(250 days)
No
The summary describes a mechanical device for tissue removal and does not mention any AI/ML terms or functionalities.
Yes
The device is intended for the "removal of necrotic or inflamed tissue" during root canal treatment, which is a therapeutic action aimed at treating a disease or condition.
No
The device is described as an ablator designed to remove tissue, which is a therapeutic function, not a diagnostic one. Its intended use is to remove necrotic or inflamed tissue, not to identify or characterize it.
No
The device description explicitly states it consists of two physical parts, the Apexum NiTi Ablator and the Apexum PGA Ablator, which are designed to be used with a powered handpiece. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Removal of necrotic or inflamed tissue from the apical foramen and periapical region during root canal treatment." This is a therapeutic procedure performed directly on the patient's tissue, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The device is described as an "Ablator" designed to "remove inflamed tissue." This further reinforces its role in a therapeutic intervention.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue sample, etc.)
- Providing information about a patient's health status, disease, or condition based on the analysis of a sample.
- Using reagents or assays.
In summary, the Apexum device is a surgical/therapeutic device used in a clinical procedure, not a diagnostic device used to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Removal of necrotic or inflamed tissues from the apical foramen and periapical region during root canal treatment.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The Apexum device consists of two parts, designed to be used sequentially: the Apexum NiTi Ablator and the Apexum PGA Ablator. It is designed to remove inflamed tissue during root canal treatment with a powered handpiece device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
apical foramen and periapical region (during root canal treatment)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.
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)
Safety and effectiveness evaluations based on animal and clinical studies indicate the device is substantially equivalent to the predicates cited.
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.
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
7.0 510(K) SUMMARY
Submission Date: August 5, 2008
Submitter Information:
.
| Company Name: | Apexum Ltd. | APR 21 2009 |
|---|---|---|
| Company Address: | 6 Yoni Netanyahu St. | |
| Or-Yehuda | ||
| Israel | ||
| Contact Person: | Idan Tobis | |
| General Manager | ||
| Apexum Ltd. | ||
| Tel: +972-3-6349990 | ||
| Fax: +972-3-6349910 | ||
| idan@apexum.com | ||
| Notice Information: |
Devi
| Trade Name: | Apexum Ablator |
|---|---|
| Common Name: | handpiece, belt and/or gear driven, dental, file, pulp canal, br endodontic |
| Classification Name: | handpiece, belt and/or gear driven, dental, file, pulp canal, br endodontic |
| Device Class: | Class I |
| Predicate Devices: | • K971603 Sterile Sureflex Files and Instruments |
| • K062856 TF Rotary Nickel Titanium File |
- · K004031 NT Swift; TITEC; Gates Glidden; Drills; Dental Power
- · K920978 ULA (poliglecaprone 251) synthetic absor
CONFIDENTIAL
1
Device Description:
The Apexum device consists of two parts, designed to be used sequentially: the Apexum NiTi Ablator and the Apexum PGA Ablator. It is designed to remove inflamed tissue during root canal treatment with a powered handpiece device.
Intended Use:
Removal of necrotic or inflamed tissues from the apical foramen and periapical region during root canal treatment.
Indications for Use:
Same as Intended Use
Comparison to Predicate Device:
The Apexum Ablator and the cited predicate devices have the same technological characteristics and indication for use. Some technical parameters differ between the Apexum Ablator and the predicate devices, but these differences are minor and do not affect safety or effectiveness. Safety and effectiveness evaluations based on animal and clinical studies indicate the device is substantially equivalent to the predicates cited.
Conclusion:
The results of the evaluation of the Apexum Ablator support the conclusion that it is as safe and effective as, and is substantially equivalent to, the cited predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Idan Tobis General Manager Apexum Limited 6 Yoni Netanyahu Street Or-Yehuda 60376 ISRAEL
APR 2 1 2009
Re: K082325
Trade/Device Name: Apexum Ablator Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: I Product Code: EKX Dated: March 31, 2009 Received: April 2, 2009
Dear Mr. Tobis:
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.
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.
3
Page 2- Mr. Tobis
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 yours,
Susan Runner, D.D.S., MA
Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
6.0 INDICATIONS FOR USE STATEMENT
K082325 510(k) Number (if known):
Device Name:
Apexum Ablator
Indications for Use:
Removal of necrotic or inflamed tissue from the apical foramen and periapical region during root canal treatment.
Caution: Federal law restricts this device to sale by or on the order of a medical practitioner licensed by the law of the State in which he / she practices to use or order the use of the device.
Prescription Use X (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rin Muly. for HSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices