(141 days)
RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
- The RomiApex™ A-15 is used to measure the distance to the apex during root canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.
- The RomiApex™ A-15 operates on the measurement of a weak electrical current flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal.
- The measurements in RomiAPEX™ A-15 are performed utilizing AC signals at two frequencies - 500 Hz and 8 kHz. The frequencies are alternated rather then mixed, as it is done in other apex locators, thus canceling the need for signal filtering and eliminating the noise caused by non-ideal filters.
- The device consists of a main body incorporating the LCD display, a lip Clip, a file clip a cable and a touch prob.
- The device is powered by one 1.5 AAA Alkaline battery.
The provided text is a 510(k) summary for the RomiApex™ A-15 Electronic Apex Locator. This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on detailed acceptance criteria and a specific study proving those criteria were met in the same way a de novo device would. Therefore, much of the requested information (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training ground truth was established) is not available in the provided text.
However, I can extract information related to the device's performance characteristics in comparison to its predicate.
1. Table of acceptance criteria and the reported device performance
The document presents a "Substantial Equivalence Comparison Table" (Table 5.6) which compares the RomiApex™ A-15 (Candidate Device) to the predicate device, BINGO-1020, focusing on characteristics rather than specific performance metrics and acceptance criteria in numerical terms. The acceptance criteria, in this context, appear to be that the candidate device's performance characteristics should be equivalent or better than the predicate's.
| Characteristic | Predicate Device (Bingo-1020) | Candidate Device (RomiApex™ A-15) | Equivalence Claim / Performance Relative to Predicate |
|---|---|---|---|
| Device definition | Electronic apex locator | Same as in Bingo-1020 | Equivalent |
| Intended Use | Precise apex localization during root canal treatment. | Same as in Bingo-1020 | Equivalent |
| Indications for use | Bingo-1020 is a modern device for precise apex localization during root channel treatment. Bingo-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed. | RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex. | Equivalent (description slightly different, but core indication is the same) |
| Where to be used (clinics, home etc.) | This product must only be used in hospital environments, clinics or dental offices by qualified dental personnel. | Same as in Bingo-1020 | Equivalent |
| Device category | Active, invasive | Same as in Bingo-1020 | Equivalent |
| Power Source | 2.4V NiMH rechargeable batteries | 1.5V alkaline primary battery | Different, but considered acceptable |
| External charger | Input: 230V/50-60Hz Output: 6Vdc @ 200mA | External charger is not required | Different, but considered acceptable |
| Current Consumption | Maximum - 30 mA DC. | Maximum – 13 mA DC. | Lower (better) |
| Method of calculating location of root canal apex | RMS functions of the measured signals at two frequencies are used to calculate the test scores which are compared to statistically predefined thresholds. | Same as in Bingo-1020 | Equivalent |
| Display | Custom monochrome LCD Display | Custom color LCD Display | Different, considered an improvement |
| Buttons | Three push buttons: 1. On / Off 2. Sound control 3. Demo MODE (training mode) | Two push buttons: 1. Same as in Bingo-1020 2. Same as in Bingo-1020 3. "Demo MODE" (for training) is not an offered feature in RomiApex™ A-15. | Slightly different feature set, considered acceptable |
| Sound indication | Piezo transducer with sound level control (high, medium, low, mute). | Same as in Bingo-1020 | Equivalent |
| Adjustment before measurement | Not required | Same as in Bingo-1020 | Equivalent |
| Calibration | Not required | Same as in Bingo-1020 | Equivalent |
| Measuring signal amplitude | Nominal - doesn't exceed 25 mV AC. The maximum voltage applied to the patient doesn't exceed 300 mV DC. | Same as in Bingo-1020 | Equivalent |
| Frequencies used for measurements | 500 Hz and 8 kHz | Same as in Bingo-1020 | Equivalent |
| Weight | 430 Gr | 100 Gr | Lighter (better) |
| Dimensions | W160 x H95 x T35 mm | W55 x H92 x T16mm | Smaller (better) |
| Files to be used with the device | Any kind of standard dental files may be used | Same as in Bingo-1020 | Equivalent |
| Safety features | The same connector on the device is used both for measuring cable connection and for battery charging. This safety feature prevents simultaneous connection of the device to the patient and to the mains via external charger. | No external charger should be connected to the device. And due that such safety feature is not needed in RomiApex™ A-15 at all. A new type of connector is used - Micro USB. This type of connector was specially designed to provide particularly high mechanical strength and is guaranteed by the manufacturer for 10,000 mating cycles. | Different (no external charger needed, improved connector strength) |
| Automatic on/off switch | Automatic turn-off after 5 min. of the idle state. | Same as in Bingo-1020 | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a separate "test set" or provide details on sample size, data provenance, or whether it was retrospective or prospective. The submission is for substantial equivalence, which primarily relies on comparing device specifications and intended use to a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not available in the provided text. Electronic Apex Locators are not AI systems in the context of "human readers" interpreting data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The RomiApex™ A-15 is a device for measuring the distance to the root apex during root canal procedures, it's not an "algorithm only" device. Its performance is measured directly by its ability to accurately determine the apex, which is inherent in its design and comparison to the predicate. No specific "standalone" performance study in the context of an AI algorithm is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. For apex locators, "ground truth" for accuracy would typically be established by direct measurement with radiography or physical measurement after tooth extraction, compared to the device's reading. However, this level of detail for a performance study is not included in the 510(k) summary provided. The comparison relies on the predicate's established performance and the candidate device's similar scientific technology.
8. The sample size for the training set
This information is not available in the provided text, as this type of device does not have a "training set" in the context of machine learning. Its operation is based on established electrical impedance principles.
9. How the ground truth for the training set was established
This information is not available in the provided text, for same reasons as point 8.
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RomidanLtd.
premium quality products
- Simcha Holzberg St., 55022 Kiryat Ono, Israel.
图 +972-3-7360099 export@romidan.com 록 +972-3-7360097 Web: www.romidan.com
Document No .: 05.00
"510(k) Summary" Section 5.:
C
SEP 3 · 2010
RomiApex™ A-15, Electronic Apex Locator
The following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a)
Section's content
- 807.92(a)(1) Owner & Submitter's Details 5.1.
- 807.92(a)(2) Candidate Device Details. 5.2.
- 5.3. 807.92(a)(3) - Predicate Device Identification:
- 5.4. 807.92(a)(4) - Device Description:
- 5.5. 807.92(a)(5) - Intended Use
- 5.6. 807.92(a)(6) - Substantial Equivalence Comparison Table:
- 807.92(b)(3) Conclusions 5.7.
5.1 Owner &Submitter's Details: [ 807.92(a)(1) ]
| Owner & Submitter Name: | Romidan LTD |
|---|---|
| Address: | 5 Simcha Holzberg St., 55022 Kiryat Ono, Israel |
| Phone: | +972-3-7360099 |
| Fax number: | +972-3-7360097 |
| eitan@romidan.com | |
| Name of Contact Person: | Mr. Eitan Margalit |
Establishment Registration No.: 3003518307
Date prepared:
July 18t, 2010
US Agent:
15.00 100701-6 51000 Summenr of Sulaty and Effe
NORMAN F.ESTRIN, PH.D., ESTRIN CONSULTING GROUP, INC. (ECG) 9109 Copenhaver Drive, Potomac, MD 20854 Phone: +001-301-279-2899 +001-301-294-0126 Fax: estrin@yourfdaconsultant.com Email:
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Romidan Ltd. The logo features a diamond shape on the left, followed by the company name in bold, sans-serif font. Below the company name, the words "premium quality products" are written in a smaller, italicized font.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel. 粵 +972-3-7360097 @ +972-3-7360099 export@romidan.com Web: www.romidan.com
Document No .: 05.00
| 5.2 Candidate Device Details: | [ 807.92(a)(2) ] |
|---|---|
| Trade Name: | RomiApex™ A15 – Electronic Apex Locator |
| Common Name: | Apex Locator |
| Classification Name: | Locator, Root Apex |
| Product Code: | LQY – Locator, ROOT APEX |
| Review Panel: | Dental |
| Device Class: | Unclassified |
5.3 Predicate Device Identification: [ 807.92(a)(3) ]
Devices to which substantial equivalence is claimed:
Table 5.3: Predicate Device Identification
| Predicate MedicalDevice Name | Applicant Name | 510(k)Number(*) |
|---|---|---|
| BINGO-1020 | DENT CORP, Research & Development | K992233 |
(4) See "510(k) Premarket Notification Database Search for more details.
Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table. (see Para 807.92(a)(6)).
5.4 Device Description: [ 807.92(a)(4) ]
- The RomiApex™ A-15 is used to measure the distance to the apex during root � canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.
- The RomiApex™ A-15 operates on the measurement of a weak electrical current . flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal.
- The measurements in RomiAPEX™ A-15 are performed utilizing AC signals at . two frequencies - 500 Hz and 8 kHz. The frequencies are alternated rather then mixed, as it is done in other apex locators, thus canceling the need for signal filtering and eliminating the noise caused by non-ideal filters.
- The device consists of a main body incorporating the LCD display, a lip Clip, a file . clip a cable and a touch prob.
- The device is powered by one 1.5 AAA Alkaline battery. .
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Image /page/2/Picture/0 description: The image shows a logo for Romidan LTD. The logo features a diamond shape on the left, followed by the word "Romidan" in bold, sans-serif font. To the right of "Romidan" is "LTD." in a smaller font size. Below "Romidan" is the phrase "premium quality products" in a smaller, italicized font, underlined with a solid line.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel. 图 +972-3-7360099 톰 +972-3-7360097
Web: www.romidan.com
Document No .: 05.00
5.5 Intended Use : [ 807.92(a)(5) ]
RomiAPEX™ A-15 is indicated for patients who need to undergo root canal treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
5.6 Substantial Equivalence Comparison Table: [ 807.92(a)(6) ]
| LineNo. | DeviceCharacteristics | Predicate DeviceBingo-1020 | Candidate DeviceRomiApex™ A-15 |
|---|---|---|---|
| 1. | Device definition | Electronic apex locator | Same as in Bingo-1020 |
| 2. | Intended Use | Precise apex localization duringroot canal treatment. | Same as in Bingo-1020 |
| 3. | Indications for use | Bingo-1020 is a modern devicefor precise apex localizationduring root channel treatment.Bingo-1020 is distinguished byincreasing precision at 0.1mmon wet/dry, large graphicdisplay where current positionof endo file is reflected andother essential information isdisplayed. | RomiAPEX™ A-15 is indicatedfor patients who need toundergo root canal treatment,which requires precisedetermination of position of thedental file in the canal relativelyto the root apex. |
| 4. | Where to be used(clinics, home etc.) | This product must only be usedin hospital environments, clinicsor dental offices by qualifieddental personnel. | Same as in Bingo-1020 |
| 5. | Device category | Active, invasive | Same as in Bingo-1020 |
| 6. | Power Source | 2.4V NiMH rechargeablebatteries | 1.5V alkaline primary battery |
| 7. | External charger | Input: 230V/50-60HzOutput: 6Vdc @ 200mA | External charger is not required |
| 8. | Current Consumption | Maximum - 30 mA DC. | Maximum – 13 mA DC. |
| 9. | Method of calculatinglocation of root canalapex | RMS functions of the measuredsignals at two frequencies areused to calculate the testscores which are compared tostatistically predefinedthresholds. | Same as in Bingo-1020 |
| 10. | Display | Custom monochrome LCDDisplay | Custom color LCD Display |
| Line | Device | Predicate Device | Candidate Device |
| No. | Characteristics | Bingo-1020 | RomiApex™ A-15 |
| 11. | Buttons | Three push buttons:1. On / Off2. Sound control3. Demo MODE(training mode) | Two push buttons:1. Same as in Bingo-10202. Same as in Bingo-10203. "Demo MODE" (for training)is not an offered feature inRomiApex™ A-15. |
| 12. | Sound indication | Piezo transducer with soundlevel control (high, medium,low, mute). | Same as in Bingo-1020 |
| 13. | Adjustment beforemeasurement | Not required | Same as in Bingo-1020 |
| 14. | Calibration | Not required | Same as in Bingo-1020 |
| 15a. | Measuring signal | Nominal - doesn't exceed 25mV AC. | Same as in Bingo-1020 |
| 15.b | amplitude | The maximum voltage appliedto the patient doesn't exceed300 mV DC. | Same as in Bingo-1020 |
| 16. | Frequencies used formeasurements | 500 Hz and 8 kHz | Same as in Bingo-1020 |
| 17. | Weight | 430 Gr | 100 Gr |
| 18. | Dimensions | W160 x H95 x T35 mm | W55 x H92 x T16mm |
| 19. | Files to be used withthe device | Any kind of standarddentalfiles may be used | Same as in Bingo-1020 |
| 20a. | Safety features | The same connector on thedevice is used both formeasuring cable connectionand for battery charging.This safety feature preventssimultaneous connection of thedevice to the patient and to themains via external charger. | No external charger should beconnected to the device. Anddue that such safety feature isnot needed in RomiApex™ A-15 at all. |
| 20b. | Safety features(Continue) | The type of connector used -Mini DIN | A new type of connector isused - Micro USB.This type of connector wasspecially designed to provideparticularly high mechanicalstrength and is guaranteed bythe manufacturer for 10,000mating cycles. |
| 21. | Automatic on/offswitch | Automatic turn-off after 5 min.of the idle state. | Same as in Bingo-1020 |
Table 5.6: Substantial Equivalence Comparison
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Image /page/3/Picture/0 description: The image shows a logo for Romidan Ltd. The logo features a diamond shape on the left, followed by the word "Romidan" in bold, and "Ltd." in smaller font. Below the company name, the words "premium quality products" are printed in a smaller font with a line underneath.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel.
图 +972-3-7360099 | | |
惠 +972-3-7360097
Document No.: 05.00
Web: www.romidan.com
End of Table 5.6
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Image /page/4/Picture/0 description: The image shows the logo for Romidan Ltd. The logo features a diamond shape on the left, followed by the company name in bold, black letters. Below the company name, the words "premium quality products" are written in a smaller font.
5, Simcha Holzberg St., 55022 Kiryat Ono, Israel.
图 +972-3-7360099
g
鳥 +972-3-7360097 Web: www.romidan.com
Document No .: 05.00
5.7 Conclusions: [ 807.92(b)(3) ]
- Romidan's RomiApex™ A-15, subject of this submission, constitutes a safe, . reliable, and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks to patients when use as intended.
- The RomiApex™ A-15 has the same intended use and fundamental scientific . technology as its predicate device - Bingo 1020 (K992233)
- The RomiApex™ A-15 was evaluated against it's predicate, and was found to be . Substantial Equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Eitan Margalit General Manager Romidan, Limited 5 Simcha Holzberg Street Kirvat Ono Israel 55022
2010 SEP 3
Re: K101054
Trade/Device Name: RomiApex™ A-15, (an Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LOY Dated: August 26, 2010 Received: August 30, 2010
Dear Mr. Margalit:
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.
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Page 2- Mr. Margalit
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Antony D. Anatan
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
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| Romidan Ltd. | ||
|---|---|---|
| 5, Simcha Holzberg St., 55022 Kiryat Ono, Israel. | ||
| +972-3-7360099 | +972-3-7360097 | |
| eitan@romidan.com | Web: www.romidan.com | |
| Device Name: | RomiApex™ A-15 | Valid from: 4/9/2010 |
| Document No.: | 04.00 | Section 4; Page 1 (of 1) |
| Document Name: | Indication for Use Statement |
2010 SEP 3
Indication for Use Statement Section 4 .:
510(k) Number (if known):
RomiApex™ A-15, (an Apex Locator) Device Name:
Indications for Use:
- RomiAPEX™ A-15 is indicated for patients who need to undergo root canal . treatment, which requires precise determination of position of the dental file in the canal relatively to the root apex.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT.WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
&oncurrence of CDRH, Office of Device Evaluation (ODE)
Susan Renner
Division Sign-OH) livision of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K110154
Page 1 of 1
4-1 (Page 1 of 1)
N/A