OSSTELL ISQ IMPLANT STABILITY METER

K082523 · Osstell AB · EKX · Sep 26, 2008 · Dental

Device Facts

• Record ID: K082523
• Device Name: OSSTELL ISQ IMPLANT STABILITY METER
• Applicant: Osstell AB
• Product Code: EKX · Dental
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

Osstell® ISQ Implant Stability Meter is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. The Osstell ISQ 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.

Device Story

Portable, handheld instrument for measuring dental implant stability via Resonance Frequency Analysis (RFA). System uses SmartPeg (aluminum rod) attached to implant via screw; probe emits magnetic pulse to excite SmartPeg. Device calculates resonance frequency from response signal; displays result as Implant Stability Quotient (ISQ). Used by clinicians in dental/oral surgery settings to provide objective data for treatment evaluation. Output assists surgeons in assessing implant integration; informs clinical decision-making regarding treatment progression. Benefits include noninvasive, quantitative assessment of implant stability.

Clinical Evidence

Bench testing only. Verification and validation tests performed to confirm compliance with design specifications; all functions verified to operate as designed. No clinical data presented.

Technological Characteristics

Handheld instrument; Resonance Frequency Analysis (RFA) sensing principle. Components: aluminum SmartPeg, magnetic pulse probe, circuit boards, docking station. Connectivity: integrated docking station. Software: updated from predicate. Sterilization: not specified.

Indications for Use

Indicated for measuring dental implant stability in the oral cavity and craniofacial region to assist in treatment evaluation. No specific age or gender restrictions noted.

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 Mentor Resonance Frequency Analyzer (K033689)

Submission Summary (Full Text)

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510(k) Premarket Application

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SEP 2 6 2008

| Applicant/<br>Manufacturer: | Satu Komulainen<br>Osstell AB<br>Gamlestadsvagen 3 B<br>415 02 Goteborg<br>Sweden |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration: | 3004070020 |
| US Contact: | Cherita James<br>M Squared Associates, Inc.<br>901 King Street, Suite 200<br>Alexandria, VA 22314<br>Ph: 703-562-9800 Ext 257<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date submitted: | September 2, 2008 |
| Proprietary Name: | Osstell® ISQ Implant Stability Meter |
| Common Name: | Dental implant stability analyzer |
| Classification Status: | Class I |
| Product Codes: | EKX - handpiece, direct drive, ac-powered |
| Predicate Device: | Osstell Mentor Resonance Frequency Analyzer (K033689) |

## Device Description:

The Osstell® ISQ Implant Stability Meter is an updated version of the Osstell Mentor (K033689). The system is designed to measure dental implant stability in the oral cavity and craniofacial region. Similar to K033689, the Osstell 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

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510(k) Premarket Application

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.

# Indication for Use:

The Osstell ISQ is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region. The Osstell ISQ 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.

#### Summary of Technological Characteristics:

The modifications to the Osstell Mentor since its previous clearance in K033689 include change to the circuit boards, integration of the docking station, and the software. These minor differences do not affect the safety or performance of the device and do not change the intended use of the Osstell ISQ.

### Summary of Nonclinical Testing:

Based on the Risk Analysis, the verification and validation tests that were performed and the acceptance criteria applied for each are listed in Section 10. The Osstell ISQ was subject to the same preclinical requirements as the predicate device. Performance testing was conducted to confirm compliance to design specifications; all functions were verified to operate as designed.

#### Substantial Equivalence Discussion:

The change to the circuit boards, integration of the docking station, and the software of the Osstell ISQ do not change the intended use nor do they affect the safety and effectiveness as compared to the Osstell Mentor previously cleared in K033689.

#### Conclusion:

The modified Osstell ISQ has the following similarities to the Osstell Mentor previously cleared in K033689:

- has the same indicated use, .
- uses the same operating principle, .

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- incorporates the same basic device design and physical properties, .
- incorporates the same materials. .

Therefore the modification to the Osstell ISQ can be found substantially equivalent to the Osstell Mentor cleared in K033689.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black against a white background. The overall design is simple and professional, reflecting the organization's role in public health and human services.

FEB 17 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Osstell AB c/o Ms. Cherita James Regulatory Consultant M Squared Associates, Incorporated 901 King Street, Suite 200 Alexandria, Virginia 22314

Re: K082523

Trade/Device Name: Osstell® ISQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: September 2, 2008 Received: September 2, 2008

Dear Ms. James:

This letter corrects our substantially equivalent letter of September 2, 2008

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 (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.

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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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at [phone] http://www.fda.gov/cdrh/ organiz.html#OCfor OC organization structure). Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Syrite Y. Michie Durs

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Application

# 2523 Section 5: Indications for Use Statement

510(k) Number (if known): __

Device Name: Osstell® ISQ

Indications For Use: Osstell® ISQ Implant Stability Meter is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . . . . .. 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

Syra Punna

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082523

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Osstell September 2, 2008