(167 days)
The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.
The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.
The Zyphr TM Disposable Cranial Perforator is a mechanically powered tool specifically designed to rapidly create an access hole through the skull in a safe and reliable manner.
The provided text is a 510(k) summary for the Stryker Zyphr™ Disposable Cranial Perforator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request for providing a table of acceptance criteria and reported device performance based on the input text, nor can I answer the specific questions about the study design. The document focuses on regulatory submission for substantial equivalence rather than detailing performance validation studies.
{0}------------------------------------------------
DEC 2 9 2008
1000 .
stryker®
Instruments
510(k) Summary
Carrigtwobill Business & Technology Park, Carrigtwohill, Co. Cork, Ireland
t: +353 21 4532900 f: +353 21 4532961
www.stryker.com
| Device Sponsor: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412 |
|---|---|
| Registration No.: | 1811755 |
| Trade Name: | Zyphr TM Disposable Cranial Perforator Bit |
| Common Name: | Cranial Perforator |
| Classification Name: | Drills, Burs, Trephines & Accessories (Compound, Powered) (HBF) |
| Equivalent to: | K892866 Acra-Cut Automatic Cranial Drill (Perforator)K071931 Codman Disposable Perforator |
| Device Description: | The Zyphr TM Disposable Cranial Perforator is a mechanically powered toolspecifically designed to rapidly create an access hole through the skull in asafe and reliable manner. |
| Indications For Use; | The Stryker Zyphr TM Disposable Cranial Perforator Large 14/11mm(perforator) is a sterile, single use cutting accessory intended for cutting an11 mm diameter access hole through the cranium of adult patients. It isintended for thin bone that is at least 3mm thick. |
| The Stryker Zyphr TM Disposable Cranial Perforator Small 11/7mm(perforator) is a sterile, single use cutting accessory intended for cutting a 7mm diameter access hole through the cranium of adult and pediatricpatients. It is intended for thin bone that is at least 1mm thick. | |
| Substantial Equivalence(SE) Rational: | The Zyphr TM Cranial Perforator has the same intended use as the Acra-Cut Automatic Cranial Drill (Perforator) and Codman DisposablePerforator. This device and the predicate devices have the sametechnological characteristics, the same operating principles, use the samepatient contacting materials and have similar performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Zyphr TM CranialPerforator is substantially equivalent to legally marketed devices. |
.
Page 1 of 2
{1}------------------------------------------------
KC82010
Pg. 2 of 2
.
Submitted by:
Colette O'Connor Regulatory Specialist
Collette O'Connor
Signature
22 Decor
Date submitted:
Page 2 of 2
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, clutching a caduceus in its talons. The eagle is depicted in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 9 2008
Stryker Ireland Ltd. % Ms. Colette O'Connor Carrigtwohill Business & Technology Park Carrigtwohill, Co. Cork Ireland
Re: K082010
Trade/Device Name: Zyphr Disposable 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 7, 2008 Received: November 10, 2008
Dear Ms. O'Connor:
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 (Spccial 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.
{3}------------------------------------------------
Page 2 - Ms. Colette O'Connor
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. Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K082010
Device Name: Zyphr TM Disposable Cranial Perforator
Indications For Use:
The Stryker Zyphr ™ Disposable Cranial Perforator Large 14/11mm (perforator) is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. It is intended for thin bone that is at least 3mm thick.
The Stryker Zyphr ™ Disposable Cranial Perforator Small 11/7mm (perforator) is a sterile, single use cutting accessory intended for cutting a 7 mm diameter access hole through the cranium of adult and pediatric patients. It is intended for thin bone that is at least 1mm thick.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krave for MXM
neral, Restorative and Neurological Devices
510(k) Number < `K062010
Page 1 of __ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
§ 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).