The IlluminOss Photodynamic Bone Stabilization System is 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.

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, and anterior ring of the pelvic. The purpose of this Special 510(k) is to expand the indications for use to include the fibula.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the IlluminOss Photodynamic Bone Stabilization System.

It includes:

Device Name and Regulation Information: IlluminOss Photodynamic Bone Stabilization System, regulated as an in vivo cured intramedullary fixation rod (21 CFR 888.3023).
Clearance Date and Reference Number: August 13, 2020, K201961.
Indications for Use: Treatment of traumatic, fragility, pathological, and impending pathological fractures of humerus, radius, pelvis, fibula, metacarpals, metatarsals, and phalanges, and as supplemental fixation.
Predicate Device Information: The device is deemed substantially equivalent to the Synthes Elastic Intramedullary Nail System (K081452). A previously cleared IlluminOss system (K200295) is also referenced for expanding indications to the fibula.
Device Description: Details on how the system works (inflatable PET balloon, photodynamic monomer, light curing).
Performance Testing Summary (brief): States that testing demonstrates "sufficient strength upon curing for the fibular indications."

However, it does not include:

A table of acceptance criteria and reported device performance.
Details on sample size, data provenance, number/qualifications of experts, or adjudication methods for any test set or ground truth establishment.
Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Specific types of ground truth used (e.g., pathology, outcomes data).
Training set size or how its ground truth was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

Summary

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IlluminOss Medical, Inc. Robert Rabiner Chief Technical Officer 993 Waterman Avenue East Providence, Rhode Island 02914 USA

August 13, 2020

Re: K201961

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: July 14, 2020 Received: July 14, 2020

Dear Robert Rabiner:

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.

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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) 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, M.S. R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201961

Device Name

IlluminOss Photodynamic Bone Stabilization System

Indications for Use (Describe)

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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510(k) Summary

Manufacturer:	IlluminOss Medical, Inc.993 Waterman AvenueEast Providence, RI 02914Phone: 401.714.0008
Contact:	Mr. Robert RabinerChief Technical OfficerIlluminOss Medical, Inc.993 Waterman AvenueEast Providence, RI 02914Phone: 401.714.0008 x207rrabiner@illuminoss.com
Prepared By:	MCRA, LLC1050 K Street, NW, Suite 1000Washington, DC 20001Phone: 202.552.5800
Date Prepared:	July 14, 2020
Device Trade Name:	IlluminOss Photodynamic Bone Stabilization System
Classification:	21 CFR 888.3023, In vivo cured intramedullary fixation rod
Class:	Class II
Product Code:	QAD

Predicate Device:

The IlluminOss Photodynamic Bone Stabilization System is substantially equivalent to the Synthes Elastic Intramedullary Nail System (K081452) with respect to intended use, indications for use, technological characteristics, and performance data. The previously cleared IlluminOss Photodynamic Bone Stabilization System (K200295) serves as a reference device, with identical device design and technological characteristics, with the exception of expanding the indications to include use in the fibula. The information summarized in the Design Control Activities Summary demonstrates that the IlluminOss Photodynamic Bone Stabilization System met the pre-determined acceptance criteria for the verification activities.

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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, metatarsals, 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.

Device Description:

Performance Testing Summary:

Testing of the IlluminOss PBSS device includes testing to demonstrate that the device is of sufficient strength upon curing for the fibular indications.

Substantial Equivalence:

The subject device was demonstrated to be substantially equivalent to the predicates cited above with respect to indications, design, function, and performance. The technological characteristics of the subject device are identical to the previously cleared IlluminOss PBSS devices. Specifically, they are identical in design, size, materials, and chemical composition.

Regulation Number and Section

§ 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.