CRANIAL PERFORATOR

K082637 · The Anspach Effort, Inc. · HBF · Dec 22, 2008 · Neurology

Device Facts

• Record ID: K082637
• Device Name: CRANIAL PERFORATOR
• Applicant: The Anspach Effort, Inc.
• Product Code: HBF · Neurology
• Decision Date: Dec 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4305
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Cranial Perforator is a sterile, single-use bone cutting instrument for cranial trephination. Device attaches to surgical motor and speed reducer; requires 800-1200 RPM operational speed. Features mechanical clutch to disengage drilling upon skull penetration, preventing injury to underlying dura and brain tissue. Used by surgeons in clinical settings. Benefits include controlled, clean hole creation and reduced risk of plunging during craniotomy.

Clinical Evidence

Bench testing only. Performance evaluated using human cadaver samples and pneumatic drill at 120 psi with 60:1 gear ratio. Metrics included plunge prevention, declutching reliability, and cutting rate (>= 0.24 mm/sec). Results showed equivalence to predicate devices (Acra-Cut and Codman) with no gross mechanical failures.

Technological Characteristics

Compound powered cranial drill; mechanical clutch mechanism for automatic disengagement. Requires external motor (Anspach Black Max, MicroMax, or eMax) and speed reducer. Sterile, single-use. No specific material standards cited.

Indications for Use

Indicated for cranial trephination in adult patients with bone thickness of at least 3 mm.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• Acra-Cut model DGR-1
• Codman 26-1221

Submission Summary (Full Text)

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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. [phone] Fax. [phone] Email [e-mail]

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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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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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