2.1 x 255mm Drill, 22mm Stop

K223199 · Biomet Microfixation · HBE · Nov 15, 2022 · Neurology

Device Facts

• Record ID: K223199
• Device Name: 2.1 x 255mm Drill, 22mm Stop
• Applicant: Biomet Microfixation
• Product Code: HBE · Neurology
• Decision Date: Nov 15, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lorenz Twist Drills are intended to be used for drilling holes in bone during neurosurgical procedures.

Device Story

The 2.1 x 255mm Drill, 22mm Stop is a surgical drill bit used to create holes in bone during neurosurgical procedures. It is designed for attachment to either a manual instrument handle or a powered handpiece/drill motor. The device is now compatible with neurosurgical stereotactic instrument systems. It is a single-use, non-sterile device intended for use by neurosurgeons in a clinical or operating room setting. The drill bit facilitates precise bone access, aiding the surgeon in performing neurosurgical interventions. The device is provided non-sterile and requires sterilization by the end-user prior to use.

Clinical Evidence

Bench testing only. Performance was validated through tolerance analysis confirming dimensional compatibility with stereotactic placement devices and summative usability testing conducted per IEC 62366-1:2015+A1:2020, which demonstrated safe and effective use with neurosurgical stereotactic instruments.

Technological Characteristics

Material: medical grade stainless steel per ASTM F899. Form factor: drill bit with 22mm stop. Connectivity: mechanical interface for manual handles or powered handpieces; compatible with stereotactic instrument systems. Sterilization: provided non-sterile; requires end-user sterilization.

Indications for Use

Indicated for drilling holes in bone during neurosurgical procedures. Intended for prescription use.

Regulatory Classification

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.

Predicate Devices

• 2.1 x 255mm Drill, 22mm Stop (K213072)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> 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<br>1520 Tradeport Drive<br>Jacksonville, FL 32218 |
|-------------------------------|------------------------------------------------------------------------------------|
| Company Contact: | Jay Sharma<br>[e-mail]<br>Phone: [phone] |
| Official<br>Correspondent: | Danielle Besal<br>[e-mail]<br>Phone: [phone] |
| 510(k) Number:<br>Trade Name: | K223199<br>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<br>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<br>determine if the drill is compatible with<br>the neurosurgical stereotactic placement<br>devices. | The tolerance analyses showed that the<br>subject device dimensions are compatible<br>with the dimensions of the neurosurgical<br>stereotactic placement devices; thus, the<br>subject drill bit mates effectively. |
| Summative Usability<br>Validation | Summative usability evaluations were<br>conducted in accordance with IEC 62366-<br>1:2015+A1:2020. | The acceptance criteria were met and the<br>results demonstrated the subject device<br>can be used safely and effectively with<br>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.