The ERBE APC 300 Argon Plasma Coagulator is an argon gas delivery system that is designed for coagulation when used in combination with ERBE ICC Electrosurgery Generators and ERBE APC Probes.

Device Description

The APC 300 is a table-top device which allows for placement of an ERBE ICC Generator on its top cover. The front panel of the device provides access to and viewing of all controls and indicators. The device is designed to interface with APC flexible applicator probes. The device automatically sets a fixed argon gas flow to match the inner diameter of the three available flexible probes. The rate of gas flow for each flexible probe is as follows: 1.5 mm -0.1 I/min to 0.5 I/min, 2.3 mm - 0.5 I/min to 2.4 I/min, 3.2 mm - 0.6 I/min to 5.0 I/min. The flow rates are also adjustable up to 9 I/min by accessing a special program via a "Program" button on the front panel, and utilizing an appropriately sized (diameter) probe to safely allow the flow rate desired.

There are two connections on the front panel, one for argon gas flow to a probe, the other for activation, either from a foot pedal or a finger-control handpiece. There is also a purge button on the front panel. A cable is provided on the rear panel of the device to be connected to the electrosurgical generator foot pedal control input.

There are inputs for two argon gas cylinders on the rear panel. Argon gas level, flow rate, operating and program information is indicated via liquid crystal display on the front panel. Gas cylinder changeover is automatic. The APC 300 Accessory Cart has four wheels (2 locking), a hospital grade power strip, storage shelf, and a compartment for two argon gas cylinders.

AI/ML Overview

The provided text is a 510(k) summary for the ERBE APC 300 Argon Plasma Coagulator and Accessories. It outlines the device's description, intended use, and comparison to predicate devices, and discusses non-clinical tests. However, it explicitly states "Not Applicable" under "Discussion of Clinical Tests Performed."

Therefore, based on the provided document, the following information regarding acceptance criteria and a study proving device performance cannot be provided:

A table of acceptance criteria and the reported device performance: No clinical performance criteria or results are mentioned.
Sample size used for the test set and the data provenance: No clinical test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set exists.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set exists.
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. The device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. The device is a medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical study is described.
The sample size for the training set: Not applicable as no AI/machine learning model is being developed or described.
How the ground truth for the training set was established: Not applicable as no AI/machine learning model is being developed or described.

The document focuses on demonstrating substantial equivalence through non-clinical tests (electrical and mechanical results) and adherence to FDA guidance documents and applicable standards.

Specifically, it states:

Non-Clinical Tests: "Testing information demonstrating safety and effectiveness of the ERBE APC 300 and APC Probe in the intended environment of use is supported by testing that was conducted in accordance with the FDA October 1993 Draft '510(k) Guideline for General Surgical Electrosurgical Devices', which outlines performance requirements."
Standards Adherence: "We certify that the ERBE APC 300 Argon Plasma Coagulator is designed to meet all applicable requirements of the ANSI/AAMI HF-18/1993 American National Standard for Electrosurgical Devices, as well as IEC 601-1-2."

In summary, the provided text does not contain information about clinical acceptance criteria or studies involving human subjects or AI performance. It bases its claim of safety and effectiveness on non-clinical engineering and performance testing in adherence to established regulatory guidelines and industry standards for electrosurgical devices.

Summary

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K963189

Image /page/0/Picture/1 description: The image shows the logo for ERBE USA Incorporated Electrosurgical Equipment. The word "ERBE" is in large, bold, sans-serif font at the top. Below that, "USA INCORPORATED" is in a smaller, sans-serif font, and below that, "Electrosurgical Equipment" is in a similar font.

EXHIBIT #1 Page 1 of 3

NOV 26 1996

2225 Northwest Parkway Suite 105 Marietta, GA 30067 Tel. (770) 955-4400 Tel. (800) 778-3723 Fax (770) 955-2577

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _

Submitter's Identification: 1.

Mr. Donovan G. Hunter Vice President, Marketing ERBE USA Inc. 2225 Northwest Parkway Suite 105 Marietta, Georgia 30067 TEL: 770-955-4400 FAX: 770-955-2577

August 12, 1996 Date Summary Prepared:

2. Name of the Device:

ERBE APC 300 Argon Plasma Coagulator and Accessories (APC probe for flexible endoscopes)

3. Predicate Device Information:

Beamer 1/2/4/6/8, K#903724 manufactured by Beacon Laboratories, Inc.; and Beacon B-101 Laparoscopic Switching Disposable Hand Piece, K#894762, manufactured by Beacon Laboratories, Inc.

4. Device Description:

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EXHIBIT #1 Page 2 of 3

argon gas flow to match the inner diameter of the three available flexible probes. The rate of gas flow for each flexible probe is as follows: 1.5 mm -0.1 I/min to 0.5 I/min, 2.3 mm - 0.5 I/min to 2.4 I/min, 3.2 mm - 0.6 I/min to 5.0 I/min. The flow rates are also adjustable up to 9 I/min by accessing a special program via a "Program" button on the front panel, and utilizing an appropriately sized (diameter) probe to safely allow the flow rate desired.

There are inputs for two argon gas cylinders on the rear panel. Argon gas level, flow rate, operating and program information is indicated via liquid crystal display on the front panel. Gas cvlinder changeover is automatic. The APC 300 Accessory Cart has four wheels (2 locking), a hospital grade power strip, storage shelf, and a compartment for two argon gas cylinders.

5. Intended Use:

The ERBE APC 300 Argon Plasma Coagulator is an argon gas delivery system that is designed for coagulation when used in combination with ERBE ICC Electrosurgery Generators and ERBE APC Probes.

6. Comparison to Predicate Devices:

Intended use for both devices is coagulation using pure argon. Gas flow rates are both automatic and adjustable, using both foot pedals and hand controls for activation. There are more standard indicators with the APC 300 and only a "gas flow" indicator for the program menu with the Beamer. The APC 300 applicator probe is flexible, whereas the Beamer utilizes a rigid probe.

The APC applicator probe is similar to Beacon's B-101 Laparoscopic Switching Disposable Hand Piece; the Beacon product is rigid and hand or foot switching and the APC probe is flexible and foot switching. Both devices provide a conduit to deliver argon gas from the machine to the patient.

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EXHIBIT #1 Page 3 of 3

Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the ERBE APC 300 and APC Probe in the intended environment of use is supported by testing that was conducted in accordance with the FDA October 1993 Draft "510(k) Guideline for General Surgical Electrosurgical Devices", which outlines performance requirements.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.

We certify that the ERBE APC 300 Argon Plasma Coagulator is designed to meet all applicable requirements of the ANSI/AAMI HF-18/1993 American National Standard for Electrosurgical Devices, as well as IEC 601-1-2.

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

We have demonstrated that the ERBE APC 300 Argon Plasma Coagulator and Accessories is as safe and effective as predicate devices presently on the market, based on electrical and mechanical results, as well as FDA quidance document criteria.

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.