(53 days)
Not Found
No
The device description and the absence of mentions of AI, ML, or related concepts indicate it is a material-based product without AI/ML components.
No
The device is a bone replacement product used for augmentation, attachment, stabilization, and reconstruction of middle ear structures. It is a material implanted to aid in surgical repair, rather than a device that directly treats a disease or condition through non-invasive means or by actively performing a therapeutic function.
No
The Intended Use and Device Description clearly state that OtoMimix™ is a bone replacement product used for surgical augmentation, attachment, stabilization, and reconstruction of middle ear structures. It does not mention detection, diagnosis, or assessment of diseases or conditions.
No
The device description clearly states that OtoMimix™ is a "sterile calcium phosphate Bone Replacement product" and a "moldable material," indicating it is a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- OtoMimix™ Function: OtoMimix™ is a bone replacement product used within the body during surgical procedures to augment, attach, stabilize, and reconstruct structures in the middle ear. It is a surgical implant/material, not a diagnostic test.
The provided information clearly describes a material used for surgical reconstruction and stabilization, not for analyzing biological samples to diagnose a condition.
N/A
Intended Use / Indications for Use
OtoMimixTM is indicated for the following:
-
- Augmentation or coupling of the middle ear ossicles.
-
- Attachment of the middle ear ossicles to middle ear implants.
-
- Mechanical stabilization of middle ear prostheses
-
- Reconstruction of the posterior canal wall
Product codes (comma separated list FDA assigned to the subject device)
NEA
Device Description
OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear ossicles, middle ear, posterior canal wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
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.
K990290, K003494, K011338, K861369
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
Summary of Safety and Effectiveness
Device Name: OtoMimix™
Classification Name and Reference:
Product Code: NEA
Device Classification: Class II
Device Description: OtoMimix™ is a sterile calcium phosphate Bone Replacement product. When mixed with a stering solution, it becomes moldable material for use in otology procedures. With time, this moldable filler material hardens.
Intended Use: OtoMimix™ is indicated for use in the following: 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.
Materials Powder component - calcium phosphate powder and sodium citrate dihydrate Liquid component - anhydrous citric acid and distilled water
POSSIBLE ADVERSE EFFECTS
-
- Wound complications including hemotoma, site drainage, bone fracture, infections that are possible with any surgery. Any of these complications can lead to failure of the procedure and further surgery,
- Fracture or extrusion of the filler, with or without generation of particulate debris. 2.
-
- Deformity of the bone at the surgical site.
- Incomplete or lack of osseous ingrowth into bone void, as is possible with any bone void filler. 4.
- ર. Implantation of foreign materials can result in an inflammatory response or allergic reaction, or subsequent cholestotoma.
Substantial Equivalence
The OtoMimix10 product is believed to be substantially equivalent in application and function to
Mimix (Craniofacial Calcium Phosphate Ceramic Bone Void Filler (K990290) Oto-Cem® - OtoTech®, Inc. (K011338) Incus Stapes Prosthesis - Richards Medical, Inc. (K861369)
Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of Biomet, Inc. The proposed OtoMinix™ product is equivalent in material characteristics and processing methods to the approved Mimix. Only packaging will change, slightly, to accommodate wolument material (0.5 to 5 grams). The anticipated size to be delivered to the market is 2 grams.
The approved HA middle ear prostheses (Richards, Xomed) are composed of the same material class (hydroxyagatite) and have the same field of use (middle ear applications).
The approved Oto-Cem device and the proposed OtoMinix device have an equivalent application in the cementing of ossicles of the middle ear.
Based on the characteristics of these predicate devices, the safety and effectiveness of OtoMimix is assessed to be substantially equivalent to approved devices for the same intended use in restoration of hearing the function of the ossicular chain.
1
Summary of Substantial Equivalence
| | Proposed OtoMimix | Approved Oto-Cem | Approved Mimix
Biomet, Inc.
K 990290, K003494 | Approved Incus Stapes
Prosthesis - Richards
Medical Co., Inc.
K861369 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Material | Calcium Phosphate cement
Same as Mimix Predicate | Hybrid glass polymer
composite | Calcium Phosphate cement | Subsequent HA middle ear
prostheses (e.g. Xomed)
No 510K summary available. |
| | | | | 1st approved hydroxyapatite
prosthesis known to be
marketed by Richards in
1986 |
| | | | | Hydroxyapatite
No 510K summary available. |
| Indications for
use | 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 | "for use in otological surgery
for reconstruction of the
ossicular chain" | "...neurosurgical burr holes,
craniotomy cuts and other
cranial defects as well as in
the augmentation or
restoration of bony contour
in the craniofacial skeleton." | |
| Contraindications | | | | No 510K summary available. |
| Ototoxicity | Demonstrated to be non-ototoxic (Dornhoffer et al.) | No information available | Demonstrated to be non-ototoxic (Dornhoffer et al.) | No information available - commonly used for middle ear prostheses |
| Use | Single Use | Single Use | Single Use | Single Use |
| Sterility | Provided Sterile | Provided Sterile | Provided Sterile | Provided Sterile |
| Technological Features | 2 component cement Hand Mixed HA material History of clinical use near dura, CSF | 2 component cement Mixing Machine Polymaleinate derived cement Contraindicated for use near nerve tissue | 2 component cement Hand Mixed HA material History of clinical use near dura, CSF | Preformed Implant No mixing required HA material Extensive history of middle ear use |
2
100 million in the state
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2004
Walter Lorenz Surgical, Inc. c/o Ms. Kim Reed 1520 Tradeport Dr. Jacksonville, FL 32218
Re: K042516 Trade/Device Name: OtoMimixTM Regulation Number: 21 CFR 872.3275 Regulation Name: Ear Nose and Throat (ENT) Cement Regulatory Class: II Product Code: NEA Dated: September 15, 2004 Received: September 16, 2004
Dear Ms. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o no reviewed your bookear ================================================================================================================================================= referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the energent 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 therefore, mainers of the Act include requirements for annual registration, listing of devices, good vanufacturing 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 - Ms. Kim Reed
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
A halyi Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
STATEMENT OF INDICATIONS FOR USE
510(k) Number K042516
Device Name: OtoMimix™
Indications for Use:
OtoMimix™ is indicated for the following:
-
- Augmentation or coupling of the middle ear ossicles.
-
- Attachment of the middle ear ossicles to middle ear implants.
-
- Mechanical stabilization of middle ear prostheses
-
- Reconstruction of the posterior canal wall
Prescription Use XX
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off)
(Division Sign-Oll
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K042516
Page 1 of of
(Posted November 13, 2003)