Osstell Beacon

K181888 · Osstell AB · EKX · Aug 22, 2019 · Dental

Device Facts

• Record ID: K181888
• Device Name: Osstell Beacon
• Applicant: Osstell AB
• Product Code: EKX · Dental
• Decision Date: Aug 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

Osstell Beacon is intended for use as a Dental Implant Stability Analyzer

Device Story

Osstell Beacon is a portable, handheld dental implant stability analyzer. It utilizes Resonance Frequency Analysis (RFA) to measure implant stability. A Smartpeg (aluminum rod) is screwed onto the implant; the device emits a magnetic pulse from its integrated measurement tip to excite the Smartpeg. The device detects the resulting resonance frequency via a second coil in the tip. A microcontroller calculates the Implant Stability Quotient (ISQ) value (0-100) from the frequency response. The ISQ value is displayed on the device's OLED screens. Used by professional clinicians in dental practices or operating rooms. The device is battery-operated and non-sterile, requiring a transparent barrier sleeve for use. The output assists clinicians in assessing implant stability over time; higher ISQ values generally indicate increased stability, while lower values may suggest stability loss or potential failure.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Portable, handheld instrument; battery-powered (Lithium-ion). Materials: ABS and PC plastic (food grade compliant). Sensing: Resonance Frequency Analysis (RFA) using magnetic excitation and detection coils. Connectivity: Bluetooth 4.0 LE (for production purposes only). Dimensions: 210 x 35 x 25 mm. Weight: 0.07 kg. Sterilization: Not autoclavable; requires transparent barrier sleeve. Software: Embedded firmware for signal processing and ISQ calculation.

Indications for Use

Indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

Regulatory Classification

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.

Predicate Devices

• Osstell ISQ (K082523)

Reference Devices

• Tellos ISQ Buddy (K143445)
• Implantmed SI-1015 (K161957)

Submission Summary (Full Text)

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August 22, 2019

Osstell AB % Cherita James Regulatory Consultant M Squared Associates, Inc 575 8th Ave Suite 1212 New York, NY 10018

Re: K181888

Trade/Device Name: Osstell Beacon Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: July 23, 2019 Received: July 24, 2019

Dear Cherita 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K181888

Device Name Osstell Beacon

Indications for Use (Describe)

Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the Osstell Beacon 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

| <b>Sponsor:</b> | <b>Osstell AB</b><br>Stampgatan 14<br>411 01 Goteborg<br>Sweden |
|-----------------|-----------------------------------------------------------------|
|-----------------|-----------------------------------------------------------------|

Contact: Cherita James M Squared Associates, Inc. 575 8th Ave, Suite 1212 New York, New York 10018 Ph. 347-954-0624 Fax. [phone] [e-mail]

| Revision Date: | August 19, 2019 |
|------------------------------------------------------------------------|-------------------------------------------|
| Proprietary Name: | Osstell Beacon |
| Common Name: | Dental implant stability analyzer |
| Regulatory Class: | Class 1 |
| Regulation: | 872.4200 |
| Product Codes: | EKX - handpiece, direct drive, ac-powered |
| Predicate Device: | Osstell ISQ (K082523)-Primary |
| Tellos ISO Buddy (K143445) and Implantmed SI-1015 (K161957)- Reference | |

#### Device Description:

The Osstell Beacon 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 Beacon 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 implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement tip 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 implant and is

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#### K181888

derived from the resonance frequency value obtained from the Smartpeg.

#### Intended Use:

Osstell Beacon is intended for use as a Dental Implant Stability Analyzer

#### Indications for Use:

Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

#### Summary of the Technological Characteristics:

The modifications to the Osstell ISQ since its previous clearance in K082523 include the following changes:

- . Enclosure design is smaller to be fully handheld. The measurement probe with tip is integrated into the enclosure and referred to as the measurement tip
- . Not possible to sterilize (autoclave). The device must be used with a transparent barrier sleeve. Commercially available transparent, barrier sleeves are recommended in the Instructions for Use.
- Different plastic material used in the enclosure (all being food grade compliant, 21 CFR §181.32 and 21 CFR §177.1580)
- . Updated user interface to make the measurement procedure even more easy and intuitive
- The device cannot measure while charging
- Bluetooth data communication .

These differences do not affect the substantial equivalence or performance of the device and do not change the intended use of the Osstell Beacon.

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#### K181888

#### Summary of the Nonclinical Testing:

Based on the Risk Analysis, the verification and validation testing confirms the Beacon performs as intended. The Osstell Beacon was subjected to the same preclinical requirements and testing as the primary predicate device.

Though the recommendation require use of a transparent barrier sleeve, due to material changes, the device was evaluated in accordance with ISO 10993-1.

Additionally, cleaning and disinfection recommendations were validated in the event the Osstell Beacon should become contaminated due to a damaged barrier sleeve.

Performance testing was conducted to confirm compliance to the design specifications.

Osstell has provided information to support compliance of Beacon with applicable portions of the following standards and FDA Guidance documents:

- FDA Dental Handpieces Premarket Notification [510(k)] Submissions, 2007 ●
- . FDA Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005
- . ISO 10993-1
- . ISO 10993-5
- . AAMI TIR12:2010
- AAMI TIR30:2011
- . ASTM E1837-96 (2014)
- ISO 17665-1
- ISO 17664
- IEC 60601-1, Ed 3 2005 ●
- . IEC 60601-1-2:2015
- . IEC 62133

#### Substantial Equivalence Discussion:

The changes to the enclosure, no longer capable to withstand sterilization and instead use of barrier sleeves, electronics, user interface and communication do not change the intended use, nor do they affect the substantial equivalence as compared to the Osstell ISQ previously cleared in

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# K082523.

| | Osstell<br>Beacon | Predicate<br>Device: Osstell<br>ISQ | Reference<br>Device:<br>Tellos ISQ<br>Buddy | Reference Device:<br>Implantmed SI-<br>1015 incl.<br>Accessories | Substantial<br>Equivalence |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | To be assigned | K082523 | K143445 | K161957 | |
| Device name | Osstell Beacon | Osstell® ISQ | Tellos ISQ<br>Buddy<br>(marketed as<br>Penquin RFD) | Implantmed SI-1015<br>incl. Accessories | - |
| Company name | Osstell AB | Osstell AB | Tellos Medical<br>AB | W & H<br>DENTALWERK<br>BÜRMOOS GMBH | |
| Classification | Class I | Same | Same | Same | - |
| Regulation<br>Number | 872.4200 | Same | Same | Same | - |
| Classification<br>name | Handpiece,<br>Direct Drive,<br>AC-powered | Same | Same | Same | - |
| Intended Use | Dental implant<br>stability<br>analyzer | Same | Same | Mechanical drive for<br>dental instruments<br>with ISQ module<br>used to measure<br>implant stability. | Same |
| Indication for<br>use | Indicated for use<br>in measuring the<br>stability of<br>implants in the<br>oral cavity and<br>maxillofacial<br>region. | Indicated for use<br>in measuring the<br>stability of<br>implants in the<br>oral cavity and<br>craniofacial<br>region. | Indicated for use<br>in measuring the<br>stability of<br>dental implants<br>in the oral<br>cavity and the<br>maxillofacial<br>region. | Mechanical drive unit<br>with coolant supply<br>for transmission<br>instruments<br>with ISO 3964<br>(DIN13940)<br>compatible coupling<br>system, for use in<br>dental surgery,<br>implantology and<br>maxillofacial surgery<br>(CMF) for treatment<br>of dental hard tissue.<br>Includes ISQ module<br>used to measure<br>implant stability. | Subject, primary<br>predicate, and<br>K143445<br>reference device<br>are identical.<br>K161957<br>reference device<br>used for<br>Bluetooth<br>technology has a<br>different<br>indication,<br>however the<br>comparison is<br>only for<br>Bluetooth<br>technology and<br>does not have<br>specific<br>indications for<br>this technology |
| Description | Portable,<br>handheld<br>battery driven<br>instrument<br>indicated for use<br>in measuring the<br>stability of<br>implants in the<br>oral cavity and<br>maxillofacial<br>region. | Portable,<br>handheld, or<br>freestanding<br>instrument<br>indicated for use<br>in measuring the<br>stability of<br>implants in the<br>oral cavity and<br>craniofacial<br>region. | Hand-held.<br>battery-driven<br>device for<br>measuring the<br>relative stability<br>of a dental<br>implant. | - the control unit.<br>- a motor with cable<br>with or without light<br>(EM-19 LC/EM-19),<br>- a wireless or wired<br>foot control (S-NW<br>or S-N2).<br>- the Osstell Module<br>(SI-SQ)<br>- and as an attachment<br>the surgical<br>handpieces | All are portable<br>handheld<br>devices, the<br>change in<br>configuration<br>compared to ISQ<br>which<br>incorporates the<br>device controls<br>and displays into<br>a single handheld<br>does not impact<br>the substantial |
| | Osstell<br>Beacon | Predicate<br>Device: Osstell<br>ISQ | Reference<br>Device:<br>Tellos ISQ<br>Buddy | Reference Device:<br>Implantmed SI-<br>1015 incl.<br>Accessories | Substantial<br>Equivalence |
| | | | | - (WS-56 L, WS-75<br>L, WS-91 L, WS-92<br>L and S-11 L).<br>The user can select<br>five different<br>programs. Switching<br>between<br>these programs is<br>performed by foot<br>control or via touch<br>display. | the device.<br><br>ISQ Buddy is<br>also portable,<br>handheld and<br>Implantmed uses<br>a wireless foot<br>pedal via<br>Bluetooth<br>technology.<br><br>Verification of<br>the Beacon<br>confirms it<br>performs as<br>intended. |
| Operation of<br>System | Measures the<br>frequency<br>response from<br>Smartpeg that is<br>directly attached<br>to the implant or<br>abutment. The<br>system includes<br>the following<br>components:<br>Instrument,<br>Osstell<br>Smartpeg,<br>Osstell<br>SmartPeg<br>Mount, Osstell<br>USB cable,<br>Osstell TestPeg<br><br>The technique<br>involves a<br>SmartPeg (10<br>mm x 3 mm)<br>that is attached<br>to the implant or<br>abutment. The<br>SmartPeg is<br>excited over a<br>range of<br>frequencies (1<br>kHz to 10 kHz)<br>and the<br>resonance<br>frequency is<br>measured with<br>the Osstell<br>Beacon<br>instrument and<br>software. The<br>resonance<br>frequency is | Measures the<br>frequency<br>response from<br>Smartpeg that is<br>directly attached<br>to the implant or<br>abutment. The<br>system includes<br>the following<br>components:<br>Instrument,<br>Osstell SmartPeg,<br>Osstell<br>Measurement<br>Probe, Osstell<br>SmartPeg Mount,<br>Osstell USB<br>Cable, Osstell<br>TestPeg<br><br>Same technique is<br>used in operating<br>the system as the<br>Osstell Beacon<br>device. | A<br>microcontroller<br>sends electric<br>pulses to a coil<br>in the<br>instrument tip.<br>As a<br>consequence,<br>magnetic pulses<br>are emitted that<br>affect the pin<br>connected to the<br>implant. The pin<br>then starts to<br>vibrate with its<br>resonance<br>frequency.<br>Vibration<br>creates an<br>alternating<br>magnetic field<br>which is being<br>picked up by<br>another coil in<br>the instrument<br>tip. The<br>electrical signal<br>from the<br>receiving coil is<br>analyzed and<br>the frequency is<br>determined. The<br>Frequency is<br>presented on the<br>display as an<br>"ISQ- value"<br><br>Resonance<br>frequency of the<br>ISQ peg as an<br>ISQ number, 1- | Referenced specific<br>to wireless foot pedal;<br>however, devices<br>include a ISQ module<br>used to measure<br>implant stability. | There is no<br>difference in the<br>system operation<br>between the<br>subject device<br>and K082523 or<br>K143445. |
| | Osstell<br>Beacon | Predicate Device: Osstell<br>ISQ | Reference<br>Device:<br>Tellos ISQ<br>Buddy | Reference Device:<br>Implantmed SI-<br>1015 incl.<br>Accessories | Substantial<br>Equivalence |
| | the stiffness of<br>the implant<br>system. The<br>Osstell Beacon<br>presents the<br>resonance<br>frequency as an<br>Implant<br>Stability<br>Quotient (ISQ)<br>value (scaled 0-<br>100). The ISQ<br>value is<br>proportional to<br>the stability of<br>the implant.<br>(In general, an<br>increase in ISQ<br>value from one<br>measurement<br>time to the next<br>indicates a<br>progression<br>towards higher<br>stability and a<br>lower ISQ value<br>may indicate a<br>loss in stability<br>and perhaps,<br>implant failure.)<br>Bluetooth<br>functionality for<br>device<br>production | number is<br>calculated from<br>the resonance<br>frequency. | | | |
| | purposes only | | | | |
| System<br>Components | Instrument<br>A portable,<br>handheld<br>instrument with<br>2 built-in<br>graphical<br>displays. The<br>unit operates<br>from a<br>rechargeable<br>power source<br>offering more<br>than 400 ISQ<br>measurements<br>between<br>charges.<br>The size of the<br>displays is 14 x<br>11 mm. | Instrument<br>A portable,<br>handheld, or<br>freestanding<br>instrument with<br>built-in graphical<br>display. The unit<br>operates from a<br>rechargeable<br>power source<br>offering over 6<br>hours of<br>continuous use<br>between charges.<br>The size of the<br>LCD display is 69<br>x 37 mm<br>The instrument<br>can be connected<br>to a PC via the<br>USB cable and the | Tellos ISQ<br>Buddy<br>instrument, ISQ<br>Peg, ISQ Peg<br>Driver and<br>instrument<br>charger.<br>Tellos ISQ<br>Buddy has two<br>LED-displays;<br>one on each side<br>of the<br>instrument for<br>easy reading.<br>Tellos ISQ<br>Buddy uses the<br>Osstell<br>SmartPegs, or<br>corresponding<br>Tellos pins, | - the control unit,<br>- a motor with cable<br>with or without light<br>(EM-19 LC/EM-19),<br>- a wireless or wired<br>foot control (S-NW<br>or S-N2),<br>- the Osstell Module<br>(SI-SQ)<br>- and as an<br>attachment the<br>surgical handpieces<br>- (WS-56 L, WS-75<br>L, WS-91 L, WS-92<br>L and S-11 L). | The change in<br>configuration and<br>components from<br>the ISQ which<br>incorporates the<br>device controls<br>and displays into<br>a single handheld<br>for the Beacon<br>does not impact<br>the substantial<br>equivalence of<br>the device.<br>Tellos ISQ<br>Buddy also is<br>portable,<br>handheld device<br>with LED<br>displays, and<br>employs<br>"SmartPegs or |
| Osstell<br>Beacon | Predicate<br>Device: Osstell<br>ISQ | Reference<br>Device:<br>Tellos ISQ<br>Buddy | Reference Device:<br>Implantmed SI-<br>1015 incl.<br>Accessories | Substantial<br>Equivalence | |
| The<br>measurement tip | can be transferred<br>to the optional | "ISQ Pegs"<br>from titanium. | | ISQ Pegs. The<br>Implantmed SI | |
| is held close to<br>the Smartpeg.<br>The | ISQ Data Manager<br>Software. | | | device, is<br>referenced<br>specific to | |
| measurement<br>electronics<br>sends the<br>excitation signal | Measurement<br>Probe with tip<br>The Measurement<br>Probe is connected | | | wireless foot<br>pedal, which also<br>utilizes Bluetooth<br>software | |
| to the coils in<br>the tip, and also | to the instrument<br>via the probe | | | functionality.. | |
| detects the<br>response signal<br>from the<br>detection coil in | cable and is held<br>close to the<br>Smartpeg. The<br>measurement | | | Verification of<br>the Beacon<br>confirms it | |
| the tip. The<br>microcontroller<br>in the | electronics sends<br>the excitation<br>signal to the coil | | | performs as<br>intended. | |
| instrument<br>calculates the<br>frequency of the | in the probe with<br>tip, and also<br>detects the | | | | |
| response signal,<br>and presents it<br>on the display | response signal<br>from the detection<br>coil in the probe | | | | |
| as a number, the<br>Implant<br>Stability | with tip. The<br>microcontroller in<br>the instrument…