(243 days)
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Not Found
No
The summary describes a mechanical drilling device and makes no mention of AI or ML.
No
The device is described as a drill intended to assist surgeons in accessing bony tissue and creating holes or obtaining samples, which are surgical tools or aids rather than products that deliver therapy or treatment to a patient.
No
Explanation: The device is described as a drilling machine intended to assist surgeons in accessing bony tissue and obtaining tissue samples. It is a surgical tool, not a device used for diagnosis.
No
The device is described as a "piezoelectrically driven hand held drill," which is a physical hardware device, not software.
Based on the provided information, the Daum p-lectric Drilling Machine is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist the surgeon to access bony tissue" and "drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples." This describes a surgical tool used on the patient's body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
The device is clearly described as a surgical drilling machine used for accessing and sampling bone tissue directly from the patient.
N/A
Intended Use / Indications for Use
The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill intended to assist the surgeon to access bony tissue. The Daum p-lectric Drilling Machine can drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples. The Daum p-lectric Drilling Machine is designed to be used inside or close to an MRI Unit up to 1.5 Tesla.
Product codes
ERL
Device Description
The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bony tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
Description of the training set, sample size, data source, and annotation protocol
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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.)
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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.
Not Found
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
Not Found
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 .2002
Smith Associates c/o E.J. Smith P.O. Box 4341 Crofton, MD 21114
Re: K021098
Trade/Device Name: Daum x-lectric Drilling Machine Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: September 17, 2002 Received: September 19, 2002
Dear Mr. Smith:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 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.
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This letter will allow you to begin 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address . http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number: K021098
Device Name: Daum n-lectric Drilling. Machi
Classification Panel:
Indications for Use: -
The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill intended to assist the surgeon to access bony tissue. The Daum p-lectric Drilling Machine can drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples.
The Daum p-lectric Drilling Machine is designed to be used inside or close to an MRI Unit up to 1.5 Tesla.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-the-Counter Use:
Karen L Baker
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K021098