(193 days)
No
The description focuses on the material composition and intended use of a subdermal implant for vocal fold augmentation. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes.
The device is used to treat vocal fold insufficiency and improve phonation, which are therapeutic applications.
No
The device is described as a soft tissue bulking agent used for vocal fold medialization and insufficiency, which aims to improve phonation. Its intended use is to augment the size of the vocal fold so it can meet the opposing fold, rather than to diagnose a condition.
No
The device description clearly states it is a "Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant" composed of physical materials like calcium hydroxylapatite and a gel carrier. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Description and Intended Use: The description clearly states that Vocalis and Vocalis SM are subdermal implants intended for injection into the vocal folds to augment their size. This is a direct intervention within the body, not an examination of a specimen outside the body.
- Lack of Specimen Examination: There is no mention of the device being used to analyze blood, tissue, or any other bodily fluid or sample.
Therefore, Vocalis and Vocalis SM are therapeutic devices used for direct treatment, not diagnostic devices used for examining specimens.
N/A
Intended Use / Indications for Use
Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis 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 period of one month.
Product codes
MIX
Device Description
Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laryngeal, vocal fold
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)
In vivo and in vitro tests were performed to address irritation, sensitization, cytotoxicity, acute and sub-chronic toxicity, genotoxicity, and hemolysis. Results identified the Vocalis and Vocalis SM as a nonirritant, nontoxic, with no concerns for long-term safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K013243, K070090, K071663, K080956
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JAN - 5 2009
SECTION 4
1081816
510(k) Summary of Safety and Effectiveness
Trade Name:
- 2
Vocalis and Vocalis SM
Common Name:
Vocal Fold Implant
Classification Name:
Official Contact Name:
Greg Johnson President & CEO
Address:
Cytophil, Inc. 5546 N Santa Monica Blvd Whitefish Bay, WI 53217
System, Vocal Cord Medialization
Phone: Fax: E-mail: Date Prepared: 414-961-7372 414-961-6167 gjohnson@cytophil.com 6/23/2008
4.1 Intended Use
Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis 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 period of one month.
4.2 Product Description
Sterile, latex free, non-pyrogenic, semi-solid, cohesive subdermal implant. The principle durable component is synthetic calcium hydroxylapatite. The semi-sold nature is created by suspending the calcium hydroxylapatite particles in a durable high yield strength thixotropic gel. The isotonic gel carrier consists primarily of sterile water for injection (USP), glycerin (USP) and mannitol (USP). The thixotropic high yield strength gel is created by the Carbopol 974P NF (USP).
Cytophil, Inc.
Section 4
4-1
1
4.3 Substantial Equivalence
The following are the predicate devices that are substantially equivalent to Vocalis and Vocalis SM:
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
K080956
Modification to VF Gel 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 the Vocalis and Vocalis SM are biocompatible when injected into soft tissues.
4.5 Sterilization
Vocalis and Vocalis SM are sterilized using steam. Processing is preformed by a contract sterilization company, Haemonetics, using a computer controlled Cycle parameters were validated using an overkill autoclave system. methodology to 10 6 SAL. Sterilization by the user is not required.
Cytophil, Inc.
Section 4
4-2
2
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 the Vocalis and Vocalis SM as a nonirritant, nontoxic, with no concerns for long-term safety.
4.7 Risk Assessment
The primary risks with Vocalis and Vocalis SM 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
The Vocalis and Vocalis SM are 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
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the eagle in a circular pattern. The eagle is facing to the right. The image is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2009
Cytophil. Inc. c/o Mr. Greg Johnson President & CEO 5546 N Santa Monica Blvd Whitefish Bay, WI 53217
Re: K081816
Trade/Device Name: Vocalis and Vocalis SM 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 (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
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.
Madina B. Eglada, S. 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
5
KOB1816
SECTION 2
Indications for Use
510(k) Number: K081816
Device Name: Vocalis and Vocalis SM
Indications for Use:
Vocalis and Vocalis SM are indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Vocalis 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 period of one month.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
or Over-the-Counter Use Prescription Use ਮ (Per 21 CFR 801.109
unter Use
Daniel Clouse
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number K08/8/6
Cytophil, Inc.
Section 2
2-1