Vocalis Gel is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication. The product is intended to be durable for a minimum of one month.

Device Description

Sterile, latex free, non-pyrogenic, high yield strength, isotonic, clear gel injectable implant. The gel consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The high yield strength is created by small amounts of carbomer (USP). The gel carrier allows tissue infiltration over time. All components are listed as GRAS (Generally Recognized as Safe 21 CFR 182). The character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Vocalis Gel device.

Acceptance Criteria and Device Performance for Vocalis Gel

Unfortunately, the provided document does not explicitly state specific acceptance criteria (e.g., numerical targets for performance metrics) for Vocalis Gel.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices and fulfilling general regulatory requirements for medical devices. The primary "performance" is implicitly demonstrated through biocompatibility, sterilization, and pre-clinical safety assessments.

The device's intended effect, "vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent...to meet the opposing fold at the midline for improved phonation" and being "durable for a minimum of one month," are clinical outcomes rather than quantifiable device performance metrics presented in this 510(k) summary.

Based on the available information, the closest approximation to "acceptance criteria" and "reported device performance" are as follows:

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (Summary of results)
Biocompatibility: Device must be biocompatible when injected into soft tissues.	"The battery of preclinical safety studies and animal implant studies show that Vocalis Gel is biocompatible when injected into soft tissues."
Safety - Non-irritant: Device must not cause irritation.	"Results identified Vocalis Gel as a non-irritant..."
Safety - Non-toxic: Device must not be toxic.	"...and nontoxic with no concerns for long-term safety."
Sterility Assurance Level (SAL): Sterilization process must achieve a 10⁻⁶ SAL.	"Cycle parameters were validated using an overkill methodology to 10⁻⁶ SAL."
Mechanical Properties: Gel must be capable of being easily injected through fine needles with minimal force. (Implied by description: "the character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force.")	"The character of the gel allows it to be very thick and cohesive but sheer to be easily injected through very fine needles with minimal force."
Primary Risks: Identified risks must be associated with nasopharyngoscopy and injection laryngoplasty (as typical for the procedure).	"The risks identified are primarily associated with nasopharyngoscopy and injection laryngoplasty."

Study Details Proving Device Meets Acceptance Criteria:

The provided document describes pre-clinical tests rather than a study with a defined "test set" or "ground truth" as might be seen for diagnostic AI devices.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of subjects or samples. The document refers to "in vivo and in vitro tests" and "animal implant studies" but does not give specific numbers for these.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based pre-clinical (in vitro and in vivo animal) rather than human clinical data. They are retrospective in the sense that they were conducted before the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to the type of pre-clinical studies described. Ground truth, in this context, would be established by scientific methods and validated assays (e.g., cytotoxicity assays, irritation tests, histological analysis for biocompatibility in animal models) performed by trained laboratory personnel or specialists in relevant fields (e.g., toxicology, pathology). There is no mention of "experts" in the sense of clinical reviewers adjudicating results for the pre-clinical tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to human review of data, typically in diagnostic or qualitative assessment studies. The pre-clinical tests described would be evaluated based on objective scientific measurements and established criteria for toxicity, irritation, etc.
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. Vocalis Gel is an injectable medical device, not a diagnostic imaging or AI-assisted system for human readers. Therefore, an MRMC study is not relevant to its evaluation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This refers to AI algorithm performance. Vocalis Gel is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Histological analysis from animal implants, and various laboratory assays (e.g., cytotoxicity, hemocompatibility).
- For irritation, sensitization, acute and sub-chronic toxicity, genotoxicity, and hemolysis: Standardized in vivo (animal) and in vitro (cell culture, biochemical) assays with pre-defined endpoints and controls.
- For sterility: Biological indicators and physical parameters measured during the sterilization cycle to confirm a 10⁻⁶ SAL.
The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable. See point 7.

In summary, the provided document for Vocalis Gel focuses on demonstrating the device's safety, biocompatibility, and manufacturing quality through pre-clinical laboratory and animal studies, rather than clinical performance metrics with specific numerical acceptance criteria typically seen for diagnostic devices or those with direct, quantifiable output. The acceptance is based on demonstrating substantial equivalence to predicate devices and fulfilling these fundamental safety and sterilization requirements.

Summary

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K081815

JAN - 5 2009

SECTION 4 510(k) Summary of Safety and Effectiveness

Vocalis Gel Trade Name: Common Name: Vocal Cord Medialization System, Vocal Cord Medialization Classification Name: Official Contact Name: Greg Johnson President & CEO Cytophil, Inc. Address: 5546 N Santa Monica Blvd Whitefish Bay, WI 53217 Phone: 414-961-7372 414-961-6167 Fax:

6/28/2008

4.1 Intended Use

Date Prepared:

E-mail:

Vocalis Gel is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis Gel injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved Vocal fold insufficiency associated with serious aspiration phonation. difficulties may be an urgent indication. The product is intended to be durable for a minimum of one month.

gjohnson@cytophil.com

4.2 Product Description

Cytophil, Inc.

Section 4

4-1

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4.3 Substantial Equivalence

The following is the predicate device that is substantially equivalent to Vocalis Gel:

K080956

Modification to VF Gel Coapt Systems, Inc. 1820 Embarcadero Rd. Palo Alto, CA 94303

K013243

Coaptite Laryngeal Augmentation System BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126

K070090

Radiesse Laryngeal Implant BioForm Medical, Inc. 1875 South Grant St., Suite 110 San Mateo, CA 94402

K071663 VF Long Term Coapt Systems, Inc. 1820 Embarcadero Rd. Palo Alto, CA 94303

4.4 Biocompatibility Evaluations

The battery of preclinical safety studies and animal implant studies show that Vocalis Gel is biocompatible when injected into soft tissues.

4.5 Sterilization

Vocalis Gel is sterilized using steam. Processing is preformed by a contract sterilization company, Haemonetics, using a computer controlled autoclave system. Cycle parameters were validated using an overkill methodology to 100 SAL. Sterilization by the user is not required.

Cytophil, Inc.

Section 4

4-2

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4.6 Pre-Clinical Tests Performed

In vivo and in vitro tests were performed to address irritation, sensitization, cytotoxicity, acute and sub-chronic toxicity, genotoxicity and hemolysis. Results identified Vocalis Gel as a nonirritant, and nontoxic with no concerns for long-term safety.

4.7 Risk Assessment

਼ ਸ

The primary risks with Vocalis Gel have been identified through a risk assessment procedure in accordance with EN 1441. The risks identified are primarily associated with nasopharyngoscopy and injection laryngoplasty.

4.8 Summary

Vocalis Gel is a safe and effective implant used as a space filling material for soft tissue augmentation in laryngeal procedures for vocal fold medialization and augmentation.

Section 4

4-3

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an emblem featuring an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cytophil, Inc. c/o Mr. Greg Johnson President & CEO 5546 N Santa Monica Blvd Whitefish Bay, WI 53217

AN - 5 2009

Re: K081815

Trade/Device Name: Vocalis Gel Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIX Dated: December 12, 2008 Received: December 15, 2008

Dear Mr. Johnson:

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 (OS) 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. Greg Johnson

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. Egleston, and

Malvina B. Eydelman, 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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K0818/5

SECTION 2 Indications for Use

510(k) Number: K081815

Device Name: Vocalis Gel

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or Over-the-Counter Use X (Per 21 CFR 801.109

Daniel Cearron

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K081815

Section 2

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.