(98 days)
ProCem™ is intended for non-weight bearing applications in Otologic surgery, such as:
- Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
- Mechanical stabilization of middle ear and cochlear implants.
- Attachment of middle ear implants to the ossicular bones.
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.
Acceptance Criteria and Device Performance for ProCem™ Otologic Bone Cement
This document summarizes the acceptance criteria and supporting study for the ProCem™ Otologic Bone Cement, as derived from the provided 510(k) summary (K140644).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for ProCem™ Otologic Bone Cement are based on its substantial equivalence to predicate devices (SerenoCem, K003567 and EnvoyCem, K080032). The study conducted was primarily to demonstrate that ProCem™ meets physical and functional requirements comparable to these predicate devices.
| Acceptance Criteria | Reported Device Performance (ProCem™) | Reference to Predicate Device |
|---|---|---|
| Exothermic Reaction | Successfully performed and met requirements | Comparable to SerenoCem |
| Working Time | Successfully performed and met requirements | Comparable to SerenoCem |
| Snap Set Time | Successfully performed and met requirements | Comparable to SerenoCem |
| Simulated Preparation Properties | Successfully performed and met requirements | Comparable to SerenoCem |
| Biocompatibility | Demonstrated compliance to biocompatibility testing required for intended use | GIC cements (including predicates) have a long history of safe and effective use |
| Sterility (SAL) | 10-6 SAL achieved via gamma radiation | Packaged in the same manner as predicate devices to assure sterility |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes "Design verification testing" but does not explicitly state specific sample sizes for each test (exothermic reaction, working time, snap set time, simulated preparation properties). The data provenance is not specified in terms of country of origin, but the studies were conducted by Ototronix LLC, the submitter, as part of their 510(k) application. This would be considered a prospective study conducted for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
There is no mention of experts being used to establish a "ground truth" in the context of clinical performance or diagnostic accuracy. The testing described focuses on the physical and functional properties of the bone cement itself, rather than interpretation of clinical outcomes by experts.
4. Adjudication Method for the Test Set
Not applicable. The described testing is focused on objective physical and chemical properties of the device, not on subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is a bone cement, not an imaging or diagnostic AI device that would typically involve human readers.
6. Standalone Performance Study
Yes, a standalone study was done. The "Performance Bench Testing" describes in-house design verification testing, demonstrating the physical and functional properties of the ProCem™ device on its own. This testing was performed independent of human interaction in a clinical setting for performance evaluation.
7. Type of Ground Truth Used
The ground truth for the performance bench testing was based on established engineering specifications and comparison to the known performance characteristics of the predicate device (SerenoCem). This involves objective measurements of physical and chemical properties.
8. Sample Size for the Training Set
Not applicable. The ProCem™ Otologic Bone Cement is a physical medical device (bone cement), not a software algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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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: 281-203-0253 Fax: 832-550-2116
Contact:
Mr. Bernard Horwath Regulatory Affairs Consultant 4486 Timberline Ct Vadnais Heights, MN 55127 Telephone: 651- 231-1761
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:
-
- Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
-
- Mechanical stabilization of middle ear and cochlear implants.
-
- 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:
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 (800) 638-2041 or (301) 796-7100 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:
- Reconstruction of ossicular bones or mechanical coupling of the ossicular chain.
- Mechanical stabilization of middle ear and cochlear implants.
- Attachment of middle ear implants to the ossicular bones.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------- |
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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§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.