(36 days)
The Telescoping PenEvac is intended to be used as the active monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during the procedure.
The Telessoping PenEvac is a combination of an electrosurgery switching handpiece and a smoke evacuation shroud with a telescoping tip that allows the surgeon to adjust the tip length. It includes pushbutton switches to allow the surgeon to select "cut" or "coagulation" operating modes on typical electrosurgery generators.
The device will be marketed in two versions:
As a complete single use sterile product.
As a partially reusable product with the PenEvac body and electrosurgery cord being reusable and the remainder of the device as a sterile single use product.
Electrodes of various lengths and shapes will be available.
This 510(k) summary for the I.C. Medical Telescoping PenEvac does not contain the level of detail typically found in a study demonstrating device performance against specific acceptance criteria. This document is a summary primarily focused on establishing substantial equivalence to predicate devices, rather than a detailed report of performance testing with specified acceptance criteria and outcomes.
Therefore, for your request, I will have to extract what information is present regarding testing and make inferences about "acceptance criteria" where they are not explicitly stated as numerical targets.
Here's the breakdown of the information based on your request:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission details modifications to an existing device (Telescoping PenEvac) and claims substantial equivalence to predicate devices. The "studies" described are primarily non-clinical bench tests and material compatibility tests, not clinical studies with human participants. The acceptance criteria are largely inferred from the statement of equivalence to predicate devices and compliance with industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from 510(k)) | Reported Device Performance |
|---|---|
| Flammability: Device materials must not exhibit flammability when used with various electrosurgery generators, similar to the predicate ESU shroud. | Samples of all proposed tip materials have been tested for flammability when used with various electrosurgery generators and all have passed the same tests that were applied to the Lexan polycarbonate used with the predicate ESU shroud. |
| Functionality (Smoke Evacuation): The smoke evacuation function must perform comparably to the predicate ESU shroud. | The PenEvac was bench tested with a number of different electrosurgery generators, and the smoke evacuation function of the PenEvac was comparable to the predicate ESU shroud. |
| Functionality (Electrocautery Pencil): The electrocautery pencil function must perform comparably to predicate electrosurgery pencils (Valleylab Disposable/Reusable Handswitching Pencils). | The PenEvac was bench tested with a number of different electrosurgery generators, and the electrocautery pencil function of the PenEvac was comparable to the predicate electrosurgery pencils. |
| Compliance with ANSI/AAMI HF-18: 1993 Electrosurgical Device Standard: Prototype devices must comply with applicable portions of this standard. | The Chief Engineer and/or the manufacturer of the cable/connector/switches tested the prototype devices and they comply with the applicable portions of ANSI/AAMI HF-18: 1993 Electrosurgical Device standard. (Further validation on production devices is planned for initial release). |
| Biocompatibility of New Material (Reusable PenEvac Body): The added material must be biocompatible. | Test data on the material added for the reusable PenEvac body indicate that the material is USP Class VI certified. |
| Sterilization Compatibility of New Material: The added material must be compatible with specified sterilization parameters (ETO, steam, steris, flash autoclave up to 134 degrees C). | Test data on the material added for the reusable PenEvac body indicate that the material is compatible with the sterilization parameters. (The addition of this material does not change any sterilization or use parameters). |
| Substantial Equivalence: Overall safety and effectiveness are not significantly changed compared to predicate devices. | I.C. Medical explicitly states: "I.C. Medical feels that the Telescoping PenEvac functions the same as the predicate devices and we have not identified any significant changes in safety and effectiveness." The non-clinical tests described support this claim. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated with a specific number for each test. The document refers to "samples of all proposed tip materials" for flammability and "the prototype devices" for ANSI/AAMI compliance. For the bench testing of functionality, it mentions "a number of different electrosurgery generators," implying multiple tests but not a precise count of devices or test runs.
- Data Provenance: The tests appear to be retrospective in the sense that they were conducted internally by I.C. Medical, the Chief Engineer, and/or the manufacturer of components, to support the 510(k) submission. There is no mention of external labs or country of origin other than the submitter's address in Glendale, AZ, USA. These are non-clinical tests, so there's no patient data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts: The "Chief Engineer and/or the manufacturer of the cable/connector/switches" are mentioned as having tested the prototype devices for compliance with ANSI/AAMI HF-18.
- Qualifications: "Chief Engineer" implies relevant engineering expertise in electrosurgical devices. The manufacturer of components would also possess expertise related to their specific parts. No further specific qualifications (e.g., years of experience, certifications) are provided.
There is no mention of clinical experts (like radiologists) as these are non-clinical, bench and material tests.
4. Adjudication method for the test set
- Adjudication Method: Not applicable or explicitly stated as there is no mention of multiple raters or consensus-building processes for these types of non-clinical tests. The tests involve direct measurement, observation of functionality, and material testing, rather than subjective interpretations 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
- MRMC Study: No. This device is an electrosurgical pencil and smoke evacuation system, not an AI-based diagnostic tool. Therefore, an MRMC study and discussions of AI assistance are not relevant to this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm or AI system. Its performance is inherent to its design and materials, and evaluated through bench testing simulating use conditions, not through an algorithm's standalone output.
7. The type of ground truth used
- Ground Truth: The "ground truth" for these tests is implicitly defined by:
- Predicate Device Performance: The functional behavior and material properties of the legally marketed predicate devices (I.C. Medical ESU Shroud, Valleylab Disposable/Reusable Handswitching Pencils) serve as a comparative ground truth.
- Industry Standards: Compliance with "applicable portions of ANSI/AAMI HF-18: 1993 Electrosurgical Device standard" represents a defined ground truth for electrical safety and performance.
- Material Certifications: "USP Class VI certified" is a specific industry standard for biocompatibility, acting as a ground truth.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This submission concerns a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for an AI/machine learning model.
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510(k) Summary I.C. Medical Telescoping PenEvac (Modification) K961616
MAY 28 1996
510(k) Summary
| Submitter | Name: | I.C. Medical, Inc. |
|---|---|---|
| Address: | 5170 West Phelps RoadGlendale, AZ 85306 | |
| Phone: | (602) 547-9200 | |
| FAX: | (602) 547-0750 | |
| Contact Person: | Kurt Hasper | |
| Date Summary Was Prepared: | May 7, 1996 | |
| Device | Trade Name: | Telescoping PenEvac |
| Common Name: | Electrosurgery Pencil with SmokeEvacuation Tube and Telescoping Tip,and electrodes | |
| Classification Name: | GEI: Device, Electrosurgical, Cutting &Coagulating, & Accessories | |
| Substantial equivalence to the following: | 1. Valleylab Disposable HandswitchingPencil2. Valleylab Reusable Handswitching encil3. I.C. Medical Electrocautery Shroud |
This submission is the same as a previously submitted 510(k) application (1954088) that was found substantially equivalent with the following exceptions:
- An additional material is being added to the list of materials that may be used to mold the Reusable PenEvac . Body;
- Biocompatability and sterilization compatability infornation that will be used on reusable . products only has been added and sterilization information on disposable products has been eliminated.
Description of Telescoping PenEvac:
The Telessoping PenEvac is a combination of an electrosurgery switching handpiece and a smoke evacuation shroud with a telescoping tip that allows the surgeon to adjust the tip length. It includes pushbutton switches to allow the surgeon to select "cut" or "coagulation" operating modes on typical electrosurgery generators.
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510(k) Summary I.C. Medical Telescoping PenEvac (Modification) K961616
The device will be marketed in two versions:
As a complete single use sterile product. One:
As a partially reusable product with the PenEvac body and electrosurgery cord being reusable and the Two: remainder of the device as a sterile single use product.
Electrodes of various lengths and shapes will be available.
Intended Use of the Telescoping PenEvac:
The Telescoping PenEvac is intended to be used as the active monopolar electrosurgery generator system and to facilitate the removal of smoke that is generated during the procedure.
Summary of Technological Characteristics: PenEvac/Predicate Device(s)
The PenEvac is a combination smoke evacuator and electrocautery handswitching pencil. The smoke evacuator portion is being compared to the I.C. Medical ESU shroud and the electrocautery pencil portion is being compared to the ValleyLab Disposable Handswitching Pencil and the ValleyLab Reusable Handswitching Pencil. The PenEvac will be marketed in two ways: a) as a completely disposable product b) as a partially reusable product (the PenEvac body with handswitches, ESU cord, and connector) with disposable sterile accessories.
The reusable PenEvac body (includes: ESU shroud/handswitching pencil body, three conductor cord, & connector; does not include: telessope tip/electrode, or smoke evacuator tube.) may be sternized by ETO, steam, steris, or flash autoclave up to 134 degrees centigrade. It may be reused until it fails a continuity check or shows signs of wear, damage, cracking, or chipping.
An additional material is being added to the list of material: that the reusable PenEvac body may be molded from. Biocompatability and sterilization data is included in the addition of this material does not change any sterilization or use parameters.
The predicate ESU shroud has optional tips of various lengths to accommodate different pencil electrode lengths of the predicate electrosurgical pencil. The PenEvac uses a single tip that telescopes to the length desired by the surgeon. The PenEvac smoke evacuator/pencil body will be molded from the same material as the predicate ESU shroud or from other plastic resins that are on file with the FDA. The smoke evacuator and connectors are identical to the predicate device.
The predicate electrosurgical pencil features optional electrodes and shapes. The PenEvac also has optional electrode shapes.
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510(k) Summary I.C. Medical Telescoping PenEvac (Modification) K961616
The PenEvac and the predicate electrosurgery pencils are handswitching monopolar devices. The PenEvac has a "cut" and a "coag" pushbutton as do the predicate pencils. The PenEvac electrode is made of materials that are commonly used on surgical devices. The connector fits common electrosurgery generators and the connecting cable is a ten foot, flexible, three conductor product as are the predicate pencils.
The electrical cord, generator, and switches (cut & coag) are being purchased from a manufacturer that supplies these items to other electrosurgical handpiece manufacturers for use in their devices.
The specifications of the PenEvac are comparable to the predicate I.C. Medical ESU Shroud and Valleylab electrosurgery handpieces.
I.C. Medical feels that the Telescoping PenEvac functions the same as the predicate devices and we have not identified any significant changes in safety and effectiveness.
Summary of Nonclinical Tests & How Results Support Equivalence:
Samples of all proposed tip materials have been tested for flanmability when used with various electrosurgery generators and all have passed the same tests that were applied to the Lexan polycarbonate used with the predicate ESU shroud.
The PenEvac was also bench tested with a number of different electrosurgery generators and the smoke evacuation and electrocautery pencil functions of the PenEvac were the predicate ESU shroud and pencils.
The Chief Engineer and/or the manufacturer of the cable/connector/switches tested the prototype devices and they comply with the applicable portions of ANSI/AAMI HF-18: 1993 Electrosurgical Device standard. Validation will also be performed on production devices prior to their initial release for compliance to the standard.
Test data on the material added for the reusable PenEvac body indicate that the material is USP Class VI certified and that the material is compatable with the sterilization parameters.
END OF 510(K) SUMMARY
Information beyond this statement is NOT part of the 510(k) Summary
§ 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.