(24 days)
Not Found
No
The description focuses on Resonance Frequency Analysis and calculating ISQ from the resonance frequency, with no mention of AI or ML terms or processes.
No.
The device measures implant stability and does not provide therapy.
No
The device measures implant stability, which provides information for clinical decision-making, but it does not diagnose a disease or condition.
No
The device description clearly states it is a portable, handheld instrument that uses a magnetic pulse to excite a SmartPeg attached to the implant, indicating it is a hardware device with software components, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Osstell ISQ Function: The Osstell ISQ measures the stability of dental implants in situ (within the patient's body) using a non-invasive technique (Resonance Frequency Analysis). It does not analyze samples taken from the body.
The device description clearly states it's a "portable, handheld instrument" that interacts directly with the implant in the oral cavity. This is a diagnostic tool used on the patient, not with a sample from the patient.
N/A
Intended Use / Indications for Use
The Osstell® ISQ Implant Stability Meter is indicated for use in measuring the stability of implants in the oral cavity and craniofacial region.
Product codes (comma separated list FDA assigned to the subject device)
EKX
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 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 craniofacial 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 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.
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 Mentor Resonance Frequency Analyzer (K033689)
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
510(k) Premarket Application
Image /page/0/Picture/2 description: The image shows the text "Section 6: 510(k) Summary" along with the number K082523 written above it. The text is written in a clear, sans-serif font and is positioned at the bottom of the image. The number is handwritten in cursive and underlined.
SEP 2 6 2008
| Applicant/
Manufacturer: | Satu Komulainen
Osstell AB
Gamlestadsvagen 3 B
415 02 Goteborg
Sweden |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration: | 3004070020 |
| US Contact: | Cherita James
M Squared Associates, Inc.
901 King Street, Suite 200
Alexandria, VA 22314
Ph: 703-562-9800 Ext 257
Fax: 703-562-9797
E-mail: CJames@MSquaredAssociates.com |
| 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
1
2 4 3
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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3583
- 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.
3
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.
4
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 (240) 276-3773 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 (800) 638-2041 or (240) 276-3150 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
5
/ 08/
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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Osstell September 2, 2008