(30 days)
BrainLAB VectorVision Hip Software, K05221
No
The description focuses on passive marker tracking, 3D visualization, and navigation based on pre-operative imaging, without mentioning any learning or adaptive algorithms.
No
The device is a surgical navigation system that assists surgeons in preparing bone during hip reconstructive procedures by providing guidance, rather than directly treating a medical condition itself.
No
The device is described as surgical instruments used for navigation and precise bone preparation during surgery, not for diagnosing medical conditions.
No
The device description explicitly states it includes reusable manual orthopaedic surgical instruments modified with a navigation adapter, BrainLAB Starlock arrays, and marble-sized optical spheres, which are hardware components.
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 described device is a surgical navigation system. It uses optical tracking and computer software to help a surgeon accurately position instruments during hip surgery. It interacts directly with the patient's anatomy during the procedure, not with specimens taken from the body.
- Intended Use: The intended use clearly states its purpose is for "accurately navigate the position of instrumentation... for precise bone preparation during intraoperative hip reconstructive procedures." This is a surgical guidance function, not a diagnostic function performed on in vitro samples.
The device is a surgical navigation system, which falls under the category of medical devices used during surgical procedures, not IVDs.
N/A
Intended Use / Indications for Use
The DePuy Ci Hip Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrument tion by a virtual 3-D computer generated image for precise bone preparation during intraoperative total hip replacement (THR) procedures. The system is indicated for total hip replacement procedures in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR-based model of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
- . Total Joint Replacement (TJR)
- . Revision Surgery of TJR
- Tumor resection and Bone/Joint Reconstruction .
Also:
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This condics a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer a generated image for precise bone preparation during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in vhich the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomic of structure, such as a long bone, can be identified relative to a CT or MR hased model of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
- Total Joint Replacement (TJR)
- Revision Surgery of TJR .
- Tumor resection and Bone/Joint Reconstruction
Product codes
84 HAW
Device Description
The DePuy Ci ™ Hip Instruments are reusable manual orthopaedic surgical instruments modified with a navigation adapter for use with BrainLAB's VectorVision Hip version software on the DePuy Ci hardware platform.
These instruments are designed for either manual or computer navigation use. The BrainLAB Starlock arrays and marble-sized optical spheres enable the instruments to interface with computer assisted imaging hardware and software. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intra-operatively during surgery.
Instruments are tracked by marble sized marker spheres attached to a reference array creating a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. A virtual 3-D computer image is generated enabling a surgeon to accurately navigate the position of instrumentation for precise bone preparation during intraoperative hip surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR-based model of the anatomy.
Anatomical Site
Hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative
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)
DePuy CAS Hip Instrumentation, K052178
Reference Device(s)
BrainLAB VectorVision Hip Software, K05221
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
1071135
510 (k) Summary
(As required by 21 CFR 807.92 and 21 CFR 807.93)
| NAME OF SPONSOR: | DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46582
Establishment Registration Number: 1818910 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Natalie S. Heck
Manager, Regulatory Affairs
Telephone: (574) 372-7469
Facsimile: (574) 371-4987
Electronic Mail: Nheck@dpyus.jnj.com |
| DATE PREPARED: | April 20, 2007 |
| PROPRIETARY NAME: | DePuy Ci ™ Hip Instrumentation |
| COMMON NAME: | Computer Assisted Surgery Instruments |
| CLASSIFICATION: | Class II per 21 CFR 882.4560, Stereotaxic
Instrument |
| DEVICE PRODUCT CODE: | 84 HAW |
| SUBSTANTIALLY EQUIVALENT
DEVICE: | DePuy CAS Hip Instrumentation, K052178
BrainLAB VectorVision Hip Software, K05221 |
DEVICE DESCRIPTION AND INTENDED USE:
The DePuy Ci ™ Hip Instruments are reusable manual orthopaedic surgical instruments modified with a navigation adapter for use with BrainLAB's VectorVision Hip version software on the DePuy Ci hardware platform.
These instruments are designed for either manual or computer navigation use. The BrainLAB Starlock arrays and marble-sized optical spheres enable the instruments to interface with computer assisted imaging hardware and software. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intra-operatively during surgery.
Instruments are tracked by marble sized marker spheres attached to a reference array creating a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. A virtual 3-D computer image is
1
generated enabling a surgeon to accurately navigate the position of instrumentation for precise bone preparation during intraoperative hip surgery.
INDICATIONS FOR USE:
The DePuy Ci Hip Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This enables a surgeon to accurately navigate the position of instrument tion by a virtual 3-D computer generated image for precise bone preparation during intraoperative total hip replacement (THR) procedures. The system is indicated for total hip replacement procedures in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, can be identified relative to a CT or MR-based model of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
- . Total Joint Replacement (TJR)
- . Revision Surgery of TJR
- Tumor resection and Bone/Joint Reconstruction .
BASIS OF SUBSTANTIAL EQUIVALENCE:
The subject DePuy Ci Hip Instrumentation is substantially equivalent to the existing DePuy CAS Hip Instrumentation (K052178), based on the similarities in design, intended use, materials, sterility, and use of computer navigation, and does not raise new issues of safety or effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Orthopaedics, Inc. % Ms. Natalie S. Heck Manager, Regulatory Affairs 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
MAY 2 3 2007
Re: K071135
Trade/Device Name: DePuy Ci" Hip Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 20, 2007 Received: April 23, 2007
Dear Ms. Heck:
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. Natalie S. Heck
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Mark N. Melkerson son
Director
Division of General, Restorativ
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Indications for Use Statement
510 (k) Number (if known):
DePuy Ci ™ Hip Instrumentation Device Name:
Indications for Use:
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interfaced with computer hardware and software. This condics a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer a generated image for precise bone preparation during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in vhich the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomic of structure, such as a long bone, can be identified relative to a CT or MR hased model of the anatomy.
Example orthopaedic procedures for these instruments include, but are not limited to:
- Total Joint Replacement (TJR)
- Revision Surgery of TJR .
- Tumor resection and Bone/Joint Reconstruction
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | 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)
(Division Sign-Off)
(Posted November 13, 2003) Division of General, Restorative, Page 1 of 1
and Neurological Devices
| 510(k) Number | k 071135 |
|---|---|
| --------------- | ---------- |