(87 days)
Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.
Denjector is a gun type electronic dental anesthetic cartridge syringe. This device is used with injectable local anesthetics packaged in cartridge form. The device consists of: Injector gun, battery, battery charger stand, DC adapter for battery charger stand, Cartridge holder and Cartridge pushing/pulling pin. Standard needles may be used with the device.
This document is a 510(k) summary for the Denjector, an electronic dental anesthetic cartridge syringe. It indicates that no clinical tests were performed to establish its safety and effectiveness. Instead, the submission relies on non-clinical tests and a comparison to a predicate device to claim substantial equivalence. Therefore, the information requested regarding acceptance criteria and a study proving those criteria cannot be extracted from this document, as such a study was not conducted.
Here is a summary of the information that can be extracted, along with explanations for the missing data:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (No specific acceptance criteria for performance were defined or tested clinically in this submission.) | (No device performance metrics from a clinical study are reported as no clinical study was performed.) |
Explanation: The document explicitly states, "Clinical testing was not conducted." Therefore, there are no acceptance criteria derived from clinical performance and no reported device performance against such criteria. The substantial equivalence claim is based on non-clinical standards and comparison to a predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable (No clinical test set was used).
- Data Provenance: Not applicable (No clinical data was used).
Explanation: As no clinical testing was performed, there is no test set or associated data provenance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable (No clinical test set requiring ground truth established by experts).
- Qualifications: Not applicable.
Explanation: Without clinical testing, there was no need for experts to establish ground truth for a test set.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
Explanation: No clinical test set means no adjudication method was necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No.
- Effect Size: Not applicable.
Explanation: An MRMC comparative effectiveness study involves human readers and clinical cases. Since no clinical testing was done, no such study was conducted.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study Done: No.
Explanation: The "Denjector" is a hardware device (an electronic dental anesthetic cartridge syringe), not a software algorithm. Therefore, a standalone algorithm-only performance study is not relevant. The testing mentioned (EN 60601-1, EN 61000-3-2, and EN 61000-3-3) refers to electrical safety and electromagnetic compatibility standards for medical devices, which are not performance studies in the clinical sense.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable.
Explanation: There are no clinical outcomes or diagnostic assessments to establish ground truth for, as no clinical study was performed.
8. Sample Size for the Training Set:
- Sample Size: Not applicable.
Explanation: The Denjector is a hardware device, not an AI/ML algorithm that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Method: Not applicable.
Explanation: As no training set was used, no ground truth needed to be established for it.
In summary, the provided 510(k) submission for the Denjector explicitly states that no clinical trials were conducted. The device's safety and effectiveness were established through non-clinical testing against recognized standards (EN 60601-1, EN 61000-3-2, EN 61000-3-3) and a comparison to a predicate device (CC:3; computer controlled syringe by DENTSPLY Midwest Professional Ltd., K983105) to demonstrate substantial equivalence.
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SEP 1 2 2008
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K0811694
1. Submitter's Identification:
| Company Name: | DXM CO. LTD. |
|---|---|
| Address: | 1016, ILsantechnotown Bldg.,1141-1, Baekseok-dong, ILsan-guGoyang-si, Gyeonggi-do,KOREA |
| Tel: | 011 82 31 909 8275 |
| Fax: | 011 82 31 909 8276 |
Date Prepared: June 16, 2008
- Name of the Device: Denjector
-
- Common or Usual Name: Syringe, Cartridge
-
- Classification: Class II, 21 CFR 872.6670
-
- Predicate Device Information: CC:3; computer controlled syringe distributed by DENTSPLY Midwest Professional Ltd., K983105
6. Device Description :
Denjector is a gun type electronic dental anesthetic cartridge syringe. This device is used with injectable local an:1sthetics packaged in cartridge form. The device consists of: Injector gun, battery, battery charger stand, DC adapter for battery charger stand, Cartridge holder and Cartridge pushing/pulling pin. Standard needles may be used with the device.
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7. Intended Use
Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.
Comparison to Predicate Devices: 8.
The Denjector is substantially identical to the predicate in intended use, operation, safety and function. The main difference between the two devices is that the predicate is software controlled and the Denjector is motor controlled.
Discussion of Non-Clinical Tests Performed for Determination of 9. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Denjector in the intended environment of use is supported by testing that was conducted in accordance with 🇪N 60601-1, EN 61000-3-2 and EN 61000-3-3.
None of the testing demonstrated ar y design characteristics that violated the requirements of the standards or resulted in any safety hazards.
10. Discussion of Clinical Tests Performed:
Clinical testing was not conducted.
11. Conclusions:
Based on the information provided in this submission we conclude that the Denjector is substantially equivalent to the predicate and is safe and effective for it's intended use.
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
SEP 1 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DXM Company, Limited C/O Ms. Maria Griffin Mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Rc: K081694
Trade/Device Name: Denjector Regulation Number: 21 CFR 872.6770 Regulation Name: Cartridge Syringe Regulatory Class: II Product Codc: EJI Dated: June 16, 2008 Received: June 17, 2008
Dear Ms. Griffin:
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.
and the comments of the comments of
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Page 2 - Ms. Griffin
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 Ccnter for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
. . . . . .
Sincerely vours,
Qur
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Exhibit 3
Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name: Denjector
Indications For Use:
Indicated for the use of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with dental procedures.
Prescription Use × (Per 21CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Hays
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
er. K081694
§ 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.