K Number

Device Name

DEPUY CAS HIP INSTRUMENTATION

Manufacturer

DEPUY ORTHOPAEDICS, INC.

Date Cleared

2005-10-21

(72 days)

Product Code

HAW

Regulation Number

882.4560

Intended 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 enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone cuts and implant positioning during intraoperative hip reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, 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

Device Description

DePuy CAS Hip Instruments are computer recognized by application specific VectorVision Hip software on Ci hardware platform, owned by BrainLAB. Together, instruments and hardware/software enable operational planning and navigation during orthopaedic hip surgery. The VectorVision Hip software is designed to read DePuy instrument and implant data and offers planning and navigating intraoperatively during surgery. BrainLAB designed the Ci hardware platform exclusively for DePuy. Instrument/implant data is tracked by flexible passive markers imposed on a virtual computer 3D image of the patient's bone. Landmarks on the bone surface are acquired to intraoperatively navigate the femoral and acetabular instrumentation and implants for the most accurate position.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K040368, K033223, K033341, K021798

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on passive marker tracking and 3D visualization for surgical navigation, without mentioning AI or ML algorithms for image analysis, decision support, or other functions.

Therapeutic

No
This device is a surgical navigation system that assists surgeons in performing precise bone cuts and implant positioning. It does not directly treat or cure a medical condition, but rather aids in a surgical procedure that may be therapeutic.

Diagnostic

This device is described as an intraoperative navigation system that assists surgeons in accurately positioning instrumentation and implants during hip reconstructive procedures. It uses a virtual 3D computer-generated image based on CT or MR data to guide surgical actions, rather than to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

The device description explicitly states that the system includes "computer hardware and software" and "instruments and hardware/software." It also mentions a "Ci hardware platform" designed exclusively for DePuy. This indicates the device is a combination of hardware and software, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is an instrument system used during surgery to track and navigate surgical instruments based on a 3D computer model of the patient's anatomy. It is used for intraoperative guidance and surgical planning, not for analyzing biological samples.
Intended Use: The intended use is for "accurately navigate the position of instrumentation... during intraoperative hip reconstructive procedures." This is a surgical guidance system, not a diagnostic test.
Device Description: The description focuses on the interaction between instruments, software, and hardware for tracking and navigation during surgery. There is no mention of analyzing biological samples.

Therefore, this device falls under the category of a surgical navigation system or computer-assisted surgery (CAS) system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Indications for Use:
Instruments are tracked by a passive marker sensor system that acquires landmarks of the bone surface when interphased with computer hardware and software. This enables a surgeon to accurately navigate the position of instrumentation by a virtual 3-D computer generated image for precise bone cuts in orthopaedic hip reconstructive procedures. The system is indicated for any medical condition in which the use of stereotaxe surgery may be appropriate, and where reference to a rigid anatomical structure, 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

Product codes

HAW

Device Description

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

Not Found

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)

K040368, K033223, K033341, K021798

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

0C1 2 1 2005

K052178 SUMMARY OF SAFETY AND EFFECTIVENESS

| Name of Firm: | DePuy Orthopaedics, Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, IN 46581-0988 |
|----------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randa Franklin
Sr. Regulatory Specialist |
| Trade Name: | DePuy CAS Hip Instrumentation |
| Common Name: | Computer Assisted Surgery (CAS) Hip
Instrumentation |
| Regulatory Classification: | 882.4560; Stereotaxic Instrument; Class II |
| Device Product Code: | HAW |
| Substantially Equivalent Device: | • K040368 VectorVision Hip |
| | • K033223 Zimmer Ortho Guidance Systems –
Hip Instruments |
| | • K033341 Smith & Nephew Image-Guided
Surgical Instruments for Hip Applications |
| | • K021798 Image Guided Surgical Instruments
for Hip Applications |

Device Description and Intended Use:

Basis of Substantial Equivalence:

Computer Assisted Surgical Hip Instruments are substantially equivalent to other legally marketed Class II stereotaxic instruments by means of tracking patient anatomy through infrared passive markers imposed onto computer images.

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

OCT 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Randa Franklin Sr. Regulatory Specialist DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K052178

Trade/Device Name: DePuy CAS Hip Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: October 4, 2005 Received: October 5, 2005

Dear Mr. Franklin:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o neve roviewed your 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 for ass stated in to May 28, 1976, the enactment date of the Medical Device Amendments, or to commer of prior to 1125 2011 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.

Page 2- Randa Franklin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse of substantial equivalence of your device to a legally premaince health a 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 11 you t 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 other Ectoral 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/industry/support/index.html

Sincerely yours,

farbine Buehns

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/3/Picture/0 description: The image shows the logo for DePuy, a Johnson & Johnson company. The logo consists of a black circle followed by the word "DePuy" in a bold, sans-serif font. A horizontal line underlines the word "DePuy". Below the line, in a smaller font, is the text "a Johnson-Johnson company".

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: DePuy CAS Hip Instrumentation

Indications for Use:

Instruments are tracked by a passive marker sensor system that acquires landmarks of the instruments are trucked by a pacerro mouter hardware and software. This enables a bone surface when interrasod with bosition of instrumentation by a virtual 3-D computer surgeon to accurately navigato the position on on the perative hip reconstructive generated image for proclos bensted for any medical condition in which the use of procedures. The system'is indication for any where reference to a rigid anatomical structure, stereotaxe surgery may be approphato, antive 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

Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page I of of of

(Posted November 13, 2003)
Jan Marie Buehler for Nixon

Division of General, Restorative, and Neurological Devices

510(k) Number K052178