(91 days)
The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
Hawk Intraoral Camera composed of light (25g), small (185 x10mm) hand piece along with docking station. The hand piece consists of a focusing mechanism to assist the doctor in taking video of the patient's mouth. The hand piece connects to docking station via cable. The docking station attaches directly to monitor, TV, or computer via standard composite connection. It uses high definition imaging (480 lines) to capture images at 78 degrees field of view. Hawk Intraoral Camera includes also footswitch.
The provided 510(k) summary for the "Hawk Intraoral Camera and Accessories" does not describe any acceptance criteria or a study proving the device meets them. This type of submission, especially for a Class I device seeking substantial equivalence, generally relies on demonstrating equivalence to a predicate device through non-clinical testing of safety and performance against recognized standards, rather than clinical efficacy studies with specific performance metrics.
Here's why the requested information cannot be extracted from this document:
- No Acceptance Criteria: The document does not define specific metrics (e.g., sensitivity, specificity, accuracy, image resolution thresholds, field of view clarity) that the device must achieve to be considered effective.
- No Performance Study: There is no study described that measures the device's performance against predefined acceptance criteria. The document explicitly states: "Clinical testing was not conducted."
- Reliance on Substantial Equivalence: The approval is based on demonstrating substantial equivalence to a predicate device (Veracan Intraoral camera and accessories, K021083) in terms of intended use, operation, safety, and function, supported by non-clinical testing against electrical and medical device safety standards (EN 60601-1, EN 60601-2, EN 61000-3-2 and EN 61000-3-3).
Since the specific information requested about acceptance criteria and a performance study is not present in the provided text, the table and other details cannot be filled as requested. The available information primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Explanation of Missing Elements:
- Table of acceptance criteria and reported device performance: Not present. The submission focuses on meeting safety standards and equivalence to a predicate, not specific performance metrics.
- Sample size, data provenance, number of experts, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training was established: All these elements are relevant to performance studies, especially those involving AI or diagnostic devices, which were not conducted for this camera. The device is a viewing tool, not a diagnostic one requiring such detailed performance evaluation.
Summary of available relevant information:
- Intended Use: To provide a view of the mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
- Predicate Device: Veracan Intraoral camera and accessories (K021083).
- Non-Clinical Testing Standards: EN 60601-1, EN 60601-2, EN 61000-3-2, and EN 61000-3-3. These are safety and electromagnetic compatibility standards, not performance criteria for diagnostic accuracy or image quality exceeding basic functionality.
- Clinical Testing: Not conducted.
- Conclusion: Substantially equivalent to the predicate and safe and effective for its intended use based on non-clinical testing against standards.
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Exhibit #1
510(K) SUMMARY
This summary of 510(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:
Submitter's Identification: 1.
DXM Co.,Ltd 1016.Ilsantechnotwon Bldg., 1141-1, Baekseok-dong ,Ilsan-gu, Govang-si .Gyeongqi-do, Korea. PHONE : +82-31-909-8275 FAX: +82-31-909-8276
Date Summary Prepared: January 19, 2004
2. Name of the Device:
Trade/Proprietary Name:
Hawk Intraoral Camera and Accessories
Classification Name:
Dental Operative Unit and Accessories
Class in which Device has been placed:
The Dental devices panel has classified this device as Class I, 21 CFR Part 820.6640, Product Code EIA.
3. Predicate Device Information:
The Hawk Intraoral Camera and Accessories is substantially equivalent to the Veracan Intraoral camera and accessories distributed by Lumalite, Inc., K 021083.
Device Description: 4.
Hawk Intraoral Camera composed of light (25g), small (185 x10mm) hand piece along with docking station.
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The hand piece consists of a focusing mechanism to assist the doctor in taking video of the patient's mouth. The hand piece connects to docking station via cable. The docking station attaches directly to monitor, TV, or computer via standard composite connection. It uses high definition imaging (480 lines) to capture images at 78 degrees field of view. Hawk Intraoral Camera includes also footswitch.
5. Intended Use:
The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
6. Comparison to Predicate Device:
The Hawk Intraoral Camera is substantially identical to the predicate in intended use, operation, safety and function.
Discussion of Non-Clinical Tests Performed for Determination of 7. Substantial Equivalence are as follows:
Testing information demonstrating safety and effectiveness of the Hawk Intraoral Camera in the intended environment of use is supported by testing that was conducted in accordance with EN 60601-1, EN 60601-2, EN 61000-3-2 and EN 61000-3-3.
None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazards.
8. Discussion of Clinical Tests Performed:
Clinical testing was not conducted.
9. Conclusions:
The Hawk Intraoral Camera is substantially equivalent to the predicate and is safe and effective for it's intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 0 2004
DXM Company Limited C/O Ms. Carolann Kotula Official Correspondents MDI Consultants, Incorporated 55 Northern Boulevard Suite 200 Great Neck, New York 11021
Re: K040116
Trade/Device Name: Hawk Intraoral Camera and Accessories Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: April 8, 2004 Received: April 9, 2004
Dear Ms. Kotula:
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 - Ms. Kotula
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. or the rece of 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 and listing (21 CF read in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as betternic 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) Fins letter will 210 w J The FDA finding of substantial equivalence of your device to a premainter noticate 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), 11 you donte 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 may overn 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 yours,
Kein Mely
Sor-Chiu Lin, Ph.D. 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 B
Indications for Use
510(k) Number (if known): 510
Device Name: Hawk Intraoral Camera
Indications For Use:
The Hawk Intraoral Camera and Accessories are indicated for use to provide a view of mouth to assist the dentist in describing dental procedures and to show the patient the mouth before and after dental procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Shitz DDS for Dr. Susan Kinner
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040116
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.