KI works' Anesthesia Injection Tool Set (KIW-1000) is a device for injecting local anesthetic for anesthesia prior to, or in conjunction with, dental procedures. This device consists of Main body, Hand-piece, Battery pack and Adapter. All operating displays and the majority of the operator controls are located on front panel of the control unit.

AI/ML Overview

The provided text describes the KI works' Anesthesia Injection Tool Set (KIW-1000) and its submission for 510(k) clearance, asserting substantial equivalence to a predicate device. However, the document does not contain explicit "acceptance criteria" presented as quantitative thresholds or specific performance metrics that the device had to achieve. Instead, the document focuses on demonstrating that the KIW-1000 is "substantially equivalent" to a legally marketed predicate device (Comfort Control Syringe System) based on intended use, technological characteristics, and safety/effectiveness considerations, primarily relying on non-clinical performance and electrical testing.

The study presented is a non-clinical performance test, not a clinical trial evaluating effectiveness against specific acceptance criteria.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating similarity to a predicate device and adherence to safety standards. The performance aspects discussed are comparative and qualitative/descriptive, rather than explicitly defined acceptance thresholds.

Performance Aspect	Acceptance Criteria (Explicitly stated)	Reported Device Performance (KIW-1000)
Intended Use	For the injection of local anesthetics for anesthesia prior to, or in conjunction with, dental procedures.	For the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures. (Matches predicate and intended use)
Indications for Use	To administer consistent and comfortable injections.	To deliver anesthetics in dental procedure safely and effectively without pain for patient. (Similar to predicate's intent)
Sterility	Not specified as an acceptance criterion; described as not contacting human body directly, used with disposable syringe/needle.	All the system is not contact with human body. Using in conjunction with disposable, one time use, standard syringe and needle. (Matches predicate's approach)
Control of anesthesia-time	Free control (High/Low speed)	Free control (High/Low speed) (Matches predicate functionality)
Anesthesia time (dose)	Small doses, Short time	Small doses, Short time (Matches predicate functionality)
Electric power source	Internal	Internal Battery (Similar to predicate, internal)
Operation	Automatic/Manual (5-step speed control)	Automatic/Manual (6-step speed control) (Similar to predicate, slight difference in steps)
Injection Mode	5 mode button (-Block, -Infiltration, -Palate, -PDL, -intraosseous)	3 Mode (Auto1, Auto2, Manual 6 phases) (Different from predicate, but described as an electronic pre-programmed anesthetic delivery device)
Initial Slow Injection Time	Not explicitly stated as an acceptance criterion beyond being "similar" to the predicate.	"First slow injection time of Auto 1, KIW-1000 is similar to Predicate device's first 10 seconds. Auto 1 is designed for adult and Auto 2 is for children. For the children the first slow injection time is 22 second."
Safety Standards Adherence	Adherence to EN60601-1, EN60601-1-2, EN55011:2007.	Testing conducted in accordance with EN60601-1, EN60601-1-2, EN55011:2007. "None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards."

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

Sample Size for Test Set: Not explicitly stated as a number of devices or injections. The "performance test" mentions evaluating "initial slow injection time" for Auto 1 (adult) and Auto 2 (children) settings of the KIW-1000 and comparing it to the predicate device's "first 10 seconds." It implies direct comparison, but the number of tests performed is not quantified.
Data Provenance: The testing was "non-clinical" (bench testing) performed by KIWORKS Co., Ltd. (Korea). The data is retrospective in the sense that it's reported after the testing, but it's not patient data.

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

Number of Experts: Not applicable. This was a non-clinical bench test. There were no human experts establishing ground truth for performance. The comparison was to a predicate device's known characteristics and general engineering principles.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No human adjudication was involved in this non-clinical bench testing.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an anesthetic delivery tool, not an AI-assisted diagnostic or interpretation system.

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

Standalone Performance: Not applicable in the context of AI. This device is a physical, automated-assist medical tool, not an algorithm for diagnosis or interpretation. The device's "standalone" performance was assessed via bench testing, as described in point 2.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: For the performance test, the "ground truth" was the performance characteristics of the predicate device (Comfort Control Syringe System) and engineering standards/specifications (e.g., EN60601-1) for safety. There was no clinical ground truth (like pathology or outcomes data) established.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI/machine learning system that requires a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there was no training set for this device.

Summary

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K113247

MAR 2 7 2012

510(k) Summary

1. Submitter's Identification:

KI works Co., Ltd.

Gimhae Biomedical Center #113, 155-1, Nongso-ri, Juchon-myeon,

Gyeongnam, Korea

Tel: +82-55-329-707, Fax: +82-55-329-7072

E-mail: woo1819@hananet.net

2. 510(k) Preparer

Company name: BSR KOREA Corp.

Address: Migun Technowolrd 2 C-dong 524, #533-1 Yongsan-dong Yuseong-gu, Daejeon, KOREA

Tel: +82-42-476-2977, Fax: +82-42-476-2978

Name of contact person: Eileen Yang

3. Identification of the device

Trade name / proprietary name: Anesthesia Injection Tool Set Model No.: KIW-1000 Common / usual name: Anesthetic delivery device Classification name: Cartridge syringe Regulation number: 872.6770 Product code: EJI

4. Equivalent legally marketed device

The KI works' Anesthetic Injection Tool Set (KIW-1000) is substantially equivalent, with respect to questions of safety and effectiveness, to;

Predicate Device 1 - K002387 Comfort Control Syringe System

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5. Intended use of the device

The device is indicated for the injection of local anesthesia administered prior to, or in conjunction with, dental procedures.

6. Description of the device

7. Safety and Effectiveness, comparison to predicate device

This subject device, KI works' Anesthesia Injection Tool Set (KIW-1000), and predicate device are substantially equivalent and have the same intended use. Technological and performance difference do not raise any new questions of safety or effectiveness. Comparison analysis, including comparison tables, of the subject device versus the predicate device is provided in section 7.Comparison chart._____

1 + 1 = 2

Section	Predicate DeviceDENTSPLY Professional(U.S.A.)	KIWORKS Co., Ltd.
Productname	MIDWESTComfort Control Syringe	KIW-1000 (e-joa)
WebAddress	www.dentsply.com	www.kiworks.co.kr
IntendedUse	For the injection of localanesthetics for anesthesia priorto, or in conjunction with, dentalprocedures.	For the injection of localanesthetics for anesthesiaadministered prior to, or inconjunction with, dentalprocedures
Indications for use	To administer consistent andcomfortable injections.	To deliver anesthetics in dentalprocedure safely and effectivelywithout pain for patient.

8. Comparison chart

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Target	Anesthesia prior to, or inconjunction with, dentalprocedures	Anesthesia prior to, or inconjunction with, dentalprocedures
Point of use	Dental clinic	Dental clinic
Performance	To control motor by program toinject anesthetic safely andeffectively. It will alleviate thepatient's pain.	To control motor by program toinject anesthetic safely andeffectively. It will alleviate thepatient's pain.
FDAclearance	K002387Class II
Sterility	All the system is not contact withhuman body.Using in conjunction withdisposable, one time use,standard syringe and needle.	All the system is not contact withhuman body.Using in conjunction withdisposable, one time use,standard syringe and needle.
Control ofanesthesia- time	Free control(High/Low speed)	Free control(High/Low speed)
anesthesia time	Small dosesShort time	Small dosesShort time
Source ofElectric power	Internal	Internal Battery
operation	Automatic/Manual(5step speed control)	Automatic/Manual(6step speed control)

9. Statement of substantial equivalence

. .

をする。 …

Please refer to the electrical test report and performance test report. This device, Anesthesia Injection Tool Set (KIW-1000) is very similar with predicate device, DENTSPLY Professional.

Section	Predicate DeviceDENTSPLY Professional (U.S.A.)	KIWORKS Co., Ltd.
Productname	MIDWESTComfort Control Syringe	KIW-1000 (e-joa)
WebAddress	www.dentsply.com	www.kiworks.co.kr

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Injectionmode	5mode button-Block-Infiltration-Palate-PDL-intraosseous	3 ModeAuto1Auto2Manual 6 phases
Similarity	-An electronic pre-programmed anesthetic delivery device-Use a motor to control the injection flow speed

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Testing information demonstrating safety and effectiveness of the Anesthesia Injection Tool Set (KIW-1000) in the intended environment of use is supported by testing that was conducted in accordance with EN60601-1, EN60601-1-2, EN55011:2007 and performance test (Bench). Both KIWORKS device and predicate device have first slow rate injection time in which the patient gets some degree of anesthesia. So for the performance test report, initial slow injection time was performed with predicate device. First slow injection time of Auto 1, KIW-1000 is similar to Predicate device's first 10 seconds. Auto 1 is designed for adult and Auto 2 is for children. For the children the first slow injection time is 22 second. "2013" ------------------------------------------------------------------------------------------------------------------------------------------ーーーーーーーーーーーーーーーーーーーーーーーー

None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.

11. Discussion of Clinical Tests Performed:

Clinical testing was not conducted.

12. Conclusions:

Based on the information provided in this submission we concluded that the Auto controlled injection system is substantially equivalent to the predicate and is safe and effective for its intended use. Technological and performance difference do not raise any new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

KI Works Company, LTD C/O Ms. Eileen Yang BSR Korea Corporation Migun Technoworld 2 C-Dong 524 #533-1 Yongsan-Dong, Daejeon Republic of Korea KS

MAR 2 7 2012

Re: K113247

Trade/Device Name: Anesthesia Injection Tool Set Model No. KIW-1000 Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Code: EJI Dated: March 16, 2012 Received: March 16, 2012

Dear Ms. Yang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K113247.

Indications for Use

510(k) Number (if known):

Model No. KIW-1000 Device Name: Anesthesia Injection Tool Set

Indications for Use:

The device is indicated for the injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures.

Prescription Use x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruaro

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

510(k) Number:

Page 1 of 1

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.