(29 days)
No
The device description and intended use focus on a mechanical and photodynamic process for bone stabilization. There is no mention of AI/ML in the device description, intended use, or the "Mentions AI, DNN, or ML" section. The performance studies focus on mechanical properties (pull-out strength).
Yes
The device is indicated for the treatment of traumatic, fragility, pathological, and impending pathological fractures, and provides fixation and stabilization of fractures, which are therapeutic actions.
No
The device is described as a "Bone Stabilization System" used for the "fixation and stabilization of fractures" by deploying an inflatable balloon with a light-cured monomer into the medullary canal. Its purpose is to treat fractures, not to diagnose them.
No
The device description clearly outlines multiple hardware components including a catheter, balloon, syringe, and light system. It is a physical medical device used for bone stabilization.
Based on the provided text, the IlluminOss Photodynamic Bone Stabilization System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The IlluminOss system is a surgical device used to stabilize bone fractures directly within the patient's body.
- The intended use and device description clearly describe a surgical procedure and a device implanted within the bone. There is no mention of analyzing biological samples or providing diagnostic information.
The device is a therapeutic device used for fracture fixation and stabilization.
N/A
Intended Use / Indications for Use
The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.
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 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 fiber 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 system is currently indicated for use in the humerus, radius, ulna, clavicle, metacarpal, metatarsal, phalanges, ulna, fibula, and anterior ring of the pelvis. The purpose of this Special 510(k) is to expand the indications of the IlluminOss Photodynamic Bone Stabilization System (PBSS) to include use in the femur and tibia in conjunction with FDA-cleared fracture fixation systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, radius, pelvis, fibula, metacarpals, metatarsals, phalanges, femur, tibia, ulna, clavicle, anterior ring of the pelvis
Indicated Patient Age Range
skeletally mature patients
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)
Testing of the IlluminOss PBSS device demonstrates that it improves pull-out strength compared to a stand-alone screw-plate construct.
When the IlluminOss System is used to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system, the samples demonstrated statistically significantly higher screw pull-out loads compared to when the IlluminOss device is not used. These results demonstrate that the device is as safe and effective as the predicate, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K000066, K030858, K011978, K013248, K160167
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.
0
October 27, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
IlluminOss Medical, Inc. Hollace Rhodes Vice President, Orthopedic Regulatory Affairs MCRA, LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001 USA
Re: K202887
Trade/Device Name: IlluminOss 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: September 28, 2020 Received: September 28, 2020
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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202887
Device Name
IlluminOss Photodynamic Bone Stabilization System
Indications for Use (Describe)
The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.
| 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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3
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
rrabiner@illuminoss.com |
| Prepared By: | MCRA, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | October 22, 2020 |
| Device Trade Name: | IlluminOss Photodynamic Bone Stabilization System ("IlluminOss
PBSS") |
| Classification: | 21 CFR 888.3023, In vivo cured intramedullary fixation rod |
| Class: | Class II |
| Product Code: | OAD |
Predicate Device:
The IlluminOss Photodynamic Bone Stabilization System (PBSS) is substantially equivalent to the previously cleared IlluminOss PBSS (K201961), with identical device design, intended use, technological characteristics, and performance data. The Synthes LCP System (K000066), Synthes LCP Proximal Femur Plates and Screws (K030858), Synthes LCP Proximal Tibia Plates (K011978), Synthes LCP Distal Tibia Plates (K013248), and DePuy Synthes TFNA Augmentation System (K160167) serve as reference devices, supporting the proposed modifications to the Indications for Use statement to include use in the femur and tibia in conjunction with FDA-cleared fracture fixation systems. The information summarized in the Design Control Activities Summary demonstrates that the IlluminOss Photodynamic Bone Stabilization System met the predetermined acceptance criteria for the verification activities.
4
Indications for Use:
The IlluminOss Photodynamic Bone Stabilization System is indicated for use in skeletally mature patients in the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, fibula, metacarpals, and phalanges. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with FDAcleared fracture fixation systems to provide supplemental fixation in these anatomic sites. The IlluminOss System may be used in the femur and tibia to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system.
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 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 fiber 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 system is currently indicated for use in the humerus, radius, ulna, clavicle, metacarpal, metatarsal, phalanges, ulna, fibula, and anterior ring of the pelvis. The purpose of this Special 510(k) is to expand the indications of the IlluminOss Photodynamic Bone Stabilization System (PBSS) to include use in the femur and tibia in conjunction with FDA-cleared fracture fixation systems.
Performance Testing Summary:
Testing of the IlluminOss PBSS device demonstrates that it improves pull-out strength compared to a stand-alone screw-plate construct.
Substantial Equivalence:
The subject device is substantially equivalent to the predicates cited above with respect to intended use, design, function, and performance. The technological characteristics of the subject device are identical to the previously cleared IlluminOss PBSS devices in design, size, materials, and chemical composition. When the IlluminOss System is used to provide supplemental fixation to an anatomically appropriate FDA-cleared fracture fixation system, the samples demonstrated statistically significantly higher screw pull-out loads compared to when the IlluminOss device is not used. These results demonstrate that the device is as safe and effective as the predicate, and performs as well as or better than the predicate device.