IlluminOss Photodynamic Bone Stabilization System

K183145 · Illuminoss Medical, Inc. · QAD · Dec 13, 2018 · Orthopedic

Device Facts

• Record ID: K183145
• Device Name: IlluminOss Photodynamic Bone Stabilization System
• Applicant: Illuminoss Medical, Inc.
• Product Code: QAD · Orthopedic
• Decision Date: Dec 13, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3023
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Minimally invasive bone stabilization system; uses catheter to deploy inflatable, noncompliant PET balloon into medullary canal across fracture site. Physician infuses balloon with photodynamic (light-cured) monomer via syringe; balloon expands to fill intramedullary canal. Visible light delivered via radially emitting light pipe temporarily positioned in central lumen cures monomer in situ. System provides internal fixation/stabilization. Used in clinical settings by physicians. Output is a cured, rigid intramedullary implant providing structural support to fractured bone. Benefits include minimally invasive fracture fixation.

Clinical Evidence

Bench testing only. Testing demonstrated new sizes withstand infusion pressures, monomer achieves sufficient cure and mechanical strength, balloon catheter bonds maintain adequate tensile characteristics, and light pipes function without breakage.

Technological Characteristics

Intramedullary fixation rod; PET balloon; photodynamic monomer; visible light curing system; radially emitting light pipe. System includes catheter, sheath/dilator, and delivery instruments. Minimally invasive; non-implantable components are reusable. No specific ASTM standards cited.

Indications for Use

Indicated for skeletally mature patients with traumatic, fragility, pathological, or impending pathological fractures of the humerus, radius, or 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

• IlluminOss Photodynamic Bone Stabilization System (K181228)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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>Fax: [phone]<br>[e-mail] |
| Prepared By: | Musculoskeletal Clinical Regulatory Advisers, LLC<br>1050 K Street, NW, Suite 1000<br>Washington, DC 20001<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | November 12, 2018 |
| Device Trade Name: | IlluminOss Photodynamic Bone Stabilization System<br>("IlluminOss PBSS") |
| Classifications: | 21 CFR 888.3023, In vivo cured intramedullary fixation<br>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:

- 1. Testing to demonstrate that the new device sizes could withstand the pressures necessary to complete the infusion process with the liquid monomer.
- 2. Testing to demonstrate that monomer sufficiently cures during the given cure time for the new implant sizes, providing sufficient mechanical strength
- 3. Mechanical testing to demonstrate the strength of the balloon catheter bond possess adequate tensile characteristics.
- 4. 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.