(30 days)
Not Found
No
The document describes a mechanical and photodynamic bone stabilization system with no mention of AI or ML components.
Yes
The device is used for the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, and ulna, which aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose is for "fixation and stabilization of fractures through a minimally invasive procedure," using a light-cured monomer to stabilize bone. This is a therapeutic or surgical intervention, not a diagnostic one.
No
The device description clearly outlines physical components like catheters, balloons, syringes, and light pipes, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat bone fractures (traumatic, fragility, pathological, and impending pathological) in the humerus, radius, and ulna. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a system for stabilizing bone fractures using an inflatable balloon filled with a light-cured monomer. This is a physical implant and delivery system used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of bodily specimens.
The IlluminOss Photodynamic Bone Stabilization System is a surgical implant and delivery system used for the treatment of bone fractures.
N/A
Intended Use / Indications for Use
IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, and ulna.
Product codes
QAD
Device Description
The IlluminOss Photodynamic Bone Stabilization System provides an important treatment option in the fixation and stabilization of fractures through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a standard 20cc syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light pipe that is temporarily positioned into a central lumen of the catheter that runs the length of the balloon. With this design, the liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. The purpose of this Special 510(k) is to add smaller, intermediate, and larger sizes of the implant, an intermediate size of the Sheath/Dilator Set, and a smaller size of the Delivery Set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
humerus, radius, and ulna.
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing of the IlluminOss PBSS device includes:
-
- Testing to demonstrate that the new device sizes could withstand the pressures necessary to complete the infusion process with the liquid monomer.
-
- Testing to demonstrate that monomer sufficiently cures during the given cure time for the new implant sizes, providing sufficient mechanical strength
-
- Mechanical testing to demonstrate the strength of the balloon catheter bond possess adequate tensile characteristics.
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- Mechanical testing to demonstrate the light pipe does not break upon removal and can sufficiently cure the monomer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3023 In vivo cured intramedullary fixation rod.
(a)
Identification. An in vivo cured intramedullary fixation rod is a prescription implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is exposed to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Mechanical testing must be conducted on the final device to assess burst, abrasion, bending, and torsion in static and dynamic conditions.
(ii) Mechanical testing must demonstrate the integrity of the balloon including testing for leaks, ruptures, and release of cured/uncured material.
(iii) Performance testing must demonstrate that the device can be inserted and removed.
(iv) Performance testing must demonstrate the ability, in the event of a leak, to remove the uncured material from its in vivo location.
(v) Performance testing must demonstrate the reliability and accuracy of the curing method used.
(vi) Thermal safety testing must be conducted to evaluate the temperature rise during curing.
(2) Electrical safety, electromagnetic compatibility (EMC) testing, and electromagnetic interference (EMI) testing must be conducted for all electrical components.
(3) All patient-contacting components must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility and pyrogenicity of patient contacting components of the device that are provided sterile.
(5) Performance data must validate the reprocessing instructions for any reusable components or instruments.
(6) Performance data must support the shelf life of the system by demonstrating continued sterility, package integrity, and system functionality over the established shelf life.
(7) Technological characterization of the device must include materials, curing agents, and a description of the operating principles of the device, including the delivery system and devices which initiate the curing process.
(8) Labeling must include the following:
(i) A detailed summary of the device technical parameters.
(ii) Information describing all materials of the device.
(iii) Information describing how to perform the procedure and use the device, including the delivery system and devices which initiate the curing process, as well as how to remove the device and any uncured materials.
(iv) A shelf life.
(v) Validated methods and instructions for reprocessing any reusable components or instruments.
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December 13, 2018
Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
IlluminOss Medical, Inc. % Hollace Rhodes Senior Director, Orthopedic Regulatory Affairs Musculoskeletal Clinical Regulatory Advisors, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K183145
Trade/Device Name: IlluminOss Photodynamic Bone Stabilization System Regulation Number: 21 CFR 888.3023 Regulation Name: In Vivo Cured Intramedullary Fixation Rod Regulatory Class: Class II Product Code: QAD Dated: November 12, 2018 Received: November 13, 2018
Dear Hollace Rhodes:
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 mav, 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 avare 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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.
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183145
Device Name
IlluminOss Photodynamic Bone Stabilization System ("IlluminOss PBSS")
Indications for Use (Describe)
IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, and ulna.
| 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.
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510(k) Summary
| Manufacturer: | IlluminOss Medical, Inc.
993 Waterman Avenue
East Providence, RI 02914
Phone: 401.714.0008 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Robert Rabiner
Chief Technical Officer
IlluminOss Medical, Inc.
993 Waterman Avenue
East Providence, RI 02914
Phone: 401.714.0008 x207
Fax: 401.714.0009
rrabiner@illuminoss.com |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800
Fax: 202.552.5798 |
| Date Prepared: | November 12, 2018 |
| Device Trade Name: | IlluminOss Photodynamic Bone Stabilization System
("IlluminOss PBSS") |
| Classifications: | 21 CFR 888.3023, In vivo cured intramedullary fixation
rod |
| Class: | Class II |
| Product Code: | QAD |
Predicate Device:
The modified IlluminOss Photodynamic Bone Stabilization System is substantially equivalent to the predicate IlluminOss Photodynamic Bone Stabilization System (K181228) with respect to indications, design, materials, function, and performance. The information summarized in the Design Control Activities Summary demonstrates that the modified IlluminOss Photodynamic Bone Stabilization System met the pre-determined acceptance criteria for the verification activities.
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Indications for Use:
IlluminOss Photodynamic Bone Stabilization System (PBSS) is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, and ulna.
The Indications for Use statement for the IlluminOss Photodynamic Bone Stabilization System device is identical to the predicate device.
Device Description:
The IlluminOss Photodynamic Bone Stabilization System provides an important treatment option in the fixation and stabilization of fractures through a minimally invasive procedure. The system uses a catheter to deploy an inflatable, noncompliant, thin wall PET balloon into the medullary canal of the bone across the fracture site. The balloon is infused using a standard 20cc syringe with a photodynamic (light cured) monomer that causes the balloon to slowly expand and fill the intramedullary canal of the fractured bone. Activation of the light system allows for visible spectrum light to be delivered through a radially emitting light pipe that is temporarily positioned into a central lumen of the catheter that runs the length of the balloon. With this design, the liquid monomer within the balloon is exposed to light along the entire length of the balloon during the curing process. The purpose of this Special 510(k) is to add smaller, intermediate, and larger sizes of the implant, an intermediate size of the Sheath/Dilator Set, and a smaller size of the Delivery Set.
Comparison of Technological Characteristics with Predicate Device:
The subject device and the IlluminOss PBSS predicate device are identical, with the exception of the addition of new small, intermediate, and large sizes of the implant and the auxiliary components to support these new sizes, specifically a new intermediate Sheath/Dilator Set and smaller reusable instruments and light pipe. These additional parts are not anticipated to introduce any new issues regarding device safety or effectiveness.
Performance Testing Summary:
Testing of the IlluminOss PBSS device includes:
-
- Testing to demonstrate that the new device sizes could withstand the pressures necessary to complete the infusion process with the liquid monomer.
-
- Testing to demonstrate that monomer sufficiently cures during the given cure time for the new implant sizes, providing sufficient mechanical strength
-
- Mechanical testing to demonstrate the strength of the balloon catheter bond possess adequate tensile characteristics.
-
- Mechanical testing to demonstrate the light pipe does not break upon removal and can sufficiently cure the monomer.
Substantial Equivalence:
The subject device was demonstrated to be substantially equivalent to the predicate cited above with respect to indications, design, function, and performance.
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Conclusion:
The IlluminOss PBSS device is substantially equivalent to the previously cleared device with respect to its indications for use, design, function, and performance.