BEAMCATH
Device Facts
| Record ID | K042110 |
|---|---|
| Device Name | BEAMCATH |
| Applicant | Beampoint AB |
| Product Code | EZL · Gastroenterology, Urology |
| Decision Date | Feb 25, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.5130 |
| Device Class | Class 2 |
Indications for Use
The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy.
Device Story
BeamCath is a disposable, sterile, 14 French, 430 mm long urological catheter with a 10 ml balloon retention mechanism; functions as a patient positioning device for external beam conformal radiation therapy. Device inserted into urethra; balloon inflated to retain position. Contains tantalum radiopaque markers to aid radiographic visualization of prostate position. Used by clinicians during radiation therapy planning, simulation, and treatment. Radiopaque markers allow precise prostate localization, enabling accurate dose delivery while minimizing radiation exposure to surrounding healthy tissue. Device combines urological catheter configuration with radiographic positioning functionality.
Clinical Evidence
Device performance tests successfully completed. Clinical evidence includes use in several clinical studies as a prostate positioning aid during dose-escalation radiotherapy.
Technological Characteristics
2-way Foley catheter design; 14 French diameter; 10 ml natural latex balloon; PVC shaft and connector; tantalum radiopaque markers. Sterile, single-use. Functions as a passive radiographic positioning aid. No electronic components or software.
Indications for Use
Indicated for prostate cancer patients undergoing external beam conformal radiation therapy; used as a positioning aid for prostate visualization during planning, simulation, and dose escalation radiotherapy.
Regulatory Classification
Identification
A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).
Predicate Devices
- BrainLAB ExacTrac (K003285)
- NOMOS BAT (K981424)
- Rusch Simplastic Councill Tip Catheter (K974419)
- Kendall Ultramer Coude Foley Catheter (K990500)
Submission Summary (Full Text)
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K042110
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# SECTION 2. SUMMARY AND CERTIFICATION
## A. 510(K) SUMMARY
### Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the summary for the BeamCath.
| SUBMITTER'S NAME: | Beampoint AB |
|---------------------|-----------------------------------|
| ADDRESS: | Box 7984, S-907 19 Umeå<br>Sweden |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | 4 August 2004 |
#### 1. Identification of device
Proprietary Name: BeamCath Common Name: Urological Catheter Patient Positioning Device Classification Status: This device is classified as a Patient Positioning System, an accessory to Radiation Therapy Medical Systems, Class II per regulation 892.5050. In addition, its configuration and material composition are similar to Urological Catheters, Class II per regulation 876.5130.
Product Codes: IYE (Patient Positioning System Accessory), EZL (Foley Catheter),
#### 2. Equivalent devices
The BeamCath combines the function of a radiographic positioning device with the configuration of a urological Foley catheter. Beampoint believes that, from a patient positioning indication for use, BeamCath is substantially equivalent to predicate systems such as BrainLAB ExacTrac (K003285) and NOMOS BAT (K981424) devices. In addition, Beampoint believes that, from a configuration and material composition standpoint, the BeamCath is substantially equivalent to the predicate urological catheters Rusch Simplastic Councill Tip Catheter (K974419) and the Kendall Ultramer Coude Foley Catheter (K990500).
#### 3. Description of the Device
The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BearnCath combines the function of a radiographic positioning device with the configuration of a urological Foley catheter. The BeamCath configuration and material composition are similar to urological catheters with a balloon retention mechanism. The device is
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disposable, sterile and intended for single use. The BeamCath is approximately 430 mm in length and 14 French diameter with a balloon size of 10 ml. The device consists of a PVC ficitiation in 1 1 renon alaxites in instillation of contrast into the bladder and air-inflation lumen for balloon function; PVC tubing with tantalum radiopaque markers; and a natural latex balloon retention mechanism.
The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy. Precise positioning of the prostate allows for more precise dose radiation treatment without excessive side effects to surrounding tissue.
#### Intended use 4.
The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy.
#### Technological characteristics, comparison to predicate devices. ડ.
The BeamCath combines the function of a radiographic positioning device with the configuration of a urological Foley catheter. The BeamCath is similar in its indications for use as a patient positioning system to the ExacTrac and BAT systems. All the systems use standard visualization techniques that have a long history of use.
| Device | BeamCath | BrainLAB ExacTrac | NOMOS BAT |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy. | ExacTrac is a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiotherapy procedures. The ExacTrac system uses optical tracking of infrared markers on the skin and x-ray registration as the method of locating the position of the patient. | BAT can be used for the positioning of all patients that are prescribed external beam radiation treatments to organs, which are readily identifiable on ultrasound images. |
Patient Positioning Comparison Table
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Like the predicate 2-way Foley catheter devices, the BeamCath is similar in its design LIKE the predicate 2 way Forey cation characteristics. The catheters are manufactured Contriguration and materials. The catheters are designed in a similar size range. All of the devices are supplied sterile for single use.
| Device | BeamCath | Rusch Simplastic | Kendall Ultramer |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter type | 2-way Foley | 2-way Foley | 2-way Foley |
| Materials | PVC shaft and connector | PVC shaft and connector | Natural latex |
| Sizes | 10 ml latex balloon<br>14 FR | 5 ml balloon<br>12 to 26 FR | 5 to 30 ml latex balloon<br>12 to 24 FR |
| Sterile, Single Use | Yes | Yes | Yes |
| Intended Use | The BeamCath is a positioning device used with external beam conformal radiation therapy for visualizing the prostate position during treatment of prostate cancer. The BeamCath is introduced into the urethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy. | The device is intended for placement of the Foley catheter in the bladder for drainage when there is difficulty in negotiating the urethra. | The Kendall Coude Foley catheter is a urethral catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage. |
Urological Catheter Comparison Table
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#### Discussion of performance testing. 6.
Discussion of performance testing.
Device performance tests have been conducted and successfully completed. In addition, the Dovice has been successfully used in several clinical studies as a prostate positioning aid during dose-escalation radiotherapy.
#### 7. Conclusion
Based upon performance and clinical testing and a comparison to the predicate devices, it is the conclusion of Beampoint that the BeamCath is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three curved lines representing its wings and body. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2005
Beampoint AB c/o Mr. Bernard Horwath C. G. Bundy Associates, Inc. 6740 Riverview Terrace MINNEAPOLIS MN 55432
Re: K042110
Trade/Device Name: BeamCath® Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EZL Dated: February 4, 2005 Received: February 7, 2005
Dear Mr. Horwath:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your Section 910(t) promation illy equivalent (for the indications for use stated in above and have determined the ac needicate devices marketed in interstate commerce prior to the enclosure) to regary marketed predicate deal Device Amendments, or to devices that have been May 26, 1978, the elacincin date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondatics while proval application (PMA). You may, therefore, market the do not require approval of a promance approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provided on 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 (Premarket If your device is classified (360 as 10) attional controls. Existing major regulations affecting your Approval), it thay of subject to subject to same Regulations, Title 21, Parts 800 to 898. In addition, FDA ucevice can be round in the cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that r lease be advised mar 1 DTT i station in the requirements of the requirements of the Act or any FDA hade a ucternmation make your as router Federal agencies. You must comply with all the rederal statues and regulations adminisered 19 cegistration and listing (21 CFR Part 807); labeling Act STEQuirements, menuding, bat hot a mactice requirements as set forth in the quality systems (QS) (21 CFR Fart 801); and if and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whi anow you to begin marketing of substantial equivalence of your device to a legally premarket notheation: The I DA mainly of bassification 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 If you desire specific advice for your downer more of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, formation on your responsibilities under the Act from the 807.97). Tou may obtain other general missanal 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,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# B. INDICATIONS FOR USE
510(k) Number KO4ZI | O
Device Name: BeamCath
### Indications for Use:
The BeamCath is a positioning device used with external beam conformal radiation the Dealis outhering the prostate position during treatment of prostate cancer. The therapy for visualizang the probably ethra as is a sterile urological catheter and is retained in place by inflating the balloon tip. Its radiopaque markers aid in radiographic visualization of the prostate position for planning, simulation and treatment of prostate cancer using dose escalation radiotherapy.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over the Counter Use
David R. Symm
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
