(85 days)
Not Found
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI or ML.
No
The device is a surgical drill intended for creating holes in bone, not for treating a disease or condition. While used during therapeutic procedures, it is a tool for a specific surgical step rather than a therapeutic device itself.
No
The device is a surgical tool used for drilling holes in bone during various medical procedures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the device is manufactured from Stainless Steel and is a physical drill used for surgical procedures, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "twist drill" made of stainless steel, used for creating holes in bone. This is a surgical instrument.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any tests on samples.
The description clearly indicates a surgical tool used in vivo (within the living body), not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HBE, HBG, DZI, HTZ, GFG, HTW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large and small 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and validation testing were performed on the subject devices. Clinical data was not required for the determination of substantial equivalence. 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.
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.
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
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
2
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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3
Twist Drills 510(k) Summary
A. Device Information
| Category | Comments | |
|---|---|---|
| Sponsor | Biomet Microfixation | |
| 1520 Tradeport Dr | ||
| Jacksonville FL 32218 | ||
| (904)362-3940 | ||
| Correspondent Contact | Danielle Besal | |
| Principal Consultant MRC Global | ||
| Danielle.Besal@askmrcglobal.com | ||
| (901)827-8670 | ||
| Device Common Name | Drill bit | |
| Device | ||
| Regulation & | ||
| Name | Primary | 888.4310: Powered simple cranial drills, burrs, trephines, and |
| their accessories | ||
| Secondary | 882.4300: Manual cranial drills, burrs, trephines, and their | |
| accessories | ||
| 872.4120: Bone cutting instrument and accessories | ||
| 878.4800: Manual surgical instrument for general use | ||
| 878.4820: Surgical instrument motors and accessories/ | ||
| attachment | ||
| 888.4540: Orthopedic manual surgical instrument | ||
| Classification | ||
| & Product | ||
| Code | Primary | Class 2: HBE |
| Secondary | Class 2: HBG, DZI | |
| 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, |
| and their accessories | |
| 882.4300: Manual cranial drills, burrs, trephines, and their | |
| accessories | |
| 872.4120: Bone cutting instrument and accessories | |
| 878.4800: Manual surgical instrument for general use | |
| 878.4820: Surgical instrument motors and accessories | |
| 888.4540: Orthopedic manual surgical instrument | |
| Predicate Device Classification & Product Code | Class 2: HBE, HBG, DZI |
| 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
Twist Drills K213208 | Predicate Device
Twist Drills K062842 | Impact on
Substantial
Equivalence | |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------|
| 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 Microfixation
Twist Drills are
intended for drilling
holes in large and
small bone during
orthopedic, spinal,
neurosurgical, medial
sternotomy, and oral
and maxillofacial
procedures. | 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. | 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
length supported by
design verification
and validation. |
| Drill working ends | 5 types | | 5 types | Identical |
| Drill connection ends | 10 types | | 7 types | Substantially
equivalent;
additional |
E. Comparison of the Technological Characteristics
5
| | | | connection end
designs supported by
design verification
and validation. |
|---------------|---------------------------------|---------------------------------|------------------------------------------------------------------------------------------------------------------|
| Drill stops | Fixed or adjustable | Fixed | Substantially
equivalent;
adjustable stop
design supported by
design verification
and validation. |
| Sterilization | End user steam
sterilization | End user steam
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.