(107 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on material composition and intended use, not computational capabilities.
Yes
The device is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality, which describes a therapeutic intervention.
No
The device is an implant system used for medialization thyroplasty to treat vocal cord paralysis and improve voice quality, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states the device is an "implant and shim" made from Hydroxylapatite, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality." This is a surgical procedure performed directly on the patient's vocal cords.
- Device Description: The device is an implant made of Hydroxylapatite, designed to be surgically placed to medialize a vocal cord.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of specimens.
The device is a surgical implant used for a therapeutic purpose, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Smith & Nephew, Inc., ENT Division, Vocal Cord Medialization System is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.
Product codes
77 KHJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vocal cord
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Montgomery® Thyroplasty Implant System, Hydroxylapatite Bone Graft Material
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) Summary of Safety and Effectiveness MAR - 4 1998
Vocal Cord Medialization (VoCoM®) System Trade Name: Vocal Cord Medialization Implants Common Name: Ear, Nose, and Throat Synthetic Polymer Material (§ 874.3620) Classification Name:
Official Contact: Alicia E. Farage Senior Regulatory Affairs Specialist Smith & Nephew, Inc. ENT Division 2925 Appling Road Bartlett, TN 38133
(901) 373-0200 Telephone: Telefax: (901) 373-0242
November 14, 1997 Date Prepared:
The VoCoM System is substantially equivalent to the Montgomery® Thyroplasty Implant System manufactured by Boston Medical Products, Inc. These devices have the same indications for use, medialization of a paralyzed vocal cord. The VoCoM implant and shim are made from Hydroxylapatite, a widely accepted material for Otolaryngological use. The Montgomery Thyroplasty Implant System implants are made of silicone.
The VoCoM System is also substantially equivalent to the Hydroxylapatite Bone Graft Material manufactured by Smith & Nephew, Inc., ENT Division. Both devices are made of hydroxylapatite. The VoCoM device is intended for medialization of a paralyzed vocal cord, while the Hydroxylapatite Bone Graft Material is intended to augment bony deficiencies or reconstruction of bony defects in head and neck applications.
The differences between the VoCoM system and the predicate devices should not affect the safety or effectiveness.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1998
Deborah Arthur Smith & Nephew, Inc. Director or Regulatory/Clinical Affairs and Quality Assurance ENT Division 2925 Appling Rd. Bartlett, TN 38133
Re:
Vocal Cord Medialization (VoCoM®) System Dated: February 17, 1998 Received: February 20, 1998 Regulatory class: II 21 CFR 874.3620/Procode: 77 KHJ
Dear Ms. Arthur:
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 stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls 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 (Premarket Approval), 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 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 OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP 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 under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odrb/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Food and Drug Administration 510(k) Notification - VoCoM System
510(k) Number:
Device Name:
Vocal Cord Medialization (VoCoM®) System
Indications For Use:
The Smith & Nephew, Inc., ENT Division, Vocal Cord Medialization System is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.
David A. Segura
Division Sign-Off
Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number
OR
Prescription Use
(per 21 CFR 801.109) ↘
Over - The - Counter Use