(123 days)
Not Found
No
The description focuses on a physical, non-powered positioning device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a non-powered positioning device designed to immobilize the prostate during radiation therapy, not to treat a disease or condition itself.
No
The device is described as a "positioning device" and "immobilizer" for the prostate during radiation therapy, not for diagnosing conditions. Its primary function is to stabilize the prostate for imaging and treatment, not to detect or identify a disease or medical condition.
No
The device description clearly states it is a physical, inflatable positioning device (balloon and tubing) and does not mention any software components.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device, the ERB, is a physical positioning device. It is inserted into the rectum to immobilize the prostate during radiation therapy. It does not analyze any biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use is for physical positioning and immobilization during radiation therapy, not for diagnostic testing.
Therefore, the ERB falls under the category of a medical device used for treatment support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
PCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) exam and X-ray
Anatomical Site
Rectum (for prostate immobilization)
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)
Product testing was completed and met all of the acceptance criteria. Testing included dimensional, visual, mechanical and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K141958
Device Name ERB
Indications for Use (Describe)
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.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Attachment 6
510(k) Summary
4
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 Mathison |
| Regulatory 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
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.
5
Indications for Use
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.
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 Medical
System) | RadiaDyne Prostate
Immobilizer Rectal Balloon | SE Discussion | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | PCT | PCT | Same product code - PCT | |
| 510k number | - | K132194 | | |
| Device
Classification | II | II | Same - Class II | |
| Device
description | The ERB is designed as an
immobilizer to assist in
positioning the prostate in a
more predictable and | The RadiaDyne Prostate
Immobilizer Rectal Balloon is
designed as an immobilizer to
assist in positioning the | The device description is the
same. | |
| | | | | |
| | reproducible location during
Computed Tomography (CT)
exam and X-ray, 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.
Visual and radiopaque
markers aid placement. The
ERB is meant to stabilize the
prostate once it is inflated.
The ERB is deflated and
removed after each individual
scan or therapy procedure is
compete, and a new balloon is
used in the next therapy
session. 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. | prostate in a more predictable
and reproducible location
during Computed Tomography
(CT) exam and X-ray, when
these imaging techniques are
used for Radiation Therapy
(RT) planning. The Prostate
Immobilizer Rectal Balloon is
inserted into the rectum and
inflated prior to the start of a
CT scan or RT therapy
procedure. Visual and
radiopaque markers aid
placement. The device
stabilizes the prostate once the
device is inflated. The Prostate
Immobilizer Rectal Balloon is
deflated and removed after
each individual scan or
therapy procedure is compete,
and a new balloon is used in
the next therapy session.
RadiaDyne's device is
designed for single use, is
provided non-sterile to the end
user, and is not intended to be
sterilized by the end user. | | |
| Intended Use | 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. | The 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. | Same Indications for Use | |
| Length | Balloon: 10cm; Device: 30cm | Balloon: 9cm; Device: 20cm | The small differences in the
balloon length does not affect
the safety or efficacy of the
device's ability to immobilize
the prostate. | |
| Diameter | 4.6cm | Balloon: 3.9cm when inflated | The diameter difference does
not affect the safety of the
device as the inflation of both
devices is within typical
anatomical patient differences. | |
| Deflated | 0.38cm | 0.32cm | The diameters are equivalent | |
| insertion
diameter | | | | for the insertion of the device
to the target area. |
| Method of
visualization | X-ray | X-ray | | Same |
| Conforming
treatment length | 10cm | 9cm | | The treatment length is
slightly longer for the subject
device. As stated previously,
the lengths are within patient
anatomical variability.
Therefore, the safety profile o
both devices is equivalent. |
| Sterilization | None | None | | Both devices are supplied non
sterile. |
| Single use | Y | Y | | Same |
| Shelf life | 180 days after production | Not indicated in submission | | This will be on the product
label |
| Packaging | Tyvek / nylon pouch. IFU on
8"x11" paper. | Tyvek / nylon pouch. IFU on
8"x11" paper. | | Same |
| Materials | Biocompatible | Biocompatible | | The Edge Medical device
materials were tested to the
ISO10993 standard and found
to be biocompatible. As the
RadiaDyne Prostate
Immobilizer Rectal Balloon
device was reviewed and
cleared by FDA, we assume
the materials of construction
for the RadiaDyne Prostate
Immobilizer Rectal Balloon
are biocompatible as well. |
Comparison of Product Features
6
7
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.