(70 days)
Not Found
Not Found
No
The summary describes a mechanical device for polyp removal and collection, with no mention of AI/ML, image processing, or data-driven performance metrics.
No
Explanation: A therapeutic device is designed to treat a medical condition or disease. This device is described as an electrosurgical tool for removing polyps, which is a therapeutic intervention. However, the question asks "Is this device a therapeutic device?" which requires a yes or no answer for the device itself. While it performs a therapeutic function, the question is simply asking if the device is therapeutic, which is not what therapeutic devices are defined as. Rather, the use is therapeutic.
No
The device is described as an electrosurgical tool for removing and collecting polyps, which is a therapeutic rather than a diagnostic function.
No
The device description and intended use clearly indicate a physical device (snare and polyp catcher) used for electrosurgical removal and collection, not a software-only application.
Based on the provided information, the Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Electrosurgically Remove and collect Polyps from the Gastro Intestinal Tract Under Endoscopic Visualization." This describes a surgical/interventional procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Anatomical Site: The device is used within the "Gastro Intestinal Tract," which is inside the patient's body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, tissue, etc.) or any diagnostic testing performed outside of the body.
Therefore, this device falls under the category of a surgical instrument or medical device used for treatment and collection, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is intended to Electrosurgically Remove and collect Polyps from the Gastro Intestinal Tract Under Endoscopic Visualization.
Product codes
FDI
Device Description
Horizons Rotatabel Snare and Polyp Catcher TORNADO™
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastro Intestinal Tract
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)
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rafic Saleh, President Horizons International Corporation P.O. Box 213-3006 Zona Franca Metro Barreal De Heredia COSTA RICA
DEC 2 3 2008
Re: K083049
Trade/Device Name: Horizons Rotatable Snare and Polyp Catcher TORNADO™ Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: December 8, 2008 Received: December 10, 2008
Dear Mr. Saleh:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2
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 807): labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
loque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510K INDICATION FOR USE STATEMENT
510(k) Number (if known): K083049
:
| Device Name: | Horizons Rotatabel Snare and Polyp Catcher TORNADOTM |
|---|---|
| Applicant Name: | Horizons International Corp. |
| Indications for Use: | Horizons Rotatabel Snare and Polyp Catcher TORNADO™ is |
| intended to Electrosurgically Remove and collect Polyps from the | |
| Gastro Intestinal Tract Under Endoscopic Visualization. |
Horizons International Corp.
Signature:
100 - 100 -
Rafic Saleh – President
Date: Date: Date: Date:
Prescription Use
(Per 21 CFR 801.109)
: 上一篇:
:
:
1
·
: 上一篇: 上一篇:
. . . . .
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number -083049