(78 days)
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Not Found
No
The summary describes a polypectomy snare, a mechanical device for removing polyps, with no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
The device is intended for electrosurgical removal of polyps in the GI tract, which is a treatment for a medical condition.
No
Explanation: The device is intended for the electrosurgical removal of polyps, which is a therapeutic procedure, not a diagnostic one.
No
The device is described as "POLYPECTOMY SNARES," which are physical instruments used for electrosurgical removal. The description of the intended use clearly indicates a hardware device used in conjunction with endoscopic visualization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "ELECTROSURGICALLY REMOVE POLYPS IN THE GI TRACT UNDER ENDOSCOPIC VISUALIZATION." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Anatomical Site: The anatomical site is the "GI TRACT," which is within the living patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of samples
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for direct intervention on the patient.
N/A
Intended Use / Indications for Use
HORIZONS POLYPECTOMY SNARES ARE INTENDED TO ELECTROSURGICALLY REMOVE POLYPS IN THE GI TRACT UNDER ENDOSCOPIC VISUALIZATION
Product codes
78 FDI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
GI 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
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Description of the test set, sample size, data source, and annotation protocol
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Rafic Saleh President Horizons International Corp. P.O. Box 7273 PONCE PR 00732-7273 USA AUG 1 6 2001
Re: K011667
Horizons International Polypectomy Snares Dated: May 29, 2001 Received: May 30, 2001 Regulatory Class: II 21 CFR §876.4300/Procode: 78 FDI
Dear Mr. Saleh:
We have reviewed your Section 510(k) notification of intent to maket the device referenced above and we have designed devices We have reviewed your Section 510(k) nonthenon of mich in the enclosure) to legally marketed procicate devices
device is substantially equivalent (for the increations of the device is substantially equivalent (or the nactment and and of the Medial Device Amendents, or to devices,
marketed in interstate commerce prior to May 28, 1976, the Medial D marketed in interstate commerce prior to May 26, 1970, and Cosmetic Act (Act.). You may, and Cosmetic Act (Act.) You may,
that have been reclassified in accordance with th that have been reclassified in accordance with the provisions of the Act. The general onntrols provisions of the Act therefore, market the device, subject of the general controls of the Pro. " The general of the prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premater Approval), it may be subject If your device is classified (see above) into entrely of only in the first intent in the Code of Federal Regulations, to such additional controls. Existing major equivalent can bibliogen with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantally equivalent connes compil Title 21, Parts 800 to 895. A substantalion (QS) for Acelical Devices: General regulation (21 CFR Par
Practice requirements, as set forth in the Oualion (QS) for Medical Dev Practice requirements, as set forth in the Quality System Negation (PDA) will benfy such assumtions. Failure
820) and that, through periodic QS inspections, the Food and Drug 820) and that, through periodic (S inspection. In addition, FDA may publish further announcements
to comply with the GMP regulation may result in regulatory action systems on to comply with the GMP regulation may result in response to your previor position sumission does not
conceming your device in the Federal Regulter and effect of the Personal concerning your device in the Federal Register. Trease note for promoter the Electronic Product affect any obligation of other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in the PDA finding for your device and This letter will allow you to begin marketing your device in your break and the managements 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 809.00 to the promotion If you desire specific advice for your device of compliance at (301) 594-4639. Additionally, for questions on the promotion diagnosic devices), please contact the Office of Complance at (301) 594-4639. Also, please not the regulation and advertising of your device, premarket notification" (2). Other general information on your of your of entitled, "Misbranding by reterence to prematic nothe Division of Small Manufaman in this toll-free number (800)
responsibilities under the Act may be obtained from the Divis responsibilities under the Acc may be obtained from the Driver of British of Dr.
638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdc/dsmamain.html".
Sincerely yours.
Nancy C Brogdon
rogdon Nancy C. B Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
Image /page/0/Picture/16 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wing-like shapes, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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510(k) Number (if known): K011667
Device Name:__ HORIZONS POLYPECTOMY SNARES
Indications For Use: HORIZONS POLYPECTOMY SNARES ARE INTENDED TO ELECTROSURGICALLY REMOVE POLYPS IN THE GI TRACT UNDER ENDOSCOPIC VISUALIZATION
SIGNITURE: DATE: 08-07-01
RAFIC SALEH - PRESIDENT
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓
(Per 21 CFR 801.109)
IOR
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive. Abdominal,
bdominal, Division of Reploductive, and Radiological Device 510(k) Number
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)