(329 days)
No
The summary describes a navigation system that tracks surgical instruments in real-time using image-guided technology and pre-existing models or images. There is no mention of AI or ML being used for image analysis, decision support, or any other function.
No
The device is described as "Image Guided Surgical Instruments" intended to assist the surgeon in precisely locating anatomical structures during hip procedures. It is a tool for guidance, not a device that directly treats or prevents disease or affects the structure or function of the body.
No
The device is intended to assist the surgeon in precisely locating anatomical structures during surgical hip procedures, functioning as a navigation tool rather than providing a medical diagnosis.
No
The device description explicitly states "Along with the associated hip software, the image guided surgical instruments for hip applications can be recognized and tracked in real time in the surgical field." and refers to "Image Guided Surgical Instruments," indicating the device includes hardware components (the instruments) in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: This device is a surgical instrument used during a surgical procedure to assist the surgeon in locating anatomical structures. It interacts directly with the patient's body during surgery, not with a specimen taken from the body.
- Intended Use: The intended use clearly states it's for "surgical hip procedures" to assist the surgeon in "precisely locating anatomical structures." This is an in-vivo application, not in-vitro.
The device description and intended use are consistent with a surgical navigation system component, which is a type of medical device used in surgery, but not an IVD.
N/A
Intended Use / Indications for Use
The Indication / Intended Use of the Smith & Nephew Image-guided Hip Instrumentation and the BrainLAB VectorVision System, as described in its labeling, has not changed as a result of the modifications. The indications for use for the BrainLAB VectorVision2 Hip Navigation System are the indications cleared for market by FDA through 510(k) K040368. The system is intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Smith & Nephew Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a ngid anatomical structure such as a long bone can be identified relative to a CT based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).
Image Guided Surgical Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone can be identified relative to a CT based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).
Product codes
HAW
Device Description
Subject of this Premarket Notification are the Smith & Nephew Image Guided Surgical Instruments for Hip Applications for use on the BrainLAB VectorVision? Hip Navigation System. Along with the associated hip software, the image guided surgical instruments for hip applications can be recognized and tracked in real time in the surgical field. Smith & Nephew has previously received clearance for Image-Guided Instruments and Software for Hip Applications under K021798 for use on the Medironic Surgical Navigation Technologies SteathStation® Platform Systems. The Smith & Nephew Image Guided Surgical Instruments for Hip Applications have been developed in order to utilize the intra-operative image-guided technology to track the immediate location and position of the surgical instruments during surgical hip procedures using the BrainLAB VectorVision2 Hip Navigation System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT based model or fluoroscopic image of the anatomy
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Reference Device(s)
K022365, K010602, K021980, K022364, K040368
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
K03341
SUMMARY OF SAFETY AND EFFECTIVENESS SMITH & NEPHEW IMAGE-GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS
SEP 1 0 2004
CONTACT PERSON
Janet Johnson Akil Director, Regulatory Affairs (901) 399-5153
ADDRESS
Smith & Nephew, Inc., Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116
DEVICE DESCRIPTION
Subject of this Premarket Notification are the Smith & Nephew Image Guided Surgical Instruments for Hip Applications for use on the BrainLAB VectorVision? Hip Navigation System. Along with the associated hip software, the image guided surgical instruments for hip applications can be recognized and tracked in real time in the surgical field. Smith & Nephew has previously received clearance for Image-Guided Instruments and Software for Hip Applications under K021798 for use on the Medironic Surgical Navigation Technologies SteathStation® Platform Systems. The Smith & Nephew Image Guided Surgical Instruments for Hip Applications have been developed in order to utilize the intra-operative image-guided technology to track the immediate location and position of the surgical instruments during surgical hip procedures using the BrainLAB VectorVision2 Hip Navigation System.
INDICATIONS FOR USE
The Indication / Intended Use of the Smith & Nephew Image-guided Hip Instrumentation and the BrainLAB VectorVision System, as described in its labeling, has not changed as a result of the modifications. The indications for use for the BrainLAB VectorVision2 Hip Navigation System are the indications cleared for market by FDA through 510(k) K040368. The system is intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Smith & Nephew Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a ngid anatomical structure such as a long bone can be identified relative to a CT based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).
TECHNOLOGICAL CHARACTERISTICS
The Smith & Nephew Image Guided Surgical System for Hip Applications uses the same Fundamental Scientific Technology found in the following Premarket Notifications:
| DESCRIPTION | 510(k) | CLEARANCE |
|---|---|---|
| STRYKER NAVIGATION - HIP MODULE | K022365 | 1/22/03 |
| VECTORVISION HIP | K010602 | 9/12/01 |
| STEALTHSTATION SYSTEM HIP MODULE | K021980 | 11/19/02 |
| NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT | K022364 | 2/04/03 |
| SMITH & NEPHEW IMAGE-GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS | K021798 | 12/09/02 |
| VECTORVISION HIP | K040368 | 8/23/04 |
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread.
SEP 1 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Ms. Janet Johnson Akil Director, Regulatory Affairs Smith and Nephew, Inc. Orthopedic Division 1450 East Brooks Road Memphis, Tennessee 38116
Re: K033341
Trade/Device Name: Smith & Nephew Image-Guided Surgical Instruments for Hip Applications Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: August 31, 2004 Received: September 1, 2004
Dear Ms. Akil:
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.
2
Page 2 - Ms. Janet Johnson Akil
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
3
Indications for Use
510(k) Number (if known): K033341
Device Name: Smith & Nephew Image-Guided Surgical instruments for Hip Applications
Indications For Use:
Image Guided Surgical Instruments for Hip Applications are intended to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Hip Applications are indicated for use in surgical hip procedures, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone can be identified relative to a CT based model or fluoroscopic image of the anatomy or by an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. These procedures include but are not limited to, acetabular cup placement as part of a partial or total hip arthroplasty (primary or revision).
Prescription Use (Part 21 CFR 801 Subpart D)
f
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K033341