Twist Drills

K213208 · Biomet Microfixation · HBE · Dec 23, 2021 · Neurology

Device Facts

• Record ID: K213208
• Device Name: Twist Drills
• Applicant: Biomet Microfixation
• Product Code: HBE · Neurology
• Decision Date: Dec 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4310
• Device Class: Class 2

Intended Use

Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Device Story

Single-use stainless steel twist drills; used to create holes in bone for implant placement. Features include fluted shafts, fixed depth stops, or adjustable depth stops to prevent over-drilling. Distributed non-sterile; requires steam sterilization by healthcare facility prior to use. Operated by surgeons in orthopedic, spinal, neurosurgical, or oral/maxillofacial clinical settings. Output is a prepared bone site for subsequent hardware implantation; facilitates surgical fixation.

Clinical Evidence

No clinical data. Substantial equivalence supported by design verification and validation testing.

Technological Characteristics

Stainless steel construction; manual or powered drill bit form factor; includes fluted shafts, fixed or adjustable depth stops; steam sterilization; single-use.

Indications for Use

Indicated for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

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

• Twist Drills (K062842)

Submission Summary (Full Text)

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December 23, 2021

Biomet Microfixation % Danielle Besal Principal Consultant MRC Global, LLC 9085 E Mineral Circle. Suite 110 Centennial, Colorado 80112

Re: K213208

Trade/Device Name: Twist Drills 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 26, 2021 Received: October 27, 2021

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,

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) K213208

Device Name Twist Drills

Indications for Use (Describe)

Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

Type of Use (Select one or both, as applicable)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# Twist Drills 510(k) Summary

## A. Device Information

| Category | | Comments |
|-------------------------------------|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | | Biomet Microfixation<br>1520 Tradeport Dr<br>Jacksonville FL 32218<br>[phone] |
| Correspondent Contact | | Danielle Besal<br>Principal Consultant MRC Global<br>[e-mail]<br>[phone] |
| Device Common Name | | Drill bit |
| Device<br>Regulation &<br>Name | Primary | 888.4310: Powered simple cranial drills, burrs, trephines, and<br>their accessories |
| | Secondary | 882.4300: Manual cranial drills, burrs, trephines, and their<br>accessories<br>872.4120: Bone cutting instrument and accessories<br>878.4800: Manual surgical instrument for general use<br>878.4820: Surgical instrument motors and accessories/<br>attachment<br>888.4540: Orthopedic manual surgical instrument |
| Classification<br>& Product<br>Code | Primary | Class 2: HBE |
| | Secondary | Class 2: HBG, DZI<br>Class 1: HTZ, GFG, HTW |
| 510(k) Number | | K213208 |
| Device Proprietary Name | | Twist Drills |

## Predicate Device Information

| Predicate Device | Twist Drills |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device Manufacturer | Biomet Microfixation |
| Predicate Device Common Name | Drill bit |
| Predicate Device 510(k) | K062842 |
| Predicate Device Classification & Name | 882.4310: Powered simple cranial drills, burrs, trephines,<br>and their accessories<br>882.4300: Manual cranial drills, burrs, trephines, and their<br>accessories<br>872.4120: Bone cutting instrument and accessories<br>878.4800: Manual surgical instrument for general use<br>878.4820: Surgical instrument motors and accessories<br>888.4540: Orthopedic manual surgical instrument |
| Predicate Device Classification & Product Code | Class 2: HBE, HBG, DZI<br>Class 1: HTZ, GFG, HTW |

### B. Date Summary Prepared

December 21, 2021

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#### C. Description of Device

Biomet Microfixation manufactures and distributes a variety of single use twist drills to aid in the implantation of Biomet Microfixation implants. Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures. The drills are manufactured from Stainless Steel. Some drills contain flutes along the majority of the drill length, while others contain a "stop" feature which prevents further drilling past a designated length. Additionally, some drills contain an "adjustable stop" feature which allows to surgeon to set the stop length intraoperatively. Twist Drills are distributed non-sterile and are intended for single-patient use. Cleaning should only be performed on new or uncompromised drills. The drills should be steam sterilized by the health-care facility prior to use.

#### D. Indications for Use

Biomet Microfixation Twist Drills are intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.

| Characteristic | Subject Device<br>Twist Drills K213208 | Predicate Device<br>Twist Drills K062842 | Impact on<br>Substantial<br>Equivalence | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------|
| Company | Biomet Microfixation | Biomet Microfixation | Identical | |
| Regulation Number | 882.4310, 882.4300,<br>872.4120, 878.4800,<br>878.4820, 888.4540 | 882.4310, 882.4300,<br>872.4120, 878.4800,<br>878.4820, 888.4540 | Identical | |
| Product Code | HBE, HBG, DZI, HTZ,<br>GFG, HTW | HBE, HBG, DZI, HTZ,<br>GFG, HTW | Identical | |
| Indications for Use | Biomet Microfixation<br>Twist Drills are<br>intended for drilling<br>holes in large and<br>small bone during<br>orthopedic, spinal,<br>neurosurgical, medial<br>sternotomy, and oral<br>and maxillofacial<br>procedures. | Biomet Microfixation<br>Twist Drills are<br>intended for drilling<br>holes in large and<br>small bone during<br>orthopedic, spinal,<br>neurosurgical, medial<br>sternotomy, and oral<br>and maxillofacial<br>procedures. | Identical | |
| Material | Stainless steel | Stainless steel | Identical | |
| Sizing | Diameter | 0.7-2.5mm | 0.7-2.7mm | Substantially |
| | Length | 0.866-6.818 in | 0.866-4.528 in | equivalent; longer<br>length supported by<br>design verification<br>and validation. |
| Drill working ends | 5 types | | 5 types | Identical |
| Drill connection ends | 10 types | | 7 types | Substantially<br>equivalent;<br>additional |

#### E. Comparison of the Technological Characteristics

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| | | | connection end<br>designs supported by<br>design verification<br>and validation. |
|---------------|---------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------|
| Drill stops | Fixed or adjustable | Fixed | Substantially<br>equivalent;<br>adjustable stop<br>design supported by<br>design verification<br>and validation. |
| Sterilization | End user steam<br>sterilization | End user steam<br>sterilization | Identical |
| Use | Single use | Single use | Identical |

#### F. Summary of Supporting Data

Design verification and validation testing were performed on the subject devices. Clinical data was not required for the determination of substantial equivalence.

#### G. Discussion of Performance Testing

The results from all design verification and validation tests confirmed that the subject devices met the predetermined acceptance criteria. Thus, the minor differences in technological characteristics versus the predicate (longer lengths, additional connection end designs, and adjustable stop feature) do not raise any new questions or safety and effectiveness and the subject devices are at least as safe and effective as the predicate.

#### H. Conclusion

The subject devices are substantially equivalent to the predicate Twist Drills (K062842). The subject components are identical in indications and materials, and similar in sizing, geometry, and features to the predicate devices. The minor differences in technological characteristics between the subject and predicate devices do not raise any new questions of safety and effectiveness and the subject device is at least as safe and effective as the predicate. It is concluded that subject Twist Drills are substantially equivalent to the predicate devices.