(204 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical aspects of a surgical snare, with no mention of AI or ML capabilities.
Yes
The device is used for the "electrosurgical removal and cauterization of gastrointestinal tract polyps," which constitutes a medical treatment.
No
The device is described as an electrosurgical tool for removing and cauterizing tissue (polyps), indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components (flexible wire cable, loop, outer shaft, three-finger actuator) and its function involves delivering electrical current, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope." This describes a surgical procedure performed directly on the patient's tissue.
- Device Description: The description details a physical tool used for cutting and cauterizing tissue. It does not involve analyzing samples taken from the body (like blood, urine, or tissue biopsies) to provide diagnostic information.
- Lack of Diagnostic Function: The device's function is therapeutic (removing and treating tissue), not diagnostic (identifying a disease or condition).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.
Product codes (comma separated list FDA assigned to the subject device)
FDI
Device Description
The Ethicon Endo Surgery Articulating Snare consists of a flexible wire cable and loop, which can be extended, rotated, articulated, and retracted from the flexible outer shaft using a three-finger actuator. It is passed through endoscopes having a 3.2 mm or larger working channels. When activated, the snare delivers a monopolar electrical current to cut and cauterize tissue within the loop. The device is supplied sterile for single-patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic visualization
Anatomical Site
gastrointestinal 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)
Bench testing was performed to demonstrate that the EES device performs as intended. The device materials have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1. The device was tested to demonstrate compliance with the following standards:
- AAMI HF 18, 2001 : Electrosurgical Devices
- IEC/EN 60601-2-2, 2000 : Particular Requirements for the Safety of Endoscopic Equipment
- IEC/EN 60601-2-18, 1996 : Particular Requirements for the Safety of High Frequency of Surgical Equipment
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K073288
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510(k) Summary
JUN 1 2 2008
Company Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
Contact Glenda C Marsh QS/RA Sr. Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242 Telephone: (513) 337-7659 (513) 337-2860 Fax: Email: gmarsh(@eesus.jnj.com
Date Prepared November 19, 2007
- New Device Name Trade Name: Ethicon Endo Surgery Articulating Snare Common or Usual Name: Snare, Flexible Classification Name: Endoscopic electrosurgical unit and accessories (21 CFR 876.4300, Product Code FDI)
Predicate Devices Rotatable Snare (K992477) Single-Use Polypectomy Snare (K941750)
Device Description The Ethicon Endo Surgery Articulating Snare consists of a flexible wire cable and loop, which can be extended, rotated, articulated, and retracted from the flexible outer shaft using a three-finger actuator. It is passed through endoscopes having a 3.2 mm or larger working channels. When activated, the snare delivers a monopolar electrical current to cut and cauterize tissue within the loop. The device is supplied sterile for single-patient use.
Indications for Use The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.
Technological Characteristics The EES device has similar technologic characteristics to the predicate devices in that it consists of a flexible wire cable and loop that is used to remove polyps utilizing monopolar RF energy under endoscopic visualization. In all devices, the operator can deploy and retract the snare by using three fingers. As in the predicate devices, the EES device features rotation of the end-effector by manipulation of a rotation knob. In addition, the EES device features articulation of the end-effector to provide the clinician with improved tissue targeting capability.
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K073288
Page 2 of 2
Performance Data. Bench testing was performed to demonstrate that the EES device performs as intended. The device materials have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1. The device was tested to demonstrate compliance with the following standards:
-
AAMI HF 18, 2001 : Electrosurgical Devices
-
IEC/EN 60601-2-2, 2000 : Particular Requirements for the Safety of Endoscopic Equipment
-
IEC/EN 60601-2-18, 1996 : Particular Requirements for the Safety of High Frequency of Surgical Equipment
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 12 2008
Ms. Glenda Marsh Senior Project Manager, Quality Systems & Regulatory Affairs Ethicon Endo-Surgery, Incorporated 4545 Creek Road CINCINNATI OH 45242
Re: K073288
Trade/Device Name: Ethicon Endo Surgery® Articulating Snare Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: May 29, 2008 Received: May 29, 2008
Dear Ms. Marsh:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a stylized "FDA" abbreviation. The word "Centennial" is written below the abbreviation. Three stars are at the bottom of the logo.
Protecting and Promoting Public Health
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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 max 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.
Nancy C. Burgdon
Nancy C. Brogdon . Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 13288
Device Name:
Ethicon Endo Surgery® Articulating Snare
Indications for Use:
The Articulating Snare is intended for the electrosurgical removal and cauterization of gastrointestinal tract polyps through an endoscope.
Prescription Use _ X (Part 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)
Page 1 of 1
(Posted November 13, 2003)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K073288 |