(301 days)
The SafetyWand™ is intended to inject local anesthetic agents subcutaneously or intramuscularly for dental applications. It is a sterile single use handpiece assembly for use with the Milestone Compudent™ computer controlled injection system. The SafetyWand™ incorporates safety engineering sharps protection features to aid in the prevention of needlesticks.
The SafetyWand™ disposable handpiece is a safety engineered syringe component designed for use with the CompuDent™ computer controlled injection system (K992819). The CompuDent® 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 hanbdpiece is made of rigid PVC. The anesthetic cartridge holder, 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 svringes. The device provides audible status indicators, including optional voice announcement of injection rate, and volume of anesthetic dispensed. The SafetyWand™ handpiece incorporates a protective barrel inside of which a movable needle hub assembly can be extended and locked in place for use in performing iniections. When not in use, or for disposal, the needle can be retracted within the barrel to aid in the prevention of needlesticks.
This document is a 510(k) premarket notification for the SafetyWand™ disposable handpiece, a component of a dental anesthetic delivery system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report for a new device's performance.
Therefore, the requested information cannot be fully extracted from the provided text for the following reasons:
- This is a 510(k) submission, not a study report: A 510(k) aims to prove "substantial equivalence" to an already legally marketed predicate device, not necessarily to independently establish performance against novel acceptance criteria through extensive studies. The "study" here refers to the comparison against the predicate.
- Focus on substantial equivalence: The document emphasizes that the SafetyWand™ handpiece is "substantially equivalent" to the company's Wand® handpiece (K992819) and the IntegriTech Safety Injection System (K962999). This means its performance is considered acceptable if it matches the predicate's established performance, implicitly meeting the same unstated "acceptance criteria" as those devices.
- Lack of detailed performance metrics: The document describes the device's function and safety features (retractible needle to prevent needlesticks) but does not provide specific quantitative performance metrics (e.g., accuracy, reliability, lifespan) or acceptance criteria for those metrics.
Despite these limitations, I can infer and state what might be considered "acceptance criteria" based on the nature of the device and the 510(k) process, and then indicate that the "study" is the substantial equivalence comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence and Device Function) | Reported Device Performance (Inferred from 510(k) and Predicate Equivalence) |
|---|---|
| Puncture Prevention: Effective mechanism to prevent accidental needlesticks during and after use. | Incorporates a protective barrel allowing the needle to be retracted within the barrel "to aid in the prevention of needlesticks." |
| Compatibility: Compatible with the CompuDent™ computer controlled injection system and standard 1.8mm pre-filled anesthetic carpules. | Designed for use with the CompuDent™ system and utilizes standard 1.8mm pre-filled carpules. |
| Material Safety/Biocompatibility: Materials are safe for medical contact and intended use. | Made of rigid PVC; "materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes." (Implicitly, materials are safe if similar to predicate). |
| Sterility: Provided in a sterile condition suitable for single-use. | The anesthetic cartridge holder, tubing, and handpiece are sold in a sterile condition as a disposable assembly for one-time use. |
| Functional Equivalence: Performs the intended function of delivering local anesthetic for dental applications comparably to predicate devices. | "The SafetyWand™ is substantially equivalent to the company's Wand® handpiece (K992819) and to the IntegriTech Safety Injection System (K962999)." Functionally, it "injects local anesthetic agents subcutaneously or intramuscularly for dental applications." |
| Usability/Operation: Easy and safe to operate by dental professionals. | Implied by "principal of operation... same as other marketed piston and cartridge syringes" and the addition of safety features. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as this is a substantial equivalence claim based on device design and features, rather than a clinical trial with a specific "test set" of patients or users. Demonstrating substantial equivalence primarily relies on technical comparisons (design, materials, intended use, energy, safety principles) to the predicate device.
- Data Provenance: Not applicable in the sense of patient data. The "data" involves device specifications and comparisons to predicate devices (K992819 and K962999).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for a test set is not described in a 510(k) submission focused on substantial equivalence of a physical medical device. The "truth" here is its equivalence to an already approved device.
4. Adjudication method for the test set
- Not applicable. There is no mention of a "test set" requiring adjudication in a clinical or experiential sense.
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 device is a disposable handpiece for anesthetic delivery, not an AI-assisted diagnostic tool or imaging system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device; no algorithm is described.
7. The type of ground truth used
- Not applicable in the conventional sense of clinical ground truth (pathology, outcomes). The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and performance of the identified predicate devices (Wand® handpiece K992819 and IntegriTech Safety Injection System K962999). The new device is considered acceptable if it can demonstrate substantial equivalence to these devices.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI device.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.