(198 days)
No
The summary describes manual surgical instruments that interface with existing navigation systems and does not mention any AI/ML capabilities or image processing beyond standard navigation.
No
This device is intended to assist surgeons in precisely locating anatomical structures during spinal procedures. It does not directly treat a disease or condition.
No
The device is described as "manual surgical instruments" intended to "assist the surgeon in precisely locating anatomical structures" during surgical procedures. It does not perform diagnosis; instead, it is a tool used during surgery.
No
The device description explicitly states "The AIS S4 Navigation Instruments are manual surgical instruments," 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 medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The AIS S4 Navigation Instruments are described as "manual surgical instruments" intended to "assist the surgeon in precisely locating anatomical structures" during surgical procedures. They interface with navigation systems and are used directly on the patient during surgery.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens taken from the patient. Its function is entirely focused on guiding the surgeon's actions within the body based on imaging data.
Therefore, the AIS S4 Navigation Instruments fall under the category of surgical navigation devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The AIS S4 Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are 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 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 polyaxial screws (T1-T3).
Product codes (comma separated list FDA assigned to the subject device)
OLO, HAW
Device Description
The AIS S4 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
pelvis or a vertebrae (spinal, specifically T1-T3 for polyaxial screws)
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 S4 Navigation Instruments. The AIS S4 Navigation Instruments met the performance requirements. No safety or effectiveness issues were raised by the performance testing. Clinical data was not needed for the additional AIS S4 Navigation Instruments.
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.
K070106 BrainLAB VectorVision Fluro3D / Spine & Trauma 3D, K053159 VectorVision Spine, K042721 Kolibri Spine, K062358 —Trauma, K083310 -Spine & Trauma iCT, K110204 -Spine & Trauma 2D / Fluro Express
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
§ 882.4560 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2016
Aesculap Implant Systems, LLC Mr. Paul Amudala Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K153700
Trade/Device Name: Aesculap® Implant Systems (AIS) S4 Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: June 3, 2016 Received: June 6, 2016
Dear Mr. Amudala:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153700
Device Name AIS S4 Navigation Instruments
Indications for Use (Describe)
The AIS S4 Navigation Instruments are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. They are 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 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 polyaxial screws (T1-T3).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
B. 510(k) SUMMARY (as required by 21 CFR 807.92)
Aesculap® Implant Systems (AIS) S4 Spinal System Jul 07, 2016
| COMPANY: | Aesculap® Implant Systems (AIS), LLC.
3773 Corporate Parkway
Center Valley, PA 18034
Establishment Registration Number: 3005673311 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Paul Amudala, Regulatory Affairs Specialist
610-984-9303 (phone)
610-791-6882 (fax)
paul.amudala@aesculap.com |
| TRADE NAME:
COMMON NAME: | AIS S4 Navigation Instruments
Stereotaxic Instrument |
| REGULATION NUMBER: | 882.4560 – Instrument, Stereotaxic |
| PRODUCT CODE: | OLO and HAW |
Orthopedics
INDICATIONS FOR USE
REVIEW PANEL:
The AIS S4 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 polyaxial screws (T1-T3).
DEVICE DESCRIPTION
The AIS S4 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 Navigation Instruments have similar design features, materials, and indications for use as the current AIS manual instruments and are substantially equivalent to the instruments used with the BrainLAB's various navigation systems. The polyaxial screws can be placed in the thoracic spine (T1-T3) only. Screws are not intended to be placed in the cervical spine.
4
PERFORMANCE DATA
BrainLAB conducted validation activities including usability testing with the AIS S4 Navigation Instruments. The AIS S4 Navigation Instruments met the performance requirements. No safety or effectiveness issues were raised by the performance testing. Clinical data was not needed for the additional AIS S4 Navigation Instruments.
PREDICATE DEVICES
- K130887 AIS S4 Cervical Navigation Instruments (Primary) ● Reference Predicates:
- K070106 BrainLAB VectorVision Fluro3D / Spine & Trauma 3D ●
- K053159 VectorVision Spine ●
- K042721 Kolibri Spine ●
- K062358 —Trauma ●
- K083310 -Spine & Trauma iCT
- K110204 -Spine & Trauma 2D / Fluro Express .
CONCULSION
Aesculap believes that the instruments presented in this submission are substantially equivalent in design, materials, intended use, and perform as safe and effective as Aesculap's currently marketed devices.