(49 days)
BioForm's Laryngeal Augmentation Implant is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. The Laryngeal Augmentation Implant is a temporary implant and resorbs within a period of 3-6 months.
The Laryngeal Augmentation Implant is a flexible, resorbable implant used as a space filling material for soft tissue augmentation. The Laryngeal Augmentation Implant is placed via percutaneous injection under local anesthesia with direct visualization via nasopharyngoscope. The ability to place the implant without open surgery offers both safety and convenience to the surgeon and patient. The system is designed to resorb with eventual in-growth of surrounding tissue. Every component of the implant has a minimum of twenty years use as a biomaterial.
The provided text is a 510(k) summary for a medical device called the Laryngeal Augmentation Implant. This type of document is for regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, rather than a clinical study report proving performance against acceptance criteria in the context of AI/software device evaluation.
Therefore, the information required in the prompt (acceptance criteria, device performance, sample sizes for test/training sets, ground truth methodology, expert qualifications, adjudication, MRMC studies, standalone performance) is not present in this document. The document primarily focuses on:
- Product Description and Intended Use: Explains what the device is, how it works, and its purpose.
- Substantial Equivalence: Compares the device to existing, legally marketed predicate devices to argue that it is equally safe and effective.
- Biocompatibility and Sterilization: Details preclinical safety studies and sterilization methods.
- Summary: Reaffirms the device's safety and effectiveness.
- FDA Response: The FDA's letter granting 510(k) clearance based on substantial equivalence.
It is important to note: For a physical medical implant like this, "acceptance criteria" and "device performance" would typically refer to outcomes from non-clinical (e.g., in-vitro, animal studies) and clinical trials (human studies) measuring safety endpoints (e.g., adverse events, infection rates, rejection) and effectiveness endpoints (e.g., vocal fold medialization success, duration of effect, patient-reported outcomes). However, the 510(k) summary provided does not detail specific, quantitative acceptance criteria or corresponding clinical study results in the format requested for AI/software evaluations.
In summary, based on the provided document:
The document does not contain the information necessary to fulfill any of the requested points regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth, expert qualifications, adjudication), or AI-specific evaluations (MRMC, standalone performance). This is because the nature of a 510(k) summary for an ordinary medical device submission differs significantly from a clinical study report for an AI/software as a medical device.
{0}------------------------------------------------
DEC 1 2 2003
BioForm, Inc. Dior only, ino.
510(k) No. K033398: Laryngeal Augmentation Implant Additional Information
510(k) Summary of Safety and Effectiveness
Manufacturing Facility:
BioForm, Inc. 4133 Courtney Road, #10 Franksville, WI 53126
Trade Name:
Laryngeal Augmentation Implant
Common Name:
Vocal cord medialization implant
Classification Name:
Vocal cord medialization system
Official Contact:
Tessa Yamut Director of Requlatory Affairs BioForm, Inc. 1875 South Grant Street, Suite 110 San Mateo, CA 94402 Tel. 650-286-4043
Date Modifications of this Summary of Safety and Effectiveness:
December 4, 2003
Intended Use
BioForm's Laryngeal Augmentation Implant is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. The Laryngeal Augmentation Implant is a temporary implant and resorbs within a period of 3-6 months.
Product Description
The Laryngeal Augmentation Implant is a flexible, resorbable implant used as a space filling material for soft tissue augmentation. The Laryngeal Augmentation Implant is placed via percutaneous injection under local anesthesia with direct visualization via nasopharyngoscope. The ability to place the implant without open surgery offers both safety and convenience to the surgeon and patient. The system is designed to resorb with eventual in-growth of surrounding tissue. Every component of the implant has a minimum of twenty years use as a biomaterial.
{1}------------------------------------------------
BioForm, Inc. 510(k) No. K033398: Laryngeal Augmentation Implant Additional Information
Substantial Equivalence
The following are predicate devices that are substantially equivalent to the Laryngeal Augmentation lmplant:
K013243 Coaptite Laryngeal Augmentation System BioForm, Inc. 4133 Courtney Road, #10 Franksville, WI 53126
K030682 Calcium Hydroxylapatite Implant BioForm Inc. 1875 South Grant Street San Mateo, CA 94402
K942014 Sterile Water Wet Dressing Trinity Laboratories, Inc. 201 Kiley Drive Salisbury, MD 21801
Biocompatibility Evaluations
The battery of preclinical safety studies and canine implant studies has shown that Laryngeal Augmentation Implant is biocompatible when injected into various submucosal or other tissues of animals.
Sterilization
- ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------using a computer controlled autoclave system. Cycle parameters were validated using an overkill methodology to 10-6 SAL. Sterilization by the user is not required.
Pre-Clinical Tests Performed
In vivo tests were performed to address sensitization, tissue reaction during short-term implantation, systemic reactions and long term safety issues. Results identified the Laryngeal Augmentation Implant as nonantigenic, a nonirritant, and nontoxic with no concerns for long-term safety issues based on thirty-six month data.
Summary
{2}------------------------------------------------
BioForm, Inc. Dior offit, Inc.
510(k) No. K033398: Laryngeal Augmentation Implant Additional Information
The Laryngeal Augmentation Implant™ is a safe and effective cohesive implant used as a space Trie Carynged Augmentation in laryant - 16 is care and orcedures for vocal fold medialization and illing matchar for son though and in anyments share extensive safety history in medicine.
The differences between the Laryngeal Augmentation implant and the predicate devices do not affect the safety or effectiveness.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 2003
BioForm, Inc. c/o Tessa Yamut Director of Regulatory Affairs BioForm, Inc. 1875 South Grant Street, Suite 110 San Mateo, CA 94402
Re: K033398
Trade/Device Name: Laryngeal Augmentation Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: MIX Dated: October 23, 2003 Received: October 24, 2003
Dear Ms. Yamut:
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 - Tessa Yamut
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 (301) 594-4613. 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 (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
Enclosure
{5}------------------------------------------------
510(k) Number: K033398 Device Name: Laryngeal Augmentation Implant
Indications for Use:
BioForm's Laryngeal Augmentation Implant is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. The Laryngeal Augmentation Implant is a temporary implant and resorbs within a period of 3-6 months.
Kunt H Bahr
Sian-Off
510(k) Number C033398
Prescription Use (Per 21 CFR 801.109)
CONFIDENTIAL INFORMATION
§ 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.