(33 days)
Not Found
No
The description focuses on a mechanical drill bit and its compatibility with stereotactic systems, with no mention of AI or ML capabilities.
No
The device is a drill bit used to create holes in bone during neurosurgical procedures, which is an instrument, not a therapeutic treatment for disease or condition.
No
The device is described as a drill bit used to create holes in bone during neurosurgical procedures, which is a surgical tool, not a diagnostic one.
No
The device description clearly states it is a physical drill bit made of medical grade stainless steel, intended for drilling holes in bone. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "drilling holes in bone during neurosurgical procedures." This is a surgical tool used directly on the patient's body.
- Device Description: The description confirms it's a drill bit for surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
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
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 in neurosurgical procedures. The 2.1 x 255mm Drill, 22mm Stop is manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterilized by the end-user prior to use. The subject submission seeks to add the compatibility of the 2.1 x 255mm Drill, 22mm Stop drill with neurosurgical stereotactic instrument systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Tolerance analysis and summative usability testing were conducted on the subject device and successfully verified and validated compatibility with stereotactic instrument systems.
Test: Tolerance Analysis, Test Method Summary: Dimensional analyses were conducted to determine if the drill is compatible with the neurosurgical stereotactic placement devices., Results: The tolerance analyses showed that the subject device dimensions are compatible with the dimensions of the neurosurgical stereotactic placement devices; thus, the subject drill bit mates effectively.
Test: Summative Usability Validation, Test Method Summary: Summative usability evaluations were conducted in accordance with IEC 62366-1:2015+A1:2020., Results: The acceptance criteria were met and the results demonstrated the subject device can be used safely and effectively with neurosurgical stereotactic instrument.
Key Metrics
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).
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2022
Biomet Microfixation % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle. Suite 110 Centennial, Colorado 80112
Re: K223199
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: October 13, 2022 Received: October 13, 2022
Dear Danielle Besal:
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
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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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2022.11.15, and the time is 11:27:20 -05'00'.
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) K223199
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)
| ☑ 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 November 15, 2022
| Company: | Biomet Microfixation
1520 Tradeport Drive
Jacksonville, FL 32218 |
|-------------------------------|------------------------------------------------------------------------------------|
| Company Contact: | Jay Sharma
Jay.Sharma@zimmerbiomet.com
Phone: (904) 741-4400 |
| Official
Correspondent: | Danielle Besal
Danielle.Besal@askmrcglobal.com
Phone: (901) 827-8670 |
| 510(k) Number:
Trade Name: | K223199
2.1 x 255mm Drill, 22mm Stop |
| Predicate Device: | K213072 - 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 in neurosurgical procedures. The 2.1 x 255mm Drill, 22mm Stop is manufactured from medical grade stainless steel per ASTM F899. The subject drill bit is intended for single use only and is provided non-sterilized by the end-user prior to use. The subject submission seeks to add the compatibility of the 2.1 x 255mm Drill, 22mm Stop drill with neurosurgical stereotactic instrument systems.
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 predicate Biomet Microfixation; 2.1 x 255mm Drill, 22mm Stop (K213072). The subject and predicate devices are identical in intended use, technological characteristics, and materials. The addition of compatibility with
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stereotactic instruments does not raise different questions of safety and effectiveness as they are intended for use with generic instrumentation, such as the subject drill, and this compatibility does not impact the drill's intended use or mechanism of action.
Performance Testing:
Tolerance analysis and summative usability testing were conducted on the subject device and successfully verified and validated compatibility with stereotactic instrument systems.
| Test | Test Method Summary | Results |
|---|---|---|
| Tolerance Analysis | Dimensional analyses were conducted to | |
| determine if the drill is compatible with | ||
| the neurosurgical stereotactic placement | ||
| devices. | The tolerance analyses showed that the | |
| subject device dimensions are compatible | ||
| with the dimensions of the neurosurgical | ||
| stereotactic placement devices; thus, the | ||
| subject drill bit mates effectively. | ||
| Summative Usability | ||
| Validation | Summative usability evaluations were | |
| conducted in accordance with IEC 62366- | ||
| 1:2015+A1:2020. | The acceptance criteria were met and the | |
| results demonstrated the subject device | ||
| can be used safely and effectively with | ||
| neurosurgical stereotactic instrument. |
Conclusion:
Based on the summary of design control activities, the subject device is determined to be substantially equivalent to the predicate device.