(90 days)
K/DEN: Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is indicated for improving voice quality in patients with unilateral vocal cord paralysis, which is a therapeutic purpose.
No
The device is an implant used for surgical thyroplasty to improve voice quality, rather than for diagnosing a medical condition.
No
The device description clearly states that the device is a physical implant and associated surgical instruments, 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 a surgical procedure (medialization thyroplasty) to improve voice quality in patients with vocal cord paralysis. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an implant and associated surgical instruments used during a surgical procedure. It is not designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device is physically implanted into the patient's body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patient with unilateral vocal cord paralysis to improve quality of vocalization.
The Boston Medical Products, Inc. Montgomery® Thyroplasty Implant is indicated for medialization thyroplasty in patients with unilateral vocal cord paralysis to improve voice quality.
Product codes
77 KHJ
Device Description
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.
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
K955368, K955370, K955433, K970910
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
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: 508-898-9300
DEVICE NAME: 4.
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.
1
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.
2
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.
3
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 (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/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
4
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.
(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