The SafeStep™ Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStep™ Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStep™ Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operated with one hand.

Device Description

The SafeStep™ Safety Dental Cartridge Syringe consists of a single-use, disposable aspirating syringe-type injector with a separate re-usable plunger assembly indicated for the use in delivering dental anesthetics. The SafeStep™ Safety Dental Cartridge Syringe incorporates a needle safety mechanism that can be activated with one hand.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SafeStep™ Safety Dental Cartridge Injector:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Primary Safety Criterion: Zero prevalence of sharp injuries during use.	Met. The simulated use clinical study reported "zero prevalence of sharp injuries" for the MDC SDCI.
Primary Safety Criterion: Zero failures of the safety protection feature that could lead to a sharps injury.	Met. The simulated use clinical study reported "no failures of the protection feature of the device that could reasonably lead to a sharps injury."
Equivalency to Predicate Device (Septodont Safety Plus) in Performance.	Met. The simulated use study demonstrated that the MDC SDCI is "equivalent to the Septodont Safety Plus predicate device in terms of performance and evaluator preference." Non-clinical performance testing also concluded the device was "acceptable in all test cases" and "equivalent to the Septodont Safety Plus in terms of materials, function and intended use."
Biocompatibility in accordance with ISO standards.	Met. "The results of the biocompatibility tests, including cytotoxicity, sensitization and acute intracutaneous reactivity, were found to be acceptable."
Sterilization validation to ANSI/AAMI/ISO 11137-1999 (Method 1).	Met (Certification). MDC Research "certifies that the SafeStep™ Safety Dental Cartridge Injector will pass ANSI/AAMI/ISO 11137-1994, Method 1 validation prior to marketing of the device." (Note: This is a certification of future compliance rather than a direct report of a completed validation for the specific submission, but it's presented as an assurance.)
Functional Attributes: Thermal stress, functional attribute, injection force, compression/tension loading before and after retraction, release force, leakage/splatter, aspiration testing.	Met. "The results of the performance evaluations of the SafeStep™ Safety Dental Cartridge Injector were found to be acceptable in all test cases."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided text. The study is described as a "simulated use clinical study."
Data Provenance: The study was conducted by "MDC Research Ltd." The text does not specify the country of origin of the data or the participants, nor does it explicitly state if the data was retrospective or prospective. Given it's a "simulated use clinical study," it would inherently be prospective in nature, as new data would be generated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not explicitly stated. The study involved "evaluator preference," implying multiple evaluators, but their number and specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The text mentions "evaluator preference" and a comparison of performance, but it doesn't describe the process of resolving discrepancies or establishing a consensus "ground truth" if multiple evaluators were involved.

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

No Multi-Reader Multi-Case (MRMC) Study was performed. This device is a manual medical device (a dental cartridge injector), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" is not applicable. The study compared the device's performance to a predicate device in a simulated clinical setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No Standalone (algorithm only) study was done. This is a physical medical device. The "simulated use clinical study" inherently involved humans interacting with the device, making it an "algorithm with human-in-the-loop performance" in a metaphorical sense, as the device's mechanism (the "algorithm") is activated and operated by a user.

7. The Type of Ground Truth Used

The "ground truth" for the simulated use clinical study revolved around:

Observed Safety Outcomes: Zero prevalence of sharp injuries and zero failures of the protection feature that could lead to sharps injury. This is based on direct observation and recording within the simulation.
Performance Equivalency and Evaluator Preference: This would be based on subjective and objective assessments made by the evaluators/participants of the simulated use study, comparing the device to the predicate.

8. The Sample Size for the Training Set

Not Applicable. This device is a mechanical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. Design and functional testing would have been done during its development, but these are not "training sets."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

Summary

{0}------------------------------------------------

FEB 0 5 2003

SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.

SUBMITTER INFORMATION 16.1

Original Premarket 510(k) Notification

a.	Company Name:	MDC Research Ltd.
b.	Company Address:	2810 Bunsen AvenueVentura, CA 93003
c.	Company Phone:Company Facsimile:	(805) 339-0375(805) 339-9751
d.	Contact Person:	David DowsettExecutive V.P. and C.O.O.
e.	Date Summary Prepared:	December 11, 2002

DEVICE IDENTIFICATION 16.2.

a. Trade/Proprietary Name:	SafeStepTM Safety Dental Cartridge Injector
b. Classification Name:	Cartridge Syringe21 CFR 872.6770

IDENTIFICATION OF PREDICATE DEVICE 16.3

Company	Device	510(k) No.	Date Cleared
Specialties Septodont	Safety Plus DentalNeedle System	K913573	11/07/91

16.4 DEVICE DESCRIPTION

{1}------------------------------------------------

SUBSTANTIAL EQUIVALENCE 16.5

The SafeStep™ Safety Dental Cartridge Injector is substantially equivalent to the Septodont Safety Plus Dental Needle Injection System in terms of function, materials, and intended use. In a simulated use clinical study, the SafeStep™ Safety Dental Cartridge Injector was found to perform equivalently to the predicate device.

16.6 INTENDED USE

The SafeStep™ Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStep™ Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStepTM Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operating with one hand.

TECHNOLOGICAL CHARACTERISTICS 16.7

The SafeStep™ Safety Dental Cartridge Injector is equivalent to the Septodont Safety Plus in terms of materials, function and intended use. Both devices are constructed of a single use, disposable injector barrel component and a reusable plunger assembly. Both devices utilize pre-filled 1.8 mL dental anesthetic cartridges and standard screw-on dental needles.

16.8 NON-CLINICAL STUDIES

Performance testing of the SafeStep™ Safety Dental Cartridge Injector included thermal stress, functional attribute, injection force, compression/tension loading before and after retraction, release force, leakage/splatter and aspiration testing. The results of the performance evaluations of the SafeStep™ Safety Dental Cartridge Injector were found to be acceptable in all test cases.

{2}------------------------------------------------

The materials of the SafeSter™ Safety Dental Cartridge Injector were tested for biocompatibility in accordance with ISO standards. The results of the biocompatibility tests, including cytotoxicity, sensitization and acute intracutaneous reactivity, were found to be acceptable.

The SafeStep™ Safety Dental Cartridge Injector is sterilized by gamma irradiation using a dosage of 25 kGy. Sterilization validation is to be performed on the final form-fill-seal production package in accordance with ANSI/AAMI/ISO 1137-1999 using Method 1 validation. MDC Research certifies that the SafeStep™ Safety Dental Cartridge Injector will pass ANSV/AAMI/ISO 11137-1994, Method 1 validation prior to marketing of the device.

16.9 CLINICAL STUDIES

MDC Research Ltd. conducted a simulated use clinical study to evaluate the safety and effectiveness of the MDC SafeStep™ Safety Dental Cartridge Injector (SIDCI), for use in the injection of dental anesthetic medication into a patient. The primary research hypothesis being tested is that the use of the MDC SDCI for injection of dental anesthetic medication causes zero prevalence of sharp injuries, or failures of the safety protection feature of the device that could reasonably lead to a sharps injury. The simulated use clinical study evaluated the MDC SafeStep™ Safety Dental Cartridge Injector in comparison to the Septodont Safety Plus predicate device.

The results of the simulated use study demonstrated that the MDC SDCI is equivalent to the Septodont Safety Plus predicate device in terms of performance and evaluator preference. Further, there were no adverse events reported (i.e., sharps injuries) and no failures of the protection feature of the device that could reasonably lead to a sharps injury.

{3}------------------------------------------------

16.10 CONCLUSIONS

This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission. Performance testing, non-clinical and clinical evaluations of the SafeStep™ Safety Dental Cartridge Injector show that the device performs as intended. Comparison the SafeStep™ Safety Dental Cartridge Injector to the predicate devices show that the device is substantially equivalent.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure in profile, with three curved lines above it, resembling a bird in flight. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 5 2003

MDC Research Limited C/O Ms. Carol Patterson Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630

Re: K022959

Trade/Device Name: SafeStep™ Safety Dental Cartridge Injector Regulation Number: 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: December 11, 2002 Received: December 13, 2002

Dear Ms. Patterson:

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.

{5}------------------------------------------------

Page 2 - Ms. Patterson

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 (QS) 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 Runne

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

{6}------------------------------------------------

K022959

INDICATION FOR USE

510(k) Number:	K022959
Device Name:	SafeStep™ Safety Dental Cartridge Injector
Indications for Use:	The SafeStep™ Safety Dental Cartridge Injector is a sterile, single use disposable injector barrel assembly and a reusable plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges and existing screw-on dental needles for injection of anesthetic solution in oral tissues. The SafeStep™ Safety Dental Cartridge Injector aids in the prevention of needle stick injuries. The SafeStep™ Safety Dental Cartridge Injector incorporates a needle retraction and re-advancing mechanism which may be operated with one hand.

510(k) Number:

K022959

Device Name:

SafeStep™ Safety Dental Cartridge Injector

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
------------------	---

(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Ken Mnhuy for M.Sir

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K022959

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.