Who is the manufacturer of ENVOYCEM, MODEL 1640?

Envoy Medical Corporation filed the 510(k) submission for ENVOYCEM, MODEL 1640 (K080032).

What is the FDA product code for ENVOYCEM, MODEL 1640?

NEA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ENVOYCEM, MODEL 1640?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ENVOYCEM, MODEL 1640?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ENVOYCEM, MODEL 1640

Q: What are the predicate devices for ENVOYCEM, MODEL 1640?

OTO-CEM (K011338); SerenoCem (K003567); OtoMimix (K042516).

K080032 · Envoy Medical Corporation · NEA · Feb 28, 2008 · Dental

Device Facts

Record ID	K080032
Device Name	ENVOYCEM, MODEL 1640
Applicant	Envoy Medical Corporation
Product Code	NEA · Dental
Decision Date	Feb 28, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

Intended Use

EnvoyCem is intended for use in otologic surgery for the following applications: - Augmentation or coupling of the middle ear ossicles. - Attachment of the middle ear ossicles to middle ear implants. - Mechanical stabilization of middle ear prostheses.

Device Story

EnvoyCem is a glass ionomer cement (GIC) used in otologic surgery; provided as two-component system (glass powder and polyalkenoic acid liquid). Components mixed to form viscous, moldable cement; hardens in situ. Used by surgeons in clinical settings for ossicular chain reconstruction, implant attachment, and prosthesis stabilization. Single-use device; provided sterile via gamma irradiation. Benefits include mechanical support and stabilization of middle ear structures during reconstructive procedures.

Clinical Evidence

Bench testing only. Includes functional testing, accelerated shelf life, biocompatibility (MEM elution, genotoxicity, irritation, sensitization), and sterilization validation. No clinical data presented.

Technological Characteristics

Glass ionomer cement (GIC); two-component system (powder/liquid). Single-use; provided sterile via gamma irradiation. Packaged in 0.5g capsules with activator, applicator, and mixer. Biocompatibility verified via MEM elution and Fourier transform infrared spectroscopy.

Indications for Use

Indicated for patients undergoing otologic surgery requiring augmentation/coupling of middle ear ossicles, attachment of ossicles to implants, or mechanical stabilization of middle ear prostheses.

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

OTO-CEM (K011338)
SerenoCem (K003567)
OtoMimix (K042516)

Related Devices

K140644 — PROCEM · Ototronix, LLC · Jun 19, 2014
K060750 — STRYKER INJECTABLE CEMENT · Stryker Cmf · Apr 19, 2006
K042516 — OTOMIMIX · Walter Lorenz Surgical, Inc. · Nov 8, 2004
K210473 — Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Nov 2, 2021
K101869 — PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER) · Silmet , Ltd. · Sep 29, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ KO 80032 FEB 2 8 % .. # SUMMARY AND CERTIFICATION ## B. 510(K) SUMMARY ### Summary of Safety and Effectiveness In accordance with 21 CFR 807.92, the following information constitutes the summary of safety and effectiveness for EnvoyCem. | SUBMITTER'S NAME: | Envoy Medical Corporation | |---------------------|---------------------------------------------| | ADDRESS: | 5000 Township Parkway St. Paul, MN 55110 | | CONTACT PERSON: | Bernard (Bud) Horwath | | TELEPHONE NUMBER: | 651-361-8041 | | FAX NUMBER: | 651-351-8001 | | DATE OF SUBMISSION: | 28 December 2007 | #### 1. Identification of device Proprietary Name: EnvoyCem Common Name: Cement, Ear, Nose and Throat Classification Status: Class II per regulations 872.3275 Product Codes: NEA #### 2. Equivalent devices Envoy Medical believes that EnvoyCem is substantially equivalent to the following devices: > OTO-CEM, K011338 SerenoCem, K003567 OtoMimix, K042516 EnvoyCem is glass ionomer cement as is OTO-CEM and SerenoCem and has essentially the same intended use as all three of the predicate devices. #### 3. Description of the Device EnvoyCem is glass ionomer cement that is provided as two components, a glass powder and polyalkenoic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ. #### 4. Intended use EnvoyCem is intended for use in otologic surgery for the following applications: - Augmentation or coupling of the middle ear ossicles. . - Attachment of the middle ear ossicles to middle ear implants. . - Mechanical stabilization of middle ear prostheses. ● Envoy Medical Corporation EnvoyCem 510k {1}------------------------------------------------ #### 5. Technological characteristics, comparison to predicate device. Like all the predicate devices, EnvoyCem is intended for use in various otologic surgical applications. EnvoyCem is glass ionomer cement as is OTO-CEM and SerenoCem. The following table provides a detailed comparison between EnvoyCem and the identified predicate devices. | Characteristic | EnvoyCem | OTO-CEM | SerenoCem | OtoMimix | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Material | Glass Ionomer Cement (GIC) | Glass Ionomer Cement (GIC) | Glass Ionomer Cement (GIC) | Calcium Phosphate Cement (Hydroxyapatite-HA) | | Indications for Use | Use in otologic surgery for 1. Augmentation or coupling of the middle ear ossicles 2. Attachment of the middle ear ossicles to middle ear implants 3. Mechanical stabilization of middle ear prostheses | Use in otological surgery for reconstruction of the ossicular chain. | Non-weight bearing applications in otologic surgery, such as: 1. The reconstruction of the ossicular chain where the cement can be used to repair bony ossicles in their normal position 2. Acoustic meatal wall construction in well-ventilated middle ears 3. Cementation of cochlear implants | Use in otologic surgery for 1. Augmentation or coupling of the middle ear ossicles 2. Attachment of the middle ear ossicles to middle ear implants 3. Mechanical stabilization of middle ear prostheses 4.Reconstruction of the posterior canal wall | | Clinical Use | GIC has an extensive history of middle ear use | GIC has an extensive history of middle ear use | GIC has an extensive history of middle ear use | HA has a history of clinical use near dura, CSF | | Biocompatibility | Non-cytotoxic per MEM Elution extract testing and shown to be equivalent to chemical composition of | Demonstrated biocompatibility per genotoxicity, acute oral toxicity, irritation, intramuscular implantation. | In vitro and in vivo clinical investigations have shown SerenoCem to be highly biocompatible | Demonstrated to be non-ototoxic | | | OTO-CEM via chemical analysis testing using Fourier transform infrared spectroscopy. | subcutaneous implantation, intracutaneous reactivity, kinetics, pyrogen, skin sensitivity and cytoxicity. | | | | Use | Single use | Single use | Single use | Single use | | Sterility | Provided sterile by Gamma Irradiation | Provided sterile by Gamma Irradiation | Provided sterile by Gamma Irradiation | Provided sterile by Gamma Irradiation | | Packaging | 0.5 gram capsule with proper ratio of liquid to powder | 0.5 gram capsule with proper ratio of liquid to powder | Double foil pack around capsule | 2 gram vials of powder and liquid | | Accessories | Activator Applicator Mixer | Activator Applicator Mixer | Applicator Mixer | None (Hand Mixed) | rison tahle ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ Envoy Medical Corporation EnvoyCem 510k {2}------------------------------------------------ #### 6. Discussion of performance testing. An extensive collection of tests has been conducted and successfully completed, including functional, accelerated shelf life, biocompatibility and sterilization validation. All testing indicates that EnvoyCem meets its specification requirements. #### 7. Conclusion Based on extensive performance testing and a comparison to the predicate devices, it is the conclusion of Envoy Medical that EnvoyCem is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. Public Health Service FEB 28 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Envoy Medical Corporation c/o Mr. Bernard Horwath Regulatory Manager 5000 Township Parkway Saint Paul, MN 55110 Re: K080032 Trade/Device Name: EnvoyCem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental cement Regulatory Class: Class II Product Code: NEA Dated: January 4, 2008 Received: January 7, 2008 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, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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. {4}------------------------------------------------ Page 2 -Mr. Bernard Horwath This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Malina B. Epple, und Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K080032 Page 1 of 1 ## A. INDICATIONS FOR USE 510(k) Number_KO80032 Device Name: EnvoyCem ### Indications for Use: EnvoyCem is intended for use in otologic surgery for the following applications: - Augmentation or coupling of the middle ear ossicles. ● - . Attachment of the middle ear ossicles to middle ear implants. - Mechanical stabilization of middle ear prostheses. ◆ (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over the Counter Use ***_*** Daniel Cepp (Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devices Envoy Medical Corporation EnvoyCem 510k **510(k) Number** K080032 5