(178 days)
No
The description focuses on a non-invasive technique (Resonance Frequency Analysis) and the calculation of a value (ISQ) based on a physical measurement (resonance frequency). There is no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
No
The device measures implant stability and provides information for treatment evaluation, but it does not directly treat or alleviate a disease or condition. Its purpose is diagnostic information gathering, not therapy.
Yes
The device is described as measuring the stability of implants and displaying results as an Implant Stability Quotient (ISQ), which is a measure of the stability of the implant. This information is used to evaluate implant stability and can be part of an overall treatment evaluation program, indicating its role in providing diagnostic information.
No
The device description explicitly mentions a "portable, handheld/tabletop instrument" and a "measurement probe," indicating the presence of physical hardware components beyond just software.
Based on the provided information, the Osstell IDx is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Osstell IDx Function: The Osstell IDx measures the stability of implants in situ (within the body) using a non-invasive technique (Resonance Frequency Analysis). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to measure implant stability in the oral cavity and maxillofacial region, which is a direct measurement on the implant within the patient, not an analysis of a biological sample.
Therefore, the Osstell IDx falls under the category of a medical device used for direct measurement within the body, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Osstell IDx is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Product codes
EKX
Device Description
The Osstell IDx is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell IDx is a portable, handheld/tabletop 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 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. The Osstell IDx can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.
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
Professional clinicians / Dental practice or operating room.
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
Nonclinical evaluation compared Osstell IDx to the predicate device Osstell ISQ. Two different evaluations were performed.
Test Method: 30229-07 SmartPeg development verification tests Osstell Instrument nr 024 IDx instrument. SW version p2f. Hardware version Circuit board: C
- ISQ correlation evaluation: The average difference was -1 ISQ and 3,17 ISQ. Accepted criteria was average difference up to +/-5 ISQ.
- Torque correlation evaluation: The highest variance due to tightening torque were measured to 1,33 ISQ. Most of the measured variances were 0 or below 1 ISQ. Accepted criteria was average variance due to tightening torque stays within 3 ISQ between 4 and 6 Ncm.
- Nonclinical Biocompatibility evaluation of the new probe material: Mediprene 500M has passed cytotoxicity test according to ISO 10993-5 and biocompatibility tests according to USP Class VI. The biocompatibility evaluation was approved for the IDx Probe. Accepted criteria was Biocompatibility evaluation according to ISO 10993.
Clinical data was not required.
Key Metrics
- ISQ correlation evaluation: The average difference was -1 ISQ and 3,17 ISQ.
- Torque correlation evaluation: The highest variance due to tightening torque were measured to 1,33 ISQ.
Predicate Device(s)
Osstell ISQ (K082523)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 19, 2015
Osstell AB Ms. Karin Breding QA & RA Manager Stampgatan 14 411 01 Goteborg SWEDEN
Re: K142358 Trade/Device Name: Osstell IDx Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I Product Code: EKX Dated: January 29, 2015 Received: February 2, 2015
Dear Ms. Breding:
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.
1
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 devicerelated 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin Keith, M.S. 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): K142358
Device Name: Osstell IDx
Indications For Use: The Osstell IDx is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
AND/OR
Over-The-Counter Use Use
(Part 21 CFR 801 Subpart D) Subpart C)
Prescription Use __ X
(21 CFR 807
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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Section 6: 510(k) Summary
Applicant/ Manufacturer: Karin Breding Osstell AB Stampgatan 14 411 01 Göteborg Sweden Ph: +46 31 340 82 54 Fax: +46 31 413 115 Email: karin.breding@osstell.com
Establishment Registration Number: 3004070020
| Date submitted: | 2014-08-22 |
|---|---|
| Proprietary Name: | Osstell IDx |
| Common Name: | Dental implant stability analyzer |
| Classification Status: | Class I |
| Product Codes: | EKX - handpiece, direct drive, ac-powered |
| Predicate Device: | Osstell ISQ (K082523) |
| Regulation Number: | 21 CFR 872.4200 |
| Regulation Name: | Dental handpiece and accessories |
Device Description:
The Osstell IDx is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell IDx is a portable, handheld/tabletop 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 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. The Osstell IDx can add important information to the evaluation of implant stability and can be used as part of an overall treatment evaluation program. The final implant treatment decisions are the responsibility of the surgeon.
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Indication for Use:
The Osstell IDx 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 touch screen
- New material is added .
- . Updated user interface
- Cloud connection .
These differences do not affect the safety or performance of the device and do not change the intended use of the Osstell IDx. These changes were implemented to improve the customer need, which is done with an improved user interface. The new material in the probe improves the grip ability. The cloud connection automatically enables the user to install the latest firmware updates.
Summary of Nonclinical Testing:
Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each were found to pass. The Osstell IDx was subjected to the same preclinical requirements and testing as the predicate device. Performance testing was conducted to confirm compliance to the design specifications; all functions were verified to operate as designed.
A Nouclinical evaluation has been performed where the Osstell IDx has been compared to the predicate device Osstell ISQ. Two different evaluations have been performed.
Test Method: 30229-07 SmartPeg development verification tests Osstell Instrument nr 024 IDx instrument. SW version p2f. Hardware version Circuit board: C
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| Non-clinical evaluation method | Acceptance Criteria | Results |
|---|---|---|
| ISQ correlation evaluation | The average difference | |
| could be up to +/-5 ISQ. | Approved. | |
| The average | ||
| difference was -1 | ||
| ISQ and 3,17 ISQ | ||
| Torque correlation evaluation. | The average variance due | |
| to tightening torque is | ||
| checked so that it stays | ||
| within 3 ISQ between 4 | ||
| and 6 Ncm. | Approved. | |
| The highest | ||
| variance due to | ||
| tightening torque | ||
| were measured to | ||
| 1,33 ISQ. | ||
| Most of the | ||
| measured | ||
| variances were 0 | ||
| or below 1 ISQ: | ||
| Nonclinical Biocopmatibility evaluation | ||
| of the new probe material. | Approved | |
| Biocopmatibility | ||
| evaluation according to | ||
| ISO 10993. | Mediprene 500M | |
| has passed | ||
| cytotoxicity test | ||
| according to ISO | ||
| 10993-5 and | ||
| biocompatibility | ||
| tests according to | ||
| USP Class VI. | ||
| Due to very low | ||
| degree of skin | ||
| contact and that | ||
| the ingoing | ||
| materials are well | ||
| known. The | ||
| individual | ||
| materials have | ||
| passed the | ||
| biocompatibility | ||
| evaluation and the | ||
| combination into | ||
| a steam | ||
| autoclavable | ||
| product is judged | ||
| not to change the | ||
| risk spectrum | ||
| Based on the low | ||
| degree and | ||
| duration of skin | ||
| contact, the | ||
| biocompatibility | ||
| tests performed is | ||
| the | ||
| biocompatibility | ||
| evaluation | ||
| approved for the | ||
| IDx Probe. |
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Clinical Studies:
Clinical data was not required to support the changes to the Osstell IDx.
Substantial Equivalence Discussion:
The changes to the display, user interface, electronics and material of the Osstell IDx do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell ISQ previously cleared in K082523.
| Osstell IDx | Predicate Device: Osstell ISQ K082523 | |
|---|---|---|
| Device name | Osstell IDx | Osstell® ISQ |
| Company name | Osstell AB | Osstell AB (formerly Integration |
| Diagnostics) | ||
| Product | ||
| Code/Class | EKX/Class I | Same |
| Regulation | ||
| Number | 872.4200 | Same |
| Classification | ||
| name | Handpiece, Direct Drive, AC-Powered | Same |
| Intended Use | Dental implant stability analyzer | Same |
| Indication for use | The Osstell IDx is indicated for use in | |
| measuring the stability of implants in the | ||
| oral cavity and maxillofacial region. | The Osstell IDx is indicated for use in | |
| measuring the stability of implants in the | ||
| oral cavity and craniofacial region. | ||
| Description | Portable, handheld/tabletop, or | |
| freestanding instrument indicated for use | ||
| in measuring the stability of implants in | Portable, handheld, or freestanding | |
| instrument indicated for use in measuring | ||
| the stability of implants in the oral cavity | ||
| Osstell IDx | Predicate Device: Osstell ISQ K082523 | |
| the oral cavity and maxillofacial region. | and craniofacial region. | |
| Operation of | ||
| System | The Osstell IDx 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, | The Osstell 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 Osstell | ||
| IDx instrument and software. The | ||
| resonance frequency is determined by | ||
| the stiffness of the implant system. The | ||
| Osstell IDx 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. | 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 | ||
| Osstell ISQ instrument and software. The | ||
| resonance frequency is determined by the | ||
| stiffness of the implant system. The Osstell | ||
| 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. | ||
| (In general, a rise in ISQ values from one | ||
| measurement time to the next indicates a | ||
| (In general, a rise in ISQ values from one | ||
| measurement time to the next indicates a | ||
| progression towards stability and a | ||
| lower ISQ value may indicate a loss in | ||
| stability and perhaps, implant failure.) | progression towards stability and a lower | |
| ISQ value may indicate a loss in stability | ||
| and perhaps, implant failure.) | ||
| System | ||
| Components- | Instrument | Instrument |
| The Instrument is a portable , | ||
| handheld/tabletop instrument with a | ||
| touch display. The unit operates from a | ||
| rechargeable power source offering 1 | ||
| hour of continuous use between charges. | ||
| The operator instructions enables | ||
| patients recording and monitoring | ||
| implant progress. | ||
| The size of the touch screen is 154 x 94 | ||
| mm. | ||
| Firmware can be updated either through | ||
| USB connector or cloud connection. | The Instrument is a compact unit with built- | |
| in graphical display. The unit operates from | ||
| a rechargeable power source offering over 6 | ||
| hours of continuous use between charges. | ||
| The size of the LCD display is 69 *37 mm | ||
| 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. | ||
| Measurement Probe | Measurement Probe | |
| The Measurement Probe is connected to | ||
| the instrument via the probe cable and is | ||
| held close to the Smartpeg. The | ||
| measurement probe sends the excitation | ||
| signal to the coils in the probe, and also | ||
| detects the response signal from the | ||
| detection coil in the probe. The | ||
| microcontroller in the instrument | ||
| calculates the frequency of the response | The Measurement Probe is connected to the | |
| instrument via the probe cable and 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. | ||
| Osstell 1Dx | Predicate Device: Osstell ISQ K082523 | |
| signal, and presents it on the display as a | number, the Implant Stability Index (ISQ). | |
| number, the Implant Stability Index | ||
| (ISQ). | The measurement probe has fixed cable. | |
| The measurement probe has fixed cable. | ||
| Smartpeg | Smartpeg | |
| The stability of the implant is reflected | Same | |
| 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. | ||
| PC Data Manager Software | ||
| The system has no PC Data Manager | PC Data Manager Software | |
| 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 of the device. | ||
| Patients may be tracked and implant | ||
| progress monitored after transfer of data | ||
| from the instrument to a PC. The data is | ||
| transferred from the instrument to a PC. The | ||
| data is transferred directly from the Osstell | ||
| ISQ instrument to a PC via the USB cable. | ||
| Power, Weight | Rated Power: 12VA | Rated Power: 5VA Instrument |
| and Size | Instrument Size: 210 mm X 165 mm X | Size: 190 x 120 x 45 mm |
| 55 mm | Instrument Weight: 0.4 kg | |
| Instrument Weight: 0.750kg | Accuracy: ±2 ISQ units | |
| Accuracy: ±2ISQ units | ||
| Instrument | ||
| materials | ABS Plastic | Same |
| Probe materials | Probe: Thermoplastic elastomer, | Probe: PPSU , stainless steel |
| medical grade USP class VI | Cable: silicone | |
| Osstell IDx | Predicate Device: Osstell ISQ K082523 | |
| Cable: Silicone | ||
| Cable connector: Natural | ||
| polyestersulfone | Cable connector: Natural polyestersulfone | |
| Device Display | Touch display - 155 x 94 mm | LCD - 64x 32-mm |
| Software Testing | ||
| and Validation | Software verification and validation | |
| performed. | Same | |
| Mechanical/ | ||
| Electrical safety | ||
| /Standards | The Osstell IDx was designed and | |
| constructed with applicable standards | Same | |
| Sterile | ||
| components/ | ||
| methods | Probe with cable /autoclave | |
| SmartPeg /single patient use | Same | |
| Contraindication | None | None |
| Location of Use | Dental practice or operating room. | Same |
| User | Professional clinicians | Same |
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Conclusion:
Based on the results of the tests performed in the nonclinical testing and biocompatibility performed, the product is approved for its intended use in terms of Non clinical evaluation.
The modified Osstell IDx has the following similarities to the Osstell ISQ previously cleared in K082523:
- has the same indications for use, .
- uses the same operating principle, .
- . has no change in single use components
Therefore the modification to the Osstell IDx can be found substantially equivalent to the Osstell ISQ cleared in K082523.