(221 days)
No
The description focuses on the electrosurgical mechanism and physical components, with no mention of AI or ML.
Yes
The device is used for cutting soft tissue obstructions and providing hemostasis in the upper airways and tracheobronchial tree, which are therapeutic interventions.
No
The device is described as an electrosurgical instrument for cutting soft tissue obstructions and providing hemostasis, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly details physical components such as an electrode, shaft, and electrical adaptor, 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EC 2.7 Endoscopic Cutter is an electrosurgical instrument used for cutting and providing hemostasis directly on tissue within the upper airways and tracheobronchial tree. It is a surgical tool, not a test performed on a sample.
- Intended Use: The intended use clearly states it's for "cutting of soft tissue obstructions" and "provision of electrosurgical hemostasis," which are surgical procedures.
- Device Description: The description details a physical instrument with an electrode and cabling for connection to an electrosurgical generator, consistent with a surgical device.
Therefore, the EC 2.7 Endoscopic Cutter is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EC 2.7 Endoscopic Cutter is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, and provision of electrosurgical hemostasis during such procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The EC 2.7 Endoscopic Cutter is a disposable, single-patient-use monopolar RF (radio-frequency) surgical endotherapy device intended to be inserted through the working channel of a flexible bronchoscope. The EC 2.7 Endoscopic Cutter is terminally sterilized via ETO. It is comprised of a separately packaged, cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric, flexible multi lumen shaft , and a separately packaged, single-patient-use, electrical adaptor with cabling, intended for connection to the monopolar output port of a Covidien® Corporation, ValleyLab™ Force FX™ or FX-C Electrosurgical Generator. The ValleyLab™ Force FX™ was cleared to market via 510(k) K944602.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airways and tracheobronchial tree
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)
Performance testing per standardized methods and internal test protocols, including bench testing, human cadaveric studies and in vivo animal data collection, was conducted and provides support that the EC 2.7 Endoscopic Cutter is substantially equivalent to currently marketed predicate devices. Additional comparative performance testing was conducted inconsideration of other devices with similar intended indications and intended use.
Non-clinical performance test protocols and reports of results are identified in Sections 14 through 19 of this 510(k) submission.
Test protocols and reports of results demonstrate that, in consideration of its intended and indications for use, the performance, design, labeling, packaging and sterilization of the EC 2.7 Endoscopic Cutter is compliant with the following standards:
- ANSI/AAMI ISO 11135-1:2007: Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for the development, validation and
- ISO 11607-1:2006, Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier
- ISO 11607-2:2006: Packaging for terminally sterilized . medical devices -Part 2: Validation requirements for forming, sealing and assembly processes, including Annex B (informative) listing of standardized test methods and procedures
- ASTM F1980-07; Shelf-life and accelerated aging . techniques for standard evaluation of packaging performance
- ISO 10993-4:2002, Biological evaluation of medical . devices - Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009, Biological evaluation of medical ● devices - Part 5: Tests for In Vitro Cytotoxicity.
- ISO 10993-7:2008, Biological evaluation of medical . devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2002 (A1:2006), Biological evaluation . of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity.
- ISO 10993-11:2006, Biological evaluation of medical . devices - Part 11: Tests for systemic toxicity.
- ANSI AAMI ES 60601-1: 2005 3rd Edition: Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests.
- IEC 60601-2-2:2009, 5th Edition, Medical electrical . equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
- IEC 60601-2-18:2009, 3th Edition, Particular . requirements for the basic safety and essential performance of endoscopic equipment
Clinical data was not necessary to support that the EC 2.7 is substantially equivalent to currently marketed predicate devices.
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.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Medtronic Advanced Energy LLC Traditional 510(k)
EC 2.7 Endoscopic Cutter
NOV 2 2012
K120909 510(K) SUMMARY
EC 2.7 Endoscopic Cutter - 510(k) Summary
Submitter:
Medtronic Advanced Energy, LLC
Contact:
Martin J. Leighton Tel: 603-742-1515 Fax: 603-742-1488
November 2, 2012 Date Summary Prepared:
Device Trade Name: EC 2.7 Endoscopic Cutter
Common Name: Electrosurgical cutting and coagulation accessories and Endoscopic electrosurgical unit and accessories
Classification Name: Electrosurgical cutting and coagulation device and accessories
21 CFR §878.4400 Classification Code:
Product Code GEI
Equivalent Device(s): Olympus CD-6C-1 Coagulation Electrode (K971321)
The EC 2.7 Endoscopic Cutter is a disposable, single-Device Description: patient-use monopolar RF (radio-frequency) surgical endotherapy device intended to be inserted through the working channel of a flexible bronchoscope. The EC 2.7 Endoscopic Cutter is terminally sterilized via ETO. It is comprised of a separately packaged, cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric, flexible multi lumen shaft , and a separately packaged, single-patient-use, electrical adaptor with cabling, intended for connection to the monopolar output port of a Covidien® Corporation, ValleyLab™ Force FX™ or FX-C Electrosurgical Generator. The ValleyLab™ Force FX™ was cleared to market via 510(k) K944602.
1
EC 2.7 Endoscopic Cutter
Medtronic Advanced Energy LLC Traditional 510(k)
Intended use:
Indications for Use:
Non-clinical Performance Data: The Endoscopic Cutter System is intended to be energized for use by the foot-switch accessory supplied with the electrosurgical generator. The EC 2.7 has an active length of approximately 750 mm and a maximum diameter crossing profile of 2.68 mm. It is sized such that may be delivered through the working channel of a flexible bronchoscope 2.8 mm diameter working channel and working length of 600 mm.
The EC 2.7 Endoscopic Cutter is intended to be inserted through the working channel of a flexible bronchoscope having an instrument channel diameter of 2.8 mm minimum, a working length of 600 mm, activated by a foot-switch connected to a qualified electrosurgical generator, and utilized in electrosurgical procedures involving removal/cutting of soft tissues (excision, incision, vaporization, ablation) while also providing electrosurgical coagulation and hemostasis.
The EC 2.7 Endoscopic Cutter is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, and provision of electrosurgical hemostasis during such procedures.
Performance testing per standardized methods and internal test protocols, including bench testing, human cadaveric studies and in vivo animal data collection, was conducted and provides support that the EC 2.7 Endoscopic Cutter is substantially equivalent to currently marketed predicate devices. Additional comparative performance testing was conducted inconsideration of other devices with similar intended indications and intended use.
Non-clinical performance test protocols and reports of results are identified in Sections 14 through 19 of this 510(k) submission.
Test protocols and reports of results demonstrate that, in consideration of its intended and indications for use, the performance, design, labeling, packaging and sterilization of the EC 2.7 Endoscopic Cutter is compliant with the following standards:
- ANSI/AAMI ISO 11135-1:2007: Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for the development, validation and
2
- ISO 11607-1:2006, Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier
- ISO 11607-2:2006: Packaging for terminally sterilized . medical devices -Part 2: Validation requirements for forming, sealing and assembly processes, including Annex B (informative) listing of standardized test methods and procedures
- ASTM F1980-07; Shelf-life and accelerated aging . techniques for standard evaluation of packaging performance
- ISO 10993-4:2002, Biological evaluation of medical . devices - Part 4: Selection of tests for interactions with blood
- ISO 10993-5:2009, Biological evaluation of medical ● devices - Part 5: Tests for In Vitro Cytotoxicity.
- ISO 10993-7:2008, Biological evaluation of medical . devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2002 (A1:2006), Biological evaluation . of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity.
- ISO 10993-11:2006, Biological evaluation of medical . devices - Part 11: Tests for systemic toxicity.
- ANSI AAMI ES 60601-1: 2005 3rd Edition: Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests.
- IEC 60601-2-2:2009, 5th Edition, Medical electrical . equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
- IEC 60601-2-18:2009, 3th Edition, Particular . requirements for the basic safety and essential performance of endoscopic equipment
Clinical Performance Data:
Clinical data was not necessary to support that the EC 2.7 is substantially equivalent to currently marketed predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Dated: November 2, 2012
Medtronic Advanced Energy, LLC % Mr. Martin J. Leighton Senior Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801
Re: K120909
Trade/Device Name: EC 2.7 Endoscopic Cutter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 25, 2012 Received: October 26, 2012
Dear Mr. Leighton:
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. 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
4
Page 2 - Mr. Martin J. Leighton
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K120909
Device Name: EC 2.7 Endoscopic Cutter
Indications For Use: The EC 2.7 Endoscopic Cutter is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, and provision of electrosurgical hemostasis during such procedures.
Prescription Use X (21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Miller
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
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