The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).

Device Description

The Cranial Perforator per CFR, Part 882.4305, is a bone cutting and drilling instrument used in conjunction with a surgical motor and speed reducer attachment to drill holes through a patient's skull. The Cranial Perforator employs a clutch mechanism to disengage drilling action upon initial penetration of the skull to prevent plunging of the perforator tip into the underlying dura and brain tissues. The device is a Class II (USA) device. The Cranial Perforator is a device similar in design and construction to other devices currently on the market; (e.g.: Acra-Cut model DGR-1; 14/11mm). The Cranial Perforator is a compound drill which requires a motor to provide speed (70 - 80K RPM) and torque. But a speed reducer attachment is necessary to limit motor speed while delivering necessary torque. For this application the recommended motors are the Anspach Black Max. MicroMax and eMax motor systems. For speed reduction, it is recommended only the Anspach Speed Reducer attachments be used. The speed range when used with the listed Anspach equipment is 800 to 1200 RPM.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cranial Perforator:

The provided text describes a 510(k) submission for a Cranial Perforator. The primary goal of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, specifically the Acra-Cut DGR-1 and Codman 26-1221. The performance testing focuses on demonstrating that the Anspach Cranial Perforator's declutch features are equivalent to the predicate, and that it meets user requirements for cutting rate and hole quality, without gross mechanical failures.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Device Performance (Anspach Cranial Perforator)
Equivalence to Predicate Device (Acra-Cut DGR-1, Codman)	Found to be equivalent to competitors (Acracut and Codman) with respect to Plunge and Early Declutch failures.
Plunge Failures	Reported as equivalent to predicate devices. (Implied acceptance: no unacceptable plunge failures, similar to predicate).
Early Declutch Failures	Reported as equivalent to predicate devices. (Implied acceptance: no unacceptable early declutch failures, similar to predicate).
Cutting Rate	Found to meet the user requirement of a cutting rate equal to or greater than 0.24 mm/sec.
Hole Quality	Capable of creating clean holes when performing perforations.
Gross Mechanical Failures	Did not exhibit any gross mechanical failures.
Speed Range (when used with Anspach equipment)	Successfully operates within the range of 800 to 1200 RPM when used with recommended Anspach motors (Black Max, MicroMax, eMax) and Anspach Speed Reducer attachments. (This is a functional specification, not explicitly an acceptance criterion for the perforator itself, but rather for its intended use.)
Intended Use (cranial trephination in bone at least 3mm thick)	Intended for this use, implied successful performance in cadaver testing for this application.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text states testing was performed on "human cadaver test samples." No specific number of cadaver samples or perforations is provided.
Data Provenance: Human cadaver test samples. The country of origin is not explicitly stated, but given the US regulatory context and submitter, it's likely US-sourced cadavers. The study was prospective in the sense that the Anspach Cranial Perforator was directly tested, but the comparison to predicate devices uses their established performance as a benchmark.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The text does not mention the use of experts to establish ground truth for the test set in the traditional sense (e.g., radiologists interpreting images). The assessment of "Plunge and Early Declutch failures," "cutting rate," "clean holes," and "gross mechanical failures" appears to be based on direct physical measurement and observation during cadaver testing, likely by engineers or technicians overseeing the mechanical performance test.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the performance metrics seem to be objective measurements or direct observations of mechanical function rather than subjective assessments requiring expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not conducted. This device is a mechanical surgical tool, not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone Performance Study

Yes. A standalone performance study of the Anspach Cranial Perforator was performed. The "Performance Testing" section states: "The Anspach Cranial Perforator (75-0002-1) was tested for performance and safety: refer to Verification Report 06-0708, using a comparative method to predicate cranial perforators Acracut and Codman." This testing evaluated the device's ability to:

Perform without Plunge or Early Declutch failures (compared to predicates).
Achieve a cutting rate equal to or greater than 0.24 mm/sec.
Create clean holes.
Operate without gross mechanical failures.

While a "comparative method" was used for some aspects (Plunge/Early Declutch), the other metrics (cutting rate, clean holes, no gross failures) indicate standalone performance evaluation against defined criteria.

7. Type of Ground Truth Used

The ground truth used is primarily physical performance metrics and direct observation on human cadaver bone, compared against established performance characteristics of predicate devices and user requirements. This isn't "expert consensus" or "pathology" in the medical imaging sense, but rather engineering-based verification.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical tool, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for a mechanical device.

Summary

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DEC 2 2 2008

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

Submitter

The Anspach Effort 4500 Riverside Drive Palm Beach Gardens, FL 33410

Official Correspondent

Jim Banic Senior Regulatory Affairs Specialist The Anspach Effort 4500 Riverside Palm Beach Gardens, FL 33410 Tel. 561-627-1080 Fax. 561-625-9110 Email jimb@anspach.com

Date Prepared

September 5, 2008

Device Name

Classification Name

Device Classification

Predicate Devices

Performance

Device Description

September 3, 2008

Cranial Perforator

Drills. Burrs, Trephines & Accessories (Compound Powered)

Class II Neurology Devices Panel 21 CFR § 882.4305

Anspach Access Cranial Perforator -> K982991 Codman & Shurtleff, Inc. Disposable Perforator -> K933894, K071931 and Disposable Perforators Jacobs, Hudson -> K791101 Acra Cut. Inc. Automatic Cranial Drill (Perforator) -> K892866 and Acra Cut, Inc. -> K833266

Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act.

The Cranial Perforator per CFR, Part 882.4305, is a bone

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K082637
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cutting and drilling instrument used in conjunction with a surgical motor and speed reducer attachment to drill holes through a patient's skull. The Cranial Perforator employs a clutch mechanism to disengage drilling action upon initial penetration of the skull to prevent plunging of the perforator tip into the underlying dura and brain tissues. The device is a Class II (USA) device.

The Cranial Perforator is a device similar in design and construction to other devices currently on the market; (e.g.: Acra-Cut model DGR-1; 14/11mm).

The Cranial Perforator is a compound drill which requires a motor to provide speed (70 - 80K RPM) and torque. But a speed reducer attachment is necessary to limit motor speed while delivering necessary torque. For this application the recommended motors are the Anspach Black Max. MicroMax and eMax motor systems. For speed reduction, it is recommended only the Anspach Speed Reducer attachments be used. The speed range when used with the listed Anspach equipment is 800 to 1200 RPM.

"The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).

Substantial equivalence of the Cranial Perforator is based on:

· 1. Design features which are similar to the currently available Acra-Cut DGR-1.
- 2. Performance testing which demonstrates the declutch features of Anspach's Cranial Perforator is the same as the Acra-Cut DGR-1.

Performance Testing The Anspach Cranial Perforator (75-0002-1) was tested for performance and safety: refer to Verification Report 06-0708, using a comparative method to predicate cranial perforators Acracut and Codman. This test were performed on human cadaver test samples and a pneumatic drill set at 120 psi, the maximum allowed, using a 60:1 gear ratio Hudson Style speed reducer. The Anspach Cranial Perforator was found to be equivalent to the competitors

Technological

Indications for Use

Characteristics

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Conclusion

with respect to Plunge and Early Declutch failures. The Anspach Cranial Perforator was found to meet the user requirement of a cutting rate equal to or greater than 0.24 mm/sec. The Anspach Cranial Perforator was capable of creating clean holes when performing perforations. The Anspach Cranial Perforator did not exhibit any gross mechanical failures.

The Cranial Perforator is equivalent to the currently marketed Acra-Cut DGR-1 and Codman 26-1221 which provides similar functionality.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, (USA)" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Anspach Effort, Inc. % Mr. Jim Banic Senior Regulatory Affairs Specialist 4500 Riverside Drive Palm Beach Gardens, Florida 33410

DEC 22 2008

Re: K082637

Trade/Device Name: Cranial Perforator Regulation Number: 21 CFR 882.4305 Regulation Name: Powered compound cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBF Dated: November 20, 2008 Received: November 21, 2008

Dear Mr. Banic:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. Jim Banic

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known): K082637

Device Name: Cranial Perforator

Indications for Use: -

"The Cranial Perforator is a sterile, single use cutting device intended for performing cranial trephination in bone at least 3 mm thick (i.e., adult skulls).

Prescription Use ✔ (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone lu MXM 12/22/2005

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K052637

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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).