(167 days)
Not Found
No
The summary describes a mechanical cutting tool and does not mention any AI or ML components or functions.
No.
The device is described as a cutting accessory intended for creating access holes through the cranium, which is a surgical tool, not a therapeutic device designed for treating a disease or condition.
No
Explanation: The device is described as a "cutting accessory" or "mechanically powered tool" for creating an access hole through the cranium. Its function is to perform a physical action (cutting), not to identify, detect, or monitor a medical condition or disease.
No
The device description clearly states it is a "mechanically powered tool" and a "cutting accessory," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stryker Zyphr Disposable Cranial Perforator is a surgical tool used to create a physical opening in the skull. It is a cutting accessory used directly on the patient's body, not on a sample taken from the body.
- Intended Use: The intended use clearly states it is for "cutting an access hole through the cranium." This is a surgical procedure, not a diagnostic test performed on a sample.
Therefore, the device falls under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Zyphr TM 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 TM 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.
Product codes (comma separated list FDA assigned to the subject device)
HBF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
Indicated Patient Age Range
adult patients, adult and pediatric patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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 Instruments
4100 E. Milham Avenue
Kalamazoo, 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 tool
specifically designed to rapidly create an access hole through the skull in a
safe 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 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 TM 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. |
| Substantial Equivalence
(SE) Rational: | The Zyphr TM Cranial Perforator has the same intended use as the Acra-
Cut Automatic Cranial Drill (Perforator) and Codman Disposable
Perforator. This device and the predicate devices have the same
technological characteristics, the same operating principles, use the same
patient contacting materials and have similar performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Zyphr TM Cranial
Perforator is substantially equivalent to legally marketed devices. |
.
Page 1 of 2
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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