(22 days)
No
The document does not mention AI, ML, or any related terms, and the device description focuses on standard navigation system components.
No
The device is intended for surgical navigation, assisting with planning and providing orientation during procedures like spinal and orthopedic surgeries, rather than directly treating a medical condition itself.
No.
The "Intended Use" states that the device uses "diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures." This describes a navigational and guidance system, not a device that itself produces diagnostic images or diagnoses medical conditions.
No
The device description explicitly lists multiple hardware components, including a display, CPU, optical detector, cart, and surgical tools.
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 taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Acumen System's Function: The Acumen system uses diagnostic images of the patient (acquired in vivo) and provides navigation and reference information during surgical procedures. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it assists with presurgical planning and provides orientation and reference information during intra-operative procedures. This is a surgical navigation system, not a diagnostic test performed on a sample.
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 for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Acumen ™ Surgical Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as-
- Spinal surgical procedures involving spinal stabilization, neural . decompression, or resection of spinal neoplasms.
- Orthopedic surgical procedures .
Product codes
HAW
Device Description
The Acumen ™ Surgical Navigation System has the same intended use and indications for use as stated in the Z-Box 510(k) notice except that EBI does not indicate use in intra-cranial surgical procedures involving space occupying lesions or malfunctions (including soft tissue, vascular and osseous) or for ENT procedures. The Acumen described in this notification consists of the same following components as the previously cleared Z Box System by Z Kat :
- High Resolution color liquid crystal display (LCD) touch screen .
- Uninterruptible Power Supply (UPS) .
- Central Processing Unit (CPU)
- Isolation Transformer .
- Keyboard and Mouse .
- Optical Detector (on wheeled-base pedestal) .
- Operating Room Cart .
- Tool and accessories surgical tools and accessories . instrumented with LED or reflective markers
- dMIS kit- surgical instrument lit containing IGS tools and . accessories and dMIS key
- dMIS key- electronic storage media containing disposable . software application
The Acumen ™ Surgical Navigation System principles of operation are the same as stated in the Z-Box 510(k) notice (K030764).
The Acumen ™ Surgical Navigation System described in this notification consists of the same following software components as the previously cleared Z-Box System by Z-Kat:
- Software application .
- Linux operating system .
- Software drivers for video grabber, standard computer . components (keyboard, mouse, monitor, etc.)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic images
Anatomical Site
Spinal, Orthopedic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / intra-operative 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Z-Box; Z-Kat, Inc. K030764
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
KOS 1724
510 (K) SUMMARY
JUL 1 9 2005
SUBMITTER: EBI, L.P.
100 Interpace Parkway ADDRESS: Parsippany, NJ 07054
PHONE NUMBER: 973-299-9300
FAX NUMBER: 973-257-0232
CONTACT PERSON: Whitney Törning
DATE PREPARED: June 24 2005
TRADE NAME: The Acumen ™ Surgical Navigation System
COMMON NAME: Stereotaxic Instrument
CLASSIFICATION NAME: Stereotaxic Instrument
CLASSIFICATION #: Class II
SUBSTANTIAL EQUIVALENCE CLAIMED TO: Z-Box; Z-Kat, Inc. K030764
PURPOSE OF PREMARKET NOTIFICATION:
The Acumen™ Surgical Navigation System is identical to the previously FDA cleared Z Kat Inc., Z-Box system which was cleared by FDA (K030764). EBI is submitting this 510(k) notice as a "duplicate 510(k)" due to a transfer of ownership of the technology.
DEVICE DESCRIPTION/SOFTWARE APPLICATIONS:
The Acumen ™ Surgical Navigation System has the same intended use and indications for use as stated in the Z-Box 510(k) notice except that EBI does not indicate use in intra-cranial surgical procedures involving space occupying lesions or malfunctions (including soft tissue, vascular and osseous) or for ENT procedures.
1
K051724
The Acumen ™ Surgical Navigation System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
The Acumen ™ Surgical Navigation System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as-
- Spinal surgical procedures involving spinal stabilization, neural . decompression, or resection of spinal neoplasms.
- Orthopedic surgical procedures .
Technological Characteristics
The technical characteristics of the Acumen ™ Surgical Navigation System are the same as stated in the Z-Box 510(k) notice. The Acumen described in this notification consists of the same following components as the previously cleared Z Box System by Z Kat :
- High Resolution color liquid crystal display (LCD) touch screen .
- Uninterruptible Power Supply (UPS) .
- Central Processing Unit (CPU) ●
- Isolation Transformer .
- Keyboard and Mouse .
- Optical Detector (on wheeled-base pedestal) .
- Operating Room Cart .
- Tool and accessories surgical tools and accessories . instrumented with LED or reflective markers
- dMIS kit- surgical instrument lit containing IGS tools and . accessories and dMIS key
- dMIS key- electronic storage media containing disposable . software application
2
KOSITZY
Principles of Operation/Software Applications
The Acumen ™ Surgical Navigation System principles of operation are the same as stated in the Z-Box 510(k) notice (K030764).
The Acumen ™ Surgical Navigation System described in this I he flouinen - - Stis of the same following software components as the previously cleared Z-Box System by Z-Kat:
- Software application .
- Linux operating system .
- Software drivers for video grabber, standard computer . components (keyboard, mouse, monitor, etc.)
SUBSTANTIAL EQUIVALENCE
The Acumen ™ Surgical Navigation System is substantially equivalent to the Z Box System by Z-Kat . The Acumen ™ Surgical Navigation System has the same intended use and indications, technological characteristics, and principles of operation and software applications as the previously cleared Z-Box System. The only difference is that EBI does not indicate use in intra cranial surgical procedures involving space occupying lesions or malfunctions procedures oft tissue, vascular and osseous) or for ENT procedures. This difference does not present any new issues of safety or effectiveness.
3
Image /page/3/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" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines, often interpreted as representing people or waves, which is the main symbol of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2005
Ms. Whitney Törning Manager of Regulatory Affairs EBI, L.P. 100 Interpace Road Parsippany, New Jersey 07054
Re: K051724
Koorrez+
Trade/Device Name: Acumen™ Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: June 23, 2005 Received: June 27, 2005
Dear Ms. Törning:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications felerenced above and nave decemined are are are are are and one marketed in interstate for use stated in the encrosule) to regally manated provice Americal Device Americal Society of Cool. Drug commerce provide to May 20, 1970, the enatinent with the provisions of the Federal Food. Drug, devices that have been recuired in acceraaned was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Cosment Act (Act) that do not require approvial controls provisions of the Act. The Act. The Y ou may, therefore, market the device, basjon to the ments for annual registration, listing of general controls provisions of the rise 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 If your device is classified (socure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations may be subject to such additional controls. Extrems, and to 898. In addition, FDA may be found in the Ood of Peacher.
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 Please be advised that FDA s issuation of a building with other requirements of the Act
that FDA has made a determination that your device complies with other requirements of that FDA has made a determination administered by other Federal agencies. You must
or any Federal statutes and regulations administered by other Federal stations of the of any Pederal Statutes and regulations damindiered of not limited to: registration and listing (21) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTK Part 807), fabeling (21 CFR Part 800), government 820), and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820), and 1000, 1050 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Ms. Whitney Törning
This letter will allow you to begin marketing your device as described in your Section 510(k) i his letter will anow you to oegin manxeting of substantial equivalence of your device to a legally premarket nothication. The PDA mumg of backanded of .
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. 1 : .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your acc (240) 276-0115. Also, please note the regulation entitled, p Conlact the Office of Complance at (216) 216 at 807.97). You may obtain "Misbranding by Telefone to premainterions in this in the Act from the Division of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
KOS 1724 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Acumen ™ Surgical Navigation System
The Acumen ™ Surgical Navigation System is intended for use as a device which I he Houten - - Bargecof the patient acquired specifically to assist the physician uses uraguous infage in agains and to provide orientation and reference information during intra-operative procedures.
The Acumen ™ Surgical Navigation System is indicated for any medical condition I he health - - Dargiour and surgery may be considered to be safe and effective, In where a reference to a rigid anatomical structure may be made, such as-
- Spinal surgical procedures involving spinal stabilization, neural . decompression, or resection of spinal neoplasms.
- Orthopedic surgical procedures .
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) (Division of General, Restorative Divisionrological Devices
510(K) Number Ko 51724