(50 days)
Not Found
No
The device description focuses on the material composition and intended use as a bulking agent, with no mention of AI or ML capabilities.
Yes
The device is used for vocal fold medialization and vocal fold insufficiency to improve phonation and address aspiration difficulties, which are therapeutic interventions.
No
The device description indicates it is an "injectable material consisting of calcium hydroxylapatite" used to augment vocal folds for improved phonation, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is an "injectable material consisting of calcium hydroxylapatite (CaHA) suspended in an aqueous formulation," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Radiesse Laryngeal Implant is an injectable material used for vocal fold medialization and vocal fold insufficiency. It is a physical implant designed to augment tissue, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with in vitro diagnostics.
Therefore, the Radiesse Laryngeal Implant is a medical device, but it falls under a different category than in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
MIX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The battery of prectinical safety studies and animal implant studies show that the Radiesse Laryngeal Implant is biocompatible when injected into soft tissues.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
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
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.
4.4 Product 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.
Special 510(k): Radiesse Laryngeal Implant DOI# 120
1
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
2
9. INTENDED USE
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.
Special 510(k): Radiesse Laryngeal Implant DOI# 120
3
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.
4
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
5
Indications for Use
510(k) Number (if known): _ K070090
Device Name: Radiesse Laryngeal Implant
Indications For Use:
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.
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 __