(388 days)
Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.
RA-5 "ANESTO" is a handpiece, which, on the one hand, is provided with a coupling system according to ISO 3964. This coupling allows the handpiece's attachment onto a corresponding dental motor, for transmitting the motor's rotational movement to the attached intraosseous injection needle, intended to perforate cortical bone. On the other hand, it was designed for being equipped with an anesthetic cartridge acc. ISO 11499, volume 1.7 or 1.8ml. After having perforated the bone, this cartridge's anesthesia can be administered locally in the spongiosa by means of a manually-operated dosage lever. "ANESTO's" application is intended in dentistry.
The provided text describes the 510(k) summary for the "Handpiece RA-5 'ANESTO'" and its substantial equivalence determination. However, it explicitly states:
- "Clinical data were not needed for this new product."
- "Bench testing results demonstrate substantially equivalence."
This means that a formal clinical study with acceptance criteria, human readers, ground truth establishment, and training/test sets as typically understood for an AI/ML device was not conducted for this specific medical device submission. The substantial equivalence was based on bench testing.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance, ground truth types, or training set details because this information is not present in the provided document.
Instead, the submission relies on the device being "substantially equivalent" to predicate devices based on:
- Intended Use: Drilling system to perforate cortical bone to administer local anesthesia in spongiosa; application in dentistry.
- Technological Characteristics: Similar to the predicate, but designed to be attached to and driven by a dental micro motor (air or electric motor) instead of an integrated air-supplied driving system. Handpiece shape and ease of operation were improved.
- Performance Parameter: Stated as "very similar to the predicate device."
- Material: Stated as "very similar to the predicate device."
- Performance Testing: Bench testing results were used to demonstrate substantial equivalence.
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JAN 1 4 2010
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510(k) Handpiece RA-5 "ANESTO"
Section 5
Page 1 of 1
1083811
510(k) SUMMARY
| Applicant and Owner | W&H Dentalwerk Buermoos GmbHIgnaz-Glaser-Strasse 53A - 5111 BuermoosAustriaTel.: 0043 -6274 / 6236 -297Fax: 0043 -6274 / 6236 -234 |
|---|---|
| Contact Person | Johann Georg SCHARL |
| Date of Preparation | December 19th, 2008 |
| Device Name | Handpiece RA-5 "ANESTO" |
| Classification Name | Spring Powered Jet Injector |
| Regulation Number | 21 CFR872.4475 |
| Product Code | EGM |
| Predicate Devices | "IntraFlow HTP", Pro-Dex Micro Motors Inc., 510(k) exempt"Cyberjet", Intra Vantage Inc., K964802 |
| Device Description | RA-5 "ANESTO" is a handpiece, which, on the one hand, isprovided with a coupling system according to ISO 3964. Thiscoupling allows the handpiece's attachment onto a correspondingdental motor, for transmitting the motor's rotational movement tothe attached intraosseous injection needle, intended to perforatecortical bone.On the other hand, it was designed for being equipped with ananesthetic cartridge acc. ISO 11499, volume 1.7 or 1.8ml. Afterhaving perforated the bone, this cartridge's anesthesia can beadministered locally in the spongiosa by means of a manually-operated dosage lever."ANESTO's" application is intended in dentistry. |
| Intended Use: | Drilling system to perforate cortical bone in order to administerlocal anesthesia in spongiosa; application in dentistry. |
| TechnologicalCharacteristics | The Handpiece RA-5 "ANESTO", represents a revised andimproved version of the predicate device. The main technicalcharacteristics have been retained unchanged.New: "ANESTO" is designed to be attached on and driven by adental micro motor (air or electric motor), instead by the integratedair-supplied driving system of the predicate device. Furthermore,the handpiece's shape and ease of operation have beenimproved for more user-friendliness. |
| Comparison of thedevice to the predicatedevice | The intended use, technological characteristics, performanceparameter and material are very similar to the predicate device.The new device is substantially equivalent to the predicatedevices. |
| Performance Testing | Bench testing results demonstrate substantially equivalence |
| Clinical Testing | Clinical data were not needed for this new product. |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 1 4 2010
Mr. Johann G. Scharl Regulatory Affairs Manager W & H Dentalwerk Buermoos GmbH 53 Ignaz-Glaser-Strasse Buermoos Austria 5111
Re: K083811
Trade/Device Name: Handpiece RA-5 "ANESTO" Regulation Number: 21CFR 872.4475 Regulation Name: Spring-Powdered Jet Injector Regulatory Class: II Product Code: EGM Dated: January 7, 2010 Received: January 11, 2010
Dear Mr. Scharl:
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. Scharl
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 yours.
Wh for
Anthony D. Watson, BS, MS, MBA 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
510(k) number: K083811
Device Name: Handpiece RA-5 "ANESTO"
Indication for Use:
Drilling system to perforate cortical bone in order to administer local anesthesia in spongiosa. Application in dentistry.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over The Counter Use (Part 21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
$
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: KD83811
January 13th 2010
Rev. 01
§ 872.4475 Spring-powered jet injector.
(a)
Identification. A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.(b)
Classification. Class II.