(29 days)
Not Found
Not Found
No
The summary describes a physical implantable device (Laryngeal Keel) and its intended use for repairing or preventing glottic stenosis. There is no mention of software, algorithms, image processing, AI, ML, or any data processing that would indicate the use of AI/ML technology. The performance studies mentioned are related to material biocompatibility.
Yes
The device is intended to repair and prevent anterior glottic stenosis, which are medical conditions, aligning with the definition of a therapeutic device designed to treat or alleviate a disease or condition.
No
The device description and intended use indicate it is for repairing and preventing glottic stenosis, which are therapeutic functions, not diagnostic.
No
The device description clearly states it is an "umbrella-shaped device" available in different sizes, indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to the surgical repair and prevention of anterior glottic stenosis, which is a physical condition affecting the larynx. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant (a "Laryngeal Keel") designed to be placed in the body. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Laryngeal Keel is a surgical implant used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
To repair simple anterior glottic stenosis due to anterior commissure web formation.
-
To prevent anterior glottic stenosis in situations where anterior commissure is likely to occur (eg, following extralaryngeal or endolaryngeal trauma with loss of antenior commissure).
-
To prevent the anterior glottic stenosis immediately following removal of the Montgomery Laryngeal Stent.
Product codes
FWN
Device Description
The Laryngeal Keel is an umbrella-shaped device designed to the anatomy of the anterior commissure. The keel is available is sizes 12mm, 14mm, and 16mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior commissure
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)
Finished device samples passed cytotoxicity testing and were determined to be nonreactive and non-cytotoxic based on Elution Test, USP 23.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Montgomery Laryngeal Keel.
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
AUG - 9 1996
SMDA Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Product: Montgomery Radlopaque Laryngeal Keel
Description: The Laryngeal Keel is an umbrella-shaped device designed to the anatomy of the anterior commissure. The keel is available is sizes 12mm, 14mm, and 16mm.
Indication For Use:
-
To repair simple anterior glottic stenosis due to anterior commissure web formation.
-
To prevent anterior glottic stenosis in situations where anterior commissure is likely to occur (eg, following extralaryngeal or endolaryngeal trauma with loss of antenior commissure).
-
To prevent the anterior glottic stenosis immediately following removal of the Montgomery Laryngeal Stent.
Predicate Device: Montgomery Laryngeal Keel.
Testing: Finished device samples passed cytotoxicity testing and were determined to be nonreactive and non-cytotoxic based on Elution Test, USP 23.
Adl. Whims. PRESIDENT
7 10/98
Submitted by:
Stuart K. Montgomery, President
Date:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or other bird with outstretched wings. The seal appears to be a logo or emblem for the U.S. Department of Health and Human Services.
Public Health Service
Food and Drug Administration 1903 New Hampshire Avenue Document Control Center - WO66-GAN Silver Spring, MD 20993-0002
Boston Medical Products Mr. Stuart K. Montgomery President 117 Flanders Road Westborough, Massachusetts 01581
JAN 1 0 2017
Re: K962693
Trade/Device Name: Montgomery Raiopaque Laryngeal Keel Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: FWN Dated: July 10, 1996 Received: July 11, 1996
Dear Mr. Montgomery:
This letter corrects our substantially equivalent letter of August 9, 1996.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
2
Page 2 - Mr. Stuart K. Montgomery
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/dcfault.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Olexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K962693/A'
RECEIVED
17 Jul 96 10 00
Boston Medical Products, Inc. 117 Flanders Road FDA/CDRII/ODE/DHC Westborough, MA 01581 Westbolough, Montgomery (508) 898-9300 ext. 240 :278482373
Page 1 of 1
510(k) Number (if known): KARZESS
Montgomery Radiopaque Laryngeal Keel Device Name:
Indications For Use:
-
To repair simple anterior glottic stenosis due to anterior commissure web formation.
-
To prevent anterior glottic stenosis in situations where anterior commissure stenosis is likely to occur (eg, following extralaryigeal or endolaryngeal trauma with loss of anterior commissure).
-
To prevent the anterior glottic stenosis immediately following removal of the Montgomery Laryngeal Stent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRN, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number: | K96-2693 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)