(140 days)
Not Found
No
The description focuses on passive marker tracking and software for surgical navigation based on pre-operative imaging or imageless models. There is no mention of AI or ML algorithms for image analysis, decision support, or other functions.
No.
The device is intended to assist the surgeon with navigation and orientation during orthopedic procedures, not to provide therapy itself.
No
Explanation: The device provides orientation and reference information to assist the surgeon during procedures, rather than diagnosing a condition.
No
The device description explicitly states that the system includes "general instrumentation" and "passive markers" which are physical components, not solely software.
Based on the provided information, the Acumen™ Surgical Navigation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Acumen™ System Function: The Acumen™ system is a surgical navigation system. Its purpose is to assist the surgeon by providing orientation and reference information during surgical procedures. It uses imaging data (CT, MRI, fluoroscopy, or imageless models) and tracks instruments in relation to the patient's anatomy.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens from the patient. The system works with anatomical structures and surgical instruments.
Therefore, the Acumen™ Surgical Navigation System falls under the category of a surgical navigation or guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ Navigation System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy. These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.
Product codes
HAW
Device Description
The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).
Passive markers (spheres) are attached onto the Acumen™ instrumentation. An infrared light source generated by the camera reflects off of the passive markers to allow their position and orientation to be identified. The Acumen™ instruments are used as: 1) an independent instrument, 2) connected to instruments, which are attached to the patient, or 3) connected to the associated implant preparation and insertion instrumentation.
All Acumen™ instruments will have a minimum of three (3) passive markers to be tracked by the camera system. They will also be rigidly connected to the instrumentation. Each Acumen™ instrument, utilized in the surgical procedure, will have a defined geometry of the passive marker position for a unique identification by the camera and software system.
The instruments can be utilized with knee and trauma applications. The Acumen™ instruments are designed as one-time use components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI based model, fluoroscopy or an imageless model
Anatomical Site
rigid anatomical bony structures (for knee and trauma procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, during open or percutaneous orthopedic procedures.
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)
Non-Clinical Testing: Software verification and validation was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
SEP 1 5 2003
03/337
Image /page/0/Figure/2 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are outlined in black, with the interior of the letters being white. The word "INC" is written in a smaller font size and is located below and to the right of the word "BIOMET". The letters "INC" are also outlined in black, with the interior of the letters being white.
Summary of Safety and Effectiveness
| Applicant/Sponsor: | Biomet Orthopedics, Inc.
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Contact Person: | Kristine C. (Kacy) Arnold, RN. MBA
Telephone: (574) 267-6639
Fax: (574) 372-1683 |
| Proprietary Name: | Acumen™ Surgical Navigation System |
| Common Name: | Instrument, Stereotaxic |
| Classification Name: | Stereotaxic Instrument (21 CFR 882.4560) |
| Device Classification: | Class II |
| Legally Marketed
Devices to Which
Substantial Equivalence
is claimed: | Voyager™ Linux (K023975)
Flurelab Plus (K013025) |
Device Description: The Acumen™ Surgical Navigation System includes general instrumentation that is utilized with application specific software developed and supplied by Z-KAT, Inc. (Hollywood, Florida).
Passive markers (spheres) are attached onto the Acumen™ instrumentation. An infrared light source generated by the camera reflects off of the passive markers to allow their position and orientation to be identified. The Acumen™ instruments are used as: 1) an independent instrument, 2) connected to instruments, which are attached to the patient, or 3) connected to the associated implant preparation and insertion instrumentation.
All Acumen™ instruments will have a minimum of three (3) passive markers to be tracked by the camera system. They will also be rigidly connected to the instrumentation. Each Acumen™ instrument, utilized in the surgical procedure, will have a defined geometry of the passive marker position for a unique identification by the camera and software system.
The instruments can be utilized with knee and trauma applications. The Acumen™ instruments are designed as one-time use components.
Intended Use: The Acumen™ Surgical Navigation System is intended to assist the surgeon in providing orientation and reference information to anatomical structures during open or percutaneous orthopedic procedures. The Acumen™ Navigation System is indicated for use in surgical knee and trauma procedures, in which the use of stereotaxic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT or MRI based model, fluoroscopy or an imageless model of the anatomy.
1
These procedures include, but are not limited to knee arthroplasty or trauma reconstructive procedures.
Summary of Technologies: The Acumen™ Surgical Navigation System's technological characteristics are similar to or identical to the predicate devices.
Non-Clinical Testing: Software verification and validation was performed to establish substantial equivalence to the predicate devices.
Clinical Testing: Clinical testing was not used to establish substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing the bird's head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
SEP 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristine C. Arnold, RN, MBA Regulator Affairs Specialist Biomet, Inc. 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K031337
Trade/Device Name: Acumen™ Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 10, 2003 Received: July 14, 2003
Dear Ms. Arnold:
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.
3
Page 2 - Ms. Kristine C. Arnold, RN, MBA
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/15 description: The image shows the word "BIOMET" in a bold, sans-serif font. The letters are all capitalized and enclosed in a rectangular border. To the right of the word "BIOMET" is the abbreviation "INC.", which is also in a sans-serif font but is smaller than the word "BIOMET".
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510 (k) Number (if known) : _ |