(103 days)
Not Found
No
The description focuses on the material composition and physical properties of an injectable implant, with no mention of AI or ML technologies.
Yes
The device is described as an injectable, space-occupying implant for vocal fold medialization and augmentation, which are therapeutic interventions to improve vocal function.
No
The device is described as an injectable, space-occupying implant for vocal fold medialization and augmentation, which is a therapeutic rather than diagnostic function.
No
The device description clearly states it is a physical implant system consisting of a syringe, needle, and injectable material. It does not describe any software component.
No, 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.
- Coaptite™ Function: The Coaptite™ Laryngeal Augmentation System is an implantable device. It is injected directly into the vocal fold tissue to physically augment and medialize it. It does not analyze or test a sample from the body.
The description clearly states it's a "space-occupying implant" and describes its physical composition and how it's injected into the laryngeal tissue. This is a therapeutic device, not a diagnostic one.
N/A
Intended Use / Indications for Use
"Coaptite™ Laryngeal Augmentation System is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation."
Product codes
MIX
Device Description
"The Coaptite™ Laryngeal Augmentation System consists of a single use, nonpyrogenic, space-occupying implant contained in a prefilled syringe with an injection needle for laryngeal vocal fold augmentation and medialization.
Coaptite™ is available in 1.0cc syringes that are filled with either 1.0cc or a 0.5 cc volume. Coaptite™ contains calcium hydroxylapatite (Cas(PO4)3OH)2 particles (75-125 microns) suspended in a gel of USP glycerin, sterile water for injection and sodium carboxymethylcellulose (NaCMC). The calcium hydroxylapatite meets ASTM F1185. The excipients glycerin, sterile water, and NaCMC are both pharmaceutical USP grade and listed as GRAS. Calcium hydroxylapatite is radiopaque.
The properties of Coaptite™ facilitate ingrowth of surrounding tissue-over time. The implantation procedure uses direct injection to the laryngeal augmentation site with direct visualization via nasopharyngoscope."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vocal fold, laryngeal
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
Not Found
Key Metrics
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
510(k) Premarket Notification Submission Coaptite™
JAN 0 9 2002
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 4.0
| Trade Name: | Coaptite™ Laryngeal Augmentation System |
|---|---|
| Common Name: | Vocal fold medialization implant |
| Classification Name: | Ear, nose and throat synthetic polymer material |
| Official Contact | |
| Name: | Victor M. Bowers |
| Director Market Development | |
| Address: | BioForm, Inc. |
| 4133 Courtney Road | |
| Franksville, WI 53126 | |
| Phone: | 262-835-9800 |
| Fax: | 262-835-9311 |
| Date Prepared: | 9-27-01 |
INTENDED USE 4.1
Coaptite™ Laryngeal Augmentation System is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.
PRODUCT DESCRIPTION 4.2
The Coaptite™ Laryngeal Augmentation System consists of a single use, nonpyrogenic, space-occupying implant contained in a prefilled syringe with an injection needle for laryngeal vocal fold augmentation and medialization.
Coaptite™ is available in 1.0cc syringes that are filled with either 1.0cc or a 0.5 cc volume. Coaptite™ contains calcium hydroxylapatite (Cas(PO4)3OH)2 particles (75-125 microns) suspended in a gel of USP glycerin, sterile water for injection and sodium carboxymethylcellulose (NaCMC). The calcium hydroxylapatite meets ASTM F1185. The excipients glycerin, sterile water, and NaCMC are both pharmaceutical USP grade and listed as GRAS. Calcium hydroxylapatite is radiopaque.
The properties of Coaptite™ facilitate ingrowth of surrounding tissue-over time. The implantation procedure uses direct injection to the laryngeal augmentation site with direct visualization via nasopharyngoscope.
1
SUBSTANTIAL EQUIVALENCE 4.3
The Coaptite™ Laryngeal Augmentation System is substantially equivalent to the Smith & Nephew VoCoM Vocal Cord Medialization System (K974311; Gore ReVox Thyroplasty Implant (K983525); and Xomed Silicone Pre-form Blocks (K982294). All of the predicate devices have the same intended use as a space-occupying material for vocal fold medialization and augmentation.
The principle component in the Coaptite™ Laryngeal Augmentation System is calcium hydroxylapatite, the same material used in the cleared VoCoM System. Coaptite™ is available as an injectable gel form while the VoCoM System comes in blocks and shims.
The space-occupying material of the Gore ReVox Thyroplasty Implant and the Xomed Silicone Pre-formed Blocks are polytetrafluoroethylene and silicone respectively. These predicates, when used in the larynx for vocal fold medialization and augmentation, serve the same intended use as the Coaptite™ Laryngeal Augmentation System
The Gore ReVox Thyroplasty Implant is equivalent to the Coaptite™ Laryngeal Augmentation System in terms of biological action for facilitation of ingrowth of surrounding tissue. The patient's laryngeal tissue integrates with the implanted material over time to help further augment laryngeal tissue.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 9 2002
Bioform, Inc. c/o Victor M. Bower 4133 Courtney Road, No. 10 Franksville, Wisconsin 53126
Re: K013243
Trade/Device Name: Coaptite™ Laryngeal Augmentation System Regulation Number: 21 CFR 874.3620 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: Class II Product Code: MIX Dated: September 27, 2001 Received: September 28, 2001
Dear Mr. Bower:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use above and wo have well to devices marketed in interstate commerce prior to May 28, 1976, the sured in the encreary to the Medical Device Amendments, or to devices that have been reclassified in enceenhence with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thereofs, maintons of the Act include requirements for annual registration, listing of devices, bontons provisions or active, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( remancer ripps of ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moportions and 2000 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have response to your 31 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter watification. The FDA finding of substantial equivalence of your device to a legally promatics no licate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address , http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Premarket Notification Submission Coaptite™
INDICATIONS FOR USE / INTENDED USE STATEMENT 2.0
1-013243 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Coaptite™
Indications For Use:
Coaptite™ is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) ----------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
yes
Use
(Per 21 CFR 801.109)
Over-The-Counter Or
(Optional Format 1-2-96)
Eulun 1/4/02
Ophthalr Triat De
510(k) Number