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 Description

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 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.

AI/ML Overview

The provided text describes the BeamCath, a urological catheter with radiopaque markers intended for prostate positioning during external beam radiation therapy for prostate cancer. However, the document does not contain specific acceptance criteria, detailed results of a study proving those criteria were met, or most of the information requested in your prompt regarding study design details (sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.).

Instead, the document states:

"Device performance tests have been conducted and successfully completed."
"In addition, the Device [BeamCath] has been successfully used in several clinical studies as a prostate positioning aid during dose-escalation radiotherapy."
"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."

This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed report of clinical trials and specific performance metrics and acceptance criteria. For devices cleared through the 510(k) pathway, the primary proof of safety and effectiveness often comes from demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.

Therefore, many of the specific details you requested cannot be extracted from this document because they are generally not included in a 510(k) summary.

Based on the provided text, here is what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numeric acceptance criteria for device performance (e.g., accuracy of positioning, displacement limits, or diagnostic performance metrics) are provided in this summary. The document generally states "Device performance tests have been conducted and successfully completed," implying that the device met internal or regulatory performance specifications, but these are not enumerated.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size (Test Set): Not specified. The document mentions "several clinical studies," but no sample sizes for these studies are provided.
Data Provenance: "Several clinical studies" are mentioned, implying clinical data. The country of origin is not specified, but the applicant (Beampoint AB) is from Sweden. The studies appear to be prospective, as the device was "successfully used" in them.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not specified. The document does not describe how ground truth was established for the clinical studies.

4. Adjudication Method for the Test Set:

Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

Not specified. The document focuses on the device's function as a positioning aid and its substantial equivalence to other positioning systems and catheters. It does not present data from studies comparing human readers with and without AI assistance (as the BeamCath is a physical positioning device, not an AI diagnostic tool).

6. If a Standalone (Algorithm Only) Performance Study Was Done:

Not applicable. The BeamCath is a physical medical device (catheter) with radiopaque markers, not an algorithm. Its "standalone" performance would relate to its physical properties and ability to be visualized, which were covered by "device performance tests."

7. The Type of Ground Truth Used:

Not specified. For a positioning device, ground truth might involve highly accurate imaging modalities or physical measurements from a phantom. The document only mentions the device aids in "radiographic visualization of the prostate position."

8. The Sample Size for the Training Set:

Not applicable or not specified. As a physical device, there isn't a "training set" in the sense of machine learning algorithms. If "training set" refers to data used to refine the device's design or properties, that information is not provided.

9. How the Ground Truth for the Training Set Was Established:

Not applicable or not specified.

Summary

{0}------------------------------------------------

K042110

Page 1 of 4

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 UmeåSweden
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

{1}------------------------------------------------

K042110

Page 2 of 4

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.

Intended use 4.

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

{2}------------------------------------------------

K042110

Page 3 of 4

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 balloon14 FR	5 ml balloon12 to 26 FR	5 to 30 ml latex balloon12 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

{3}------------------------------------------------

K042110
Page 4 of 4

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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

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

{6}------------------------------------------------

Page 1 of 1

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)

Over the Counter Use

David R. Symm
(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
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).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.