Who is the manufacturer of CADPLAN BT?

Varian Assoc., Inc. submitted the Traditional clearance for CADPLAN BT (K954467).

What is the FDA product code for CADPLAN BT?

JAQ. It is classified under 21 CFR 892.5700 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for CADPLAN BT?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CADPLAN BT?

Varian VariSource Treatment Planning System (K945383).

CADPLAN BT

K954467 · Varian Assoc., Inc. · JAQ · Mar 15, 1996 · Radiology

Device Facts

Record ID	K954467
Device Name	CADPLAN BT
Applicant	Varian Assoc., Inc.
Product Code	JAQ · Radiology
Decision Date	Mar 15, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.5700
Device Class	Class 2
Attributes	Therapeutic

Intended Use

CADPLAN BT is designed to allow the dose distribution of an applicator to be individually shaped for each patient.

Device Story

CADPLAN BT is a Windows NT software application for brachytherapy treatment planning; operates in conjunction with VariSource High Dose Rate Remote Afterloader. Inputs include radiograph imaging (stereoshifted and orthogonal films) for applicator placement (up to 20 channels). Device calculates geometrically-optimal dwell times for catheters and shapes dose distribution per patient. Used by clinicians in oncology settings to facilitate radiation therapy planning. Output consists of optimized treatment plans and dwell time calculations, enabling precise radiation delivery to target tissues while sparing healthy anatomy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Windows NT software application. Supports stereoshifted and orthogonal film imaging. Utilizes linear source model for IR-192. Features automated dwell time calculation algorithm versus manual calculation in predicate. Calculates dose volume histograms.

Indications for Use

Indicated for patients undergoing brachytherapy requiring individualized dose distribution shaping and dwell time calculation for the VariSource High Dose Rate Remote Afterloader.

Regulatory Classification

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Predicate Devices

Varian VariSource Treatment Planning System (K945383)

Related Devices

K081112 — FLEXIPLAN BRACHYTHERAPY TREATMENT PLANNING SYSTEM · Isodose Control B.V. · Jul 29, 2008
K091145 — FLEXIPLAN 3D AND 3D+ · Isodose Control B.V. · May 27, 2009
K123263 — HDRPLUS, ADD IN PROSTATE MODULE FOR HDRPLUS · Eckert & Ziegler Bebig GmbH · Apr 4, 2013
K992762 — BRACHYVISION 6.0 · Varian Assoc., Inc. · Mar 9, 2000
K141900 — SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE · Eckert & Ziegler Bebig GmbH · May 20, 2015

Submission Summary (Full Text)

{0} SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION K954467 1. Submitter: Varian Oncology Systems 911 Hansen Way Palo Alto, CA 94304 (415) 424-5036 Contact: Charles H. Will, Manager Regulatory Compliance & Safety Prepared: September 15, 1995 MAR 15 1996 2. Device Name: CADPLAN BT 3. Predicate Device: Varian VariSource Treatment Planning System 510(k) Notification 945383 (Varian VariSource High Dose Rate Remote Afterloader) Cleared February 15, 1995 4. Device CADPLAN BT is a Windows NT software application that is designed to work together with the VariSource High Dose Rate Remote Afterloader. It allows for applicator placement for up to 20 channels, and allows dose distribution of an applicator to be individually shaped for each patient. It also allows for calculation of the dwell time of the catheter. 5. Intended Use: CADPLAN BT is designed to allow the dose distribution of an applicator to be individually shaped for each patient. 6. Technological Characteristics Both CADPLAN BT and VariSource Treatment Planning System have plan and multiple plan dose calculation, radiograph imaging definition that support's stereoshifted and orthogonal films and a linear source model for IR-192. Natural dose volume histogram can be calculated manually from normal dose volume histogram in both systems. CADPLAN BT calculates the geometrically-optimal dwell times through the software, whereas with the VariSource Treatment Planning System these dwell times must be calculated manually.