(14 days)
N/A
No
The document describes a physical applicator for delivering radiation and does not mention any software or algorithms that would incorporate AI or ML.
Yes
The device is intended to deliver radiation treatment, which is a therapeutic intervention, and is used to support high-dose-rate X-ray radiation delivery in brachytherapy.
No
The device is an applicator intended to support the delivery of high-dose-rate X-ray radiation for brachytherapy, not to diagnose medical conditions.
No
The device description explicitly states it is a "component of the Sensus Healthcare IORT system" and is a "single-use disposable device" that is "provided sterile," indicating it is a physical hardware component, not software only.
Based on the provided information, the Sensus Healthcare TVM Balloon Applicator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "support the delivery of high-dose-rate X-ray radiation in support for brachytherapy." This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a component of a radiation delivery system and is used to physically support the delivery of radiation. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Function: The description focuses on the physical function of the balloon applicator in positioning and supporting radiation delivery. There is no mention of analyzing samples or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Sensus Healthcare TVM Balloon Applicator does not fit this definition.
N/A
Intended Use / Indications for Use
The Sensus Healthcare TVM Balloon Applicator is intended to support the delivery of high-dose-rate X-ray radiation in support for brachytherapy.
The Sensus TVM Balloon Applicator is indicated for use with the Sensus IORT System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.
Product codes (comma separated list FDA assigned to the subject device)
JAD
Device Description
The Sensus Healthcare TVM Balloon Applicator is a component of the Sensus Healthcare IORT system, which utilizes an X-ray source and does not employ radioactive isotopes. The TVM Balloon Applicator supports the Sensus Healthcare IORT System's ability to deliver intraoperative brachytherapy wherever the physician chooses to delivery radiation therapy. The Sensus Healthcare TVM Balloon Applicator is provided in one size (variablevolume balloon) to support the achievement of proper fit within the varying patient anatomies. The applicator is a single-use disposable device that is provided sterile. Product sterility is achieved through the use of Gamma radiation (reference ISO 11137-1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
stand-alone ultrasound system, stand-alone CT image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician and other speciallyqualified individuals properly trained in the system's use and application.
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)
Performance testing consisted of bench testing that has demonstrated that the performance of the TVM Balloon Applicator provided the same technical capabilities as the predicate device. Performance testing was executed to validate the operational characteristics associated with the TVM Balloon Applicator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Xoft Axxent Balloon Applicator (K090914)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
N/A
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 21, 2019
Sensus Healthcare, Inc Nicolas Soro OA/RA Manager 851 Broken Sound Parkway NW, Suite 215 BOCA RATON FL 33487
Re: K190255
Trade/Device Name: Sensus Healthcare TVM Balloon Applicator Regulation Number: 21 CFR 892.5900 Regulation Name: X-Ray Radiation Therapy System Regulatory Class: Class II Product Code: JAD Dated: February 6, 2019 Received: February 7, 2019
Dear Mr. Soro:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use
Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
| 510(k) Number (if known) | K190255 |
|---|---|
| Device Name | TVM Balloon Applicator |
Indications for Use (Describe)
The Sensus TVM Balloon Applicator is indicated for use with the Sensus IORT System to deliver intracavity or
intraoperative brachytherapy where
| 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." | |
| FORM FDA 3881 (7/17) | Page 1 of 1 |
| PSC Publishing Services (301) 443-6740 |
3
510(k) Summary
510(k) SUMMARY
[As Required by 21 CFR 807.92(c)]
| Submitter's Name & Address: | Sensus Healthcare
851 Broken Sound Parkway NW
Suite 215
Boca Raton, FL 33487 |
|-----------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Kal Fishman, COO
Telephone (561) 922-5808
Fax (561) 948-2071
kal@sensushealthcare.com |
| Date Summary Prepared: | February 6, 2019 |
| Device Name: | Trade/Proprietary Name – TVM Balloon Applicator |
| | Common/Usual Name – Superficial X-ray Radiation
Therapy System |
| | Classification Name – X-ray Radiation Therapy System
(892.5900) |
| Predicate Device: | Xoft Axxent Balloon Applicator (K090914) |
| Reference Device: | N/A |
4
Device Description:
The Sensus Healthcare TVM Balloon Applicator is a component of the Sensus Healthcare IORT system, which utilizes an X-ray source and does not employ radioactive isotopes. The TVM Balloon Applicator supports the Sensus Healthcare IORT System's ability to deliver intraoperative brachytherapy wherever the physician chooses to delivery radiation therapy. The Sensus Healthcare TVM Balloon Applicator is provided in one size (variablevolume balloon) to support the achievement of proper fit within the varying patient anatomies. The applicator is a single-use disposable device that is provided sterile. Product sterility is achieved through the use of Gamma radiation (reference ISO 11137-1).
Intended Use:
The Sensus Healthcare TVM Balloon Applicator is intended to support the delivery of high-dose-rate X-ray radiation in support for brachytherapy.
Indications for Use:
The Sensus TVM Balloon Applicator is indicated for use with the Sensus IORT System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.
Prescriptive Statement:
The TVM Balloon Applicator is intended for use by a physician and other speciallyqualified individuals properly trained in the system's use and application.
Caution: Federal law restricts this device to sale by or on the order of a physician.
5
Technological Characteristics/Principles of Operation:
The TVM Balloon Applicator serves as an interface medium between the Sensus Healthcare IORT System and the patient's treated tissue surface. The TVM Balloon Applicator device is inserted post-surgical removal of the cancerous tumor through the surgical incision, or any other bodily cavity that allows access, and it is inflated to a desired volume in order to equally distribute the patient's tissue surface around the balloon in a pseudo-spherical geometry, which optimizes the radiation treatment planning and beam distribution in the treated tissue bed.
The TVM Balloon Applicator's volume is controlled by the inflation and deflation utilizing sterile saline solution through the Filling and Priming water lines attached to the balloon. The two syringes for inflation and deflation are connected to the water lines and flow system through the two-way and three-way stopcock valves, respectively. The saline bag that contains the saline medium solution is connected to the three-way stopcock valve and its flow is controlled by the Filling Syringe. The Priming Syringe is utilized to prime the balloon pre and during the balloon inflation/filling process and to deflate the balloon after the procedure is complete.
Once the balloon is positioned in the patient, at the designated treatment site, and secured to the patient's skin/exterior surface by the integrated Surgical Adhesive Membrane, the balloon is inflated by the Filling Syringe and its volume monitored by the operator utilizing a stand-alone ultrasound system. Once the TVM Balloon Applicator device is positioned, secured, and inflated to the required volume, the operators perform a stand-alone CT image of the nestled TVM Balloon Applicator device in the patient for image-guidance for the Treatment Planning System's (TPS) planning procedure. Once the treatment plan has been developed using the TPS, it is sent to the Sensus IORT System and the treatment is administrated to the patient. Once the
6
treatment delivery is complete, the balloon is deflated by the Priming Syringe, and the TVM Balloon Applicator device is extracted from the patient and disposed of in a bio-hazard-safe container. The patient is then sutured by the surgeon and the total procedure is complete.
The TVM Balloon Applicator device also incorporates three embedded Tantalum fiducial markers to assist with spatial orientation and registration of the TVM Balloon Applicator device in the patient. The fiducial markers are picked up by a stand-alone CT scan and provide the Treatment Planning System with the triangulating registration points of reference.
Non-Clinical Performance Testing:
Performance testing consisted of bench testing that has demonstrated that the performance of the TVM Balloon Applicator provided the same technical capabilities as the predicate device. Performance testing was executed to validate the operational characteristics associated with the TVM Balloon Applicator.
| TEST REPORT | TEST |
|---|---|
| 6-2-6684-0000 | System Level Verification Test |
| 6-2-6422-0000 | System Level Validation Test |
| TVM-PPQ-001 | Pull Testing |
| TVM-PPQ-002 | Decay Testing |
| TVM-PPQ-003 | Burst Testing |
Non-clinical Safety Tests:
The Sensus Healthcare TVM Balloon Applicator has been designed and constructed to
meet the following electrical and mechanical safety standards:
- o ISO 11137-1 - Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
7
- ISO 11607-1 Packaging for terminally sterilized medical devices -- Part 1: ● Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2- Packaging for terminally sterilized medical devices Part 2: Validation ● requirements for forming, sealing and assembly processes
- ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing ● within a risk management process
- . ISO 10993-5 - Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10 - Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic ● toxicity
| TEST STANDARD | TEST | REPORT |
|---|---|---|
| ISO 10993-5 | Cytotoxicity | 18-02594-G2 |
| ISO 10993-10 | Intracutaneous Injection | 18-02594-G3 |
| ISO 10993 | Skin Sensitization | 18-02594-G1 |
| ISO 10993-11 | Acute Systemic Toxicity | 18-04745-G1 |
| USP Chapter | Pyrogenicity Test | F18-1619-00 |
| F18-1620-00 | ||
| F18-1621-00 | ||
| ISO 11137 | Gamma Sterilization | F18-1038-00 |
| ISO 11607 | Package Validation | TVM-PV-001 |
| F18-0931-00 | ||
| F18-1039-00 | ||
| F18-1040-00 | ||
| ASTM D4169-16 | Transit Testing | 115-18-2759A |