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.

AI/ML Overview

The OtoMimix™ device is a calcium phosphate bone replacement product intended for use in otology procedures for augmentation or coupling of middle ear ossicles, attachment of ossicles to middle ear implants, mechanical stabilization of middle ear prostheses, and reconstruction of the posterior canal wall. The provided document does not contain an explicit list of acceptance criteria or a detailed study proving the device meets specific performance metrics. Instead, the submission relies on demonstrating substantial equivalence to previously approved predicate devices to establish its safety and effectiveness.

Here's an analysis based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no explicit quantitative acceptance criteria or detailed performance study results (e.g., success rates, functional outcomes, specific measurements) provided in the summaries for OtoMimix™, a direct table comparing "acceptance criteria" against "reported device performance" cannot be fully constructed in the conventional sense for a performance study.

However, we can infer the "acceptance criteria" from the substantial equivalence comparison to predicate devices, focusing on material composition, indications for use, and critical characteristics. The "reported device performance" in this context is the assertion that OtoMimix™ shares these characteristics with the approved predicates.

Acceptance Criteria (Inferred from Substantial Equivalence to Predicates)	Reported Device "Performance" (Assertion)
Material Composition
- Calcium Phosphate Cement	OtoMimix™: Calcium Phosphate cement (Same as Mimix Predicate)
Indications for Use
- Augmentation/coupling of middle ear ossicles	OtoMimix™: Indicated for Augmentation or coupling of the middle ear ossicles. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear)
- Attachment of middle ear ossicles to implants	OtoMimix™: Indicated for Attachment of the middle ear ossicles to middle ear implants. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear)
- Mechanical stabilization of middle ear prostheses	OtoMimix™: Indicated for Mechanical stabilization of middle ear prostheses. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear)
- Reconstruction of posterior canal wall	OtoMimix™: Indicated for Reconstruction of the posterior canal wall. (Similar to Oto-Cem and Incus Stapes Prosthesis predicate uses in middle ear)
Ototoxicity
- Non-ototoxic	OtoMimix™: Demonstrated to be non-ototoxic (Dornhoffer et al.). (Similar to Mimix Predicate, which also demonstrated non-ototoxicity; Oto-Cem had no information but is for otological surgery; Incus Stapes Prosthesis is commonly used for middle ear prostheses.)
Sterility
- Provided Sterile	OtoMimix™: Provided Sterile. (Same as all listed predicates)
Use
- Single Use	OtoMimix™: Single Use. (Same as all listed predicates)
Technological Features
- 2-component cement	OtoMimix™: 2 component cement. (Same as Mimix and Oto-Cem predicates)
- Hand Mixed	OtoMimix™: Hand Mixed. (Same as Mimix predicate)
- HA material	OtoMimix™: HA material (Calcium Phosphate cement). (Same as Mimix and Incus Stapes Prosthesis predicates)
- History of clinical use near dura, CSF	OtoMimix™: History of clinical use near dura, CSF. (Same as Mimix predicate)

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the context of a performance study for OtoMimix™. The device's safety and effectiveness are established through substantial equivalence to predicate devices. This means that instead of conducting a new large-scale clinical trial for OtoMimix™, its characteristics (materials, indications, technological features) were compared to predicates already legally marketed.

The key 'data' supporting equivalence are:

Material composition: OtoMimix™ uses Calcium Phosphate cement, which is stated to be the "Same as Mimix Predicate."
Ototoxicity: "Demonstrated to be non-ototoxic (Dornhoffer et al.)" for OtoMimix™, similar to the Mimix predicate. This likely refers to preclinical or clinical data associated with the material class or directly with the Mimix predicate, rather than a specific new study on OtoMimix™ itself in this submission. The origin of this Dornhoffer et al. data (country, retrospective/prospective) is not specified.

Therefore, there is no direct "test set" with a specified sample size or explicit data provenance for OtoMimix™'s performance study within this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, there was no independent "test set" requiring expert ground truth establishment for OtoMimix™'s performance study. The evaluation was primarily a comparison of device characteristics against approved predicate devices by the FDA review team.

4. Adjudication method for the test set

Not applicable. There was no "test set" for which adjudication of results would be required. The FDA's review process determines substantial equivalence based on the submitted information and comparison to predicates.

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 device is a surgical implant/cement, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This device is a physical product (bone replacement material), not a software algorithm.

7. The type of ground truth used

The "ground truth" for the substantial equivalence determination relies on:

Predicate Device Approvals: The regulatory history and approved characteristics of Mimix (K990290, K003494), Oto-Cem (K011338), and Incus Stapes Prosthesis (K861369). These devices already have established safety and effectiveness.
Material Science/Bench Testing: The assertion that OtoMimix™'s material, technological features, and ototoxicity are "Same as Mimix Predicate," implying that the data (e.g., biocompatiability, mechanical properties, ototoxicity studies like Dornhoffer et al.) associated with the Mimix predicate serve as the basis for OtoMimix™.
Literature/Expert Consensus: The affirmation that hydroxyapatite is a commonly used material for middle ear prostheses and has an "Extensive history of middle ear use."

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model, so there is no training set.

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

Not applicable.

Summary

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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

1. 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.
1. 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.

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Summary of Substantial Equivalence

	Proposed OtoMimix	Approved Oto-Cem	Approved MimixBiomet, Inc.K 990290, K003494	Approved Incus StapesProsthesis - RichardsMedical Co., Inc.K861369
Material	Calcium Phosphate cementSame as Mimix Predicate	Hybrid glass polymercomposite	Calcium Phosphate cement	Subsequent HA middle earprostheses (e.g. Xomed)No 510K summary available.
				1st approved hydroxyapatiteprosthesis known to bemarketed by Richards in1986
				HydroxyapatiteNo 510K summary available.
Indications foruse	1. Augmentation or couplingof the middle ear ossicles.2. Attachment of the middleear ossicles to middle earimplants.3. Mechanical stabilization ofmiddle ear prostheses4. Reconstruction of theposterior canal wall	"for use in otological surgeryfor reconstruction of theossicular chain"	"...neurosurgical burr holes,craniotomy cuts and othercranial defects as well as inthe augmentation orrestoration of bony contourin 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

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100 million in the state

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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.

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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

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STATEMENT OF INDICATIONS FOR USE

510(k) Number K042516

Device Name: OtoMimix™

Indications for Use:

OtoMimix™ is indicated for the following:

1. Augmentation or coupling of the middle ear ossicles.
1. Attachment of the middle ear ossicles to middle ear implants.
1. Mechanical stabilization of middle ear prostheses
1. 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)

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.