(78 days)
The Enable Endoscopic Bipolar Scissors is intended to cut tissue and control bleeding through coagulation during surgical procedures.
The ENABLE Endoscopic Bipolar Scissors are substantially equivalent to the CardioThoracic Systems. Symbiosis, Everest Medical and ENABLE Bipolar Scissors in that each consist of a handle which is connected to a pair of scissor blades with electrodes on each blade. All the devices utilize the same bipolar electrosurgical technology. i.e. radio frequency (RF) energy. 10 caurerize the blood vessels by heating proteins in the tissue to a temperature where the proteins congeal.
The ENABLE Endoscopic Bipolar Scissors contain both a negative and positive electrode on each blade. The function of the ENABLE and predicate devices is the same; current flows from a negatively charged pole through the tissue to a positively charged pole. The ENABLE, CardioThoracic. Symbiosis and Everest Bipolar Scissors are connected to a similar electrosurgical generator that supplies RF bipolar energy. The ENABLE. CardioThoracic and Everest Bipolar Scissors are all labeled for use with the Valleylab Force 2 Electrosurgical Generator or equivalent electrosurgical units. All four bipolar scissors listed in this notification are labeled for operation at a comparable range (15-35 watts). Labeling for the ENABLE Endoscopic Bipolar Scissors are provided with each product. As with other bipolar instruments. there is no need for a grounding pad for the return electrode, therefore. the current does not travel through the patient to the grounding pad as it does with monopolar instruments. Patient burns seen with monopolar devices due to electrical current passage are eliminated.
The ENABLE Endoscopic Bipolar Scissors and the listed predicate devices are of similar size with an overall length range of 33 to 48cm (13 to 19 inches) and a scissors blade length range of approximately 0.7 inches. The scissors shaft is designed to fit a standard 5mm cannula. The bipolar devices utilize similar materials of construction including stainless steel scissors blades. All of the materials utilized in the ENABLE Endoscopic Bipolar Scissors are standard medical device materials that are used in a variety of tissue contact medical devices.
The provided 510(k) summary for the ENABLE Endoscopic Bipolar Scissors focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria. This type of submission relies on the device being similar enough to already approved devices that it doesn't require new clinical efficacy studies.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a dedicated study. Instead, it relies on demonstrating equivalence through:
- Intended Use Equivalence: Stating the intended use is "substantially equivalent to the intended use statements of CardioThoracic, Symbiosis, Everest and ENABLE Bipolar Scissors."
- Technological Equivalence: Describing similar design (handle, scissor blades, electrodes), same bipolar electrosurgical technology (RF energy to cauterize), similar current flow mechanisms, compatible electrosurgical generators (Valleylab Force 2 or equivalent), comparable operating range (15-35 watts), and similar size and materials.
- Compliance with Standards: Listing compliance with relevant industrial/international standards.
| Acceptance Criterion (Inferred from Equivalence) | Reported Device Performance (Inferred from Description) |
|---|---|
| Intended Use: Cut and coagulate soft tissue during laparoscopic and general surgical procedures. | "substantially equivalent to the intended use statements of CardioThoracic, Symbiosis, Everest and ENABLE Bipolar Scissors." Device is "intended to cut and control bleeding through coagulation during tissue and control bleeding through coagulation during surgical procedures." |
| Electrosurgical Technology: Utilize bipolar radio frequency (RF) energy for cauterization. | "All the devices utilize the same bipolar electrosurgical technology, i.e. radio frequency (RF) energy. 10 caurerize the blood vessels by heating proteins in the tissue to a temperature where the proteins congeal." "The ENABLE Endoscopic Bipolar Scissors contain both a negative and positive electrode on each blade. The function of the ENABLE and predicate devices is the same; current flows from a negatively charged pole through the tissue to a positively charged pole." |
| Compatibility with Electrosurgical Generators: Compatible with standard electrosurgical generators, specifically Valleylab Force 2 or equivalent. | "The ENABLE, CardioThoracic and Everest Bipolar Scissors are all labeled for use with the Valleylab Force 2 Electrosurgical Generator or equivalent electrosurgical units." |
| Operating Range (Power): Operable within a comparable power range to predicate devices. | "All four bipolar scissors listed in this notification are labeled for operation at a comparable range (15-35 watts)." |
| Safety - No Grounding Pad Required: Does not require a patient grounding pad, eliminating burns associated with monopolar devices. | "As with other bipolar instruments, there is no need for a grounding pad for the return electrode, therefore, the current does not travel through the patient to the grounding pad as it does with monopolar instruments. Patient burns seen with monopolar devices due to electrical current passage are eliminated." |
| Physical Dimensions: Similar overall length and blade length to predicate devices. The shaft fits a standard 5mm cannula. | "The ENABLE Endoscopic Bipolar Scissors and the listed predicate devices are of similar size with an overall length range of 33 to 48cm (13 to 19 inches) and a scissors blade length range of approximately 0.7 inches. The scissors shaft is designed to fit a standard 5mm cannula." |
| Materials of Construction: Utilizes standard medical device materials, including stainless steel for blades. | "The bipolar devices utilize similar materials of construction including stainless steel scissors blades. All of the materials utilized in the ENABLE Endoscopic Bipolar Scissors are standard medical device materials that are used in a variety of tissue contact medical devices." |
| Biological Safety: Biocompatible and meets relevant biological evaluation standards. | "ISO 10993/EN 30993 Biological Evaluation of Medical Devices" (The document states the device will meet this standard, indicating compliance as part of the manufacturing process rather than a study proving performance against it for this submission). |
| Sterilization & Packaging: Packaging for terminally sterilized medical devices and sterilization by gamma irradiation meet relevant standards. | "ISO 11607 Packaging for Terminally Sterilized Medical Devices" "ISO 11137 Sterilization of Health Care Products, Sterilization of Gamma Irradiation" (Similar to above, compliance with standards for manufacturing). |
| Electrical Safety & Performance: Meets standards for electrosurgical devices and safety of high-frequency surgical equipment. | "ANSI/AAMI HF18 Electrosurgical Devices" "IEC 60601-2-2/EN 60601-2-2 Medical Electrical Equipment: Particular Requirements for Safety of High Frequency Surgical Equipment" (Similar to above, compliance with standards for manufacturing). |
| Mechanical Performance (Scissors): Meets standard specifications for insert and non-insert surgical scissors (implies appropriate cutting action and durability, though specific performance metrics are not detailed). | "ASTM F1079 Standard Specification for Insert and Non-insert Surgical Scissors" (Similar to above, compliance with standards for manufacturing). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission is for substantial equivalence, not a clinical study involving a test set of data. The "testing" referred to is likely engineering verification and validation demonstrating compliance with the listed standards, rather than a clinical performance study. There are no patient data sets or provenance mentioned.
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)
Not applicable. This device is not an AI/diagnostic device that requires expert ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of diagnostic performance.
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
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or decision support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is based on the established safety and effectiveness of its predicate devices and compliance with recognized industry standards for design, manufacturing, and general safety.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable.
§ 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.