(75 days)
Not Found
No
The device description and performance studies focus on the mechanical and electrical aspects of a traditional polypectomy snare, with no mention of AI or ML.
Yes
The device is used to resect polypoid lesions, which is a therapeutic intervention aimed at removing diseased tissue.
No
The device description states its use for "endoscopic resection of a polypoid lesion" and "delivery of electrosurgical current," indicating a therapeutic rather than diagnostic function. There is no mention of the device being used to identify, diagnose, or measure a medical condition.
No
The device description clearly outlines physical components such as a handle, sheath, snare loop, and electrode, 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 for "endoscopic resection of a polypoid lesion" using electrosurgical current. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device used for cutting tissue (a snare) and delivering electrosurgical current. This is consistent with a surgical instrument, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's 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 ConMed Polypectorny Snares may be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.
Product codes
FDI
Device Description
The ConMed Deuce Polypectomy Snare is a sterile, single patient use, disposable device used in conjunction with an electrosurgical generator for the delivery of electrosurgical current through a flexible endoscope to a stainless steel wire snare at the operative site for endoscopic resection of a polypoid lesion.
The snare consists of a non-detachable handle with a sliding finger ring mechanism for retracting/extending the distal snare loop. An external sheath covers the snare loop cable and is attached to the distal portion of the snare handle. Within the handle, an electrode completes the circuit between the electrosurgical unit and the snare loop.
The polypectomy snares are manufactured in 230cm sheath lengths with a 2.3mm outer diameter in a variety of different loop configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Bench testing has been performed to demonstrate equivalence of the ConMed Polypectorny Snares to their predicate devices. All testing passed the predetermined performance specifications.
Key Metrics
Not Found
Predicate Device(s)
K081580, K050294, K943935, K820430
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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ConMed Endoscopic Technologies Deuce Polypectomy Snares
K091355
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Image /page/0/Picture/2 description: The image shows the logo for CONMED Endoscopic Technologies. The logo features a stylized swoosh shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below the word "CONMED" is the phrase "ENDOSCOPIC TECHNOLOGIES" in a smaller font size.
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510(k) Summary of Safety and Effectiveness
- Sponsor Name: ConMed Endoscopic Technologies, Inc. One Executive Drive, Suite 101 Chelmsford, MA 01824 Telephone: 978-934-7832 Fax: 978-934-7854 Contact Individual: Karen Provencher Sr. Regulatory Affairs Specialist
- ConMed Deuce Polypectomy Snare 2. Device Name:
- Identification of Predicate or Legally Marketed Device: 3.
ConMed Beamer™ Snare Probe cleared under K081580 on June 20, 2008
Cook Sonnet™ Polypectomy Snare cleared under K050294 on March 31, 2005
Medi-Globe Polypectomy Snare cleared under K943935 on May 26, 1995 Polypectomy Snares cleared under K820430 on April 8, 1982
Device Description: 4.
The ConMed Deuce Polypectomy Snare is a sterile, single patient use, disposable device used in conjunction with an electrosurgical generator for the delivery of electrosurgical current through a flexible endoscope to a stainless steel wire snare at the operative site for endoscopic resection of a polypoid lesion.
The snare consists of a non-detachable handle with a sliding finger ring mechanism for retracting/extending the distal snare loop. An external sheath covers the snare loop cable and is attached to the distal portion of the snare handle. Within the handle, an electrode completes the circuit between the electrosurgical unit and the snare loop.
The polypectomy snares are manufactured in 230cm sheath lengths with a 2.3mm outer diameter in a variety of different loop configurations.
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ConMed Endoscopic Technologies Deuce Polypectomy Snares
K091355
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5. Intended Use:
The ConMed Polypectorny Snares may be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.
Comparison of Technological Characteristics: 6.
The ConMed Polypectomy Snares are substantially equivalent to the predicate devices both in intended use, technological characteristics and materials.
Performance Testing: 7.
Bench testing has been performed to demonstrate equivalence of the ConMed Polypectorny Snares to their predicate devices. All testing passed the predetermined performance specifications.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure with three wing-like shapes extending from its body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 222009
Ms. Karen Provencher Senior Regulatory Affairs Specialist ConMed Endoscopic Technologies One Executive Drive, Suite 101 CHELMSFORD MA 01824
Re: K091355
Trade/Device Name: ConMed Deuce Polypectomy Snares Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: May 7, 2009 Received: May 8, 2009
Dear Ms. Provencher:
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. Iisting 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 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. 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 of medical
3
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jarine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ConMed Endoscopic Technologies Deuce Polypactamy Snares
Image /page/4/Picture/1 description: The image shows the logo for CONMED Endoscopic Technologies. The logo features a stylized wave-like shape on the left, followed by the word "CONMED" in bold, sans-serif font. Below "CONMED" are the words "ENDOSCOPIC TECHNOLOGIES" in a smaller font size.
INDICATION FOR USE ்.
510(k) Number (if known) _K 09 1355
Device Name: ConMed Deuce Polypectomy Snare
Indication for Use:
May be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.
X Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Lori White
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
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