For use with electrosurgical generators that have the accessory finger tip activation feature to control bleeding through the use of suction and cautery.

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.

AI/ML Overview

The provided text is a 510(k) summary for an electrosurgical suction tube. It describes the device, its intended use, and compares it to predicate devices. However, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement in a performance study.

Instead, the document focuses on the general safety and effectiveness of electrosurgery, referencing a bibliography of articles. It states that the device "meets all applicable requirements of this standard" (ANSI/AAMI HF18-1993) to assure safety, but it does not provide specific acceptance criteria or data from tests conducted on this particular device to demonstrate that it meets the standard. It implies that due to the well-documented nature of electrosurgery, detailed performance studies for this specific device are not being presented in the summary.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets and data provenance.
Number of experts and their qualifications for ground truth.
Adjudication method for the test set.
MRMC comparative effectiveness study details.
Standalone performance study details.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

The document is a submission for a 510(k) premarket notification, which often relies on demonstrating substantial equivalence to a predicate device rather than extensive new clinical efficacy or performance studies. The safety and effectiveness claims are broadly supported by the established knowledge and standards for electrosurgery, rather than specific studies on this individual device's performance against defined acceptance criteria.

Summary

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K964621

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 )

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TRADE NAME:	A&E MEDICAL FTC ELECTROCAUTERYSUCTION TUBE WITH FINGER TIP ACTIVATIONSWITCH
COMMON NAME:	FINGER TIP CONTROL ELECTROCAUTERYSUCTION 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.

. ...

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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........2. Cannula insulation material..3. Cannula tube material........3. Suction bleed control vent .....4. Suction port size........	10 French,6 inchesPolyolefin/.025 in.BrassYes, .120x.250 in.1/4" tubing	10 French, 6 inchesPolyolefin/.025 in.ALUMINUMYes, .115x.350 in.1/4" tubing	10 French, 6 inchesPolyolefin/.025 in.BrassYes, .120x.250 in1/4" tubing
5. In handle, suction vent isolatedfrom fluid path........6. Handle material........7. Wire cord insulation........8. Wire terminal(ESU connector) ..9. Energy source (Monopolar ESU)..10. Electrode tip design........11. Mode of operation.........	YesPolystyrenePVCStandard .125 dia.Yes.060 in. bare tipPush buttonactivation	YesPolystyrenePOLYOLEFINStandard .125 dia.Yes.120 in. bare tipPush buttonactivation	YesPolystyrenePVCStandard .125 dia.Yes.060 in. bare tipfoot petalactivation
12.Push button location........13.Push button circuitry........14.Indications........15.Insulating Materials........	Near bleed hole	Near bleed holeIdentical to 510(K)SEE ITEM 7	NONENONEIdentical 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

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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.

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510(K) SUMMARY

BIBLIOGRAPHY OF ARTICLES SUPPORTING THE SAFETY AND EFFECTIVENESS OF ELECTROSURGERY

1. Church & Hamlin, Electrosurgery Demands or Vigilance, AORN Journal, Dec. 1075, Vol. 22. No 6.
1. Boughton & Spencer, Electrosurgical Fundamentals, Journal American Academy Dermatology, 1987, Vol 16, pgs. 862 to 867.
1. Moak, Electrosurgical Unit Safety, AORN Journal, March 1991, Vol.53, No. 6.
1. 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.
1. Schellhammer, Electrosurgery: Principles, Hazards, & Precautions, Urology, Mar. 1974, Vol. 3.
1. Emergency Care Research Institite, Update: Controlling the Risks of Electrosurgery, Technology For Surgery, Jan. 1990, Vol. 10.
1. Oearce, Current Electrosurgical Practice: Hazards, Journal of Medical Engineering and Technology, Jan 1990, Vol 10.
1. Sebben, Electrosurgery & Cardiac Pacemakers, Journal American Academy Dermatology, 1983, Vol. 9.
1. Battig, Electrosurgical Burn Injuries and Their Prevention, Journal American Medical Association, June 1968, Vol. 204

Regulation Number and Section

§ 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.