(86 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical and sterilization properties of a dental handpiece motor, with no mention of AI or ML.
Yes
The device is used to perform clinical procedures in the oral cavity for treating carious teeth, performing prophylaxis, and endodontic preparations, which are all therapeutic interventions.
No
Explanation: The device description and intended use focus on preparing carious teeth for restorations, prophylaxis, and endodontic preparations, which are all treatment procedures, not diagnostic ones. There is no mention of the device being used to identify or assess a medical condition.
No
The device description explicitly states it is a "slow speed dental handpiece motor" and describes physical components and sterilization procedures, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on the patient within the oral cavity (preparing teeth, prophylaxis, endodontic preparations). IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- Device Description: The description details a mechanical handpiece motor used for dental procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
- Performance Studies: The performance study described is a sterilization test, which is relevant for a device used in a clinical setting but not indicative of an IVD's analytical performance.
Therefore, this device is a dental handpiece motor used for direct patient treatment, not for in vitro diagnostic testing.
N/A
# Intended Use / Indications for Use
Use in combination with attachments, i.e., a nosecone or contra angle to prepare carious teeth for restorations; to perform prophylaxis; endodontic preparations or other procedures used by a dentist in the oral cavity.
# Product codes (comma separated list FDA assigned to the subject device)
EFB
# Device Description
20R "E" type slow speed dental handpiece motor; fully autoclavable (up to 135°C); utilizes an E type coupling to accept standard E type attachments. ISO couplings B, C and D are available.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
oral cavity
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
dentist
# 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)
Sterilization Test and Anaylsis: Autoclave procedures for the 20R "E" type slow speed motor were conducted in a Pelton & Crane Validator 8 at Athena Technology, Inc., 984 N. Amelia Ave., San Dimas, CA 91773, (800) 253-1771. Biological indicator used was Sportrol Spore Strip @106, bacillus stearothermophilus. Manufacturers lot #S51703 with an expiration date of May 1999. The biological testing facility was Namsa, 9 Morgan, Irvine, CA 92718, (714) 951-3110.
One Athena 20R "E" type motor was disassembled and a spore strip inserted into the rotor area of the motor. The motor was reassembled, inserted into an Athena standard autoclaye bag and placed into the autoclave according to the recommendations received with the spore strips.
The 20R "E" type motor was placed on a tray with a pair of tweezers to be used for the removal of the spore strips . In addition, a stainless steel plate was inserted into the autoclave to provide a sterile surface for the device on the removal from the autoclave.
The sterilization cycle in the Pelton & Crane Validator 8 consisted of 12 minutes at 132 degrees Celsius and 210 kPa pressure.
The device was removed from the autoclave using sterile gloves and the spore strip removed with the sterile tweezers. The spore strip was sealed in bag and identified. It was then forwarded to Namsa for incubation.
The spore strip was cultured at Namsa for a period of 7 days using the procedure/test method S-04491-01-00/Immersion. The spore strip tested sterile by Namsa (report included).
In conclusion, Athena devices sterilized in a Pelton & Crane Validator 8 or similar autoclave at 132 degrees Celsius at 210 kPa for 12 minutes will be sterile.
| BIOINDICATOR: B.subtilis | | | B.I. Lot Number: Not Supplied | | | |
|---|---|---|---|---|---|---|
| Articles Tested | Number of Articles Tested | Type of Media | Incubation Temperature (Degrees C) | Number of Days Incubated | Number of Positive Articles | |
| Spore Strip | 6 | SCDB 15 ml | 30-35 | 7 | 0 | |
| Positive Control | 2 | SCDB 15 ml | 30-35 | 1 | 2 | |
TEST ARTICLE MEETS THE REQUIREMENTS OF THE STERILITY TEST
Conclusion: SCDB = Soybean Casein Digest Broth
# 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.
Not Found
# 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
§ 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
Section 8: 510(k) Summary
MAR 1 1 1998
Submitted By: Athena Technology, Inc. 984 N. Amelia Ave. San Dimas, CA 91773
(800) 253-1771 FAX (800) 722-4460
Contact: William T. Anderson
Date Prepared:
Device Name: Trade or Proprietary Name - Athena 20R E Type Motor Common or Usual Name - Slow Speed Dental Handpiece Motor Classification Name - Air Powered Dental Handpiece
Identification: The following devices are identified to be equivalent in indications for use, design, material and energy source to Athena's 20R "E" Type Slow Speed Dental Handpiece motor:
- A. Champion Lowspeed Handpiece Motors marketed by Champion Dental Products Inc., 1941 Miraloma, Placentia, California 92870; and
- B. Lynx Low Speed Handpiece Motors marketed by MTI Precision Products, 175 Oberlin North Avenue, Lakewood, New Jersey 08701; and
- C. KaVo Handpieces marketed by KaVo America Corporation, 2401 West Hassell Road, Hoffman Estates, Illinois 60195; and
- D. Medidenta Slow Speed Motors marketed by Medidenta International, Inc., 39-23 62nd Street. Woodside, New York 11377.
Description: 20R "E" type slow speed dental handpiece motor; fully autoclavable (up to 135°C); utilizes an E type coupling to accept standard E type attachments. ISO couplings B, C and D are available.
Device Function: With the air driven motor, air is delivered through a port system which will allow forward, reverse or no operation to a vaned rotor system. The rotor spins as a result of the air delivery and that rotation is converted to RPM and torque used to operate any attachment coupled to the motor.
1
Significant Physical and Performance Characteristics: The exploded drawing (attached) illustrates the typical placement and function of the various components and parts of the motor. Air enters through the hose connector into the drive air port. That air is routed through the air delivery passages to the proper port which controls the direction of rotation of the motor. That porting arrangement is controlled by a rotary ring which permits the user to control either direction or operation. The air, having been ported, enters the motor stator body and impinges on the blades attached to the rotor causing them to spin in the appropriate direction. After approximately a 2/3 to 3/4 revolution, the air is permitted to exhaust from the stator cavity and is expelled from the motor through the exhaust porting to the exhaust tube attached to the air delivery and exhaust hose.
Materials Used: The motor is principally made of the following materials: aluminum; stainless steel and instrument quality stainless steel. Alternatively titanium is used in place of aluminum and stainless steel in certain applications. VITON is used for "O" rings. Flourosilicone is used for the hose to motor gasket.
Material Physical Properties: Aluminum Type 2011 or 6016 is used. Physical properties associated with these materials is defined by ASTM specification. Commonly used in medical and dental instruments and devices. Stainless steel type 300 series and 416 used. Physical properties associated with these materials is defined by ASTM specification. Commonly used in medical and dental instruments and devices. VITON is a medical grade. FDA approved elastomer commonly used in various of medical and dental instruments and devices. Flourosilicone is a commonly used gasket material for medical and dental instruments and devices.
Statement of the Intended Use: Use in combination with attachments, i.e., a nosecone or contra angle to prepare carious teeth for restorations; to perform prophylaxis; endodontic preparations or other procedures used by a dentist in the oral cavity.
Technological Characteristics: The Athena 20R "E" Type Slow Speed Handpiece Motor is similar to predicate devices in indications for use, design (E couplings and ISO couplings); material (aluminum, stainless steel, VTTON and flourosilicone); energy source (air).
Sterilization Test and Anaylsis: Autoclave procedures for the 20R "E" type slow speed motor were conducted in a Pelton & Crane Validator 8 at Athena Technology, Inc., 984 N. Amelia Ave., San Dimas, CA 91773, (800) 253-1771. Biological indicator used was Sportrol Spore Strip @106, bacillus stearothermophilus. Manufacturers lot #S51703 with an expiration date of May 1999. The biological testing facility was Namsa, 9 Morgan, Irvine, CA 92718, (714) 951-3110.
One Athena 20R "E" type motor was disassembled and a spore strip inserted into the rotor area of the motor. The motor was reassembled, inserted into an Athena standard
2
autoclaye bag and placed into the autoclave according to the recommendations received with the spore strips.
The 20R "E" type motor was placed on a tray with a pair of tweezers to be used for the removal of the spore strips . In addition, a stainless steel plate was inserted into the autoclave to provide a sterile surface for the device on the removal from the autoclave.
The sterilization cycle in the Pelton & Crane Validator 8 consisted of 12 minutes at 132 degrees Celsius and 210 kPa pressure.
The device was removed from the autoclave using sterile gloves and the spore strip removed with the sterile tweezers. The spore strip was sealed in bag and identified. It was then forwarded to Namsa for incubation.
The spore strip was cultured at Namsa for a period of 7 days using the procedure/test method S-04491-01-00/Immersion. The spore strip tested sterile by Namsa (report included).
In conclusion, Athena devices sterilized in a Pelton & Crane Validator 8 or similar autoclave at 132 degrees Celsius at 210 kPa for 12 minutes will be sterile.
Life Cycle Estimates: The Athena 20R "E" Type Slow Speed Motor has an estimated minimum life of 500 cycles when autoclaved for 12 minutes at 132 degrees Celsius and 210 kPa pressure.
3
Image /page/3/Picture/0 description: The image shows the logo for NAMSA, a company that provides testing services for the medical device industry. The logo is black and white and features the company's name in a bold, sans-serif font. Below the name is the tagline "World Leader In Testing Services for the Medical Device Industry." The TM symbol is located to the right of the logo.
Corp. Hdqtrs: 2261 Tracy Road, Northwood, OH 43619-1397, 419.666.9455, Fax 419.666.2954 100 Cobb International Blvd., Kennesaw, GA 30152-7601, 770.427.3101, Fax 770.426.5692 9 Morgan, Irvine, CA 92618-2078, 714.951.3110, Fax 714.951.3280 Affiliations: Taiwan . Germany . France
Confidential MS017-101
ATHENA TECHNOLOGY INC 984 N. AMELIA AVE.
91773 SAN DIMAS, CA ATTN: WILLIAM T. ANDERSON
| Lab No. | 97C 22873 00 |
|---|---|
| P.O. No | 97112006 |
ID No. Not Applicable
STERILITY TEST
Testing Follows USP Methods or the Client's Procedures
| Test Article: | ATHENA 20R "E" Type Slow Speed Handpiece Motor, ATHENA Compact
Nosecone, ATHENA 1:1 Contra Angle, ATHENA 64:1 Contra Angle, ATHENA
Heavy Duty 1:1 Straight Nosecone, ATHENA Heavy Duty 4:1 Straight Nosecone |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Procedure/Test Method: | S-04491-01-00/Immersion |
| Test Article Received: | 11-21-97 |
| Test Start Date: | 11-21-97 |
| Test Termination Date: | 11-28-97 |
STERILITY TEST RESULTS Test Article Identity Maintained as Submitted by Client
| BIOINDICATOR: B.subtilis | B.I. Lot Number: Not Supplied | |||||
|---|---|---|---|---|---|---|
| Articles | ||||||
| Tested | Number of | |||||
| Articles | ||||||
| Tested | Type | |||||
| of Media | Incubation | |||||
| Temperature | ||||||
| (Degrees C) | Number of | |||||
| Days | ||||||
| Incubated | Number of | |||||
| Positive | ||||||
| Articles | ||||||
| Spore Strip | 6 | SCDB 15 ml | 30-35 | 7 | 0 | |
| Positive Control | 2 | SCDB 15 ml | 30-35 | 1 | 2 |
Results and conclusions apply only to the test article tested. No further evaluation of these results is made by NAMSA. Any extrapolation of these data to other samples is the responsibility of the sponsor.
TEST ARTICLE MEETS THE REQUIREMENTS OF THE STERILITY TEST Conclusion:
SCDB = Soybean Casein Digest Broth
Record Storage: All raw data pertaining to this study and a copy of the final report are to be retained in designated NAMSA archive files. Test Facility: North American Science Associates, Inc., California Division.
Date Completed 11/25/
Frank Zuklic, M. S.
Approved By
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the department's name around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three overlapping profiles, symbolizing health and human services.
Public Health Service
JUN 1 8 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William T. Anderson President Athena Technology, Incorporated 984 North Amelia Avenue San Dimas, California 91773
Re: K974671
Trade/Device Name: Athena 20R "S" Type Slow Speed Handpiece Motor Regulation Number: Air Powered Dental Handpiece Regulation Name: 872.4200 Regulatory Class: I Product Code: EFB Dated: December 12, 1997 Received: December 15, 1997
Dear Mr. Anderson:
This letter corrects our substantially equivalent letter of March 11, 1998 regarding the product code.
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 proor to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Anticinuncia, or to ac research Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include Controls provibions of the 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 If your device is clabitional controls. Existing major regulations affecting (1 Mrx), it may of subject to fact of Federal Regulations, Title 21, Parts 800 to 898. In your device can be roundsh further announcements concerning your device in the Federal Register.
5
Page 2 - Mr. Anderson
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisor that 1 Dr. 3 lectuation that your device complies with other requirements Incall that FDA nas mace a actess and regulations administered by other Federal agencies. of the Act of ally I edena bates and survey including, but not limited to: registration r ou must comply with a807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Pat 807), laceling (21 CFR Pat 820) regulation (21 CFR Patt 820); and if requirents as set form in the quality and control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section I his letter will anow you to ocgin mains ling jo a or substantial equivalence of your device to 310(K) premarket nourceared vice results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 IT you desire specific ac not 10. your in vitro diagnostic devices), please contact the and additionally 21 - 21 - 31 - 4618. Additionally, for questions on the promotion and Office of Colliphance wee, please contact the Office of Compliance at (301) 594-4639. ad veranding or your the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under llouncation (ZTCF It Fur 6079).
the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. W. McIntosh
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Section 3: Statement of Indications for Use
Intended Use: Use in combination with attachments, i.e., nosecone or contra angle to prepare carious teeth for restorations; to perform prophylaxis; endodontic preparation or other procedures used by a dentist in the oral cavity.
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 2074107 510(k) Number
Prescription Use (Per 21 CFR 801.109) 3-1