(251 days)
No
The description focuses on Resonance Frequency Analysis and signal processing to calculate the ISQ, with no mention of AI or ML techniques.
No
Explanation: The device is described as measuring the stability of implants, which is a diagnostic or assessment function, not a therapeutic intervention. It explicitly states it calculates the resonance frequency to determine implant stability, providing an "Implant Stability Quotient (ISQ)". There is no mention of treating or preventing a condition.
Yes
Explanation: The device measures the stability of implants, providing quantitative data (Implant Stability Quotient - ISQ) that objectively assesses a physiological characteristic (implant stability). This measurement helps in making clinical decisions regarding implant health and integration, which is a diagnostic function.
No
The device description clearly states it is a "portable, handheld instrument" and involves hardware components like a "measurement probe" and a "Smartpeg".
Based on the provided information, the MEGA ISQ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MEGA ISQ directly measures the stability of an implant within the patient's oral cavity and maxillofacial region. It does not analyze a sample taken from the body.
- The device description and intended use clearly indicate direct measurement on the implant in situ. The process involves attaching a Smartpeg to the implant and using a probe to excite it and measure the resonance frequency. This is a direct physical measurement, not an analysis of a biological sample.
Therefore, the MEGA ISQ falls under the category of a medical device used for direct measurement on a patient, not an IVD.
N/A
Intended Use / Indications for Use
The MEGA ISQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Product codes (comma separated list FDA assigned to the subject device)
EKX - handpiece, direct drive, ac-powered
Device Description
The MEGA ISQ is an new generation of the Osstell ISQ, (K082523) the system is designed to measure dental implant stability in the oral cavity and maxillofacial region. Similar to K082523, the MEGA ISQ is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the dental implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity and maxillofacial region
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)
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied included:
- . Conformance to EN IEC 60601-1-2
- . Comparative performance testing to predicate
- Material biocompatibility .
- . Updated steam sterilization parameters in accordance with ANSI/AAMI/ST79:2010/A2:2011
The proposed device passed all applicable test per IEC 60601-1-2, comparative testing of the new LED display, performance of the USB interface, and performance and biocompatibility of the new material demonstrated equivalent performance to the declared predicate.
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.
Osstell ISQ (K082523)
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
Applicant/
Section 6: 510(k) Summary
APR 0 9 2014
| Manufacturer: | Osstell AB |
|---|---|
| Stampgatan 14 | |
| 411 01 Göteborg | |
| Sweden | |
| Establishment Registration Number: 3004070020 | |
| US Contact: | Cherita James |
| M Squared Associates, Inc. | |
| 901 King Street, Suite101 | |
| Alexandria, VA 22314 | |
| Ph: 703-562-9800 Ext 257 | |
| Fax: 703-562-9797 | |
| E-mail: CJames@MSquaredAssociates.com | |
| Date prepared: | 2014-04-07 |
| Proprietary Name: | MEGA ISQ |
| Common Name: | Dental implant stability analyzer |
| Classification Status: | Class I |
| Product Codes: | EKX - handpiece, direct drive, ac-powered |
| Predicate Device: | Osstell ISQ (K082523) |
Karin Breding
Device Description:
The MEGA ISQ is an new generation of the Osstell ISQ, (K082523) the system is designed to measure dental implant stability in the oral cavity and maxillofacial region. Similar to K082523, the MEGA ISQ is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the dental implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement probe on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the stability of the implant and is derived from the resonance frequency value obtained from the Smartpeg.
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Indication for Use:
The MEGA ISO is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Summary of Technological Characteristics:
The modifications to the Osstell ISQ since its previous clearance in K082523 include the following changes:
- Replacing the existing display with a LED display .
- . Removing the RAM memory
- Removing the real time clock .
- Move the USB interface to a dock station .
- A new material is added to the instrument and docking station to improve grip ability .
These minor differences do not affect the safety or performance of the device and do not change the intended use of the MEGA ISQ. These changes were implemented to address the needs of the customer for a basic device which offers the same Resonance Frequency Analysis technology, but does not offer the capability of data storage. The relocation of the USB interface allows a reduce size, as well as allowing for a slightly larger display.
Summary of Nonclinical Testing:
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied included:
- . Conformance to EN IEC 60601-1-2
- . Comparative performance testing to predicate
- Material biocompatibility .
- . Updated steam sterilization parameters in accordance with
ANSI/AAMI/ST79:2010/A2:2011
The proposed device passed all applicable test per IEC 60601-1-2, comparative testing of the new LED display, performance of the USB interface, and performance and biocompatibility of the new material demonstrated equivalent performance to the declared predicate.
Clinical Studies:
Clinical data was not required to support the changes to the Osstell ISQ.
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Substantial Equivalence Discussion:
The modified MEGA ISQ has the following similarities to the Osstell ISQ previously cleared in K082523:
- has the same indicated use, .
- . uses the same operating principle,
- incorporates the same basic device design and physical properties, .
- has no change in autoclave or single use components, or device software .
The modified MEGA ISQ has the following differences to the Osstell ISQ previously cleared in K082523:
- . Replaces the existing display with a LED display
- . Removes the RAM memory
- . Removes the real time clock
- . Moves the USB interface to a dock station
- A new material is added to the instrument and docking station to improve grip ability .
| | MEGA ISQ | Predicate Device: Osstell ISQ
K082523 |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use | The MEGA ISQ is indicated for use in measuring
the stability of implants in the oral cavity and
maxillofacial region. | No change in Indication for Use |
| Operation of
System | The MEGA ISQ measures the frequency response
from Smartpeg that is directly attached to the
implant or abutment. The system includes the
following components: Instrument,
Smartpeg/Measurement Probe, and PC Data
Manager Software.
The technique involves a smartPeg (10 mm x 3
mm) that is attached to the implant or abutment.
The SmartPeg is excited over a range of
frequencies (1 kHz to 10 kHz) and the resonance
frequency is measured with the MEGA ISQ
instrument and software. The resonance
frequency is determined by the stiffness of the
implant system. The MEGA ISQ presents the
resonance frequency as an Implant Stability
Quotient (ISQ) value (scaled 0-100). The ISQ
value is proportional to the stability of the implant. | No change in operation of system |
| System
Components- | Instrument | Instrument |
| | The Instrument is a portable , handheld instrument | The Instrument is a compact unit |
| | | Predicate Device: Osstell I:
K082523 |
| | with a built-in LED display. The unit operates
from a rechargeable power source offering over
1.5 hours of continuous use between charges. The
Measurement Probe, connected to the instrument,
is held close to the Smartpeg. The measurement
probe sends the excitation signal to the coil in the
probe, and also detects the response signal from
the second coil in the probe. The microcontroller
in the instrument calculates the frequency of the
response signal, and presents it on the display as a
number, the Implant Stability Index (ISQ).
The instrument can be connected to a PC via the
USB cable and firmware can be updated.
Smartpeg/Measurement Probe | with built-in graphical display.
The unit operates from a
rechargeable power source
offering over 6 hours of
continuous use between charges.
The Measurement Probe,
connected to the instrument, is
held close to the Smartpeg. The
measurement probe sends the
excitation signal to the coil in the
probe, and also detects the
response signal from the second
coil in the probe. The
microcontroller in the instrument
calculates the frequency of the
response signal, and presents it on |
| | The stability of the implant is reflected by the
resonance frequency of a "Smartpeg" attached to
the implant. The Smartpeg is a small aluminum
rod, approximately 3 mm in diameter and 10 mm
long, with a magnet permanently attached to its
top. The Smartpeg is screwed onto the implant.
The Smartpeg magnet is excited by a small
magnetic pulse generated by a coil in the
measurement probe. The Smartpeg vibrates freely
at its resonance frequency for some milliseconds.
Since the magnet attached to its top is vibrating
together with the Smartpeg, the vibration (the
"ringing") can be picked up by a second coil in the
measurement probe. | the display as a number, the
Implant Stability Index (ISQ).
Four hundred measurements may
be stored in the instrument.
The instrument can be connected
to a PC via the USB cable and
the measurement data can be
transferred to the optional ISQ
Data Manager Software.
Smartpeg/Measurement Probe
No change to Smartpeg or
Measurement probe |
| | PC Data Manager Software
Data transfer is not an option for the MEGA ISQ. | PC Data Manager Software
The Osstell ISQ Data Manager is
a Windows 2000/NT/XP/Vista
based software enabling storage,
viewing and printing of patient
data.
The Software is an optional
accessory to the Osstell ISQ and
is not integral to the functioning |
| Instrument and
Docking Station
materials | ABS Plastic and Dryflex TPE | of the device.
ABS Plastic
LCD - 64mm x 32mm |
| Device Display | LED -58mm x 37mm | |
3
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4
Conclusion:
The change to display, RAM memory, Clock ,USB interface, and additional device material of the MEGA ISQ do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell ISQ previously cleared in K082523. Therefore the MEGA ISQ can be found substantially equivalent to the Osstell ISQ cleared in K082523.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2014
Osstell AB C/O Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 901 King Street, Suite 101 Alexandria, VA 22314
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K132401
Trade/Device Name: MEGA ISQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: March 14, 2014 Received: March 18, 2014
Dear Ms. James:
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 - Ms. James
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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Safetv/ReportalProblem/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
Sincerely vours.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Image /page/6/Picture/7 description: The image shows a logo or stamp with the text "Tejashri Purohit-Sheth, M.D." and "Clinical Deputy Director". Below that is the word "DAGRID". The image also contains some decorative elements, including a stylized design on the left and a triangular shape on the right. The word "FOR" is at the bottom right.
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 5: Indications for Use Statement
510(k) Number (if known): _K132401
MEGA ISQ Device Name:
Indications For Use: The MEGA ISQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR ·
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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