(33 days)
Not Found
No
The summary describes a physical device (fixation pins) used in conjunction with computer-assisted surgery systems, but there is no mention of AI or ML being incorporated into the pins themselves or the described function. The "computer assisted surgery systems" are mentioned as the context for the pins' use, but the summary does not detail the technology within those systems.
No.
The device is described as temporary bone fixation pins used to attach orthopedic surgical instruments to bones for referencing locations in computer-assisted surgery systems, not for treating a disease or condition.
No
The device description indicates that CAS Fixation Pins are used as temporary bone fixation pins to attach orthopedic surgical instruments for location referencing in computer-assisted surgery systems. This function is for guiding surgical procedures, not for diagnosing a condition or disease.
No
The device description explicitly states that the device is "threaded bone pins similar to Steinmann pins," which are physical hardware components.
Based on the provided information, the CAS Fixation Pins from Zimmer CAS are not an IVD (In Vitro Diagnostic) device.
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 Description and Intended Use: The description clearly states that these pins are used for temporary bone fixation to attach surgical instruments for computer assisted surgery. They are physically inserted into bone.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely mechanical and related to surgical navigation.
Therefore, the CAS Fixation Pins fall under the category of a surgical instrument or accessory, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.
Product codes
OLO
Device Description
CAS Fixation Pins are threaded bone pins similar to Steinmann pins. They are used to temporarily fixate locational reference instruments to bones in order to reference their location in Computer Assisted Surgery (CAS) systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones
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
The proposed pin will be provided sterile using validated sterilization and packaging methods with an SAL of 10-9.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
4100599 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CAS Fixation Pins
Applicant: Zimmer CAS 75 Queen Street, suite 3300 Montreal. Quebec Canada. H3C 2N6 Tel .: 514 861 4074 Fax: 514 866 2197
APR - 5 2010
Contact Person: Christopher McLean
Date Summary Prepared: March 1, 2010
Device Trade Name: CAS Fixation Pins
Device Classification Name: Stereotaxic Instrument (84 HAW); 21 CFR § 882.4560
Predicate Device:
Navitrack System – Partial Hip Resurfacing Universal from Zimmer CAS (transferred from Orthosoft Inc.), 510(k) # K071929 -
Device Description:
CAS Fixation Pins are threaded bone pins similar to Steinmann pins. They are used to temporarily fixate locational reference instruments to bones in order to reference their location in Computer Assisted Surgery (CAS) systems.
Indications for Use / Intended Use:
CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.
Technological Comparisons to the Predicates:
The difference between the proposed and predicate pins is that the proposed pins will be provided sterile packaged while the predicate ones are provided non-sterile to be sterilized by the user facility. The proposed method of sterilization while the labeled user method for the predicate is the common steam sterilization cycle used in hospital settings. The proposed and predicate pins are otherwise identical.
Performance Data:
The proposed pin will be provided sterile using validated sterilization and packaging methods with an SAL of 10-9.
Conclusion:
The information and data provided in this 510(k) Premarket Notification established that the proposed CAS Fixation Pins are substantially equivalent to the fixation pins of the predicate.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 5 2010
Zimmer CAS % Mr. Christopher McLean Associate Director Quality & Regulatory Affairs 75 Queen Street, Suite 3300 Montreal, Quebec, Canada H3C 2N6
Re: K100599
Trade/Device Name: CAS Fixation Pins Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: March 01, 2010 Received: March 03, 2010
Dear Mr. McLean:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
2
Page 2 - Mr. Christopher McLean
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K 100599 510(k) Number:
Device Name: CAS Fixation Pins
Indications for Use.
CAS Fixation Pins from Zimmer CAS are intended for use as temporary bone fixation pins to attach orthopedic surgical instruments to bones in order to allow referencing their relative locations as required in the use of computer assisted surgery systems. Their specific uses and indications including their method of use and attachment sites are as specified in the computer assisted surgery system that involves their use.
Prescription Use (per 21CFR 801.109) Over-the-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Nil R. Dd
(Division Sign-Off)
for msm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100599