(196 days)
No
The device is a physical implantable marker and the description focuses on its material composition and intended use for marking tissue, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is used to mark the location of a tumor cavity or soft tissue for future medical procedures like radiation therapy, but it does not directly treat or cure any condition itself.
No
Explanation: The device is a fiducial marker used to mark the location of a tumor cavity or soft tissue for future medical procedures like radiation therapy. It is an implantable marker and does not perform any diagnostic function itself. Its purpose is to facilitate therapy, not to diagnose a condition.
No
The device description explicitly states it is an "implantable marker comprised of an absorbable suture... and a permanent component, a Platinum or Gold Marker". This describes a physical, implantable hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The ACCUSYTE™ 3D Fiducial Markers are implantable markers used to physically mark a location within the body for future medical procedures (like radiation therapy). They are not used to analyze samples taken from the body.
- Intended Use: The intended use clearly states the markers are used to "mark the location of a tumor cavity" and "mark for future medical procedure." This is a physical marking function, not a diagnostic testing function.
Therefore, the ACCUSYTE™ 3D Fiducial Markers fall under the category of an implantable medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ACCUSYTE 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed.
In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The ACCUSYTE™ 3D Fiducial Marker is an implantable marker comprised of an absorbable suture (polylactic acid) component which absorbs completely in less than one year, and a permanent component, a Platinum or Gold Marker attached to the suture by a crimping operation similar to the operation use to attach the Stainless-Steel Needle.
The ACCUSYTE™ 3D Fiducial Marker is provided Sterile for single use and is implantable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ikV CT, 2D Linac-based kilovoltage and megavolt-age X-ray imaging systems and kV cone-beam CT.
Mammography
Ultrasound
MRI
Anatomical Site
Soft tissue tumor cavity site including breast
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)
The Absorbable Suture component on the candidate device was tested as part of its 510 (k) submission (K130735) with the following tests:
- Bacterial Endotoxin (USP Pharmacopeia ) - Pyrogenicity
- Biocompatibility (ISO-10993) - suture component - Implant
- Physical Testing - USP 30
§ 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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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo has a blue square with the letters FDA in white.
RADIATION PRODUCTS LLC
July 18, 2018
% Mr. Victor Pereira Principal VHP Consulting 7240 NW 63 Terrace PARKLAND FL 33067
Re: K180027
Trade/Device Name: ACCUSYTE 3D Fiducial Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 3, 2018 Received: June 13, 2018
Dear Mr. Pereira:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 medical devices and radiation-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'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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
K 180027
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name ACCUSYTE 3D Fiducial Marker
Indications for Use (Describe)
The ACCUSYTE 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed.
In addition, the Markers are indicated on situations where soft tissue needs to future medical procedure such as subsequent Radiation Therapy.
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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5. 510 (k) Summary
This 510 (k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.
Applicant: Surgical Radiation Products LLC
Date Prepared: April 29, 2018 (amended)
Contact Person: John D Corbitt MD
Radiation Products LLC 142 JFK Drive Lake Worth FL 33462 Phone: (561) 379-6210 Fax: (561) 439-9902 e-mail: jdcorbitt@aol.com
Trade Name: ACCUSYTE™ 3D Fiducial Marker
Common Name: Implantable Radiographic Marker Classification Name: Medical charged-particle radiation therapy system Classification Number: 892.5050 Device Classification: Class II Product Code: IYE Predicate Device: CIVCO Suture-Type Marker (K071614) Reference Devices: BioZorb Marker (K143484) Foosin WEGO-PGLA Absorbable Suture (K130735)
Substantially Equivalent to:
The ACCUSYTE™ 3D Fiducial Marker is substantially equivalent in intended use, principle of operation, and technological characteristics to the CIVCO Suture-Type Marker (K071614), to the BioZorb Marker (K143484), and to the Foosin WEGO-PGLA Absorbable Suture (K130735).
Description of the Device subject to Premarket Notification:
The ACCUSYTE™ 3D Fiducial Marker is an implantable marker comprised of an absorbable suture (polylactic acid) component which absorbs completely in less than one year, and a permanent component, a Platinum or Gold Marker attached to the suture by a crimping operation similar to the operation use to attach the Stainless-Steel Needle.
The ACCUSYTE™ 3D Fiducial Marker is provided Sterile for single use and is implantable.
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Indication for Use:
The ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed.
In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.
Technical Characteristics:
The ACUSYTE™ 3D Fiducial Marker has similar physical and technical characteristics to the predicative and reference devices, as illustrated in the table below:
| Technical
Characteristic | Subject Device | Primary
Predicate | Reference
Device | Reference Device |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | ACCUSYTE™ 3D
Fiducial Marker | CIVCO Suture-
Type Marker
(K071614) | BioZorb Marker
(K143484) | WEGO-PGLA
Absorbable Suture
(K130735) |
| Overall
Technological
Characteristic | Radiographically
visible
permanent
marker on an
absorbable
suture | Radiographically
visible
permanent
marker on an
absorbable
suture | Radiographicall
y visible
permanent
marker element
in a bio-
absorbable
polymer space | Suture-N/A |
| Principle of
Operation | Marker is
secured on
tumor cavity
area for
radiographic
visualization of
tumor site after
removal | Marker is
positioned into
tissue site for
radiographic
visualization of
tissue site | Marker is
positioned into
tissue site for
radiographic
visualization of
tissue site | Suture holds
marker in place
during tissue
healing process |
| Absorption
time for suture
and polymer | Less than 1 year
(suture) | Unknown for
suture | Longer than 1
year
(Polymer) | Suture- Less than 1
year |
| Visualization
Compatibility | ikV CT, 2D
Linac- based
kilovoltage and
megavolt-age X-
ray imaging
systems and kV | X-Ray
CT (presumed) | Mammography,
Ultrasound, X-
Ray, and CT | Suture-N/A |
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| cone-beam CT. | ||||
|---|---|---|---|---|
| Materials of | ||||
| Construction | Gold or | |||
| Platinum/Iridium Marker | ||||
| component, | ||||
| absorbable | ||||
| suture | ||||
| (Glycolide-co- | ||||
| Lactide) | Gold Marker and | |||
| absorbable | ||||
| suture | Titanium | |||
| Markers and | ||||
| absorbable | ||||
| polymer | ||||
| (spacer) | Suture-Glycolide- | |||
| co Lactide with | ||||
| Stainless Steel | ||||
| Needle | ||||
| Overall Device | ||||
| Length | ) - Pyrogenicity |
- Biocompatibility (ISO-10993) - suture component - Implant
- Physical Testing - USP 30