(101 days)
K791101A
Not Found
No
The description focuses on mechanical function and materials, with no mention of AI/ML terms or capabilities.
No
The device is used for perforating the cranium, which is a surgical tool, not a therapeutic device designed for treating a disease or condition.
No
The device is described as a surgical tool for perforating the cranium, not for diagnosing medical conditions. Its function is to perform a physical action (perforation), not to gather information for diagnosis.
No
The device description explicitly states it consists of physical components (stainless steel inner and outer drill, stainless steel Hudson End) and is a pre-assembled, single-use, sterile device designed to perforate the cranium, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perforate the cranium." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a surgical tool designed for mechanical action (drilling).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures on the body itself.
N/A
Intended Use / Indications for Use
Codman Disposable Perforators are intended to perforate the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
The CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
Product codes
HBF
Device Description
The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. The perforators consist of a stainless steel inner and outer drill and a stainless steel Hudson End that locks onto a pneumatic or electric driving tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
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)
Substantial equivalence for this device is based upon comparison to predicate device characteristics and performance testing. Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K791101A
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).
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510(k) Summary Codman® Disposable Perforator
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350
OCT 2 2 2007
Contact Person
Emily E Valerio Regulatory Affairs Specialist II Telephone Number: (508) 828-3038 Fax Number: (508) 828-2777
Name of Device
| Proprietary Name: | Codman® Disposable Perforator |
|---|---|
| Common Name: | Disposable Perforator |
| Classification Name: | Powered compound cranial drills, burrs, trephines and their accessories |
Device Classification
Powered compound cranial drills, burrs, trephines, and their accessories are Class II devices per 21 CFR § 882.4305 (84 HBF).
Statement of Substantial Equivalence
Codman Disposable Perforators are substantially equivalent to the Codman Disposable Perforator with Hudson End (K791101A) based on the device's similarity to the predicate device in intended use, materials, design, and principles of operations.
Indications for Use
Codman Disposable Perforators are intended to perforate the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
Physical Description
The Codman Disposable Perforators are pre-assembled, single-use, sterile devices that are designed to perforate the cranium. The perforators consist of a stainless steel inner and outer drill and a stainless steel Hudson End that locks onto a pneumatic or electric driving tool.
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Image /page/1/Picture/1 description: The image shows the numbers 2, 6, 1, and 11. The numbers are written in a simple, handwritten style. The numbers are arranged in a horizontal line, with the number 11 appearing below the number 1.
Device Testing
Substantial equivalence for this device is based upon comparison to predicate device characteristics and performance testing. Device qualification criteria meet or exceed the minimum qualification criteria for the predicate device.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Codman & Shurtleff, Inc. % Ms. Emily E. Valerio Regulatory Affairs Specialist II 325 Paramount Drive Raynham, Massachusetts 02767 OCT 2 2 2007
Re: K071931
Trade/Device Name: Codman Disposable Perforators Regulation Number: 21 CFR 882.4305 Regulation Name: Powered compound cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBF Dated: September 13, 2007 Received: September 14, 2007
Dear Ms. Valerio:
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
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Page 2 - Ms. Emily E. Valerio
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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
For Mark N. Melkerson Dep 0,2
10/19/95
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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P. i. o t' l
Indications for Use
510(k) Number (if known):
Device Name:
Codman Disposable Perforators
Indications For Use:
The CODMAN® Disposable Perforators are indicated for perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P.C.M.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K07197