The EasyDrill Autostop Cranial Perforator comprises of an Inner and Outer Drill, and a Hudson Shank that is designed to lock onto a Pneumatic or an Electric Drill Motors.

The EasyDrill Autostop Cranial Perforator device is a bone cutting and drilling instrument used in conjunction with a surgical motor and a Hudson Chuck - speed reducer attachment, to drill access holes through a patient's skull. When properly used, the EasyDrill Autostop Cranial Perforator employs a clutch mechanism to automatically disengage once perforation is accomplished and as the drill ceases to find resistance to bone.

The EasyDrill Autostop Cranial Perforator is a mechanically powered tool, designed to create an access hole through the skull. The subject Perforator device derives its mechanical torque and rotational speed from various legally marketed Electric and/or Pneumatic Drill Motors. The EasyDrill Autostop Cranial Perforator device is latched onto a Hudson Chuck device, which is in turn attached to the Drill Motors.

The EasyDrill Autostop Cranial Perforator is provided Gamma Sterilized, in a sealed packaging and is designed for single patient use only.

AI/ML Overview

This document is a 510(k) summary for the EasyDrill Autostop Cranial Perforator. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a structured study validating those criteria. Therefore, several requested points, particularly those related to AI algorithm performance (such as MRMC studies, standalone AI performance, sample sizes for training/test sets as relevant to AI, and ground truth establishment methods typical for AI studies), cannot be fully addressed from the provided text.

However, I can extract the information relevant to the device's performance validation as described in the document.

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of quantitative acceptance criteria. Instead, it describes performance testing aimed at demonstrating safety, effectiveness, and equivalence to predicate devices. The "reported device performance" is qualitative and focused on meeting intended use and safety standards.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness in Intended Use (Cadaver Study)	"Results of cadaveric testing demonstrate that the EasyDrill Autostop Cranial Perforator does not present any new issues of safety or effectiveness, and that the devices perform as intended during cranial bone trephination."
Equivalent Performance to Predicate Devices (Bench Top)	"The performance data from the side-by-side testing, of the subject EasyDrill Autostop Cranial Perforator device against the predicate perforator devices, were compared to support the subject device..." (Implies similar performance to predicates).
Endotoxin Levels	"The data from the study show that the subject EasyDrill Autostop Cranial Perforators meet the required endotoxin specification limit of 2.15 EU/Device."
Automatic Disengagement (Clutch Mechanism) (Technological Characteristic)	The device description states: "When properly used, the EasyDrill Autostop Cranial Perforator employs a clutch mechanism to automatically disengage once perforation is accomplished and as the drill ceases to find resistance to bone." While not explicitly an "acceptance criterion" in the performance section, its proper functioning is a key design claim validated implicitly by the performance testing. The comparison section also highlights this as a shared technological element with predicate devices.

2. Sample sized used for the test set and the data provenance:

Cadaver Study: The document mentions "human cadaveric specimen - skull" (singular, implying one or more but not a large number specified). The exact sample size (number of cadavers or number of drilling sites) is not provided.
Bench Top Testing: The study was performed "in a Bovine Scapula" (singular, implying one or more but not a large number specified). The exact number of bovine scapulae or test instances is not provided.
Endotoxin Testing: The sample size for endotoxin testing is not specified, but it refers to "subject EasyDrill Autostop Cranial Perforator devices."
Data Provenance: Not explicitly stated, but the cadaver and bovine scapula tests would be prospective experimental data generated specifically for this submission. The country of origin for the data is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The studies described are performance tests of a mechanical device, not diagnostic studies requiring expert interpretation for ground truth.

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

This information is not applicable and therefore not provided. The studies described are performance tests of a mechanical device, not diagnostic studies requiring adjudication of output.

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 information is not provided and is not applicable. The device is a mechanical cranial perforator, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

This information is not provided and is not applicable. The device is a mechanical cranial perforator, not an algorithm.

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

For the Cadaver and Bench Top studies, the "ground truth" implicitly was the functional performance observed (e.g., successful perforation, automatic disengagement, lack of adverse events such as plunging, comparison to predicate performance). For Endotoxin testing, the ground truth was the analytical result against the specified limit. These are direct measurements of physical or biological properties, not ground truth established from expert consensus or pathology in the context of diagnostic performance.

8. The sample size for the training set:

This information is not provided and is not applicable. This is a mechanical device, not an AI algorithm requiring a training set.

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

This information is not provided and is not applicable. This is a mechanical device, not an AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16, 2015

Micromar Industria e Comercio Ltda. % Deep Pal US Agent- Principal Regulatory Affairs Specialist Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137

Re: K141455

Trade/Device Name: EasyDrill Autostop Cranial Perforator Regulation Number: 21 CFR 882.4305 Regulation Name: Powered Compound Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBF Dated: February 12, 2015 Received: February 13, 2015

Dear Deep Pal.

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. 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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carlos L. Pena -SD/Δ

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141455

Device Name EasyDrill Autostop Cranial Perforator

Indications for Use (Describe)

The EasyDrill Autostop Cranial Perforator is a sterile, single use cutting device intended for performing cranial bone trephination.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

This summary is submitted in accordance with the requirements of 21CFR807.92.

DATE PREPARED

March 16, 2015

NAME/ADDRESS OF MANUFACTURER

Micromar Industria e Comercio Ltda CNPJ: 53.168.142/0001-29 Av. Marginal ao Corrego da Serraria, nº 168 CEP 09980-390 - Serraria, Diadema, Sao Paulo, Brazil

SUBMITTER'S NAME AND ADDRESS

Micromar Industria e Comercio Ltda CNPJ: 53.168.142/0001-29 Av. Marginal ao Corrego da Serraria, nº 168 CEP 09980-390 - Serraria, Diadema, Sao Paulo, Brazil

CONTACT PERSON

Deep Pal US Agent for Micromar Telephone: 817.788.6685 Facsimile: 817.788.6225 E-Mail: deep.pal@medtronic.com

PROPRIETARY NAME

EasyDrill Autostop Cranial Perforator

COMMON/USUAL NAME

Cranial Perforator

CLASSIFICATION NAME

Powered compound cranial drills, burrs, trephines, and their accessories, HBF, 21CFR882.4305

PREDICATE DEVICE IDENTIFICATION

K071931: Codman Disposable Perforator, Codman & Shurtleff, Inc. K082010: Zyphr Disposable Cranial Perforator, Stryker Instruments K892866: Acra-Cut Disposable Cranial Perforator, Acra-Cut Inc.

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DEVICE DESCRIPTION

The EasyDrill Autostop Cranial Perforator comprises of an Inner and Outer Drill, and a Hudson Shank that is designed to lock onto a Pneumatic or an Electric Drill Motors.

The EasyDrill Autostop Cranial Perforator is provided Gamma Sterilized, in a sealed packaging and is designed for single patient use only.

Model	External Diameter	Internal Diameter	Shelf	Color	Minimum Bone Thickness
Ø9 x Ø6 x 3mm	9 mm	6 mm	3 mm	Yellow	3.25 mm
Ø11 x Ø7 x 3mm	11	7	3	Blue	3.25 mm
Ø14 x Ø11 x 3mm	14	11	3	White	3.25 mm
Ø14 x Ø11 x 1.5mm	14	11	1.5	Green	1.75 mm

INDICATIONS FOR USE

The EasyDrill Autostop Cranial Perforator is a sterile, single use cutting device intended for performing cranial bone trephination.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Mechanically powered tool, designed to create an access hole through the skull is the technological principle for both the subject and predicate devices. It is based on the use of powered instrumentation for deriving the needed mechanical torque and rotational speed for cranial bone trephination. At a high level, the subject and predicate devices are based on the following same technological elements:

Cranial Perforator Application: Used for cranial bone trephination;
Used in conjunction with Electric and/or Pneumatic Drill System and a Hudson Chuck Speed Reducer Attachment: Comprises of an Inner and Outer Drill, and a Hudson Shank that is designed to lock onto a Pneumatic or an Electric driving tool. This allows the device the needed mechanical torque and rotational speed to create an access hole through the skull;
A Clutch Mechanism: Automatically disengages once perforation is accomplished and as the drill ceases to find resistance to bone.

In terms of the materials used in manufacturing of the patient contacting components of the subject EasyDrill Autostop Cranial Perforator devices, the subject EasyDrill Autostop Cranial Perforator device is similar to the predicate devices. Like the predicate devices, the patient contacting Central and the Outer Drill components of the EasyDrill Autostop Cranial Perforator devices are made from Stainless Steel materials.

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PERFORMANCE TESTING

The following performance data were provided in support of the substantial equivalence determination:

CADAVER STUDY

In order to evaluate the performance, its application and suitability of the subject EasyDrill Autostop Cranial Perforator devices for its intended use, the EasyDrill Autostop Cranial Perforator devices were tested under simulated use conditions on human cadaveric specimen - skull. Results of cadaveric testing demonstrate that the EasyDrill Autostop Cranial Perforator does not present any new issues of safety or effectiveness, and that the devices perform as intended during cranial bone trephination.

SIDE BY SIDE BENCH TOP TESTING

In order to evaluate the performance of the subject EasyDrill Autostop Cranial Perforator devices against the predicate devices, for its intended use, the EasyDrill Autostop Cranial Perforator devices were tested alongside the predicate devices in a Bovine Scapula.

ENDOTOXIN TESTING

The subject EasyDrill Autostop Cranial Perforator devices were tested for Endotoxins using the Limulus Amebocyte Lysate (LAL) Gel-Clot test procedure. The data from the study show that the subject EasyDrill Autostop Cranial Perforators meet the required endotoxin specification limit of 2.15 EU/Device.

CONCLUSIONS

The performance data from the side-by-side testing, of the subject EasyDrill Autostop Cranial Perforator device against the predicate perforator devices, were compared to support the subject device and the cadaver study demonstrates that the subject EasyDrill Autostop Cranial Perforator should perform as intended in the specified use conditions.

Regulation Number and Section

§ 882.4305 Powered compound cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered compound cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments employ a clutch mechanism to disengage the tip of the instrument after penetrating the skull to prevent plunging of the tip into the brain.(b)
Classification. Class II (performance standards).