(159 days)
The Telescoping PenEvac ABC is intended to be used only during open surgical procedures as the active handpiece in a combination argon beam coagulator/electrosurgery generator system that uses monopolar electrodes and to facilitate the removal of smoke that is generated.
The Telescoping PenEvac ABC is a combination of an argon beam coagulator pencil and an electrosurgery switching handpiece with a smoke evacuation shroud. It is intended to be used with argon beam generators that include electrosurgery capabilities. The device has push button switches to allow the surgeon to select CUT, COAG, or ARGON functions on the generator. An ARGON ASSIST mode can be selected by sliding the tip of the ABC Telescoping Tip back to expose the monopolar electrode. The device consists of three major components: PenEvac Body, ABC Adapter, and ABC Telescoping Tip. The PenEvac Body contains the pushbutton switches and ESU cord and connector. The ABC Adapter fits into the rear of the PenEvac Body and contains flexible tubing, generator connector, electrical conductor, and a rigid metal tube that fits into the PenEvac Body. The ABC Telescoping Tip is used during open surgical procedures. The tip may be extended or shortened as desired. It also has a sliding tip that can expose, or conceal, the electrode during argon procedures.
This document is a 510(k) summary for a medical device called the "Telescoping PenEvac ABC". It aims to demonstrate that this new device is substantially equivalent to existing, legally marketed predicate devices.
Let's break down the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicitly stated numerical "acceptance criteria" or detailed quantitative "reported device performance" metrics in the way one might expect for a clinical study with quantifiable endpoints (e.g., sensitivity, specificity, accuracy).
Instead, the summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical testing. The "acceptance criteria" here are implicitly that the new device functions "the same" as or "comparably" to the predicate devices and does not introduce new safety or effectiveness concerns.
| Feature/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Flammability | Device materials should pass flammability tests with various electrosurgery generators, similar to predicate. | "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 Telescoping PenEvac." |
| Smoke Evacuation Function | Function similarly to predicate Telescoping PenEvac. | "The smoke evacuation... functions of the Telescoping PenEvac ABC were essentially the same as the predicate Telescoping PenEvac handpiece..." |
| Electrocautery Pencil Function | Function similarly to predicate Telescoping PenEvac. | "...the electrocautery pencil... functions of the Telescoping PenEvac ABC were essentially the same as the predicate Telescoping PenEvac handpiece..." |
| Argon Beam Coagulator Function | Function similarly to predicate Force GSU handpiece. | "...and the argon beam coagulator functions of the Telescoping PenEvac ABC were essentially the same as... the Force GSU handpiece." |
| Compliance with ANSIAAMI HF-18: 1993 | Complies with applicable portions of the standard. | "The Chief Engineer and/or the manufacturer of the cable/connector/switches tested they comply with the applicable portions of ANSIAAMI HF-18: 1993 Electrosurgical Device standard." (Also notes validation will be performed on production devices). |
| Overall Safety & Effectiveness | No significant changes in safety and effectiveness compared to predicate devices. | "I.C. Medical feels that the Telescoping PenEvac ABC functions the same as the predicate devices and we have not identified any significant changes in safety and effectiveness." |
| Sterility & ETO Residual Levels (for sterile disposable versions) | Same as predicate Telescoping PenEvac. | "The Sterility Assurance Level and the ETO Residual Level will be the same as the predicate Telescoping PenEvac." |
| Reusable Component Sterilization Methods | Compatible with standard sterilization methods (ETO, steam, steris, flash autoclave). | "The reusable PenEvac Body and ABC Adapter may be sterilized by ETO, steam, steris, or flash autoclave up to 134 degrees centigrade." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: Not explicitly stated numerically. The text refers to "Samples of all proposed tip materials" for flammability testing and "a number of different electrosurgery generators and an argon beam coagulator" for bench testing. This suggests a small, representative sample of materials and equipment rather than a statistically powered clinical trial sample.
- Data Provenance: The testing was "bench tested" and "nonclinical." This means the data was generated in a laboratory or engineering environment, not from human subjects. The country of origin is not specified, but the submission is to the FDA (United States). The testing is prospective for this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) summary. The testing described is non-clinical bench testing, not clinical studies involving expert interpretation of medical images or patient outcomes. The "ground truth" for these engineering tests would be derived from physical measurements against established engineering standards or direct comparison to the functional performance of predicate devices. The "Chief Engineer" is mentioned as overseeing some tests, implying engineering expertise.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable to this type of non-clinical bench testing. Adjudication methods are typically used in clinical studies when multiple human observers evaluate data and their interpretations need to be reconciled.
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 an electrosurgical handpiece, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and "improvement with AI" are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical surgical instrument, not an algorithm. Its function inherently involves a human operator (the surgeon).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described:
- Flammability: Ground truth is based on physical flammability characteristics and established safety standards.
- Functional Performance (smoke evacuation, electrocautery, argon beam coagulation): Ground truth is the observed functional output compared to the specifications and performance of the legally marketed predicate devices. This is a direct comparison to known, accepted performance.
- Electrical/Cable Compliance: Ground truth is established by adherence to the ANSI/AAMI HF-18: 1993 Electrosurgical Device standard.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no concept of a "training set" in the context of its development and testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
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K.95020
510(k) Summary of Safety & Effectiveness As Required by 21CFR807.92 I.C. Medical Telescoping PenEvac
K9550xO
510(k) Summary of Safety & Effectiveness As Required by 21CFR807.92
APR - 9 1996
| 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:Date Summary Was Amended:Date Summary Was Amended: | October 25, 1995February 8, 1996March 15, 1996 | |
| Device | Trade Name: | Telescoping PenEvac ABC |
| Common Name: | Argon Beam Coagulator/Electrosurgery Pencilwith Smoke Evacuation Tube, TelescopingTip, and electrode. | |
| Classification Name: | Electrosurgical Device Cutting & CoagulationAccessory(79GEI) | |
| Substantial equivalence to the following: | 1. I.C. Medical Telescoping PenEvac2. Valleylab "Force GSU handset" E2522H |
Description of Telescoping PenEvac ABC Handpiece:
The Telescoping PenEvac ABC is a combination of an argon beam coagulator pencil and an electrosurgery switching handpiece with a smoke evacuation shroud. It is intended to be used with argon beam generators that include electrosurgery capabilities. The device has push button switches to allow the surgeon to select CUT, COAG, or ARGON functions on the generator. An ARGON ASSIST mode can be selected by sliding the tip of the ABC Telescoping Tip back to expose the monopolar electrode.
The device consists of three major components: PenEvac Body, ABC Adapter, and ABC Telescoping Tip. The PenEvac Body contains the pushbutton switches and ESU cord and connector. The ABC Adapter fits into the rear of the PenEvac Body and contains flexible tubing, generator connector, electrical conductor, and a rigid metal tube that fits into the PenEvac Body. The ABC Telescoping Tip is used during open surgical procedures. The tip may be extended or shortened as desired. It also has a sliding tip that can expose, or conceal, the electrode during argon procedures.
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510(k) Summary of Safety & Effectiveness As Required by 21CFR807.92 I.C. Medical Telescoping PenEvac
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 ABC Adapter being reusable and the remainder Two: of the device as a sterile single use product.
The device will also be marketed with two different types of argon beam generator connectors. One will be compatible with Valleylab argon beam coagulator systems and the other with Birtcher argon beam coagulator svstems.
Intended Use of the Telescoping PenEvac ABC Handpiece:
The Telescoping PenEvac ABC is intended to be used only during open surgical procedures as the active handpiece in a combination argon beam coagulator/electrosurgery generator system that uses monopolar electrodes and to facilitate the removal of smoke that is generated.
Summary of Technological Characteristics: Telescoping PenEvac ABC Handpiece/Predicate Device(s)
The Telescoping PenEvac ABC Handpiece is a combination smoke evacuator, electrocautery handswitching pencil, and an argon beam coagulator handpiece. The smoke evacuator and electrosurgery portions are being compared to the I.C. Medical Telescoping PenEvac (K954088) and the argon beam coagulator handpiece portion is being compared to the ValleyLab Force GSU Handset (catalog number E2522H). The Telescoping PenEvac ABC will be marketed in two ways: a) as a completely disposable product b) as a partially reusable product (the PenEvac body with switches, ESU cord, and connector) with disposable sterile accessories. It will also be available with electrical and gas connector plugs to fit Valleylab or Birtcher type argon beam delivery systems.
The sterile disposable products will be sent to the same contract sterilizer who currently provides that function for the I.C. Medical ESU shrouds. The sterilization method has been reviewed and accepted by the FDA during a recent (June 1995) site inspection. The Sterility Assurance Level and the ETO Residual Level will be the same as the predicate Telescoping PenEvac.
The reusable PenEvac Body and ABC Adapter may be sterilized 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.
The Telescoping PenEvac and Telescoping PenEvac ABC feature a monopolar electrode that telescopes along with the smoke evacuator tube to the length desired by the surgeon. Telescoping PenEvac ABC and the Force GSU handset both have telescoping electrodes and a gas delivery system that allows argon to flow along both sides of the electrode. The Telescoping PenEvac ABC and Force GSU both have operating controls that allow selection of the following modes of operation: electrosurgery "cut", electrosurgery "coag", argon assisted.
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510(k) Summary of Safety & Effectiveness As Required by 21CFR807.92 I.C. Medical Telescoping PenEvac
The Telescoping PenEvac ABC, Telescoping PenEvac, and Force GSU handpieces are handswitching monopolar electrosurgery devices. The Telescoping PenEvac ABC and Force GSU also may deliver argon coagulation beams. 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 Telescoping PenEvac ABC will be available with an argon gas tube connector that is compatible with Valleylab Force GSU argon beam coagulation devices and it will also be available with a connector that fits Birtcher argon beam units.
The electrical cord, generator, and switches are being purchased from a manufacturer that supplies these items to other electrosurgical handpiece manufacturers for use in their devices.
The specifications of the Telessoping PenEvac ABC are comparable to the predicate I.C. Medical Telescoping PenEvac and Valleylab Force GSU handpieces.
I.C. Medical feels that the Telescoping PenEvac ABC 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 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 Telescoping PenEvac.
The Telescoping PenEvac ABC was also bench tested with a number of different electrosurgery generators and an argon beam coagulator. The smoke evacuation, electrocautery pencil, and argon beam coagulator functions of the Telescoping PenEvac ABC were essentially the same as the predicate Telescoping PenEvac handpiece and the Force GSU handpiece.
The Chief Engineer and/or the manufacturer of the cable/connector/switches tested they comply with the applicable portions of ANSIAAMI HF-18: 1993 Electrosurgical Device standard. Validation will also be performed on production devices prior to their initial release for compliance to the standard.
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.