CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT

K121795 · Cytophil, Inc. · MIX · Feb 22, 2013 · Ear, Nose, Throat

Device Facts

• Record ID: K121795
• Device Name: CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT
• Applicant: Cytophil, Inc.
• Product Code: MIX · Ear, Nose, Throat
• Decision Date: Feb 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Calcium Hydroxylapatite Vocal Fold Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. Calcium Hydroxylapatite Vocal Fold Implant 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.

Device Story

Injectable soft tissue bulking agent; composed of synthetic calcium hydroxylapatite particles in aqueous gel carrier (sodium carboxymethylcellulose, glycerin, phosphate buffer). Used for vocal fold medialization; augments deformed/displaced vocal folds to improve phonation and address aspiration. Administered by physician via direct injection into laryngeal site; guided by nasopharyngoscope; no open surgery required. Gel carrier resorbs in vivo; calcium hydroxylapatite particles remain as non-resorbable scaffold; facilitates local tissue infiltration for long-term augmentation. Benefits patient by restoring vocal fold closure and function.

Clinical Evidence

No clinical data provided. Evidence based on biocompatibility evaluations, preclinical safety studies, and animal implant studies. Results identified the implant as non-irritant and non-toxic with no long-term safety concerns.

Technological Characteristics

Synthetic calcium hydroxylapatite particles (ASTM F1185) in resorbable gel carrier (USP glycerin, USP sodium carboxymethylcellulose, USP phosphate buffer). Particle size 25-45 microns. Sterile, ready-to-use syringe delivery. Steam sterilization per ISO 17665.

Indications for Use

Indicated for patients with vocal fold insufficiency or displacement requiring medialization to improve phonation or address aspiration difficulties.

Regulatory Classification

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.

Predicate Devices

• Radiesse Laryngeal Implant (K070090)

Submission Summary (Full Text)

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# Chapter 5 510(k) Summary [per 21 CFR 807.92(c)]

## FEB 2 2 2013

### 5. 510(k) Summary as required by section 807.92(c)

5.1. 510(k) Owner

William G. Hubbard Ph.D. President & CEO

Cytophil, Inc. 2485 Corporate Circle, Suite 2 East Troy, WI 53120 Phone [phone] Cell [phone] Fax [phone] Email [e-mail] 5.2. 510(k) Preparer/submitter

William G. Hubbard Ph.D. President & CEO FDA Contact Person

Cytophil, Inc. 2485 Corporate Circle, Suite 2 East Troy, WI 53120 Phone [phone] Cell [phone] Fax [phone] Email [e-mail]

5.3. Date the summary was prepared [807.92(c)(1)]

12/June/2012

5.4. Device Name [807.92(a){2}]

| Proprietary Name | Calcium Hydroxylapatite Vocal Fold Implant |
|--------------------|-------------------------------------------------|
| Common Name: | Vocal Cord Medialization |
| Regulation Number: | 21 CFR 874.3620 |
| Regulation Name: | Ear, Nose and Throat Synthetic Polymer Material |
| Regulatory Class: | Class II |
| Product Code: | MIX |

5.5. Legally Marketed device to which your firm is claiming equivalence [807.92(a)(3)}

| 510(k) # | Title | Owner | Product Code |
|----------|----------------------------|-------------------------------------------------------------------|--------------|
| K070090 | Radiesse Laryngeal Implant | BioForm, Inc.<br>4311 Courtney Road, #10<br>Franksville, WI 53126 | MIX |

Table 3. Identification of Predicate

5.6. Establishment Registration

Cytophil, Inc. has been issued the device establishment registration number: 3007225376.

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5.7. Device Classification

21 CFR 874.3620

5.8. Manufacturing Facility

Cytophil, Inc. 2485 Corporate Circle, Unit 2 East Troy, WI 53120

5.9. Sterilization Facility

Biotest Laboratories 9303 West Broadway Avenue Brooklyn Park, MN 55445

#### Description of the device [807.92(a)(4)] 5.10.

Calcium Hydroxylapatite Vocal Fold Implant is a ready to use product. Calcium Hydroxylapatite Vocal Fold Implant is comprised of calcium hydroxylapatite particles, blended into an aqueous gel formulated from sodium carboxymethyicellulose, glycerin, and a phosphate buffer. The gel acts as a carrier for the particles to facilitate placement. The main component of Calcium Hydroxylapatite Vocal Fold Implant is synthetic calcium hydroxylapatite, a material with over thirty years of use as an implant material used in orthopedics, neurosurgery, dentistry, otolaryngology, plastic surgery and ophthalmology. Calcium hydroxylapatite is also the main mineral component found in bones and teeth so it is a major component of the body. The calcium hydroxylapatite meets the requirements of ASTM F1185. The carrier consists of glycerin (USP) sodium carboxymethylcellulose (USP) and phosphate buffer (USP). The carrier resorbs in vivo, so that the calcium hydroxylapatite remains at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated hydroxylapatite scaffold provides the longterm restoration and augmentation.

Intended use of the device [807.92(a)(5)] 5.11.

Calcium Hydroxylapatite Vocal Fold Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Calcium Hydroxylapatite Vocal Fold Implant 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.

Per Product Code MIX, the indication for use of this product is consistent of the intended use, "Ear, nose, and throat synthetic polymer material that is intended to be

5-2

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implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck."

. }

- Summary of the technological characteristics of your device compared to the 5.12. predicate device. [807.92(a){6)]
Calcium Hydroxylapatite Vocal Fold Implant is a paste of calcium hydroxylapatite (calcium phosphate) particles in a gel carrier, identical to the predicate K070090 (Radiesse Laryngeal Implant)). The gel carrier is resorbable and acts to hold the particles together to facilitate placement. The resorption of the carrier provides the porosity for bone ingrowth. These "pores" are the interconnected pathways around and between the calcium hydroxylapatite particles. The calcium hydroxylapatite particles provide a non-resorbable scaffold for tissue infiltration. This is the same mechanism of action as the predicate device. The premixed and ready to use characteristic facilitates the delivery of Calcium Hydroxylapatite Vocal Fold Implant by allowing direct and controlled placement using the syringe. This may be enhanced for implantation in difficult to access locations by the use of a needle on the syringe. In addition, the carrier serves to reduce or prevent migration during the application and in the postoperative healing period prior to incorporation of the particles by tissue ingrowth. The implantation procedures for both the Calcium Hydroxylapatite Vocal Fold Implant and the predicate use direct injection to the laryngeal augmentation site with direct visualization via nasopharyngoscope and without the requirement for an open surgical procedure.

The Calcium Hydroxylapatite Vocal Fold Implant is identically and physically to the predicate and has the identical intended use as the predicate device. The Calcium Hydroxylapatite Vocal Fold Implant and the predicate device are both intended to augment the size of the displaced or deformed vocal fold. The predicate device and the Calcium Hydroxylapatite Vocal Fold Implant are composites of resorbable (carrier) and non-resorbable (calcium phosphate particles) components. The tissue infiltration provides the final form of the implant.

The principle component of the Calcium Hydroxylapatite Vocal Fold Implant, calcium hydroxylapatite, is identical to the calcium hydroxylapatite chemically and in size, 25 to 45 microns, to the calcium hydroxylapatite used in the predicate. Calcium hydroxylapatite used in Calcium Hydroxylapatite Vocal Fold Implant and the predicate meet the same biocompatibility requirements. Calcium Hydroxylapatite Vocal Fold Implant and predicate are substantially equivalent in terms of biocompatibility and biological mechanism of action in that both of the products utilize tissue ingrowth to support and sustain augmentation.

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#### Biocompatibility Evaluations ਟ ਹੈ ਤੋਂ ਹੈ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤੋਂ ਤ

The battery of preclinical safety studies and animal implant studies show that the Calcium Hydroxylapatite Vocal Fold Implant is biocompatible when injected into soft tissues.

5.14. Sterilization

Calcium Hydroxylapatite Vocal Fold Implant will be sterilized using steam in accordance with ISO 17665. A contract sterilization company, Biotest Laboratories, will perform processing. Cycle parameters are validated using an overkill methodology to 10th SAL. Sterilization by the user is not required.

Pre-Clinical Tests Performed 5.15.

In vivo and in vitro tests were performed for biocompatibility. Results identified the Calcium Hydroxylapatite Vocal Fold Implant as a nonirritant, nontoxic, with no concerns for long-term safety.

#### 5.16. Risk Assessment

The primary risks with Calcium Hydroxylapatite Vocal Fold Implant have been identified through a risk assessment procedure in accordance with ISO 14971. The risks identified are primarily associated with nasopharyngoscopy and injection laryngoplasty surgery.

5.17. Summary

The Calcium Hydroxylapatite Vocal Fold Implant is a safe and effective implant when used as a space filling material for soft tissue augmentation in laryngeal procedures for vocal fold medialization and augmentation.

5.18. Conclusion

In summary, Calcium Hydroxylapatite Vocal Fold Implant is substantially equivalent to the cited predicate device K070090 (Radiesse Laryngeal Implant). The predicate has the same intended use, augment the size of the vocal folds. The components used in the Calcium Hydroxylapatite Vocal Fold Implant and the predicate device are the same and the biocompatibility is equivalent, based on the history use in many medical devices as well as from preclinical testing and the very extensive clinical utilization of this formulation. The predicate and the device both function as a composite that utilizes a resorbable carrier and a non-resorbable calcium phosphate particulate. The carrier facilitates placement and the particles function as a tissue integration matrix. Both attain their final form after tissue infiltration. Both are used with the same implantation placement procedures. Therefore, the Calcium Hydroxylapatite Vocal Fold Implant is substantially equivalent in intended use, technical characteristics and is as safe as the predicate device cited.

· 5-4

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Public Health Service

February 22, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Cytophil, Incorporated % William G. Hubbard, Ph.D. President & CEO 2485 Corporate Circle, Suite 2 East Troy, WI 53120

Re: K121795

Trade/Device Name: Calcium Hydroxylapatite Vocal Fold Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose and throat synthetic polymer material Regulatory Class: Class II Product Code: MIX Dated: January 18, 2013 Received: January 22, 2013

Dear Dr. Hubbard:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 -- William G. Hubbard, Ph.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please of note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/6 description: The image shows the text "Deborah Falls" in a stylized font. The word "Deborah" is in a simple, bold font, while the word "Falls" is in a more decorative font with lines and patterns. The overall design is clean and modern.

for 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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K121795

## Chapter 4 Indication for Use Statement

4. Indications for Use

· 4.1. 510(k) Number

(If known): K

4.2. Device Name

Calcium Hydroxylapatite Vocal Fold Implant

4.3. Indications for Use

Calcium Hydroxylapatite Vocal Fold Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent. Calcium Hydroxylapatite Vocal Fold Implant 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.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Vasant G.
Malshet
DN: CUS, o=U.S. Government,
ou=HHS/ou FDA, ou People,
cn-Vasant G. Malshet,

Vasant G.
Malshet

0.9.2342.19200300.100.1.1-1300
087851
Date: 2013.02.28 06:02:18-05'00'