BioForm's Radiesse Laryngeal Implant is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Radiesse Laryngeal 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 Description

Radiesse Laryngeal Implant is a sterile, non-pyrogenic injectable material consisting of calcium hydroxylapatite (CaHA) suspended in an aqueous formulation of USP grade pharmaceutical excipients consisting of sterile water, glycerin, and sodium carboxymethylcellulose, stabilized with a phosphate buffer. These excipients have prior and extensive use in intramuscular injectable pharmaceutical products including Cortone®, Decadron®, and Dalalone® drugs. Glycerin, sodium carboxymethylcellulose and phosphate buffer are listed in 21 CFR 182 as Generally Recognized as Safe (GRAS), Sections 182.1320, 182.1745, and 182.6285, respectively.

Calcium hydroxylapatite particles (30%-40% by volume) are combined with this aqueous formulation to create the implant media. The calcium hydroxylapatite meets ASTM F1185.

AI/ML Overview

The provided text is a 510(k) summary for the Radiesse Laryngeal Implant. This documentation focuses on demonstrating substantial equivalence to predicate devices and detailing the device's biocompatibility, sterilization, and general safety. It does not contain information about specific clinical studies with acceptance criteria or performance metrics directly related to efficacy in human subjects.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes for test set, data provenance, number of experts, adjudication methods, or ground truth for the test set.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Sample size for the training set or how ground truth was established for the training set.

The document primarily states:

Acceptance Criteria/Performance (Implied Safety/Equivalence):

Biocompatibility: "The battery of prectinical safety studies and animal implant studies show that the Radiesse Laryngeal Implant is biocompatible when injected into soft tissues." (Section 4.6)
Sterilization: Processed in-house using a computer-controlled autoclave system, validated to an "overkill methodology to 10-6 SAL." (Section 4.7)
Pre-Clinical Safety: "In vivo and In vitro tests were performed to address cytotoxicity, sensitization, mutagenticity, and hemolysis. Results identified the Radiesse Laryngeal Implant as nontoxic with no concerns for long-term safety." (Section 4.8)
Substantial Equivalence: The device is deemed substantially equivalent to predicate devices (K060812 Juliesse™ Injectable Laryngeal Augmentation Implant and K013243 Coaptite Laryngeal Augmentation System) for its stated intended use. This is the primary "acceptance criterion" for a 510(k) clearance.

Study that Proves Device Meets Acceptance Criteria:
The studies mentioned are:

Preclinical Safety Studies: These included "animal implant studies," "in vivo and in vitro tests" for cytotoxicity, sensitization, mutagenicity, and hemolysis. (Sections 4.6, 4.8)
Sterilization Validation: An "overkill methodology to 10-6 SAL" was used for steam sterilization. (Section 4.7)

Summary of available information based on your request:

Field	Information from Document
Acceptance Criteria & Reported Device Performance	- Biocompatibility: Demonstrated as biocompatible in soft tissues via preclinical safety studies and animal implant studies. - Sterilization: Achieved 10-6 SAL (Sterility Assurance Level) through validated steam sterilization. - Toxicity: Identified as nontoxic with no long-term safety concerns based on in vivo and in vitro tests (cytotoxicity, sensitization, mutagenicity, hemolysis). - Substantial Equivalence: Deemed substantially equivalent to predicate devices K060812 (Juliesse™) and K013243 (Coaptite).
Test Set Sample Size & Data Provenance	Not applicable / Not provided. The review is based on preclinical data and equivalence to existing devices, not a clinical test set with human performance data.
Number & Qualifications of Experts for Ground Truth	Not applicable / Not provided.
Adjudication Method for Test Set	Not applicable / Not provided.
MRMC Comparative Effectiveness Study Done? Effect Size?	No MRMC study was done or reported in this document.
Standalone (Algorithm Only) Performance Done?	Not applicable. This is a physical implant, not an algorithm.
Type of Ground Truth Used	For preclinical studies: biological endpoints (cytotoxicity, sensitization, etc.) and observations from animal implants. For substantial equivalence: comparison to predicate device characteristics and performance (as previously established).
Training Set Sample Size	Not applicable / Not provided. This term typically applies to machine learning algorithms, which is not the case here.
How Ground Truth for Training Set Established	Not applicable / Not provided.

Summary

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K070090

MAR 0 1 2007

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 4.

4.1 Manufacturing Facility

BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126

Contact: James Miller Vice President Regulatory Affairs and Quality Assurance Telephone: (262)835-3043

4.2 Trade Name

Radiesse Laryngeal Implant

4.3 Intended Use

4.4 Product Description

Calcium hydroxylapatite particles (30%-40% by volume) are combined with this aqueous formulation to create the implant media. The calcium hydroxylapatite meets ASTM F1185.

Special 510(k): Radiesse Laryngeal Implant DOI# 120

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4.5 Substantial Equivalence

The following are the predicate devices that are substantially equivalent to Radiesse Laryngeal Implant:

K060812 Juliesse™ Injectable Laryngeal Augmentation Implant BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126

K013243' Coaptite Laryngeal Augmentation System BioForm Medical, Inc. 4133 Courtney Road, Suite 10 Franksville, WI 53126

4.6 Biocompatibility Evaluations

The battery of prectinical safety studies and animal implant studies show that the Radiesse Laryngeal Implant is biocompatible when injected into soft tissues.

4.7 Sterilization

Radiesse Laryngeal Implant is sterilized using steam; processing is performed in-house using a computer controlled autoclave system. Cycle parameters are being validated using an overkill methodology to 10° SAL. Sterilization by the user is not required.

Pre-Clinical Tests Performed 4.8

In vivo and In vitro tests were performed to address cytotoxicity, sensitization, mutagenticity, and hemolysis. Results identified the Radiesse Laryngeal Implant as nontoxic with no concerns for long-term safety.

4.9 Summary

The Radiesse Laryngeal Implant 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. All syringe component share extensive safety history in medicine.

1 Pre-market notification 510(k) K013243 was initially approved for the Coaptite product and subsequently has been expanded to include the Radiesse product. The only difference between these two products is the size of the calcium hydroxylapatite particles.

Special 510(k): Radiesse Laryngeal Implant DOI# 120

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9. INTENDED USE

Special 510(k): Radiesse Laryngeal Implant DOI# 120

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 1 2007

BioForm Medical, Inc. c/o James S. Miller Vice President Regulatory Affairs and Quality Assurance 1875 South Grant St., Suite 110 San Mateo, CA 94402

Re: K070090

Trade/Device Name: Radiesse Laryngeal Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: MIX Dated: February 23, 2007 Received: February 23, 2007

Dear Mr. Miller:

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.

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Page 2 - James S. Miller

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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M.B. Egelman, M.D.

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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Indications for Use

510(k) Number (if known): _ K070090

Device Name: Radiesse Laryngeal Implant

Indications For Use:

Prescription Use (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)

Amulal

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

510(k) Number K070690

Page 1 of __

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.