Search Results
Found 5 results
510(k) Data Aggregation
(45 days)
THE WAND MICROACCESS SAFETY INTRODUCER
The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
Here's an analysis of the provided text regarding the acceptance criteria and study for the WAND™ MicroAccess Safety Introducer:
It's important to note that this 510(k) summary is for a medical device, specifically a catheter introducer, not an AI/ML-based diagnostic device. Therefore, many of the requested categories (like MRMC studies, AI effect size, ground truth for training sets, etc.) are not applicable to this type of submission. The performance evaluation for this device focuses on physical and biological characteristics, not diagnostic accuracy.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria are implicitly defined by demonstrating equivalence to predicate devices and meeting established biomechanical and biocompatibility requirements for the intended use. Specific numerical acceptance criteria are not detailed in this summary; rather, it refers to a full application (K081697) for the details.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are biologically safe for in-body contact. | "A program of design verification testing including biocompatibility testing... has been completed to demonstrate the biological safety... Test results indicate that the device is equivalent to the predicate devices..." (Section 5.6 & 5.8) |
| Biomechanical Performance: Device meets mechanical requirements for its intended function (e.g., integrity, ease of use, safety mechanism). | "A program of design verification testing including... in vitro bench testing has been completed to demonstrate the... biomechanical performance characteristics... Test results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use." (Section 5.6 & 5.8) |
| Sterility: Device is sterile at the point of use. | "The WAND™ MicroAccess Safety Introducer is provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-6." (Section 5.7) |
| Substantial Equivalence: Device is equivalent in design, function, and indications for use to predicate devices. | "The results of testing demonstrate that the WAND™ MicroAccess Safety Introducer is substantially equivalent to the predicate devices in design, function, and indications for use." (Section 5.8) |
Predicate devices listed: Arrow International Emergency Infusion Device (K840455), BD Introsyte Precision Introducer (K020834), Stiffer Coaxial Micro-Introducer Set (K071574). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this summary. The summary refers to the original 510(k) application (K081697) for details on device performance evaluation and testing.
- Data Provenance: Not specified, but generally, bench and biocompatibility testing are conducted in laboratories according to established standards.
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 a medical device for facilitating catheter placement, not a diagnostic AI/ML device requiring expert interpretation for ground truth establishment. Performance is evaluated through engineering and biological testing, not clinical reads by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a medical device, not a diagnostic AI/ML device requiring adjudication of 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 a physical medical device, not an AI/ML system, so an MRMC study and AI assistance effect size are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This question typically applies to AI/ML software. The device itself is "standalone" in the sense that its physical functionality is tested, but it's not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For biocompatibility: Ground truth is typically based on established biological safety standards, in vitro testing (e.g., cytotoxicity, sensitization, irritation), and in vivo animal studies, rather than expert clinical consensus.
- For biomechanical performance: Ground truth is based on engineering specifications, industry standards, and functional testing to ensure the device performs as intended (e.g., strength, integrity, flow rates).
8. The sample size for the training set
- Not Applicable. This device does not involve machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established
- Not Applicable. This device does not involve machine learning algorithms and therefore has no "training set" or associated ground truth establishment.
Summary of Relevant Information from the K090372 Summary:
- Device Type: Catheter Introducer (physical medical device).
- Performance Evaluation: Focused on biocompatibility, in vitro bench testing for biomechanical performance, and sterility.
- Key Conclusion: Substantial equivalence to predicate devices (Arrow International Emergency Infusion Device, BD Introsyte Precision Introducer, Stiffer Coaxial Micro-Introducer Set) in design, function, and indications for use.
- Missing Details: Specific test protocols, numerical results, and sample sizes for the performance studies are not included in this summary but are referenced as being in the original 510(k) application K081697.
Ask a specific question about this device
(170 days)
THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006
The WAND™ MicroAccess Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the peripheral circulatory system.
The WAND™ MicroAccess Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and Introducer Sheath in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
The provided 510(k) summary for "The WAND™ MicroAccess Safety Introducer" does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered system. The document describes a traditional medical device (catheter introducer) and its premarket notification rather than an AI/ML diagnostic or assistive device.
Therefore, I cannot extract the requested information such as test set sample size, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set size, or how ground truth for training was established, as these concepts are not relevant to the described device and its regulatory submission.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and in vitro bench testing. It does not involve AI or algorithms that would require evaluation against clinical performance metrics like sensitivity, specificity, or reader improvement.
Ask a specific question about this device
(113 days)
THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEM
Ask a specific question about this device
(323 days)
THE WAND
For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.
The Wand™ is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes.
The provided document is a 510(k) summary for "The Wand™ Syringe," which is a computer-controlled syringe for anesthetic delivery. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain information about a formal study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods for performance evaluation.
Therefore, I cannot provide the requested information from the given text. The document's purpose is to clear the device for market based on its similarity to existing devices, not to present a detailed performance study against specific acceptance criteria.
Ask a specific question about this device
(67 days)
THE WAND
Ask a specific question about this device
Page 1 of 1