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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medtronic Advanced Energy LLC EC 2.7 Endoscopic Cutter. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the typical format of a performance study with specific metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy).

Instead, it lists performance testing methods as evidence of compliance and substantial equivalence:

Acceptance Criteria Category (Implied)	Reported Device Performance (as demonstrated by)
Biocompatibility	Compliance with ISO 10993 series for:
	- Blood interactions (ISO 10993-4)
	- In Vitro Cytotoxicity (ISO 10993-5)
	- Ethylene oxide sterilization residuals (ISO 10993-7)
	- Irritation and delayed-type hypersensitivity (ISO 10993-10)
	- Systemic toxicity (ISO 10993-11)
Sterilization & Packaging	Compliance with:
	- ANSI/AAMI ISO 11135-1:2007 (Ethylene Oxide Sterilization)
	- ISO 11607-1:2006 (Packaging materials/sterile barrier)
	- ISO 11607-2:2006 (Packaging validation)
	- ASTM F1980-07 (Shelf-life/accelerated aging)
Electrical Safety & Performance	Compliance with:
	- ANSI AAMI ES 60601-1: 2005 (General safety/performance)
	- IEC 60601-1-2:2007 (EMC requirements)
	- IEC 60601-2-2:2009 (High frequency surgical equipment)
	- IEC 60601-2-18:2009 (Endoscopic equipment)
Functional Performance	Bench testing, human cadaveric studies, and in vivo animal data demonstrating substantial equivalence to predicate device (Olympus CD-6C-1 Coagulation Electrode K971321) for:
	- Cutting/excision of soft tissues
	- Vaporization, ablation
	- Electrosurgical coagulation and hemostasis
Physical Dimensions/Compatibility	Active length approx. 750 mm, max diameter 2.68 mm, sized for 2.8 mm min. diameter, 600 mm working length bronchoscope channel.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench testing, human cadaveric studies and in vivo animal data collection." However, specific sample sizes for these tests are not provided. The provenance (country of origin, retrospective/prospective) of these studies is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This device is an electrosurgical cutting tool, not an AI/imaging device requiring expert ground truth for classification. Therefore, this information is not applicable and not present in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable to this type of device and submission. The performance testing focuses on functional parameters, material compatibility, and adherence to standards, rather than diagnostic accuracy requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted or is relevant to this electrosurgical device. This type of study is specific to AI-powered diagnostic tools.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance data (bench, cadaveric, animal studies), the "ground truth" would be related to the observed physical effects and measurements, such as:

Bench Testing: Direct physical measurements (e.g., cutting depth, coagulation area, power output, electrode integrity), functional evaluations (e.g., ability to cut specific tissue analogs), and material science tests.
Human Cadaveric Studies: Observation of tissue cutting and coagulation characteristics on post-mortem human tissue.
In Vivo Animal Studies: Direct observation of the device's effects on live animal tissue (e.g., cutting, coagulation, hemostasis, tissue response) under simulated surgical conditions.

These "ground truths" are based on direct physical and biological interaction observations and measurements, often compared to the known effects of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable for the same reason as point 8.

Summary

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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.

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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.

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

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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.

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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

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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

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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)

K120909

Mark M. Miller

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number _

Regulation Number and Section

§ 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.