(159 days)
K/DEN number: Not Found
No
The device description and performance studies focus on the mechanical and electrical functions of the device for electrosurgery and argon beam coagulation, with no mention of AI or ML.
Yes
The device is used in open surgical procedures to perform electrosurgery and argon beam coagulation, both of which are therapeutic interventions.
No
This device is used for surgical procedures like electrosurgery and argon beam coagulation, which are therapeutic and not diagnostic functions. It is used to remove smoke generated during these procedures, which is also a therapeutic support function.
No
The device description clearly outlines physical components (PenEvac Body, ABC Adapter, ABC Telescoping Tip) and their functions, indicating it is a hardware device with electromechanical capabilities, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use during open surgical procedures as an active handpiece in a combination argon beam coagulator/electrosurgery generator system. This describes a device used directly on a patient during surgery, not a device used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a surgical handpiece with functions for coagulation, cutting, and smoke evacuation. This aligns with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, diagnostic tests, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Telescoping PenEvac ABC is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
79GEI
Device Description
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.
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 ABC Adapter being reusable and the remainder 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 systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
I.C. Medical Telescoping PenEvac, Valleylab "Force GSU handset" E2522H
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Road | |
| Glendale, 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, 1995 | |
| February 8, 1996 | ||
| March 15, 1996 | ||
| Device | Trade Name: | Telescoping PenEvac ABC |
| Common Name: | Argon Beam Coagulator/Electrosurgery Pencil | |
| with Smoke Evacuation Tube, Telescoping | ||
| Tip, and electrode. | ||
| Classification Name: | Electrosurgical Device Cutting & Coagulation | |
| Accessory | ||
| (79GEI) | ||
| Substantial equivalence to the following: | 1. I.C. Medical Telescoping PenEvac |
- 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.
1
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.
2
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.