(36 days)
Valleylab Disposable Handswitching Pencil, Valleylab Reusable Handswitching encil, I.C. Medical Electrocautery Shroud
Not Found
No
The description focuses on the electrosurgery and smoke evacuation functions, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is described as an electrosurgery generator system combined with a smoke evacuation shroud, intended for use during surgical procedures to cut tissue and remove smoke, rather than to treat or diagnose a disease or condition itself.
No
The device is described as an electrosurgery generator system used to remove smoke during a procedure and facilitate "cut" or "coagulation" operating modes. This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly indicates it is a combination of hardware components (electrosurgery switching handpiece, smoke evacuation shroud, telescoping tip, pushbutton switches, electrodes, cord) and is marketed as a physical product (single use sterile or partially reusable). There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as being used as an active monopolar electrosurgery generator system and to facilitate the removal of smoke generated during the procedure. This is a surgical procedure performed directly on a patient.
- Device Description: The device is described as a combination of an electrosurgery handpiece and a smoke evacuation shroud. These are tools used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing samples taken from the human body. This device is designed for use on the human body during a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
Device Description
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:
One: As a complete single use sterile product.
Two: 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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
- Valleylab Disposable Handswitching Pencil
- Valleylab Reusable Handswitching encil
- I.C. Medical Electrocautery Shroud
Reference Device(s)
Not Found
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
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 Road | |
| Glendale, 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 Smoke | |
| Evacuation Tube and Telescoping Tip, | ||
| and electrodes | ||
| Classification Name: | GEI: Device, Electrosurgical, Cutting & | |
| Coagulating, & Accessories | ||
| Substantial equivalence to the following: | 1. Valleylab Disposable Handswitching | |
| Pencil |
- Valleylab Reusable Handswitching encil
- 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.
1
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.
2
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.