(221 days)
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.
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.
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.
§ 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.