(137 days)
No
The summary describes manual surgical instruments that interface with existing navigation systems. There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is described as "manual surgical instruments" intended to assist surgeons in precisely locating anatomical structures during spinal procedures. It does not directly treat or cure a condition, but rather aids in surgical navigation.
No
This device is described as surgical instruments intended to assist surgeons in locating anatomical structures during spinal procedures. It does not perform a diagnostic function, but rather aids in surgical navigation.
No
The device description explicitly states "manual surgical instruments" and describes them as designed to "interface with BrainLAB's already cleared surgical navigation systems," indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The AIS S4 Cervical Navigation Instruments are described as manual surgical instruments used to assist surgeons in precisely locating anatomical structures during surgical procedures. They interface with surgical navigation systems and are used directly on the patient's anatomy during surgery.
- Lack of Specimen Analysis: There is no mention of the device collecting, preparing, or analyzing any specimens from the human body. Its function is entirely focused on guiding surgical procedures based on imaging data and anatomical reference.
Therefore, the intended use and description of the AIS S4 Cervical Navigation Instruments clearly place it outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AIS S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure , such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of pedicle screws (T1-T3).
Product codes
OLO, HAW
Device Description
The AIS S4 Cervical Navigation Instruments are manual surgical instruments which are designed to interface with BrainLAB's already cleared surgical navigation systems. Instruments in this system may be pre-calibrated or manually calibrated to already cleared systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general or manual functions within the orthopedic surgical environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
Spinal, pelvis, vertebrae, T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, orthopedic surgical environment
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)
BrainLAB conducted validation activities including usability testing with the AIS Navigation Instruments. The AIS Navigation Instruments met the performance requirements. No safety or effectiveness issues were raised by the performance testing. Clinical data was not needed for the AIS Navigation Instruments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VectorVision Spine K053159, Kolibri Spine K042721, Trauma K062358, VectorVision Fluoro3D K070106, Spine & Trauma iCT K083310, BrainLab Trauma - 1100204, Spine & Trauma 3D K070106, Spine & Trauma 2D / Fluro Express K110204, Aesculap S4C Spinal System (K050797, K060152, K062327)
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
Traditional 510(k) Premarket Notification
Aesculap S4 Cervical Navigation Instrumentation
Page 1 of 2
2012
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap® Implant Systems (AIS) S4 Spinal System Auqust 6, 2013
| COMPANY: | Aesculap®Implant Systems (AIS), LLC.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Boyle, Sr Regulatory Affairs Specialist
610-984-9274 (phone)
610-791-6882 (fax)
lisa.boyle@aesculap.com |
| TRADE NAME: | AIS S4 Cervical Navigation Instruments |
| COMMON NAME: | Stereotaxic Instrument |
| REGULATION NUMBER: | 882.4560 - Instrument, Stereotaxic |
| PRODUCT CODE: | OLO and HAW |
|---|---|
| REVIEW PANEL: | Orthopedics |
INDICATIONS FOR USE
The AIS S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure , such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of pedicle screws (T1-T3).
DEVICE DESCRIPTION
The AIS S4 Cervical Navigation Instruments are manual surgical instruments which are designed to interface with BrainLAB's already cleared surgical navigation systems. Instruments in this system may be pre-calibrated or manually calibrated to already cleared systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general or manual functions within the orthopedic surgical environment.
TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s)}
The AIS S4 Cervical Navigation Instruments have similar design features, materials, and indications for use as the current AIS manual instruments (class I instrumentation)
1
Page 2 of 2
and are substantially equivalent to the instruments used with the BrainLAB's various navigation systems. The use of the navigated polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
PERFORMANCE DATA
BrainLAB conducted validation activities including usability testing with the AIS Navigation Instruments. The AIS Navigation Instruments met the performance requirements. No safety or effectiveness issues were raised by the performance testing. Clinical data was not needed for the AIS Navigation Instruments.
PREDICATE DEVICES
- VectorVision Spine K053159 .
- Kolibri Spine K042721 .
- Trauma K062358 t
- VectorVision Fluoro3D K070106 .
- Spine & Trauma iCT K083310 .
- . BrainLab Trauma - 1100204
- Spine & Trauma 3D K070106 .
- Spine & Trauma 2D / Fluro Express K110204 .
- Aesculap S4C Spinal System (K050797, K060152, K062327) .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a stylized representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2013
Ms. Lisa M. Boyle Senior Regulatory Affairs Specialist Aesculap Implant Systems, LLC 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K130887
Trade/Device Name: Aesculap S4 Cervical Navigation Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: June 13, 2013 Received: June 14, 2013
Dear Ms. Boyle:
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Lisa M. Boyle
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Erini Meith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT A.
K130887 510(k) Number:
Device Name: Aesculap S4 Cervical Navigation Instrumentation
Indications for Use:
The Aesculap S4 Cervical Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure , such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion during the navigation of pedicle screws (T1-T3).
| Prescription Use | X |
|---|---|
| (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)
Elizabeth L. Frank -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130887