(29 days)
Not Found
No
The summary describes a mechanical drill for bone and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a drill for creating holes in bones during surgical procedures, which is an operative tool rather than a therapeutic device. It facilitates surgery but does not directly provide a therapeutic effect on the patient's condition.
No
The device, Stryker® Twist Drills, is described as being used for drilling holes in bone during surgical procedures. Its function is interventional (drilling), not diagnostic (identifying or characterizing a medical condition).
No
The device is described as "Twist Drills" intended for drilling holes in bone, which are physical instruments, not software.
Based on the provided information, the Stryker® Twist Drills are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the drills are used for "drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures." This describes a surgical tool used directly on the patient's body for a mechanical purpose.
- 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. The Stryker® Twist Drills do not perform any such tests on bodily samples.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Mentions of IVD-related terms (image processing, AI, DNN, ML, input imaging modality, training/test sets, performance studies, key metrics): None of these are mentioned, which further supports that it's not an IVD.
Therefore, the Stryker® Twist Drills are a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Product codes
HBE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large and small bone
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
Stryker® Twist Drills
General Information
APR 2 7 2007
| Proprietary Name: | Stryker® Twist Drills |
|---|---|
| Common Name: | Drills, Burrs, Trephines, and Accessories |
| Proposed Regulatory Class: | Class II |
| Device Classification: | HBE (21 CFR 882.4310) Powered simple cranial drills, burrs, trephines, and their accessories |
| Submitter: | Stryker® Craniomaxillofacial |
| 750 Trade Centre Way | |
| Suite 200 | |
| Kalamazoo, MI 49002 | |
| 877-534-2464 x 4250 | |
| Submitter's Registration #: | 3005101424 |
| Manufacturer's Registration #: | 8010177 |
| Contact Person: | Tennille Folk |
| Regulatory Affairs Representative | |
| Phone: 877-534-2464 x 4250 | |
| Fax: 269-323-4215 | |
| Summary Preparation Date: | March 13, 2007 |
Intended Use
The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Substantial Equivalency Information
Stryker® considers the Stryker® Twist Drills equivalent to the existing Twist drills which are classified as class I devices. Stryker® Twist Drills are also equivalent to Stryker 75K Straight Drill K943541, Stryker Oral Max System K954690 and Lorenz Twist Drills K062842.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol, with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circle, with "DEPARTMENT OF HEALTH" at the bottom, "& HUMAN SERVICES" on the left side, and "- USA" at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Stryker Craniomaxillofacial % Ms. Tennille Folk Regulatory Affairs Representative 750 Trade Centre Way, Suite 200 Portage, Michigan 49002
APR 2 7 2007
Re: K070876
Trade/Device Name: Stryker® Twist Drills Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE Dated: April 12, 2007 Received: April 17, 2007
Dear Ms. Folk:
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.
2
Page 2 - Ms. Tennille Folk
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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) Number (if known): K
Device Name: Stryker® Twist Drills
Indications for Use:
The Stryker® Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
| Prescription Use | X | AND/OR Over-the-Counter |
|---|---|---|
| Use | ||
| (21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page estorative, (Posted Novemb 510(k) Nul