(59 days)
Not Found
No
The description details mechanical instruments for bone preparation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The device is described as a surgical instrument for preparing bone during dental and craniofacial procedures, not for therapy or treatment.
No.
The device description and intended use indicate that the FRIOS MicroSaw is used for preparing bone (cutting, predrilling, elevating, luxating) during surgical procedures, which are therapeutic actions, not diagnostic.
No
The device description clearly outlines physical instruments (disc, drill, chisel, protector) used in conjunction with handpieces, indicating it is a hardware device, not software-only.
Based on the provided information, the FRIOS MicroSaw is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "preparing bone in conjunction with dental and craniofacial surgical procedures." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details instruments for cutting, drilling, and chiseling bone, along with a protector for soft tissue. These are all mechanical tools for surgical manipulation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The FRIOS MicroSaw does not interact with or analyze such specimens.
Therefore, the FRIOS MicroSaw is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
The FRIOS MicroSaw is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
KMW
Device Description
The FRIOS MicroSaw is a series of instruments used in preparing bone in dental and craniofacial surgical procedures. The MicroSaw components are used in conjunction with the FRIOS Contra-Angle and Straight Handpieces. The MicroSaw consists of the disc for cutting bone, the drill for predrilling techniques and the chisel for elevating and luxating bone. The FRIOS MicroSaw also includes a protector which is attached to the handpiece which is designed to protect the soft tissue and limit the cutting depth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone in dental and craniofacial
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)
Not Found
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.
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
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a handwritten string of characters and numbers. The string begins with the letter 'K', followed by the numbers '994298'. A horizontal line is drawn beneath the entire string, possibly indicating it is a label or identifier.
FEB 1 8 2000
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 14:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 14.1
| a. | Company Name: | FRIADENT GmbH. |
|---|---|---|
| b. | Company Address: | Steinzeugstrasse 50 |
| Mannheim D-68229 | ||
| Germany | ||
| c. | Company Phone: | |
| Company Facsimile: | (011) 49 06 21 4 86 1549 | |
| (011) 49 06 21 4 86 1866 | ||
| d. | Contact Person: | Birgit Unger |
| Quality Management and Regulatory Affairs | ||
| e. | Date Summary Prepared: | December 17, 1999 |
14.2. DEVICE IDENTIFICATION
| a. Trade/Proprietary Name: | FRIOS MicroSaw |
|---|---|
| b. Classification Name: | Bone Cutting Instruments and Accessories |
| 21 CFR 872.4120 |
IDENTIFICATION OF PREDICATE DEVICES 14.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| OsteoMed Corp. | OsteoPower System and | ||
| Accessories | K971692 | 06/27/97 |
14.4 DEVICE DESCRIPTION
The FRIOS MicroSaw is a series of instruments used in preparing bone in dental and craniofacial surgical procedures. The MicroSaw components are used in
1
conjunction with the FRIOS Contra-Angle and Straight Handpieces. The MicroSaw consists of the disc for cutting bone, the drill for predrilling techniques and the chisel for elevating and luxating bone. The FRIOS MicroSaw also includes a protector which is attached to the handpiece which is designed to protect the soft tissue and limit the cutting depth.
14.5 SUBSTANTIAL EQUIVALENCE
The FRIOS MicroSaw is substantially equivalent to the OsteoMed Corporation OsteoPower System and Accessories cleared under premarket notification K971692 on June 27, 1997.
The fundamental technical characteristics of the FRIOS MicroSaw are similar to those of the predicate. The FRIOS MicroSaw is equivalent to the OsteoMed Corporation's OsteoPower System and Accessories in design, function and intended use.
14.6 INDICATIONS FOR USE
The FRIOS MicroSaw is indicated for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
14.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the FRIOS MicroSaw with the predicate device is provided within this submission. Both the FRIOS MicroSaw and the predicate device are similar in design, materials and functionality. The FRIOS MicroSaw cutting instruments are made of stainless steel and incorporate a standard latch lock for use with the FRIOS Straight and Contra-Angle Handpieces.
14.8 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2000
Friadent GmbH c/o Ms. Carol Patterson Consultant for Friadent GmbH Patterson Consulting Group, Incorporated 21911 Erie Lane Lake Forest, California 92630
Re: K994298 Frios MicroSaw Trade Name: Requlatory Class: II Product Code: KMW Dated: December 20, 1999 Received: December 21, 1999
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
3
Page 2 - Ms. Patterson
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Direc tor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
FRIADENT GmbH FRIOS MicroSaw Original Premarket 510(k) Notification
INDICATION FOR USE
1994298 To Be Assigned By FDA 510(k) Number:
Device Name:
FRIOS MicroSaw
Indications for Use:
The FRIOS MicroSaw is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Ove
Over-The-Counter Use _
Susan Runyor
OR
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number