(334 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a drill bit, with no mention of AI or ML.
No
The device is a drill bit used to create holes in bone during neurosurgical procedures, but it does not directly treat or mitigate a disease or condition; it is an accessory tool.
No
Explanation: The device is a drill bit used for drilling holes in bone during neurosurgical procedures. Its function is to create physical alterations (holes) in bone, not to diagnose a condition.
No
The device is a physical drill bit made of medical-grade stainless steel, intended for drilling holes in bone. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for drilling holes in bone during neurosurgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The device is described as "drill bits" used to "drill holes in bone." This is a mechanical device for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body, not to perform procedures directly on the body itself.
N/A
Intended Use / Indications for Use
The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HBE
Device Description
Biomet Microfixation Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
The subject submission seeks to add the 2.1 x 255mm Drill, 22mm Stop to the Lorenz Twist Drills family to be used in neurosurgical procedures.
2.1 x 255mm Drill, 22mm Stop manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterile, to be sterilized by the end-user prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (during neurosurgical procedures)
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)
Mechanical testing, including Static Cantilever Bend Testing, Static Torsion Testing, and Lifecycle testing, have been performed on the subject 2.1 x 255mm Drill, 22mm Stop and the results have shown them to be substantially equivalent to the predicate device.
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
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2022
Biomet Micofixation % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K213072
Trade/Device Name: 2.1 x 255mm Drill, 22mm Stop Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: July 19, 2022 Received: July 20, 2022
Dear Christine Scifert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name 2.1 x 255mm Drill, 22mm Stop
Indications for Use (Describe)
The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary 2.1 x 255mm Drill, 22mm Stop August 23, 2022
| Company: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|-------------------------|------------------------------------------------------------------------------------|
| Company Contact: | Mark Wladkowski
mark.wladkowski@zimmerbiomet.com
(904) 362-3940 |
| Official Correspondent: | Christine Scifert
Christine.Scifert@askmrcglobal.com
(901) 831-8053 |
| Trade Name: | 2.1 x 255mm Drill, 22mm Stop |
| Common Name: | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Classification: | Class II |
| Regulation Number: | 882.4310 Powered simple cranial drills, burrs, trephines, and their
accessories |
| Panel: | Neurology |
| Product Code: | HBE |
Device Description:
Biomet Microfixation Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
The subject submission seeks to add the 2.1 x 255mm Drill, 22mm Stop to the Lorenz Twist Drills family to be used in neurosurgical procedures.
2.1 x 255mm Drill, 22mm Stop manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterile, to be sterilized by the end-user prior to use.
4
Indications for Use:
The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.
Substantial Equivalence:
The subject device is substantially equivalent to the following predicate device: Walter Lorenz Surgical, Inc; Lorenz Twist Drills - K062842
The subject and predicate devices are similar in Intended Use, Technological Characteristics, and Material.
| Characteristic | SUBJECT:
2.1 x 255mm Drill, 22mm Stop | Primary Predicate:
Walter Lorenz Surgical, Inc.
(now Biomet Microfixation)
Lorenz Twist Drills |
|----------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | SUBJECT | K062842 |
| Intended Use | Drills, Burrs, Trephines & Accessories (Simple,
Powered) | Drills, Burrs, Trephines & Accessories (Simple,
Powered) |
| Product Code | HBE | HBE |
| Indications for
Use | The Lorenz Twist Drills are intended to be
used for drilling holes in bone during
neurosurgical procedures. | The Lorenz 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. |
| Materials | Stainless Steel per ASTM F899 | Stainless Steel |
| Geometry and
Dimensions | Diameter: 2.1mm
Length: 255mm | Diameters: 1.0-2.9mm
Lengths: 22-115mm |
| Sterility | Non-sterile | Non-sterile |
Performance Testing:
Mechanical testing, including Static Cantilever Bend Testing, Static Torsion Testing, and Lifecycle testing, have been performed on the subject 2.1 x 255mm Drill, 22mm Stop and the results have shown them to be substantially equivalent to the predicate device.
Conclusion:
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate device.