(146 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the mechanical and control aspects of an injection tool.
Yes
The device is described as an "anesthesia injection tool" used for injecting local anesthetics prior to dental procedures, which directly impacts the patient's physiological state for therapeutic purposes (pain relief during a medical procedure).
No
The device is described as an "Anesthesia Injection Tool Set" used for "injecting local anesthetic." Its function is delivery, not diagnosis.
No
The device description explicitly lists hardware components: Main body, Hand-piece, Battery pack, and Adapter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "injection of local anesthetics for anesthesia administered prior to, or in conjunction with, dental procedures." This describes a device used on a patient for a therapeutic or procedural purpose, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description details a tool set for injecting substances, consisting of a main body, hand-piece, battery pack, and adapter. This aligns with a medical device used for administering treatment or facilitating a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
Therefore, the device described is a medical device used for administering medication during dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is indicated for the injection of local anesthesia administered prior to, or in conjunction with, dental procedures.
Product codes (comma separated list FDA assigned to the subject device)
EJI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Auto 1 is designed for adult and Auto 2 is for children.
Intended User / Care Setting
Dental clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
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.
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 Device
DENTSPLY Professional(U.S.A.) | KIWORKS Co., Ltd. |
|---------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Product
name | MIDWEST
Comfort Control Syringe | KIW-1000 (e-joa) |
| Web
Address | www.dentsply.com | www.kiworks.co.kr |
| 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 |
| Indications for use | To administer consistent and
comfortable injections. | To deliver anesthetics in dental
procedure safely and effectively
without pain for patient. |
8. Comparison chart
2
| Target | Anesthesia prior to, or in
conjunction with, dental
procedures | Anesthesia prior to, or in
conjunction with, dental
procedures |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Point of use | Dental clinic | Dental clinic |
| Performance | To control motor by program to
inject anesthetic safely and
effectively. It will alleviate the
patient's pain. | To control motor by program to
inject anesthetic safely and
effectively. It will alleviate the
patient's pain. |
| FDA
clearance | K002387
Class II | |
| Sterility | All the system is not contact with
human body.
Using in conjunction with
disposable, one time use,
standard syringe and needle. | All the system is not contact with
human body.
Using in conjunction with
disposable, one time use,
standard syringe and needle. |
| Control of
anesthesia- time | Free control
(High/Low speed) | Free control
(High/Low speed) |
| anesthesia time | Small doses
Short time | Small doses
Short time |
| Source of
Electric 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 Device
DENTSPLY Professional (U.S.A.) | KIWORKS Co., Ltd. |
|-----------------|----------------------------------------------------|-------------------|
| Product
name | MIDWEST
Comfort Control Syringe | KIW-1000 (e-joa) |
| Web
Address | www.dentsply.com | www.kiworks.co.kr |
3
| Injection
mode | 5mode button
-Block
-Infiltration
-Palate
-PDL
-intraosseous | 3 Mode
Auto1
Auto2
Manual 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.
4
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.
5
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
6
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:
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