(32 days)
Not Found
Not Found
No
The device description details a purely mechanical and electrical electrosurgical device with no mention of computational processing, algorithms, or data analysis.
Yes
The device is used to control bleeding through suction and cautery, which are therapeutic actions.
No
The device is described as a monopolar electrosurgical device used to control bleeding through suction and cautery, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical components such as a cannula, handle, suction hose fitting, power cord, and push button, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The described device is a surgical tool used directly on the patient's body during a procedure. It uses suction and cautery to control bleeding.
- Intended Use: The intended use clearly states it's "For use with electrosurgical generators... to control bleeding through the use of suction and cautery." This is a therapeutic and surgical function, not a diagnostic one performed on a specimen.
The device is an electrosurgical instrument used for surgical procedures, not for in vitro diagnostic testing.
N/A
Trade Name
A&E MEDICAL FTC ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATION SWITCH
Common Name
FINGER TIP CONTROL ELECTROCAUTERY SUCTION TUBE
Classification Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (PER 21 CFR 878.4400)
Intended Use / Indications for Use
For use with electrosurgical generators that have the accessory finger tip activation feature to control bleeding through the use of suction and cautery.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The monopolar electrosurgical device consists of an electrically conducting cannula which has plastic electrical insulation on it's exterior surface. This cannula fits into a plastic handle that has a central axial passage in line with the suction hole of the cannula. This suction hole leads to a suction hose fitting molded into the aft end of the handle. During use a hose connected to an external suction source is connected to the handle's suction fitting to provide suction to the cannula. A bleed hole in the handle allows the surgeon to control the amount of suction with his fingertip. High frequency power is supplied to the device through a 10 foot long power cord which enters the aft end of the handle and is internally connected to the cannula and switching circuitry. The distal end of the power cord has a standard plug that fits into most electrosurgical generators that have the accessory fingertip control option. The surgeon activates the cautery tip by pressing a push button located near the suction bleed hole.
The new device will be marketed in cannula french size 10 with a 6 inch length.
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
Surgeon, hospital setting (implied by content related to electrosurgery and patient safety).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 2 0 1996
510(K) SUMMARY FOR A&E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON (AS REQUIRED BY 21 CFR 807.92c and SMDA 1990)
ALTO DEVELOPMENT CORPORATION SUBMITTER: 5206 ASBURY ROAD FARMINGDALE, NJ 07727
908-938-2266 908-938-2399 FAX
(
CONTACT: MICHAEL T WOJCIECHOWICZ DATE: NOVEMBER 12,1996 ( Amended 11/27/96, 12/3/96, 12/12/96 )
1
| TRADE NAME: | A&E MEDICAL FTC ELECTROCAUTERY
SUCTION TUBE WITH FINGER TIP ACTIVATION
SWITCH |
|----------------------|-------------------------------------------------------------------------------------|
| COMMON NAME: | FINGER TIP CONTROL ELECTROCAUTERY
SUCTION TUBE |
| CLASSIFICATION NAME: | ELECTROSURGICAL, CUTTING &
COAGULATION & ACCESSORIES
(PER 21 CFR 878.4400) |
EQUIVALENT DEVICES:
1.VALLEYLAB ELECTROVAC II MODEL E2610-6 MARKETED BY VALLEYLAB INC. BOULDER, CO
- A&E MEDICAL ELECTROCAUTERY SUCTION TUBE MODEL 050-005 MARKETED BY ALTO DEVELOPMENT CORPORATION, FARMINGDALE, NJ
DEVICE DESCRIPTION: The monopolar electrosurgical device consists of an electrically conducting cannula which has plastic electrical insulation on it's exterior surface. This cannula fits into a plastic handle that has a central axial passage in line with the suction hole of the cannula. This suction hole leads to a suction hose fitting molded into the aft end of the handle. During use a hose connected to an external suction source is connected to the handle's suction fitting to provide suction to the cannula. A bleed hole in the handle allows the surgeon to control the amount of suction with his fingertip. High frequency power is supplied to the device through a 10 foot long power cord which enters the aft end of the handle and is internally connected to the cannula and switching circuitry. The distal end of the power cord has a standard plug that fits into most electrosurgical generators that have the accessory fingertip control option. The surgeon activates the cautery tip by pressing a push button located near the suction bleed hole.
The new device will be marketed in cannula french size 10 with a 6 inch length
For use with electrosurgical generators that have the accessory finger INTENDED USE: tip activation feature to control bleeding through the use of suction and cautery.
2
. ...
2
510(K) SUMMARY
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE DEVICES:
| Similarities/ Differences
| (Differences in Bold Type) | 510(K) Device | VL E2610-6 | A&E 050-005 |
|---|---|---|---|
| 1. Cannula size/length........ |
- Cannula insulation material..
- Cannula tube material........
- Suction bleed control vent .....
- Suction port size........ | 10 French,6 inches
Polyolefin/.025 in.
Brass
Yes, .120x.250 in.
1/4" tubing | 10 French, 6 inches
Polyolefin/.025 in.
ALUMINUM
Yes, .115x.350 in.
1/4" tubing | 10 French, 6 inches
Polyolefin/.025 in.
Brass
Yes, .120x.250 in
1/4" tubing |
| 5. In handle, suction vent isolated
from fluid path........ - Handle material........
- Wire cord insulation........
- Wire terminal(ESU connector) ..
- Energy source (Monopolar ESU)..
- Electrode tip design........
- Mode of operation......... | Yes
Polystyrene
PVC
Standard .125 dia.
Yes
.060 in. bare tip
Push button
activation | Yes
Polystyrene
POLYOLEFIN
Standard .125 dia.
Yes
.120 in. bare tip
Push button
activation | Yes
Polystyrene
PVC
Standard .125 dia.
Yes
.060 in. bare tip
foot petal
activation |
| 12.Push button location........
13.Push button circuitry........
14.Indications........
15.Insulating Materials........ | Near bleed hole | Near bleed hole
Identical to 510(K)
SEE ITEM 7 | NONE
NONE
Identical to 510(K)
Identical to 510(K) |
| 16.Overall length........
17.Electrosurgical effect........
18.Cleaning Stylet........ | 10.75 in. | 10 in. | 10.75 in.
Identical to 510(K)
.070 dia./polystyrene |
SAFETY AND EFFECTIVENESS STATEMENT FOR ELECTROSURGICAL DEVICES
The effectiveness and safety of electrosurgery as a cutting and coagulation method is extensively documented and well known. The hazards of electrosurgery are similarly well known and documented. The attached bibliography provides in depth information regarding the safety, effectiveness and hazards of electrosurgery.
Generally the hazards can be identified as patient /user burns or electrical interference with an electric device such an implanted pacemaker. In addition, as electrosurgery creates a spark, flammable gases or materials could ignite.
Overwhelmingly, the majority of burns are a result of a ground fault in the patient/dispersive electrode/generator return current pathway. As the current finds an alternate path to ground (through the table, ECG lead, towel clip, etc.), it concentrates at this area causing a burn. the severity of the burn depends upon the time of exposure to the current. Improper attachment of
3
510(K) SUMMARY
the dispersive electrode to the patient is the most common cause of ground fault burns. Additionally, these types of burns can also occur from a defective return circuit in the generator, a defective dispersive electrode, or user error in the system set up. The subject product of this 510(K) notification can not contribute to ground fault type burns.
Less frequently, burns occur as a result of an activated active electrode contacting electrically conductive instruments of equipment. In these cases, the electrosurgical effect is transmitted along the conductive pathway to unintended locations. Even though the active electrode is involved in these instances, contact with the instruments or equipment is required. This contact occurs accidentally by the user and is not device related.
The current interference with electronic equipment occurs when the dispersive electrode is positioned in such a way that the current pathway through the patient crosses over the equipment. Placing the dispersive electrode in a location which prevents the current flow from crossing over the electronic equipment will avoid the interference. the dispersive electrode placement is totally user dependent and unrelated to the subject device.
Specific hazards associated with the subject 510(K) device would involve insufficient materials and design to safely carry the current without leakage or switch anomalies could cause unintended activation of the current. However, as electrosurgery is so common, an industry standard has been developed to ensure the safety of all components of a electrosurgical system. This Standard, ANSI/AAMI HF18-1993 defines the parameters, tests and requirements needed to assure the safety of electrosurgical system components. The subject device of this 510(K) notification meets all applicable requirements of this standard.
4
510(K) SUMMARY
BIBLIOGRAPHY OF ARTICLES SUPPORTING THE SAFETY AND EFFECTIVENESS OF ELECTROSURGERY
-
- Church & Hamlin, Electrosurgery Demands or Vigilance, AORN Journal, Dec. 1075, Vol. 22. No 6.
-
- Boughton & Spencer, Electrosurgical Fundamentals, Journal American Academy Dermatology, 1987, Vol 16, pgs. 862 to 867.
-
- Moak, Electrosurgical Unit Safety, AORN Journal, March 1991, Vol.53, No. 6.
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- Neufeld, Principles & Hazards of electrosurgery Including Laparascopy, Surgery, Gynecology & Obstetrics, Nov. 1978. Vol. 147.
- ર) Recommended Practices - Electrosurgery, AORN Journal, April 1991, Vol. 53, No. 4.
- ୧) Emergency Care Research Institute, Electrosurgical Units, Technology for Surgery, Nov, 1987, Vol. 8.
-
- Schellhammer, Electrosurgery: Principles, Hazards, & Precautions, Urology, Mar. 1974, Vol. 3.
-
- Emergency Care Research Institite, Update: Controlling the Risks of Electrosurgery, Technology For Surgery, Jan. 1990, Vol. 10.
-
- Oearce, Current Electrosurgical Practice: Hazards, Journal of Medical Engineering and Technology, Jan 1990, Vol 10.
-
- Sebben, Electrosurgery & Cardiac Pacemakers, Journal American Academy Dermatology, 1983, Vol. 9.
-
- Battig, Electrosurgical Burn Injuries and Their Prevention, Journal American Medical Association, June 1968, Vol. 204