(235 days)
RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.
The provided 510(k) summary for the J. MORITA USA Inc.'s RCM-7 Apex Locator does not contain the detailed information requested regarding acceptance criteria and the specific study that proves the device meets those criteria.
The document focuses on establishing substantial equivalence to previously cleared predicate devices (Root ZX and DP-ZX-VL) by comparing general intended uses, principles of operation, and technological characteristics. It lists various characteristics and whether they are identical or similar to the predicate devices. However, it does not provide:
- Specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision).
- Details of a study designed to demonstrate that the RCM-7 explicitly meets such acceptance criteria.
- Information on sample sizes, data provenance, ground truth establishment, or expert involvement for any performance testing.
Therefore, most of the requested fields cannot be filled based on the provided text.
Here's an analysis of what can be inferred or what is explicitly missing:
Acceptance Criteria and Study for J. MORITA USA Inc.'s RCM-7
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| No specific quantitative acceptance criteria or performance metrics are provided in the document. | No specific quantitative performance data is provided in the document. |
| General Equivalence | General Equivalence |
| Indication for use (Canal Measurement Function) Identical to predicate devices. | Identical to Root ZX (K921979/K953867) and DP-ZX-VL (K071190). |
| Target population Identical to predicate devices. | Identical to Root ZX (K921979/K953867) and DP-ZX-VL (K071190). |
| Performance (Canal Measurement Function) Identical to predicate devices. | Identical to Root ZX (K921979/K953867) and DP-ZX-VL (K071190). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not provided. The document does not describe a specific test set or study conducted for the RCM-7.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. The document does not mention any expert involvement for establishing ground truth for performance testing of the RCM-7.
4. Adjudication method for the test set
- Not provided. No test set is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The RCM-7 is an Apex Locator, a standalone dental device for root canal length measurement, not an AI-assisted diagnostic tool that would involve human readers in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is an Apex Locator, which by its nature operates "standalone" in performing its measurement function. However, the document does not describe a specific "standalone performance study" with metrics and results for the RCM-7 itself. Instead, it relies on demonstrating equivalence in performance to predicate devices.
7. The type of ground truth used
- Not explicitly defined for the RCM-7. For an apex locator, ground truth for canal length would typically be established by direct measurement (e.g., manual file measurement to the apex) or highly accurate imaging, but this is not detailed for the RCM-7's submission. The document relies on the established performance of the predicate devices.
8. The sample size for the training set
- Not applicable/Not provided. The RCM-7 is an Apex Locator, likely based on electrical impedance principles, rather than a machine learning or AI-based device that would require a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there is no mention of a training set for this type of device.
Summary of Missing Information:
The 510(k) summary for the RCM-7 primarily focuses on demonstrating substantial equivalence to its predicate devices by comparing their specifications and intended uses. It does not include specific clinical or performance study data, acceptance criteria, or details about ground truth establishment that would typically be found in submissions requiring such evidence. For devices demonstrating substantial equivalence through comparison, the detailed performance data for the predicate devices often serves as the benchmark, and new studies are usually not required unless there are significant technological differences that raise new questions of safety or effectiveness.
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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 |
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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.
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| Predicate devices | ||
|---|---|---|
| TECHNOLOGICALCHARACTERISTICS ofRCM-7 | Root ZX (K921979/ K953867) | DP-ZX-VL(K071190) |
| Indication for useCanal Measurement Function | Identical | Identical |
| Canal Preparation FunctionLight Cure Function | Different | |
| Target population | Identical | Identical |
| Design | Similar | Similar |
| Materials | Similar | Similar |
| PerformanceCanal Measurement Function | Identical | Identical |
| Canal Preparation FunctionLight 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 environmentand 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.
·
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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.
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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
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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:
11
N/A