IlluminOss Bone Stabilization System

K200295 · Illuminoss Medical, Inc. · QAD · Jun 25, 2020 · Orthopedic

Device Facts

• Record ID: K200295
• Device Name: IlluminOss Bone Stabilization System
• Applicant: Illuminoss Medical, Inc.
• Product Code: QAD · Orthopedic
• Decision Date: Jun 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3023
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, and ulna. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with an FDA-cleared fracture fixation system to provide supplemental fixation in the humerus, radius, and ulna. It is also indicated for use in skeletally mature patients in the treatment of the pelvis, clavicle, metacarpals, metatarsals, and phalanges.

Device Story

Minimally invasive bone stabilization system; utilizes catheter to deploy inflatable, noncompliant PET balloon into medullary canal across fracture site. Balloon infused with photodynamic (light-cured) monomer; expands to fill intramedullary canal. Visible spectrum light delivered via radially emitting fiber positioned in central lumen; cures monomer in situ to create rigid implant. Used by surgeons in clinical settings for fracture fixation. Provides structural support to stabilize fractures; benefits patients via minimally invasive approach compared to traditional open fixation.

Clinical Evidence

Bench testing only. Testing verified mechanical strength of cured implants for new anatomical sites, ability of new sizes to withstand infusion pressures, and sufficient monomer curing within specified timeframes.

Technological Characteristics

System consists of PET balloon, photodynamic monomer, and light delivery fiber. Operates via in vivo light-cured polymerization. Minimally invasive intramedullary fixation. No electronic software or connectivity components.

Indications for Use

Indicated for skeletally mature patients for treatment of traumatic, fragility, pathological, and impending pathological fractures of humerus, radius, ulna, pelvis, clavicle, metacarpals, metatarsals, and phalanges; also for supplemental fixation in humerus, radius, and ulna.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act. the in vivo cured intramedullary fixation rod is subject to the following special controls: - 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: - a. Mechanical testing must be conducted on the final device to assess burst, abrasion, bending, and torsion in static and dynamic conditions. - b. Mechanical testing must demonstrate the integrity of the balloon including testing for leaks, ruptures, and release of cured/uncured material. - Performance testing must demonstrate that the device can be inserted and C. removed. - d. Performance testing must demonstrate the ability, in the event of a leak, to remove the uncured material from its in vivo location. - Performance testing must demonstrate the reliability and accuracy of the curing e. method used. - Thermal safety testing must be conducted to evaluate the temperature rise during f. 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: - a. A detailed summary of the device technical parameters. - b. Information describing all materials of the device. - Information describing how to perform the procedure and use the device, C. including the delivery system and devices which initiate the curing process, as well as how to remove the device and any uncured materials. - d. A shelf life. - Validated methods and instructions for reprocessing any reusable components or e. instruments.

*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.

Predicate Devices

• CurvaFix, Inc. Intramedullary Rod Screw System (K180050)
• Synthes (USA) Low Profile Reconstruction Plates (K042377)
• DePuy Orthopaedics, Inc. Rockwood Clavicle Pin (K103001)
• Small Bone Innovations, Inc. MetaFLEX IM Nail System (K051605)

Reference Devices

• IlluminOss Photodynamic Bone Stabilization System (K183145)

Submission Summary (Full Text)

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

# Re: K200295

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: March 3, 2020 Received: March 4, 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.

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

June 25, 2020

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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 ([e-mail]) or phone [phone] 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K200295 /

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, and ulna. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with an FDA-cleared fracture fixation system to provide supplemental fixation in the humerus, radius, and ulna. It is also indicated for use in skeletally mature patients in the treatment of the pelvis, clavicle, metacarpals, metatarsals, and phalanges.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) Summary

| Manufacturer: | IlluminOss Medical, Inc.<br>993 Waterman Avenue<br>East Providence, RI 02914<br>Phone: [phone] |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Robert Rabiner<br>Chief Technical Officer<br>IlluminOss Medical, Inc.<br>993 Waterman Avenue<br>East Providence, RI 02914<br>Phone: [phone] x207<br>[e-mail] |
| Prepared By: | MCRA, LLC<br>1050 K Street, NW, Suite 1000<br>Washington, DC 20001<br>Phone: [phone] |
| Date Prepared: | May 27, 2020 |
| Device Trade Name: | IlluminOss Photodynamic Bone Stabilization System ("IlluminOss<br>PBSS") |
| Classification: | 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 CurvaFix, Inc. Intramedullary Rod Screw System (K180050), Synthes (USA) Low Profile Reconstruction Plates (K042377), DePuy Orthopaedics, Inc. Rockwood Clavicle Pin (K103001), and Small Bone Innovations, Inc. MetaFLEX IM Nail System (K051605) with respect to intended use, indications for use, technological characteristics, and performance data. The previously cleared IlluminOss Photodynamic Bone Stabilization System (K183145) is considered a reference device, with identical device design, with the exception of the inclusion of new small and intermediate implant sizes. The information provided in this 510(k) demonstrates that the modified IlluminOss Photodynamic Bone Stabilization System is substantially equivalent to the identified predicate devices.

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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, and ulna. The IlluminOss Photodynamic Bone Stabilization System can also be used in conjunction with an FDA-cleared fracture fixation system to provide supplemental fixation in the humerus, radius, and ulna. It is also indicated for use in skeletally mature patients in the treatment of fractures of the pelvis, clavicle, metacarpals, metatarsals, and phalanges.

#### 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 purpose of this 510(k) is to add smaller, and intermediate sizes of the implant and expand the indications for use to include the pelvis, clavicle, metacarpals, metatarsals, and phalanges.

#### Performance Testing Summary:

Testing of the IlluminOss PBSS device includes:

- Testing to demonstrate that the devices is of sufficient strength upon curing for the 1. indications in the pelvis, clavicle, metacarpals, metatarsals, and phalanges.
- 2. Testing to demonstrate that the new device sizes could withstand the pressures necessary to complete the infusion process with the liquid monomer.
- 3. Testing to demonstrate that monomer sufficiently cures during the given cure time for the new implant sizes, providing sufficient mechanical strength

#### Substantial Equivalence:

The subject device was demonstrated to be substantially equivalent to the predicates cited above with respect to indications, design, function, and performance.

## Conclusion:

The IlluminOss PBSS device is substantially equivalent to the previously cleared devices with respect to its indications for use, design, function, and performance.