(104 days)
No
The device description and performance studies focus on mechanical properties, material testing, and biocompatibility of a patient positioning device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a patient-positioning device used to support and immobilize patients during radiation therapy, not to provide therapy itself. The device is used as an aid for aligning the patient and supporting the patient while receiving their treatment.
No
The device is a patient-positioning and immobilization device used during radiation therapy. It does not collect or analyze medical data to diagnose a condition.
No
The device description clearly outlines a physical patient-positioning device made of materials like carbon fiber, with mechanical components like a backboard, base, legs, and indexing systems. It also includes various physical accessories. There is no mention of software as a component of the device itself.
Based on the provided information, the ZDi Z-Tilt is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "patient support and immobilization during external beam radiation therapy." This is a therapeutic application, not a diagnostic one.
- Device Description: The description details a physical device used for positioning and stabilizing a patient during treatment. It does not involve the examination of specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Z-Tilt's function is entirely focused on supporting and positioning the patient for a therapeutic procedure (radiation therapy).
N/A
Intended Use / Indications for Use
ZDi Z-Tilt is intended for use by trained medical professionals for patient support and immobilization during external beam radiation therapy in clinics and hospitals. The Z-Tilt and accessories provide patient comfort and stability in various positions for radiation treatment. The Z-Tilt and is used in the treatment of cancer under the supervision and administration of licensed doctors and clinical staff.
Product codes
IYE
Device Description
The Z-Tilt is a patient-positioning device designed specifically for applications within Proton Therapy. The Z-Tilt features a thin, low-stopping power backboard able to hold the heaviest of patients treated with proton therapy. The Z-Tilt offers a scoop feature that acts as a seat for patients to rest against. This seat allows an easily reproducible, fixed hip position. The scoop prevents the patient from sliding down the tilt, and also ensures thoracic alignment in the treatment area. The Z-Tilt is sixteen inches wide at its widest point, tapering into a ten-inch square to receive another ZDi device, the Z-Square. The Z-Square easily indexes to the Z-Tilt backboard to securely lock and index the custom foam patient molds to the device. The Z-Tilt is designed to be strong and sturdy, but with minimal amounts of material in critical areas of potential beam passage. The Z-Tilt backboard is attached to a slim, strong base. The base is narrow in the middle to allow beam passage, but wide enough to prevent wobble. The cranial end of the base is also a ten-inch square, holding hinged support legs to brace the backboard at various positions equaling four, eight, and twelve degrees; the most commonly needed patient tilt positions. The Z-Tilt base is designed with indexing holes to index to any standard index bar used on treatment tables. It is designed to remain within sixteen inches wide to prevent interference with table edges, table tracks, and CT bores. The Z-Tilt will have marks on each hole for accurate reproducibility of the Z-Square indexing system and for the leg supports for the incline. The patient will be in contact with their custom mold used on top of the Z-System.
The associated accessories include:
- Z-Square Indexing System for patient mold reproducibility
- Z-Bar Index Bar for Z-Square mounting
- Z-Box for custom formation of patient molds
- Z-Pulls for arms-down reproducible arm positioning
- Z-Foam for various foam patient supports under the custom patient molds
- Z-Scoop for thoracic positioning on the Z-Tilt and table
- Z-Roll for lateral positioning of the Z-Tilt
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast and Thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical professionals in clinics and hospitals.
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)
Mechanical Testing:
- The subject device underwent a weight test at each of the three degrees of incline.
- Each angle held the manufacturer recommendation of 250 pounds for a 60 minute time frame.
- Each accessory was able to hold their respective manufacturer suggested weights of 50 lbs each for 60 minutes.
Material Testing:
- Standard dose effects on various beam energies for carbon fiber, the main component of the subject and predicate devices.
- Carbon Fiber thickness (Minimum and Maximum) in Z-System - .32 cm
- .32 cm Carbon Fiber WET for 230 meV (max meV)= 0.12 cm
- Stopping Power ("attenuation" in proton beam) = 3.657e/cm2 for a 230meV proton beam in Carbon Fiber
Biocompatibility:
- The subject and predicate devices are both carbon fiber composites.
- Per article – carbon fiber, in vivo and in vitro, has no cytotoxic effects.
- The subject device will be used in conjunction with a custom patient mold. The expandable foam and vacuum locking molds are already approved devices offered by Med-Tech, Inc, K951808 and K935300, respectively. The Z-System is an aide for making and supporting these other devices.
Effectiveness:
- The subject and predicate devices are both similarly designed.
- Clinics using the predicate device have had successful outcomes for treatments.
- The device is not responsible for the actual treatment, rather it is only used as an aid for aligning the patient and supporting the patient while receiving their treatment.
- Both devices are non-invasive and the subject device, considering all features, is no less effective than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2016
ZDi, Solutions, LLC % Mr. Zachary Dutton President 800 S. Gay Street, Suite 714 KNOXVILLE TN 37929
Re: K162002
Trade/Device Name: Z-Box/Z-Tilt Breast and Thoracic Positioning Device. Z-Square Indexing System. Z-Foam Cushion and Z-Bar Index Bar and Z-Pulls Patient Hand Grip Overlay Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 14, 2016 Received: October 20, 2016
Dear Mr. Dutton:
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 O'Hara
For
Robert Ochs, Ph.D. 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)
Device Name
Z-Box/Z-Titt Breast and Thoracic Positioning Device and Z-Square Indexing System and Z-Bar Index Bar and Z-Pulls Patient Hand Grip Overlay
Indications for Use (Describe)
ZDi Z-Tilt is intended for use by trained medical professionals for patient support and immobilization during external beam radiation therapy in clinics and hospitals. The Z-Tilt and accessories provide patient comfort and stability in various positions for radiation treatment. The Z-Tilt and is used in the treatment of cancer under the supervision and administration of licensed doctors and clinical staff.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for ZDi solutions. The letters "ZDi" are in bold, black font, with a light blue plus sign above the "i". The word "solutions" is written in a smaller font below the letters. The logo is surrounded by a blue oval shape.
Patient Positioning Devices for Radiation and Proton Therapy ZDi, Solutions, LLC Performance Data 510(k) - K162002
510(k) Summary
l. Submitter
ZDi, Solutions, LLC 800 S Gay St, STE 714 Knoxville, TN 37909
Phone: 865-809-7283
Contact Person: Zach Dutton Date Prepared: July 18, 2016
II. Device
Name of Device: Z-Tilt Breast and Thoracic Positioning Device and Accessories Common or Usual Name: Radiation Therapy Patient Positioning Device Classification Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: II Product Code: IYE
lll. Predicate Devices
Klarity Medical Products, Inc. Klarity Breast Board (R610), K982624
This predicate device has not been subject to a design-related recall.
IV. Device Description
The Z-Tilt is a patient-positioning device designed specifically for applications within Proton Therapy. The Z-Tilt features a thin, low-stopping power backboard able to hold the heaviest of patients treated with proton therapy. The Z-Tilt offers a scoop feature that acts as a seat for patients to rest against. This seat allows an easily reproducible, fixed hip position. The scoop prevents the patient from sliding down the tilt, and also ensures thoracic alignment in the treatment area. The Z-Tilt is sixteen inches wide at its widest point, tapering into a ten-inch square to receive another ZDi device, the Z-Square. The Z-Square easily indexes to the Z-Tilt backboard to securely lock and index the custom foam patient molds to the device. The Z-Tilt is designed to be strong and sturdy, but with minimal amounts of material in critical areas of potential beam passage. The Z-Tilt backboard is attached to a slim, strong base. The base is narrow in the middle to allow beam passage, but wide enough to prevent wobble. The cranial end of the base is also a
4
Image /page/4/Picture/0 description: The image shows the logo for ZDi Solutions. The letters "ZDI" are in a bold, black font, with a blue plus sign above the "i". The word "solutions" is written in a smaller, blue font below the letters. The logo is surrounded by a blue oval shape.
Patient Positioning Devices for Radiation and Proton Therapy ZDi, Solutions, LLC
Performance Data 510(k) - K162002
ten-inch square, holding hinged support legs to brace the backboard at various positions equaling four, eight, and twelve degrees; the most commonly needed patient tilt positions. The Z-Tilt base is designed with indexing holes to index to any standard index bar used on treatment tables. It is designed to remain within sixteen inches wide to prevent interference with table edges, table tracks, and CT bores. The Z-Tilt will have marks on each hole for accurate reproducibility of the Z-Square indexing system and for the leg supports for the incline. The patient will be in contact with their custom mold used on top of the Z-System.
The associated accessories include:
- Z-Square Indexing System for patient mold reproducibility ●
- Z-Bar Index Bar for Z-Square mounting ●
- Z-Box for custom formation of patient molds
- Z-Pulls for arms-down reproducible arm positioning
- . Z-Foam for various foam patient supports under the custom patient molds
- Z-Scoop for thoracic positioning on the Z-Tilt and table
- Z-Roll for lateral positioning of the Z-Tilt ●
V. Indications for Use:
These devices are intended for use by trained medical professionals for patient support and immobilization during external beam radiation therapy in clinics and hospitals. The devices provide patient comfort and stability in various positions for radiation treatment. The devices are used in the treatment of cancer under the supervision and administration of licensed doctors and clinical staff.
VI. Comparison of Technological Characteristics with the Predicate Device
Patient positioning for Radiation Therapy treatments is the technological principle for both the subject and predicate devices. The devices must support the patient in various positions to ensure the accurate delivery of a radiation therapy treatment. At a high level, the subject and predicate devices are based on the following same technological elements:
- . Base Plate with adjustable legs for backboard support
- Backboard for overall patient support
- Arm positioning system
- Thoracic Indexing System
- Table Indexing System
- Alignment marks
- Mainly carbon fiber design, some plastic and metal components
The following technological differences exist between the subject and predicate devices, but in no way alter the safety or effectiveness of the subject device
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Image /page/5/Picture/0 description: The image shows the logo for ZDI solutions. The letters ZDI are in bold black font, with a light blue plus sign above the I. The word "solutions" is written in a smaller font below the letters ZDI. The logo is surrounded by a blue oval shape.
Patient Positioning Devices for Radiation and Proton Therapy ZDi, Solutions, LLC Performance Data 510(k) - K162002
- Seat-like thoracic positioner
- Winged arm supports
- Foam Accessories ●
- . Custom Molding accessories
VII. Performance Data
Both the subject and the predicate consist of carbon fiber components which allow minimal radiation beam attenuation. With both devices possessing the same dimensions and characteristics, the beam influence will be the same.
Mechanical Testing
The subject device underwent a weight test at each of the three degrees of incline. Each angle held the manufacturer recommendation of 250 pounds for a 60 minute time frame. Each accessory was able to hold their respective manufacturer suggested weights of 50 lbs each for 60 minutes.
Material Testing
These are the standard dose effects on various beam energies for carbon fiber, the main component of the subject and predicate devices.
| Absorption Factor % | |||||
|---|---|---|---|---|---|
| Thickness | Material | Co- | |||
| 60 | 6MV | 8MV | 15MV | ||
| 20mm | Carbon Fiber | 2.6 | 2 | 1.7 | 1.5 |
Carbon Fiber thickness (Minimum and Maximum) in Z-System - .32 cm
.32 cm Carbon Fiber WET for 230 meV (max me/)= 0.12 cm
Stopping Power ("attenuation" in proton beam) = 3.657e/cm2 for a 230meV proton beam in Carbon Fiber
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Image /page/6/Picture/0 description: The image shows the logo for ZDi solutions. The logo features the letters "ZDi" in a bold, black font, with a light blue plus sign above the "i". The word "solutions" is written in a smaller font below the letters. The logo is surrounded by a blue oval shape.
Patient Positioning Devices for Radiation and Proton Therapy ZDi, Solutions, LLC Performance Data 510(k) - K162002
Biocompatibility
The subject and predicate devices are both carbon fiber composites. Per article – carbon fiber, in vivo and in vitro, has no cytotoxic effects. Furthermore, the subject device will be used in conjunction with a custom patient mold. The expandable foam and vacuum locking molds are already approved devices offered by Med-Tech, Inc, K951808 and K935300, respectively. The Z-System is an aide for making and supporting these other devices.
Effectiveness
The subject and predicate devices are both similarly designed. Clinics using the predicate device have had successful outcomes for treatments. The device is not responsible for the actual treatment, rather it is only used as an aid for aligning the patient and supporting the patient while receiving their treatment. Both devices are non-invasive and the subject device, considering all features, is no less effective than the predicate device.
VIII. Conclusions
Since the predicate device was cleared based on substantial equivalence to previously cleared, comparable devices, using the same materials, design, and having the same intended uses and manufacturing processes, the ZDi, Solutions, LLC Z-Tilt and accessories should be cleared based on their similarities to the predicate device and other devices. Technological, safety, effectiveness, biological, and all other factors of the subject Z-Tilt device are all substantially equivalent to the predicate device.