SAFETYWAND DISPOSABLE HANDPIECE by SPINTECH, INC.

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.

Device Description

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.

AI/ML Overview

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.

Summary

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3722

SEP - 2 2003

510(k) Summary

Submitted by: Daniel J. Manelli Manelli Denison & Selter, P.L.L.C. 2000 M Street NW (Suite 700) Washington, DC 20036

Phone: 202-261-1000

On behalf of Spintech, Inc. 220 South Orange Avenue Livingston, NJ 07039

SafetyWand™ disposable handpiece for CompuDent™ 510(k) Submission: anesthetic delivery system

Date:August 13, 2003

The SafetyWand™ disposable handpiece is a safety engineered syringe Description: 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. The SafetyWand™ is substantially equivalent to the company's Wand® handpiece (K992819) and to the IntegriTech Safety Injection System (K962999).

Indications for use:

To iniect local anesthetic aqents subcutaneously or intramuscularly for dental applications.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2003

Spintech. Incorporated Mr. Daniel J. Manelli Attorney 2000 M Street NW (Suite 700) Washington, DC 20036

Re: K023722

Trade/Device Name: SafetyWand™ Disposable Handpiece Regulation Number: 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: June 20, 2003 Received: June 20, 2003

Dear Mr. Manelli:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 -Mr. Manelli

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Runoir

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit H Page 1 of 1

510(k) Number (if known): K023722

Device Name: SafetyWand™ disposable handpiece

Indications for Use:

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K023722

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.