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.

AI/ML Overview

This submission is for a medical device (EnvoyCem, a glass ionomer cement) and as such, the performance testing described is focused on the device's physical and biological properties rather than an AI/ML algorithm's clinical performance. Therefore, many of the requested categories for AI/ML study components (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this 510(k) summary.

Here's a breakdown of the available information based on your request, with an explanation of why certain elements are not present:

1. Table of acceptance criteria and the reported device performance

The submission mentions that "All testing indicates that EnvoyCem meets its specification requirements." However, the specific acceptance criteria (numerical thresholds for success) and the detailed reported performance values for each test are not explicitly provided in this 510(k) summary. The document broadly states that the device successfully completed various tests.

Acceptance Criteria Category	Reported Device Performance
Functional Testing	Successfully completed; device meets specification requirements. (Specific criteria/results not detailed)
Accelerated Shelf Life	Successfully completed; device meets specification requirements. (Specific criteria/results not detailed)
Biocompatibility	- Non-cytotoxic per MEM Elution extract testing.- Shown to be equivalent to chemical composition of OTO-CEM via Fourier transform infrared spectroscopy.
Sterilization Validation	Successfully completed; device meets specification requirements. (Specific criteria/results not detailed)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. For non-AI/ML medical devices like this cement, "test sets" typically refer to lab-based studies on the material itself, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for a cement's physical and biological properties is established through standardized laboratory testing methods, not expert consensus on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this pertained to laboratory testing of device properties, not clinical assessment requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device for surgical applications (cement), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a medical device (cement), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established through standardized laboratory testing protocols for:

Physical properties (functional stability, hardening time, etc. – implied by "functional testing").
Shelf life properties (implied by "accelerated shelf life testing").
Biocompatibility (MEM Elution extract testing, Fourier transform infrared spectroscopy for chemical equivalence).
Sterility (sterilization validation protocols).

8. The sample size for the training set

Not applicable for a medical device (cement). "Training set" is a concept specific to AI/ML algorithms.

9. How the ground truth for the training set was established

Not applicable for a medical device (cement).

Summary

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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 ParkwaySt. 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

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

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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 IonomerCement (GIC)	Glass IonomerCement (GIC)	Glass IonomerCement (GIC)	Calcium PhosphateCement(Hydroxyapatite-HA)
Indications for Use	Use in otologicsurgery for1. Augmentationor coupling ofthe middle earossicles2. Attachment ofthe middle earossicles tomiddle earimplants3. Mechanicalstabilization ofmiddle earprostheses	Use in otologicalsurgery forreconstruction ofthe ossicularchain.	Non-weightbearingapplications inotologic surgery,such as:1. Thereconstruction ofthe ossicularchain where thecement can beused to repairbony ossicles intheir normalposition2. Acousticmeatal wallconstruction inwell-ventilatedmiddle ears3. Cementationof cochlearimplants	Use in otologicsurgery for1. Augmentation orcoupling of themiddle ear ossicles2. Attachment ofthe middle earossicles to middleear implants3. Mechanicalstabilization ofmiddle earprostheses4.Reconstructionof the posteriorcanal wall
Clinical Use	GIC has anextensive historyof middle earuse	GIC has anextensive historyof middle earuse	GIC has anextensive historyof middle earuse	HA has a historyof clinical use neardura, CSF
Biocompatibility	Non-cytotoxicper MEMElution extracttesting andshown to beequivalent tochemicalcomposition of	Demonstratedbiocompatibilityper genotoxicity,acute oraltoxicity,irritation,intramuscularimplantation.	In vitro and invivo clinicalinvestigationshave shownSerenoCem tobe highlybiocompatible	Demonstrated tobe non-ototoxic
	OTO-CEM viachemicalanalysis testingusing Fouriertransforminfraredspectroscopy.	subcutaneousimplantation,intracutaneousreactivity,kinetics,pyrogen, skinsensitivity andcytoxicity.
Use	Single use	Single use	Single use	Single use
Sterility	Provided sterileby GammaIrradiation	Provided sterileby GammaIrradiation	Provided sterileby GammaIrradiation	Provided sterile byGamma Irradiation
Packaging	0.5 gram capsulewith proper ratioof liquid topowder	0.5 gram capsulewith proper ratioof liquid topowder	Double foil packaround capsule	2 gram vials ofpowder and liquid
Accessories	ActivatorApplicatorMixer	ActivatorApplicatorMixer	ApplicatorMixer	None (HandMixed)

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Envoy Medical Corporation EnvoyCem 510k

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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.

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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.

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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

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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

Regulation Number and Section

§ 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.