(107 days)
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.
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.
This document (K974311) is a 510(k) premarket notification for a medical device called the "Vocal Cord Medialization (VoCoM®) System." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study presenting acceptance criteria and performance data.
Therefore, the provided text does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth was established for the training set.
The document focuses on establishing substantial equivalence based on:
- Indications for use: Medialization of a paralyzed vocal cord.
- Material: Hydroxylapatite.
- Comparison to predicate devices:
- Montgomery® Thyroplasty Implant System (silicone implants for the same indication).
- Hydroxylapatite Bone Graft Material (hydroxylapatite for bone repair in head and neck, but different indication).
The 510(k) summary explicitly states that "The differences between the VoCoM system and the predicate devices should not affect the safety or effectiveness." This implies that the safety and effectiveness are considered comparable based on the predicate devices, rather than being demonstrated through a separate performance study with specific acceptance criteria outlined in this document.
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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.
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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
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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
§ 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.