(235 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is for a standard apex locator.
No
The device is used to detect the apex of the root canal, which is a diagnostic function rather than a therapeutic one. It provides information for treatment but does not directly treat the condition.
Yes
The device is used to "detect the apex of root canal," which is a diagnostic function as it involves identifying a specific anatomical landmark relevant to treatment.
No
The description explicitly states "The RCM-7 is a dental device, Apex Locator." Apex locators are typically hardware devices that use electrical impedance to determine the length of a root canal. There is no mention of software being the primary or sole component.
Based on the provided information, the RCM-7 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as a "dental device, Apex Locator" used to "detect the apex of root canal." This is a direct measurement of a physical location within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces its function as an Apex Locator for root canals, again focusing on a physical measurement within the patient.
- Anatomical Site: The anatomical site is the "root canal," which is part of the patient's anatomy.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. The RCM-7's function is to physically locate the apex of a root canal, which is a procedural aid during dental treatment, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
Product codes (comma separated list FDA assigned to the subject device)
LQY
Device Description
The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anatomical sites: Identical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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
N/A
0
510(k) SUMMARY
J. MORITA USA Inc.'s RCM-7
96
1. NAME OF DEVICE
(
- NAME OF DEVICE
| Common/Usual Name: | Apex Locator | NOV 2 3 2009 |
|---|---|---|
| Device trade or proprietary name: | Multiple (Apex Locator) |
*The device may be sold under multiple product names including Root ZX mini.
| Product Model Name : | RCM-7 |
|---|---|
| ---------------------- | ------- |
- SUBMITTER NAME AND ADDRESS WITH PHONE/FAX
Registration No. 2081055 Initial Distributor: J. Morita USA, Inc. 9 Mason Irvine, CA 92618 USA 949-581-9600 Telephone: Facsimile: 949-581-9688
Registration No. 3002807636 Manufacturer: J. MORITA MFG. CORP. 680 Higashihama Minami-cho Fushimi-ku, Kyoto Japan 612-8533 +81-75-611-2141 +81-75-605-2354
3. CONTACT PERSON
Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331
March 19, 2009 4. DATE SUMMARY PREPARED:
5. DEVICE CLASSIFICATION/CLASSIFICATION PANEL
| Device: | Locator, Root Apex |
|---|---|
| Review Panel: | 872 Dental |
| Product Code: | LQY |
| Device Class: | Unclassified |
1
6. DEVICE DESCRIPTION/SUBSTANTIAL EQUIVALENCE
DEVICE DESCRIPTION
The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
SUBSTANTIAL EQUIVALENCE
The RCM-7 is substantially equivalent to Root ZX (K921979 / K953867) and the Canal Measurement Module of DP-ZX-VL (K071190).
1) Predicate device I : Root ZX (K921979 / K953867)
The RCM-7 is substantially equivalent to Root ZX from J.MORITA MFG.CORP. The RCM-7 has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device Root ZX (K921979 / K953867).
2) Predicate device II : DP-ZX-VL (Device Name: ROOT ZX II) (K071190)
The RCM-7 is substantially equivalent to the Canal Measurement Module of the DP-ZX-VL (K071190) from J.MORITA MFG.CORP. The RCM-7 has similar general intended uses, similar principles of operation, and similar technological characteristics to the predicate device, DP-ZX-VL (K071190).
Although there are minor differences in the characteristics of the RCM-7 and its predicate devices, these differences do not raise new questions of safety or effectiveness.
2
| Predicate devices | ||
|---|---|---|
| TECHNOLOGICAL | ||
| CHARACTERISTICS of | ||
| RCM-7 | Root ZX (K921979 | |
| / K953867) | DP-ZX-VL | |
| (K071190) | ||
| Indication for use | ||
| Canal Measurement Function | Identical | Identical |
| Canal Preparation Function | ||
| Light Cure Function | Different | |
| Target population | Identical | Identical |
| Design | Similar | Similar |
| Materials | Similar | Similar |
| Performance | ||
| Canal Measurement Function | Identical | Identical |
| Canal Preparation Function | ||
| Light Cure Function | Different | |
| Sterility | Similar | Similar |
| Biocompatibility | Similar | Similar |
| Mechanical safety | Identical | Identical |
| Chemical safety | Identical | Identical |
| Anatomical sites | Identical | Similar |
| Human factors | Identical | Similar |
| Energy used and/or delivered | Identical | Similar |
| Compatibility with environment | ||
| and other devices | Similar | Similar |
| Where used | Identical | Identical |
| Standards met | Similar | Identical |
| Electrical safety | Similar | Identical |
| Thermal safety | Identical | Identical |
,
i
7. INDICATIONS FOR USE
RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
·
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest feathers. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
J. Morita USA. Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 1425 K Street, Northwest, Suite 1100 Washington, D.C 20005
NOV 2 3 2009
Re: K090925 Trade/Device Name: Multiple (Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LOY Dated: November 16, 2009 Received: November 17, 2009
Dear Mr. Barritt:
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 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.
4
Page 2 - Mr. Barritt
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 contact the Center 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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.
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
999935
090925 510(k) Number (if known):
·
Multiple (Apex Locator) Device Name:
. Indications For Use: ......
RCM-7 is a dental device, Apex Locator.
It can be used to detect the apex of root canal.
AND/OR · Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rein Morley for MSE
Page 1 of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K090925 510(k) Number:
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