MONTGOMERY THYROPLASTY IMPLANT SYSTEM

K972317 · Boston Medical Products, Inc. · MIX · Sep 18, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972317
• Device Name: MONTGOMERY THYROPLASTY IMPLANT SYSTEM
• Applicant: Boston Medical Products, Inc.
• Product Code: MIX · Ear, Nose, Throat
• Decision Date: Sep 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

Device Story

Montgomery® Thyroplasty Implant System is a surgical implant used for medialization thyroplasty in patients with unilateral vocal cord paralysis. The device consists of a pre-molded, one-piece silicone implant featuring a three-tiered base and an obtuse triangular top, available in five sizes for both males and females. The implant is designed with a softer top and a firmer base to better match surrounding tissue characteristics compared to traditional solid silicone blocks. The system includes accessory surgical instruments, such as measuring kits for size selection and procedure kits for positioning and marking the thyroid cartilage. The device is used by surgeons in an operating room setting. By providing a consistent, pre-molded shape, the implant eliminates the need for intraoperative carving of silicone blocks, reducing variability in implant precision and surface finish. This standardization aims to improve surgical outcomes and voice quality for patients suffering from vocal cord paralysis.

Clinical Evidence

Clinical data from a cohort of 44 patients demonstrated safety and effectiveness. Outcomes were measured via patient surveys, acoustic analysis, and stroboscopy, showing improvement in voice quality and a low complication rate.

Technological Characteristics

One-piece molded silicone implant with dual-durometer construction (softer top, firm base). Radiopaque. Provided in five sizes for males and females. Includes sterile, single-use measuring and procedure kits. Manual surgical instruments (elevators, hooks) included. Non-electronic, mechanical device.

Indications for Use

Indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

Regulatory Classification

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.

Predicate Devices

• Duralastic Silicone (K955368, K955370, K955433)
• Silicone Block (Bentec Medical)
• Silicone Block (Xomed) (K970910)

Submission Summary (Full Text)

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K97223/7

# 510(k) Summary Boston Medical Products, Inc. Montgomery® Thyroplasty Implant System (per 21 CFR 807.92)

10077 18

June 18, 1997 DATE OF PREPARATION: 1. Boston Medical Products, Inc. SPONSOR/APPLICANT: 2. 117 Flanders Road Westborough, MA 10581

> Stuart Montgomery, President Telephone: [phone]

#### DEVICE NAME: 4.

3.

CONTACT NAME:

Montgomery® Thyroplasty Implant System Trade/Proprietary Name: Thyroplasty Implant and Accessories Common/Usual Name: Ear, nose, and throat synthetic polymer material and Classification Name: manual surgical instruments

# IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO 5. WHICH EQUIVALENCE IS BEING CLAIMED:

The Montgomery® Thyroplasty Implant is substantially equivalent to legally marketed silicone block, as carved at the time of surgery, specifically the following:

| • Duralastic Silicone | Allied Biomedical | K955368, K955370, K955433 |
|-----------------------|-------------------|---------------------------|
| • Silicone Block | Bentec Medical | Not identified |
| • Silicone Block | Xomed | K970910 |

### DEVICE DESCRIPTION 6.

The Montgomery® Thyroplasty Implant System consists of the Implant and associated accessory surgical instruments which are used for selection of implant size and for the surgical thyroplasty procedure.

The Montgomery® Thyroplasty Implant is a one-piece device consisting of a threetiered base and an obtuse triangular top. It is provided in five sizes for males and five for females. The difference in size relates to the height of the triangular portion of the Implant. There is a single base size for all five male implants and a smaller base size for all five female implants.

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Accessories to the System include the sterile, single use Measuring Kits for selection of the correct implant size at the time of surgery, the Procedure Kit for determining the correct position of the Implant and marking the window in the thyroid cartilage, and various elevators, hooks, etc. which are provided to facilitate both the surgical procedure and the placement of the Implant.

#### INTENDED USE 7.

The Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patient with unilateral vocal cord paralysis to improve quality of vocalization.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 8.

The Montgomery® Thyroplasty Implant is equivalent to silicone block, as carved at the time of surgery. It is composed of an inner, softer top and firm base which secures the implant in the thyroid laminotomy. Bentec silicone block is available in four durometers: Soft (20A), Medium (35A), Firm (50A), and Extra firm (65A). Allied Biomedical silicone block is provided as Very soft (5A), Soft (10A), Medium (20-30A), and Hard (40A and above). While Bentec and Allied Biomedical product designations for durometer are similar, they are not equal. Unlike the use of solid silicone block of a single durometer, the durometers used for the Montgomery Thyroplasty Implant are more consistent with the characteristics of the surrounding tissue.

The Montgomery® Thyroplasty Implant is radiopaque, while the radiopacity of the Bentec and Allied Biomedical silicone blocks is not specified. Bentec does not specify coloration or radiopacity of their block. Allied Biomedical silicone block is generally supplied clear; however custom colors of white, opaque, and flesh tone are available as special order items.

The Montgomery® Thyroplasty Implant is supplied sterility status of Bentec and Allied Biomedical silicone block is not specified in product literature.

While the Montgomery® Thyroplasty Implant is molded, implants fashioned from Bentec and Allied Biomedical silicone block must be carved at time of surgery. Appropriate sizing of the Montgomery Thyroplasty Implant is accomplished using the sterile, single use, and disposable Measuring Kits. Sizing of silicone blockderived medialization implants is dependent on surgeon skill.

Tolerances for the Montgomery® Thyroplasty Implant provide consistency across devices whereas the precision for medialization thyroplasty implants carved from silicone block is limited and dependent on surgeon skill.

The surface of the Montgomery® Thyroplasty Implant has smooth edges and radii. The finish quality of medialization thyroplasty implants which are fashioned from silicone block at the time of surgery is variable and dependent on surgeon skill.

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Based on the above discussion of the use of carved silicone block for medialization thyroplasty, Boston Medical Products, Inc. believes that the Montgomery® Thyroplasty Implant is substantially equivalent to solid silicone block as carved at the time of thyroplasty surgery and that differences do not adversely effect safety and effectiveness.

## CLINICAL STUDIES 9.

Clinical data for a cohort of 44 patients treated with the Montgomery® Thyroplasty Implant demonstrate that the device is safe, as evidenced by the low number of complications, and effective for improvement of voice quality, as demonstrated by responses to the patient survey, acoustic analysis, and stroboscopy.

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement on the left side of the image. To the right of the text is a symbol that appears to be an abstract representation of a human figure or a stylized flame-like design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

SEP 1 8 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Boston Medical Products, Inc. c/o Rosina Robinson, RN, MEd, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K972317 Montgomery® Thyroplasty Implant System Dated: June 19, 1997 Received: June 20, 1997 Regulatory Class: II 21 CFR 874.3620/Procode: 77 KHJ

Dear Ms. Robinson:

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 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 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 requirement, 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 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 531 through 542 of the Act for devices under 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 marked 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.J.Liau Yui

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K973317

Device Name: Boston Medical Products, Inc. Montgomery® Thyroplasty Implant System

Indications For Use:

The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972317

Boston Medical Products, Inc. 510(k) CONFIDENTIAL 6/18/97 Page v

Montgomery® Thyroplasty Implant System

6/18/97