PROCEM

K140644 · Ototronix, LLC · NEA · Jun 19, 2014 · Dental

Device Facts

• Record ID: K140644
• Device Name: PROCEM
• Applicant: Ototronix, LLC
• Product Code: NEA · Dental
• Decision Date: Jun 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as: 1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain. 2. Mechanical stabilization of middle ear and cochlear implants. 3. Attachment of middle ear implants to the ossicular bones.

Device Story

ProCem™ is a glass ionomer cement (GIC) provided as a two-component system (glass powder and polyacrylic acid liquid) in a sterile capsule. Used in otologic surgery by surgeons; device requires activation and mechanical mixing to form a viscous, moldable cement. Applied via applicator to middle ear structures; hardens in situ to provide permanent mechanical bond. Facilitates ossicular reconstruction, coupling, and implant stabilization. Benefits include stable fixation of middle ear implants and restoration of ossicular chain continuity.

Clinical Evidence

Bench testing only. Design verification testing performed to evaluate exothermic reaction, working time, snap set time, and simulated preparation properties. Results demonstrate compliance with physical and functional requirements comparable to predicate devices.

Technological Characteristics

Glass ionomer cement (GIC) consisting of glass powder and polyacrylic acid liquid. Provided in sterile capsule. Accessories include activator, mixer, and applicator. Sterilized via gamma radiation (SAL 10^-6). Biocompatibility compliant with ISO 10993-1 for permanent implantable tissue/bone contact.

Indications for Use

Indicated for patients undergoing otologic surgery requiring non-weight bearing bone reconstruction, ossicular chain coupling, or stabilization/attachment of middle ear and cochlear implants.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• SerenoCem (K003567)
• EnvoyCem (K080032)

Submission Summary (Full Text)

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# K140644 JUN 1 9 2014

:

#### 510(k) Summary ProCem™ Otologic Bone Cement

Date Prepared: 5 March, 2014

Submitter: Ototronix LLC 26620 Interstate 45 North Houston, TX 77386 Telephone: [phone] Fax: [phone]

Contact:

Mr. Bernard Horwath Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: [phone]

Proprietary Name: ProCem™ Otologic Bone Cement

Common/Usual Name: Cement, Ear. Nose and Throat

Classification Name: Classification Status: Class II per regulations 872.3275 Product Code: NEA

#### Establishment Registration Number: 3008612563

#### Description:

ProCem™ is glass ionomer cement that is provided as two components, a glass powder and polyacrylic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ.

ProCem™ is provided in a sterile capsule. The capsule includes the two separate components, a glass powder and polyacrylic acid liquid. An activator is used to release the liquid component prior to use. The capsule is then placed in a mixer, which mixes the glass powder and polyacrylic acid liquid to form a compliant cement. The applicator is used to apply the compliant cement to the appropriate location in the middle ear. The cement then hardens in place to provide a permanent bond.

#### Indications for Use:

ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as:

- 1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
- 2. Mechanical stabilization of middle ear and cochlear implants.
- 3. Attachment of middle ear implants to the ossicular bones.

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# Substantial Equivalence:

Ototronix believes that ProCem™ is substantially equivalent to the following devices:

- SerenoCem, K003567 .
- EnvoyCem. K080032 .

ProCem™ is a glass ionomer cement as is EnvoyCem and has essentially the same intended use as the predicate devices.

## Technological Characteristics:

Like the predicate devices, ProCem™ is intended for use in various otologic surgical applications. ProCem "" is glass ionomer cement (GIC) as is EnvoyCem and SerenoCem. GIC has a long history of use in otologic surgery applications. GIC is provided sterile as two components that require mixing prior to use. The ProCem™ capsule components and accessory devices (activator, mixer, applicator) are identical to those of the predicate devices.

## Biocompatibility:

The ProCem™ Otologic Bone Cement and the predicates are categorized as implantable devices for tissue/bone contact with permanent duration (>30 days) in accordance with ISO 10993-1 Biological Evaluation of Medical Devices. The GIC cements have a long history of safe and effective use in otologic surgery applications and have demonstrated compliance to biocompatibility testing required for their intended use.

## Sterilization:

The ProCem™ capsule components are sterilized using a gamma radiation method to assure a sterilization assurance level (SAL) of 10th. The ProCem™ device is packaged in the same manner as the predicate devices to assure sterility over their labeled shelf life.

#### Performance Bench Testing:

Design verification testing, including exothermic reaction, working time, snap set time, and simulated preparation properties, was successfully performed on ProCem™ to demonstrate that physical and functional requirements were met and were comparable to SerenoCem.

#### Conclusion:

Based upon the extensive testing conducted and the comparison to the predicate devices, it is the conclusion of Ototronix that ProCem™ is substantially equivalent to the predicate devices already on the market cleared by the 510(k) review process and presents no new concerns about safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-(160 Silver Spring, MID 20993-002

June 19, 2014

Ototronix, LLC c/o Mr. Bernard Horwath Regulatory Consultant 4486 Timberline Ct. Sr. Paul. MN 55127

Re: K140644

Trade/Device Name: ProCem Regulation Number: 21 CFR 872.3275 Regulation Name: Ear. Nose and Throat Cement Regulatory Class: Class II Product Code: NEA Dated: March 12, 2014 Received: March 22, 2014

Dear Mr. Horwath:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice. Iabeling, 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 cither 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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Page 2 - Mr. Bernard Horwath

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140644

Device Name ProCem™ Otologic Bone Cement

Indications for Use (Describe)

ProCem
^TM is intended for non-weight bearing applications in Otologic surgery, such as:
1. Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
2. Mechanical stabilization of middle ear and cochlear implants.
3. Attachment of middle ear implants to the ossicular bones.

Type of Use (Select one or both, as applicable)

| <span style="border: 1px solid black; padding: 0px; margin: 0px;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="border: 1px solid black; padding: 0px; margin: 0px;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
|------------------------------------------------------------------------------|
| Joyce C. Lin -S |
| 2014.06.19 12:25:25 -04'00' |

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