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 Description

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.

AI/ML Overview

This FDA 510(k) summary is for a medical device (Twist Drills), not an AI/ML algorithm. Therefore, many of the requested categories related to algorithm performance, training data, and expert review are not applicable.

Here's an analysis of the provided document based on the available information:

This document describes the FDA's decision to clear the Biomet Microfixation Twist Drills (K213208) as substantially equivalent to a predicate device (Twist Drills K062842).

1. A table of acceptance criteria and the reported device performance

The document states that "Design verification and validation testing were performed on the subject devices" and "The results from all design verification and validation tests confirmed that the subject devices met the predetermined acceptance criteria." However, the specific, quantitative acceptance criteria themselves are not provided in this summary document. The performance is reported as meeting these unspecified criteria.

Acceptance Criteria	Reported Device Performance
Specific acceptance criteria are not detailed in this summary document.	"The results from all design verification and validation tests confirmed that the subject devices met the predetermined acceptance criteria."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document discusses performance testing for a physical medical device, not a data-driven AI/ML algorithm. Therefore, terms like "test set" and "data provenance" in the context of data analysis are not directly applicable. The document refers to "design verification and validation testing," which would involve physical samples of the drill. The sample size for these physical tests is not specified in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable for a physical medical device without a diagnostic component.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the document describes a physical medical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the document describes a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a physical medical device like a drill, "ground truth" generally refers to objective physical and mechanical properties. The validation would typically involve comparing the device's performance against predefined engineering specifications and safety standards, rather than expert consensus on diagnostic images or pathology. The document generally refers to "predetermined acceptance criteria" and "design verification and validation tests."

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as the document describes a physical medical device.

Summary

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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 (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) 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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Twist Drills 510(k) Summary

A. Device Information

Category		Comments
Sponsor		Biomet Microfixation1520 Tradeport DrJacksonville FL 32218(904)362-3940
Correspondent Contact		Danielle BesalPrincipal Consultant MRC GlobalDanielle.Besal@askmrcglobal.com(901)827-8670
Device Common Name		Drill bit
DeviceRegulation &Name	Primary	888.4310: Powered simple cranial drills, burrs, trephines, andtheir accessories
	Secondary	882.4300: Manual cranial drills, burrs, trephines, and theiraccessories872.4120: Bone cutting instrument and accessories878.4800: Manual surgical instrument for general use878.4820: Surgical instrument motors and accessories/attachment888.4540: Orthopedic manual surgical instrument
Classification& ProductCode	Primary	Class 2: HBE
	Secondary	Class 2: HBG, DZIClass 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,and their accessories882.4300: Manual cranial drills, burrs, trephines, and theiraccessories872.4120: Bone cutting instrument and accessories878.4800: Manual surgical instrument for general use878.4820: Surgical instrument motors and accessories888.4540: Orthopedic manual surgical instrument
Predicate Device Classification & Product Code	Class 2: HBE, HBG, DZIClass 1: HTZ, GFG, HTW

B. Date Summary Prepared

December 21, 2021

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C. Description of Device

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 DeviceTwist Drills K213208	Predicate DeviceTwist Drills K062842	Impact onSubstantialEquivalence
Company	Biomet Microfixation	Biomet Microfixation	Identical
Regulation Number	882.4310, 882.4300,872.4120, 878.4800,878.4820, 888.4540	882.4310, 882.4300,872.4120, 878.4800,878.4820, 888.4540	Identical
Product Code	HBE, HBG, DZI, HTZ,GFG, HTW	HBE, HBG, DZI, HTZ,GFG, HTW	Identical
Indications for Use	Biomet MicrofixationTwist Drills areintended for drillingholes in large andsmall bone duringorthopedic, spinal,neurosurgical, medialsternotomy, and oraland maxillofacialprocedures.	Biomet MicrofixationTwist Drills areintended for drillingholes in large andsmall bone duringorthopedic, spinal,neurosurgical, medialsternotomy, and oraland maxillofacialprocedures.	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; longerlength supported bydesign verificationand validation.
Drill working ends	5 types		5 types	Identical
Drill connection ends	10 types		7 types	Substantiallyequivalent;additional

E. Comparison of the Technological Characteristics

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			connection enddesigns supported bydesign verificationand validation.
Drill stops	Fixed or adjustable	Fixed	Substantiallyequivalent;adjustable stopdesign supported bydesign verificationand validation.
Sterilization	End user steamsterilization	End user steamsterilization	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.

Regulation Number and Section

§ 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).