The ERB is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.

Device Description

The ERB is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and Xray, when these imaging techniques are used for Radiation Therapy (RT) planning. The ERB is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The ERB is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. The ERB is designed for single use, is provided non-sterile to the end user, and is not intended to be sterilized by the end user. The ERB consists of a balloon and tubing can be inflated with either water or air. The device can be locked into place once inserted into the rectum with a locking stopper.

AI/ML Overview

The provided text is a 510(k) summary for the ERB Endorectal Balloon, a Class II medical device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.

However, it does mention "Non-Clinical Testing" and "Performance Data" in a general sense. Based on the provided text, a detailed table of acceptance criteria and reported device performance with specific metrics cannot be fully populated. The document only states that "Product testing was completed and met all of the acceptance criteria. Testing included dimensional, visual, mechanical and performance." and "All necessary verification and validation testing has been performed for the ERB to assure substantial equivalence to the predicate devices."

Here's an attempt to extract the information requested, with limitations due to the nature of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not list specific quantitative acceptance criteria or detailed performance metrics. It generally states that testing was completed and met all acceptance criteria, and that the device's performance attributes are equivalent to the predicate. Therefore, the "Reported Device Performance" column reflects generalized statements from the document.

Acceptance Criteria Category	Reported Device Performance
Dimensional	Met all acceptance criteria. Dimensions are equivalent to predicate (minor differences in length/diameter not affecting safety/efficacy)
Visual	Met all acceptance criteria.
Mechanical	Met all acceptance criteria.
Performance	Met all acceptance criteria. Performance attributes are equivalent to predicate.
Biocompatibility	Passed ISO10993 testing (Cytotoxicity, Sensitization, Irritation). Materials are suitable for use and have been used in numerous previously cleared products.

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

The document does not specify the sample size used for the test set in non-clinical testing. It only mentions "Product testing" and "All necessary verification and validation testing."

Data Provenance: The testing appears to be non-clinical (laboratory/bench testing) rather than clinical studies on human subjects. The document does not specify the country of origin for the data or if it was retrospective or prospective, beyond stating that Edge Medical, LLC performed the testing.

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

This information is not applicable and not provided in the document. The testing described is non-clinical (dimensional, visual, mechanical, performance, biocompatibility) of a physical device, not an AI/software device that would require expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated in point 3.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging interpretation devices, often involving AI assistance for human readers. The ERB Endorectal Balloon is a physical medical device for prostate immobilization during radiation therapy.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done, as the ERB is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing mentioned (dimensional, visual, mechanical, performance), the "ground truth" would be established by engineering specifications, material standards, and benchmark measurements against known properties of the device and its predicate. For biocompatibility, the ground truth is established by adherence to ISO10993 standards.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The ERB is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable and not provided in the document for the reasons stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird or abstract human figures, with three distinct profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2014

Edge Medical LLC % Mr. Gregory Mathison President Regulatory Strategies. Inc. 3924 Cascade Beach Road LUTSEN MN 55612

Re: K141958

Trade/Device Name: ERB Endorectal Balloon Regulation Number: 21 CFR 892.5720 Regulation Name: Rectal balloon for prostate immobilization Regulatory Class: II Product Code: PCT Dated: September 11, 2014 Received: September 16, 2014

Dear Mr. Mathison:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141958

Device Name ERB

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Attachment 6

510(k) Summary

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510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

APPLICANT:	Edge Medical, LLC
TRADE NAME:	ERB
COMMON NAME:	Endorectal Balloon
CLASSIFICATION NAME:	Rectal Balloon for Prostate Immobilization,21 CFR 892.5720
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE:	PCT
PREDICATE DEVICES:	RadiaDyne Prostate Immobilizer Rectal Balloon(K132194)
CONTACT	Greg MathisonRegulatory Affairs
DATE:	July7, 2014

Substantially Equivalent to:

The ERB is equivalent in intended use, principal of operation and technological characteristics to the RadiaDyne Prostate Immobilizer Rectal Balloon (K132194).

Description of the device subject to premarket notification

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Indications for Use

Materials

All materials used in the manufacture of the ERB are suitable for this use and have been used in numerous previously cleared products. The ERB materials were tested per ISO10993 and found to be biocompatible. Testing included the following:

Cytotoxicity .
. Sensitization
Irritation .

Non-Clinical Testing

Product testing was completed and met all of the acceptance criteria. Testing included dimensional, visual, mechanical and performance.

Performance Data:

All necessary verification and validation testing has been performed for the ERB to assure substantial equivalence to the predicate devices.

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the ERB is determined by Edge Medical, to be substantially equivalent to existing legally marketed devices.

Trade name	Device (Edge MedicalSystem)	RadiaDyne ProstateImmobilizer Rectal Balloon	SE Discussion
Product code	PCT	PCT	Same product code - PCT
510k number	-	K132194
DeviceClassification	II	II	Same - Class II
Devicedescription	The ERB is designed as animmobilizer to assist inpositioning the prostate in amore predictable and	The RadiaDyne ProstateImmobilizer Rectal Balloon isdesigned as an immobilizer toassist in positioning the	The device description is thesame.

	reproducible location duringComputed Tomography (CT)exam and X-ray, when theseimaging techniques are usedfor Radiation Therapy (RT)planning. The ERB is insertedinto the rectum and inflatedprior to the start of a CT scanor RT therapy procedure.Visual and radiopaquemarkers aid placement. TheERB is meant to stabilize theprostate once it is inflated.The ERB is deflated andremoved after each individualscan or therapy procedure iscompete, and a new balloon isused in the next therapysession. ERB is designed forsingle use, is provided non-sterile to the end user, and isnot intended to be sterilized bythe end user.	prostate in a more predictableand reproducible locationduring Computed Tomography(CT) exam and X-ray, whenthese imaging techniques areused for Radiation Therapy(RT) planning. The ProstateImmobilizer Rectal Balloon isinserted into the rectum andinflated prior to the start of aCT scan or RT therapyprocedure. Visual andradiopaque markers aidplacement. The devicestabilizes the prostate once thedevice is inflated. The ProstateImmobilizer Rectal Balloon isdeflated and removed aftereach individual scan ortherapy procedure is compete,and a new balloon is used inthe next therapy session.RadiaDyne's device isdesigned for single use, isprovided non-sterile to the enduser, and is not intended to besterilized by the end user.
Intended Use	The ERB is a single use,inflatable, non-poweredpositioning device placed inthe rectum to immobilize theprostate in patients undergoingradiation therapy. The deviceis intended to be used duringall the phases of radiationtherapy, including treatmentplanning, image verification,and radiotherapy delivery.	The rectal balloon for prostateimmobilization is a single use,inflatable, non-poweredpositioning device placed inthe rectum to immobilize theprostate in patients undergoingradiation therapy. The deviceis intended to be used duringall the phases of radiationtherapy, including treatmentplanning, image verification,and radiotherapy delivery.	Same Indications for Use
Length	Balloon: 10cm; Device: 30cm	Balloon: 9cm; Device: 20cm	The small differences in theballoon length does not affectthe safety or efficacy of thedevice's ability to immobilizethe prostate.
Diameter	4.6cm	Balloon: 3.9cm when inflated	The diameter difference doesnot affect the safety of thedevice as the inflation of bothdevices is within typicalanatomical patient differences.
Deflated	0.38cm	0.32cm	The diameters are equivalent
insertiondiameter				for the insertion of the deviceto the target area.
Method ofvisualization	X-ray	X-ray		Same
Conformingtreatment length	10cm	9cm		The treatment length isslightly longer for the subjectdevice. As stated previously,the lengths are within patientanatomical variability.Therefore, the safety profile oboth devices is equivalent.
Sterilization	None	None		Both devices are supplied nonsterile.
Single use	Y	Y		Same
Shelf life	180 days after production	Not indicated in submission		This will be on the productlabel
Packaging	Tyvek / nylon pouch. IFU on8"x11" paper.	Tyvek / nylon pouch. IFU on8"x11" paper.		Same
Materials	Biocompatible	Biocompatible		The Edge Medical devicematerials were tested to theISO10993 standard and foundto be biocompatible. As theRadiaDyne ProstateImmobilizer Rectal Balloondevice was reviewed andcleared by FDA, we assumethe materials of constructionfor the RadiaDyne ProstateImmobilizer Rectal Balloonare biocompatible as well.

Comparison of Product Features

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Conclusion

The products are substantially equivalent as the indications for use are the same, the clinical application is the same, the materials are equivalent, the dimensions are equivalent and the tested product performance attributes are equivalent.

Regulation Number and Section

§ 892.5720 Rectal balloon for prostate immobilization.

(a)
Identification. A rectal balloon for prostate immobilization is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The premarket notification submission must include methodology and results of the following non-clinical and clinical performance testing:
(i) Biocompatibility testing of the final finished device;
(ii) If provided sterile, sterilization validation;
(iii) If not provided sterile, bioburden testing of the final finished device;
(iv) Shelf life and expiration date validation; and
(v) Performance testing including but not limited to:
(A) Venting mechanism (if device has a vent mechanism);
(B) Safety mechanism(s) to prevent advancement beyond its intended safe placement; and
(C) Structural integrity testing (
e.g., tensile strength, balloon leakage and burst strength).(2) Labeling that includes:
(i) Appropriate warnings and contraindications, including, but not limited to the following statements:
(A) “Do not transport the patient with the rectal balloon inserted. The balloon should be removed prior to transport.”;
(B) “Failure to perform the standard imaging position verification protocol may cause the device to not perform as intended.”;
(C) “Reduce the rectal balloon fill volume if the patient experiences discomfort due to the rectal balloon inflation.”; and
(D) “Do not apply excessive pressure/force on the shaft or tubing of the rectal balloon.”
(ii) Adequate instructions for use on the proper insertion procedure, positioning, and inflation of the rectal balloon;
(iii) Whether the device is sterile or non-sterile; and
(iv) An expiration date.