(122 days)
Not Found
No
The description mentions a microprocessor and programmable memory for controlling velocity and torque, but there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies focus on electrical and safety standards, not algorithmic performance.
Yes
The device is intended to prepare intraoral bone for implantology procedures, which is a therapeutic intervention, and its design includes components for controlled velocity and torque during these procedures.
No
Explanation: The device is described as preparing intraoral bone for implantology procedures, controlling velocity and torque, indicating it is an operative or surgical tool, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a microprocessor controlled unit, foot pedal, electric micromotor, support rods, sterile disposable irrigation tubes, and a peristaltic pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to prepare Intraoral bone for implantology procedures." This describes a surgical or procedural device used directly on the patient's body.
- Device Description: The description details a system with a micromotor, foot pedal, and irrigation, all components of a surgical or dental drill system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are used in vitro (outside the body) to examine specimens.
The device is clearly intended for a surgical procedure on the patient's bone, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Hi-Tech Implant/HT Physio Implant are intended to prepare Intraoral bone for implantology procedures.
Product codes
EKX
Device Description
The HI TECH IMPLANT and HT PHYSIO IMPLANT consist of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes.
The unit also houses the peristaltic pump.
The HI TECH IMPLANT and HT PHYSIO IMPLANT provide electronic control of velocity and torque.
The HI TECH IMPLANT and HT PHYSIO IMPLANT can be programmed and retain programs into memory.
The HI TECH IMPLANT and HT PHYSIO IMPLANT are fully operational from foot pedal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
HI TECH IMPLANT and HT PHYSIO IMPLANT were tested in accordance with the technical requirements of IEC 60601-1 and IEC 60601-1-2. All evaluation of the HI TECH IMPLANT and HT PHYSIO IMPLANT were performed by Notified Laboratory, and all the results comply to standard listed below.
The conclusions drawn from the performance test are that HI TECH IMPLANT and HT PHYSIO IMPLANT comply with:
- IEC 55011 EMC Conducted RF emissions
- Degrees of protection provided by enclosures (IP Code) IEC 60529
- Medical Electrical Equipment Part 2,"Genaral Safety Norms" IEC 60601-1
- IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC
- IEC 61000-4-2 EMC Electrostatic Discharge Immunity
- IEC 61000-4-3 Radiated RF immunity
- IEC 61000-4-4 Fast Transient Immunity
- IEC 61000-4-5 Pulse immunity
- IEC 61000-4-6 Conducted RF immunity
- IEC 61000-4-11 Supply Voltage Hole Immunity
- Transformer safety IEC 61558-1
- IEC 61558-2-6 Transformer safety-Particular prescriptions
- ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors
and are effective and safe to use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
091913
BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional
SECTION 14: SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMD 1990 and CFR 807.92. OCI 3 0 2009
SUBMITTER INFORMATION 14.1
BY DENTAL SRL a. Company Name Via Vecchia Prov.le Lucchese Company Address b. 47/F 51030 Serravalle Pistoiese Italy +39 0573 994 355 Company phone C. +39 0573 919 480 Company fax Contact Person Daniele Poli d. President Date Summary Prepared June 22, 2009 e.
DEVICE IDENTIFICATION 14.2
| a. | Trade/Proprietary Names: HI TECH IMPLANT /HT
PHYSIO IMPLANT |
| ---- | ---------------------------------------------------------------- |
|---|
- Dental Handpieces and b. Classification Name: Accessories 21 CFR 872.4200 Surgical Micromotor for Common Names: C.
IDENTIFICATION OF PREDICATE DEVICE 14.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| ATR | Implant System | K033597 | 25 Nov. 2003 |
implantology
DEVICE DESCRIPTION 14.4
The HI TECH IMPLANT and HT PHYSIO IMPLANT consist of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes.
The unit also houses the peristaltic pump.
The HI TECH IMPLANT and HT PHYSIO IMPLANT provide electronic control of velocity and torque.
1
BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional
The HI TECH IMPLANT and HT PHYSIO IMPLANT can be programmed and retain programs into memory.
The HI TECH IMPLANT and HT PHYSIO IMPLANT are fully operational from foot pedal.
SUBSTANTIAL EQUIVALENCE 14.5
The HI TECH IMPLANT and HT PHYSIO IMPLANT are substantially equivalent to the ATR Implant System Surgical Micromotor in commercial distribution by ATR. The fundamental technical characteristics of the HI TECH IMPLANT and HT PHYSIO IMPLANT are similar to those of the predicate device and are listed on the comparison chart provided in this 510(k) submission.
HI TECH IMPLANT and HT PHYSIO IMPLANT and the predicate device have adjustable speed, torque and reduction rates, and are programmable. The micromotor handpiece of HI TECH IMPLANT and HT PHYSIO IMPLANT and the one of the predicate device are autoclavable.
INTENDED USE 14.6
HI TECH IMPLANT and HT PHYSIO IMPLANT are intended for the preparation of intraoral bone for implantology procedures.
14.7 TECHNICAL CHARACTERISTICS
HI TECH IMPLANT and HT PHYSIO IMPLANT were designed and developed to provide a microprocessor controlled surgical system with similar performances compared to predicate device.
- HI TECH IMPLANT and HT PHYSIO IMPLANT .
- is equivalent in functions to the predicate device, .
- has adjustable speeds and torque values (related to the reduction rate of the handpiece ♥ selected) that are fully customisable by the end user,
- has automatic motor shutdown system which provides to switch off the motor . whenever set torque is reached,
- · has a sterilizable micromotor according the recommended protocols,
- can be operated by foot control. .
Any of these feature is found in the predicate device also.
14.8 PERFORMANCE DATA
HI TECH IMPLANT and HT PHYSIO IMPLANT were tested in accordance with the technical requirements of IEC 60601-1 and IEC 60601-1-2.
All evaluation of the HI TECH IMPLANT and HT PHYSIO IMPLANT were performed by Notified Laboratory, and all the results comply to standard listed below.
2
BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional
The conclusions drawn from the performance test are that HI TECH IMPLANT and HT PHYSIO IMPLANT comply with:
- IEC 55011 EMC Conducted RF emissions .
- Degrees of protection provided by enclosures (IP Code) IEC 60529 �
- Medical Electrical Equipment Part 2,"Genaral Safety Norms" IEC 60601-1 .
- IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC .
- IEC 61000-4-2 EMC Electrostatic Discharge Immunity .
- IEC 61000-4-3 Radiated RF immunity ●
- IEC 61000-4-4 Fast Transient Immunity .
- IEC 61000-4-5 Pulse immunity .
- IEC 61000-4-6 Conducted RF immunity .
- IEC 61000-4-11 Supply Voltage Hole Immunity ●
- Transformer safety IEC 61558-1 .
- IEC 61558-2-6 Transformer safety-Particular prescriptions .
- ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors .
and are effective and safe to use.
Declaration of conformity to a standard in Chapter 12.1 of this submission.
510(k) CHECKLIST 14.9
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
3
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 to the right. The eagle is composed of three curved lines that suggest the shape of a bird in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Dr. Daniele Poli President By Dental S.R.L. Via Vecchia Prov. le Lucchese 49/FG Serravalle Pistoiese, Pistoia ITALY 51030
OCT 3 0 2009
Re: K091913
Trade/Device Name: Hi-Tech Implant/HT Physio Implant Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories 8Regulatory Class: I Product Code: EKX Dated: September 21, 2009 Received: September 29, 2009
Dear Dr. Poli:
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.
4
Page 2 - Dr. Poli
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 yours,
h 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
5
BY DENTAL: Hi-Tech Implant/HT Physio Implant 510(k): Original Submission Traditional
INDICATIONS FOR USE
510(k) Number:
To be Assigned by FDA
Device Name:
Hi-Tech Implant/HT Physio Implant
Indications for Use:
Hi-Tech Implant/HT Physio Implant are intended to prepare Intraoral bone for implantology procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
$\times$
· (Per 21 CFR 801.109)
OR Over-The -Counter Use
Kevin Mulvey for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1 510(k) Number:
- I