(52 days)
Not Found
No
The device description and summary of performance studies indicate a traditional medical device (glass ionomer cement) without any mention of AI or ML capabilities.
No
The device is a glass ionomer cement used for augmentation, coupling, attachment, and mechanical stabilization during otologic surgery, which are structural and functional support roles during a surgical procedure, not therapeutic in nature.
No
EnvoyCem is a glass ionomer cement used for augmentation, coupling, attachment, and mechanical stabilization of middle ear ossicles and prostheses in otologic surgery. It is a material used for treatment, not for diagnosing conditions.
No
The device description clearly states that EnvoyCem is a glass ionomer cement provided as a glass powder and polyalkenoic acid liquid, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that EnvoyCem is for use in otologic surgery for applications related to the middle ear ossicles and implants. This is a surgical application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a glass ionomer cement that hardens in situ (within the body). This is a material used for structural support and attachment during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. EnvoyCem does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
otologic surgery
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
OTO-CEM, K011338, SerenoCem, K003567, OtoMimix, K042516
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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:
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 |
- Augmentation
or coupling of
the middle ear
ossicles - Attachment of
the middle ear
ossicles to
middle ear
implants - 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: - The
reconstruction of
the ossicular
chain where the
cement can be
used to repair
bony ossicles in
their normal
position - Acoustic
meatal wall
construction in
well-ventilated
middle ears - Cementation
of cochlear
implants | Use in otologic
surgery for - Augmentation or
coupling of the
middle ear ossicles - Attachment of
the middle ear
ossicles to middle
ear implants - 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
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