(83 days)
Not Found
Not Found
No
The summary describes a mechanical dilator and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as an "Esophageal Dilator" used for "dilation of... esophageal strictures" and other esophageal conditions, which are therapeutic interventions.
No
The device is described as a dilator for treating esophageal strictures and other conditions, which is a therapeutic rather than a diagnostic function.
No
The device is described as an "Esophageal Dilator," which is a physical medical device used for dilation. The summary does not mention any software component.
Based on the provided information, the TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for a physical procedure (dilation of the esophagus) within the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: While the description is "Not Found," the intended use clearly points to a physical medical device, not a diagnostic test.
- No mention of specimens or testing: The information provided does not mention the collection or analysis of any biological specimens.
Therefore, this device falls under the category of a medical device used for treatment or intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.
Product codes
78 KNQ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUI 24 1997
Mr. Mike Knoth Director of Regulatory Affairs Tri-Med Specialties, Inc. 16309 West 108th Circle Lenexa. Kansas 66219
Re: K971615 Pattison Esophageal Dilator Dated: May 1, 1997 Received: May 2, 1997 Regulatory class: II 21 CFR §876.5365/Product code: 78 KNQ
Dear Mr. Knoth:
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 (OS) 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 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 marketed 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 question 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 intp://www.fda.gov/odth/dsmamain.html".
Sincerely your
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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Image /page/1/Picture/0 description: The image shows the logo for TRI-MED Specialties Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The letters "TRI" and "MED" are connected by a triangle shape. The words "Specialties Inc." are written in a smaller, cursive font below the company name. The logo is framed by a triangle.
16309 WEST 108th CIRCLE LENEXA, KS 66219
INDICATIONS FOR USE
The TRI-MED SPECIALTIES, INC. Pattison Esophageal Dilator is for dilation of, but not limited to, peptic esophageal strictures, caustic strictures, upper esophageal webs, lower esophageal (Schatzki) rings, and palliation of esophageal cancer or lymphoma.
Mike Knoth
Mike Knoth Director of Regulatory Affairs
5/1/97
__Date
Date
Robert R. Ratliff
(Division Sign-Off)
Division of Reproductive, Abdominal. ENT, and Radiological Devices
510(k) Number K971615
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use _
(913) 362-7290