, the letter does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML powered medical device. It is a regulatory clearance document for a physical medical product (an IV set), not a software or AI product.
Therefore, I cannot provide the requested information based on the given input. The categories in your request (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance") are typically associated with performance studies for AI/ML diagnostic or assistive technologies, which are not described in this document.
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(44 days)
The MedSource IV Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a MedSource IV Administration Set. This document is a regulatory approval notice for a medical device and does not contain information about software or AI-powered devices, nor does it detail acceptance criteria, study designs, or performance metrics in the way requested for an AI/ML device.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document is solely focused on the regulatory approval of a physical medical device (an IV administration set) based on substantial equivalence to a predicate device, not on the performance evaluation of an AI/ML algorithm.
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(247 days)
The MedSource IV Safety Catheter is indicated to sample blood or administer fluids intravenously. The MedSource IV Safety Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
The MedSource IV Safety Catheter is a safety medical device used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient's body. This device is engineered to protect healthcare workers using it against accidental needle stick injury and exposure to parts of the device that have come in contact with patient's blood or other body fluids, and have hence been potentially contaminated with infectious agents. In addition this device also secures the needle (used to insert the catheter) in an enclosed chamber, thus protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded postuse.
The device comprises a sharp needle attached to a hub which projects into a chamber. In the 'unactivated' state prior to insertion, the needle and hub are 'locked' in position. There exists a retraction mechanism for 'unlocking' the needle such that on activation of this mechanism it is withdrawn and completely enclosed within the chamber. This mechanism for retracting the needle preferably includes a coiled spring or other elastic components. The retraction mechanism is activated by the user using only one hand by means of a lever or 'switch'.
The provided text is a 510(k) Summary for the MedSource IV Safety Catheter, which is a medical device and not an AI/ML product. Therefore, many of the requested elements pertaining to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document.
However, I can extract the acceptance criteria and performance data as presented for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document performs a comparison to a predicate device (Becton Dickinson Angiocath Autogaurd, K984059) to demonstrate substantial equivalence. The "acceptance criteria" for the MedSource IV Safety Catheter are implied by its performance being equivalent to or better than the predicate device's established performance, as well as compliance with specific ISO and ASTM standards.
| Comparison Point | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (MedSource IV Safety Catheter) |
|---|---|---|
| Chemical Tests | ||
| Volatile Residue | <15.0mg | <15.0mg |
| Heavy Metals | <1ppm | <1ppm |
| Residue on Ignition | <5.0mg | <5.0mg |
| Buffering Capacity | Complies to USP-34 | Complies to USP-34 |
| Biological Tests | ||
| Sterility | Sterile ETO | Sterile ETO |
| Physical Tests | ||
| Integrity | Complies to ISO 10555-1 and ISO10555-5 | Complies to ISO 10555-1 and ISO10555-5 |
| Flow-rate | ||
| 14G | 300 ml/min | 300 ml/min |
| 16G | 220 ml/min | 220 ml/min |
| 18G | 105 ml/min | 105 ml/min |
| 20G | 65ml/min | 65ml/min |
| 22G | 35ml/min | 35ml/min |
| 24G | 20ml/min | 20ml/min |
| Tensile Strength | ||
| 18G | 10N | 10N |
| 20G | 5N | 5N |
| 22G | 5N | 5N |
| 24G | 3N | 3N |
2. Sample size used for the test set and the data provenance: Not applicable. This summary presents comparative performance data against a predicate device rather than a study on a specific test set for an AI/ML algorithm. The data reflects device specifications and compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document pertains to the physical and chemical properties and performance of a medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.
4. Adjudication method for the test set: Not applicable (see point 3).
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 a traditional medical device, not an AI/ML product involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is established by compliance with international standards (ISO, USP, ASTM) and direct comparison to the specifications of a legally marketed predicate device. For example, "Sterile ETO" is a factual characteristic, and "Complies to USP-34" refers to a specific standard.
8. The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable (see point 8).
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is detailed within the "Summary of Performance Testing Characteristics" section. This study involved direct comparison testing of the MedSource IV Safety Catheter against the established specifications and performance of its predicate device, the Becton Dickinson Angiocath Autogaurd (K984059).
The testing covered:
- Chemical Tests: Volatile Residue, Heavy Metals, Residue on Ignition, and Buffering Capacity. The results showed identical performance to the predicate device, meeting the specified limits (e.g., <15.0mg for volatile residue, <1ppm for heavy metals, complies to USP-34).
- Biological Tests: Sterility. Both the submission device and predicate demonstrated "Sterile ETO."
- Physical Tests: Integrity (compliance to ISO 10555-1 and ISO10555-5), Flow-rate for various gauges, and Tensile strength for various gauges. For all these physical tests, the MedSource IV Safety Catheter exhibited performance metrics identical to those reported for the predicate device.
The study concludes that "there are no significant performance specification differences between the MedSource IV Safety Catheter and the substantially equivalent device," leading to the determination that it is as safe, as effective, and performs as well as or better than the predicate device. The reference documents listed (ISO, ASTM, USP standards) indicate the methods and criteria against which these tests were conducted to demonstrate compliance and equivalence.
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(149 days)
The MedSource IV Administration Set is designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein.
The MedSource IV Administration Set is a sterile, single use intravascular administration set used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device includes: 1. Guard for Closure 2. Closure Piercing Device (spike)- Vented with Drip flow rate (either 10, 15, or 60 drops/mL 3. Housing for air-vent with filter 4. Drip Chamber 5. Fluid Filter 6. Tubing 7. Flow Regulator 8. Injection Site (Y-site, Needleless) 9. Male Luer Lock Fitting 10. Protective Cap for Male Fitting
The MedSource IV Administration Set is a medical device designed to administer parenteral fluids. The submission focuses on demonstrating substantial equivalence to a predicate device, the Angletouch IV Administration Set (K012189), through various performance tests.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (MedSource IV Administration Set) | Predicate Device Performance (Angletouch IV Administration Set (K012189)) | Result of Comparison |
|---|---|---|---|---|
| Intended Use | Administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein. | Designed to administer parenteral fluids from a container to a vascular system through a needle or catheter inserted into a vein. | To Administer parenteral fluids/medication into the patient's intravascular system | Substantially equivalent |
| Technological Characteristics | Conforms to ISO 8536-4 | Conforms to ISO 8536-4 | Conforms to ISO 8536-4 | Substantially equivalent |
| Materials of Construction | Materials compatible with intended use (PP, ABS, HDPE, PVC, PP, Latex for predicate) | Poly-Propylene, ABS, PVC, HDPE+Nylon, Silicon, HDPE (all material of not made of natural latex) | PP, ABS, HDPE, PVC, PP, Latex | Substantially equivalent |
| Performance (Drip Rate) | Drip rate for parenteral fluid administration | Used to administer parenteral fluids at either 10 drops/ml, 15 drops/ml or 60 drops/ml | Use to administer parenteral fluids at 20 drops per ml | Substantially equivalent |
| Description of Device | Single Use Sterile Infusion Set for Medical Use | Product is a single use sterile infusion set for medical use | The product is a Single Use Sterile Infusion Set for Medical Use | Substantially equivalent |
| Instructions for Use | Standard procedure for preparing and using an IV administration set. | Prepare IV container, Remove set from pouch and close roller clamp, Remove spike protector from spike, Insert spike into container, Hang container, fill drip chamber by squeezing until approximately half full, remove protector from adaptor, open roller clamp, prime set and purge air from tubing, close roller clamp until roller meet bottom of frame, attached adapter to venipuncture device, adjust fluid flow with roller clamp, check maintenance of proper flow rate at regular intervals. | Disinfect inlet of solution container, remove set from pouch and close the air vent and roller clamp respectively. Remove spike protector from spike, insert spike into solution container, hang container, squeeze drip chamber to fill approximately half full, remove protector from Luer lock adaptor, Open the air vent and roller clamp and solution to expel air from set, close roller clamp and attach set to access device, adjust flow wit roller clamp, check maintenance for proper flow rate a regular intervals. | Substantially equivalent |
| Chemical Tests | MedSource IV Administration Set | Angletouch IV Administration Set (K012189) | ||
| Clarity | Meets stated specification for material (Clear) | Meets stated specification for material | Clear | Pass |
| Color | Meets stated specification for each material | Meets stated speciation for each material | Meets stated speciation for each material | Pass |
| Odor | Odorless | Odorless | Odorless | Pass |
| pH | 4.5-7.5 | 4.5-7.5 | 4.5-7.5 | Pass |
| Acidity/Alkalinity | NMT 1 ml of 0.01M NaOH / HCl Solution | NMT 1 ml of 0.01M NaOH / HCl Solution | NMT 1 ml of 0.01M NaOH / HCl Solution | Pass |
| Heavy Metals | NMT 1 | NMT 1 | NMT 1 | Pass |
| Oxidizable Matter | NMT 2ml | NMT 2ml | HMT 2mL | Pass |
| No Volatile Matter | NMT 5 | NMT 5 | NMT 5 | Pass |
| Absorbance | NMT 0.1 in wavelength range 250-320nm | NMT 0.1 in wavelength range 250-320nm | NMT 0.1 in wavelength range 250-320nm | Pass |
| Biological Tests | ||||
| Sterility | Sterile ETO | Sterile ETO | Sterile ETO | Pass |
| Pyrogen | Non pyrogenic | Non pyrogenic | Non pyrogenic | Pass |
| Toxicity | Non toxic | Non toxic | Non toxic | Pass |
| Physical Tests | ||||
| Integrity | No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure | No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure | No sign of leakage from any join when pressure of 50ka (500mbar) above atmospheric pressure | Pass |
| Flow-rate | Deliver not less than 1000 ml of a 0.9% NaCl solution in 10 minutes under static head of one meter. | The complete set should deliver not less than 1000 ml of a 0.9% NaCl solution in 10 minutes under static head of one meter. | Not less than 100ml/min | Pass |
| Tensile | 15N for 15 seconds | 15N for 15 seconds | 15N | Pass |
Study Proving Acceptance Criteria:
The study proving the MedSource IV Administration Set meets the acceptance criteria is a substantial equivalence comparison study against a legally marketed predicate device, the Angletouch IV Administration Set (K012189). This type of study is common for Class II medical devices seeking 510(k) clearance, where the primary goal is to demonstrate that the new device is as safe and effective as a previously cleared device.
Additional Information Required by the Prompt (not explicitly detailed in the provided text):
Since this is a submission for a physical medical device (IV administration set) and not an AI/software device, many of the requested points related to AI/software evaluation (e.g., ground truth, experts, MRMC studies) are not applicable. The information provided focuses on the physical and chemical properties and general performance of the device.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for each specific test (e.g., how many IV sets were tested for flow rate, tensile strength, etc.). It describes the criteria and results of the tests.
- Data Provenance: The data provenance is from bench testing conducted on the MedSource IV Administration Set itself and comparative analysis against the specifications and performance of the predicate device (Angletouch IV Administration Set, K012189). This is a prospective evaluation of the new device's performance based on established standards and predicate device data. The country of origin for the testing is not specified, but the submitter is Medsource International, LLC, located in Mound, MN, USA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable: This request is typically relevant for studies involving subjective human interpretation (e.g., image analysis, diagnosis). For a physical medical device like an IV administration set, the "ground truth" for chemical, biological, and physical properties is established by adherence to recognized consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, etc.) and objective laboratory measurements, rather than expert consensus on subjective interpretations. There's no mention of experts establishing a "ground truth" in this context.
4. Adjudication Method for the Test Set:
- Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or annotators when establishing ground truth for subjective tasks. This is not relevant for the objective physical and chemical testing performed on an IV administration set. The tests performed yield objective, measurable results that either meet or do not meet the predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Done: An MRMC comparative effectiveness study is used to evaluate the performance of human readers with and without AI assistance for interpretative tasks. This is not applicable to the evaluation of a physical IV administration set.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Not Applicable: This also refers to AI/software performance. The device is a physical IV administration set, not an algorithm.
7. Type of Ground Truth Used:
- The "ground truth" for the performance evaluation of the MedSource IV Administration Set is based on:
- Defined Standards and Specifications: Adherence to recognized international consensus standards (e.g., ISO 8536-4, ASTM F1982-07, ISO 954-1/2, EN 980, ISO 11138, BS EM 556-1, ISO 11135).
- Predicate Device Performance: Comparison against the known performance characteristics and materials of the legally marketed predicate device (Angletouch IV Administration Set, K012189).
- Objective Laboratory Measurements: Chemical, biological, and physical tests yielding quantifiable results that are compared against predefined acceptance thresholds derived from these standards and predicate device data.
8. Sample Size for the Training Set:
- Not Applicable: This concept of a "training set" is relevant for machine learning algorithms. For a physical device, there isn't a "training set" in the common AI sense. The design and manufacturing process are refined through engineering, testing, and adherence to quality systems and standards, not through "training data."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable: As there is no "training set" in the AI sense, this question is not relevant to the evaluation of this physical medical device.
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(262 days)
Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.
Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.
MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet:
• Constructed of Polyvinylchloride
• Single lumen tube with or without a cuff;
• Tapered tip with Murphy Eye;
• Clear medical-grade tubing(polyvinyl) with graduations;
• Connector with check valve;
• Pre-loaded with Stylet having a low friction coating;
• Various sizes
• Sterile Single-Use Device
The provided document is a 510(k) Summary for a medical device called "MedSource Endotracheal Tube" and "MedSource Pre-Loaded Endotracheal Tube and Stylet." This type of document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, and thus does not include extensive clinical study details like acceptance criteria or device performance data in the way a PMA (Pre-Market Approval) or clinical trial report would.
Therefore, the document explicitly states that "No clinical studies were conducted for safety or effectiveness." This means that the information requested about acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for a study is not available in this submission.
Instead of clinical studies, the submission relies on demonstrating substantial equivalence to existing predicate devices based on:
- Intended Use: The MedSource devices have the same intended use (oral or nasal intubation and airway management) as the predicate devices.
- Materials of Construction: The materials (Polyvinyl Chloride) are the same or equivalent to the predicate devices.
- Product Features: Both MedSource and predicate devices have features like a Murphy's Eye and Pilot balloon (where applicable).
- Instructions for Use: The instructions for use are the same or similar.
- Technological Characteristics: A table comparing characteristics shows direct equivalence for materials, sizes, manual method of use, Murphy's Eye, Pilot Balloon, and the option with/without Stylet.
- Compliance with Standards: The device complies with applicable sections of ISO 5361:1999 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors) and ISO10993-1 edition-1997-12-15 (Biological Evaluation Of Medical Devices—Part 1: Evaluation and Testing).
The FDA's letter (Page 4 of the document) confirms that the device was deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed without the need for a new premarket approval or clinical trials.
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(88 days)
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.
The CPR Mask with Oxygen Port is for prescription use.
A one piece, single use, full-size, light-weight PVC mask system which includes:
- A Universal breathing tube.
- A One-way filtered valve.
- A Head strap.
- With Oxygen Port or Without Oxygen Port.
- Packaged for easy portability and quick access.
Here's a breakdown of the acceptance criteria and the study details for the MedSource CPR Mask, based on the provided text:
MedSource CPR Mask: Acceptance Criteria and Study Details
The provided document describes a 510(k) premarket notification for the MedSource CPR Mask, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical efficacy. Therefore, the "acceptance criteria" are related to performance standards and biocompatibility, not clinical outcomes for patients. The "study" refers to the performance testing and biocompatibility assessments conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the performance expected of similar devices and recognized consensus standards, particularly AS-4259-1995 for respiratory resistance and ISO 10993 for biocompatibility.
| Acceptance Criteria Category | Specific Criteria / Standard Reference | MedSource CPR Mask Performance | Predicate Device Performance (Spiracle CPR Mask) |
|---|---|---|---|
| Inspiratory Resistance | AS-4259-1995 methods (Implicit criterion: generally comparable to predicate, ideally lower) | 1.94 cm H2O @ 50 lpm flow | 2.04 cm H2O @ 50 lpm flow |
| Expiratory Resistance | AS-4259-1995 methods (Implicit criterion: generally comparable to predicate, ideally lower) | 2.04 cm H2O @ 50 lpm flow | 2.14 cm H2O @ 50 lpm flow |
| Cytotoxicity | ISO 10993 Requirement | Passes | Not applicable (raw material testing) |
| Sensitization | ISO 10993 Requirement | Passes | Not applicable (raw material testing) |
| Irritation / Intracutaneous Reactivity | ISO 10993 Requirement | Passes | Not applicable (raw material testing) |
| Pyrogen | ISO 10993 Requirement (Not required, but tested as "beyond requirements") | Passes | Not applicable (raw material testing) |
| Haemocompatibility | ISO 10993 Requirement (Not required, but tested as "beyond requirements") | Passes | Not applicable (raw material testing) |
| Systemic Toxicity | ISO 10993 Requirement (Not required, but tested as "beyond requirements") | Passes | Not applicable (raw material testing) |
Discussion of Results: The MedSource CPR Mask showed better performance (lower resistance) than the predicate device (Spiracle CPR Mask) for both inspiratory and expiratory resistance. The difference was stated as 5%, deemed to demonstrate "substantially the same performance" given inherent variations in test methods. All required and extra biocompatibility tests were passed.
2. Sample Size and Data Provenance
- Test Set Sample Size: For the respiratory resistance testing, the exact number of individual devices or tests performed is not specified, but the results are presented as single values for "MedSource CPR Mask" and "Spiracle CPR Mask," implying a representative sample was tested and reported.
- Data Provenance: The testing was presumably conducted by or for MedSource International, LLC as part of their submission to the FDA. The specific country of origin for the data is not stated, but the manufacturer is based in Minnesota, USA. The testing is prospective as it was specifically performed to support the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This type of device (CPR mask) and submission (510(k) for substantial equivalence) typically relies on objective performance measurements (like resistance) and standardized biocompatibility tests, not subjective expert assessment of images or clinical outcomes that require establishing a "ground truth" through expert consensus.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, there was no expert assessment or adjudication process involved in performance or biocompatibility testing. The results are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess changes in accuracy or efficiency. This type of study is not applicable to a CPR mask, which is a physical medical device for mechanical assistance, not a diagnostic tool requiring interpretation.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. This is not an AI-powered device or algorithm. The performance testing was for the physical device itself.
7. Type of Ground Truth Used
- Objective Measurements and Standardized Test Results:
- For respiratory resistance: The "ground truth" is the measured physical property of the device (pressure drop at a given flow rate) as determined by methods outlined in AS-4259-1995.
- For biocompatibility: The "ground truth" is determined by standardized laboratory assays (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation) that assess biological responses to the materials, against passing criteria defined by ISO 10993.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through traditional engineering methods, not data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
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