(87 days)
Not Found
No
The description focuses on mechanical and electrosurgical components, with no mention of AI/ML terms or image processing.
No.
The device is used to resect tissue, which is a surgical procedure, not a therapeutic treatment. It removes disease/abnormal tissue but does not treat it through other means.
No
The device is used for resecting tissue, which is a therapeutic procedure, not a diagnostic one. It removes tissue, it does not analyze or detect medical conditions.
No
The device description clearly outlines physical components (snare loop, snare tube, mandrel, slider, plug) and a physical connection for electrosurgical current, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically resect tissue from within the GI tract." This is a surgical procedure performed in vivo (within the living body) to remove tissue.
- Device Description: The description details a physical device used for mechanical and electrosurgical tissue removal. It does not describe a test or assay performed on samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples after removal), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for direct tissue removal during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The EC Single Use, Polypectomy Snare is indicated to endoscopically resect tissue from within the GI tract.
Product codes
FDI
Device Description
The EC Single Use, Polypectomy Snare is a disposable sterile device comprised of a snare loop, a snare tube, a mandrel, a slider and a plug. An electrical connection enables the snare loop to be connected to an electrosurgical generator. Tissue is resected by a combination of mechanical handling of the loop and electrosurgical current.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
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)
Results of the various tests indicate that the EC Single Use, Polypectomy Snare functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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page 1 of 2
510(K) Summary
[as required by section 807.92(c)]
EC Single Use, Polypectomy Snare
510(k) Number K /23223
JAN 1 0 2013
Date Prepared:
October 10, 2012
Applicant's Name:
EndoChoice, Inc. 11800 Wills Road, Suite 100 Alpharetta, GA 30009 Phone: 678-534-6021 Fax: 770-962-6981
Contact Person:
Shoshana (Shosh) Friedman Regulatory Consultant Phone: (704) 899-0092 (704) 899-0098 FAX: shosh@pushmed.com
Trade Name:
EC Single Use, Polypectomy Snare
Classification Name:
Flexible Snare
Classification:
FDA has classified Flexible Snare devices for as class II devices (product code FDI) and they are reviewed by the Gastroenterology/Urology.
`Predicate Devices:
Olympus SD Series Snares - K955650
Device Description:
The EC Single Use, Polypectomy Snare is a disposable sterile device comprised of a snare loop, a snare tube, a mandrel, a slider and a plug. An electrical connection enables the snare loop to be connected to an electrosurgical generator. Tissue is resected by a combination of mechanical handling of the loop and electrosurgical current.
Intended Use:
The EC Single Use, Polypectomy Snare is indicated to endoscopically resect tissue from within the GI tract.
EC Single Use, Polypectomy Snare - Page 5-2
1
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Technological Characteristics:
The technological characteristics of the EC Single Use, Polypectomy Snare are virtually identical to those of the Olympus SD Series Snares cleared under K955650.
Performance Testing:
Results of the various tests indicate that the EC Single Use, Polypectomy Snare functions as intended.
Conclusion:
EndoChoice Inc. believes that, based on the information provided in this submission, EC Single Use, Polypectomy Snare is substantially equivalent to its predicate device without raising any new safety and/or effectiveness issue.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2013
EndoChoice, Inc. % Ms. Shoshana Friedman Regulatory Consultant Push-Med LLC 1914 J.N. Pease Place CHARLOTTE NC 28262
Re: K123223
Trade/Device Name: EC Single Use, Polypectomy Snare Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: December 10, 2012 Received: December 11, 2012
Dear Ms. Friedman:
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.
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.
3
Page 2 – Ms. Shoshana Friedman
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Herbert B. Lerner
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K /a3223
EC Single Use, Polypectomy Snare Device Name:
Indications for Use:
The EC Single Use, Polypectomy Snare is indicated to endoscopically resect tissue from within the GI tract.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner
Gastro-Renal, and
EC Single Use, Polypectomy Snare - Page 4-2