(103 days)
No
The description focuses on mechanical components and performance metrics related to drilling and clutch mechanisms, with no mention of AI or ML.
No.
The device is a cutting tool used for performing cranial trephination, which is a surgical procedure, not a therapeutic treatment itself.
No
Explanation: The device is a cutting and drilling instrument used for cranial trephination, which is a surgical procedure. It does not perform any diagnostic function.
No
The device is described as a "sterile, single use cutting device" and a "bone cutting and drilling instrument." It requires a surgical motor and speed reducer attachment, and performance studies were conducted on human cadaver test samples, indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to perform cranial trephination (drilling holes in the skull) in bone. This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a bone cutting and drilling instrument used in conjunction with a surgical motor. It is designed for physical interaction with the patient's skull.
- 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 tests on samples.
- Anatomical Site: The anatomical site is the skull, indicating direct application to the patient.
The information provided clearly describes a surgical instrument used for a physical procedure on a living patient, not a device used for testing biological samples outside the body.
N/A
Intended Use / 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).
Product codes
HBF
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.
"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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skull
Indicated Patient Age Range
adult skulls
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Anspach Cranial Perforator was found to be equivalent to the competitors 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982991, K933894, K071931, K791101, K892866, K833266
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
K082637
2 of 3
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
2
K082637
3 of 3
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.
3
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.
4
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
5
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
Page of