The APC Integrated Filter Probes are intended for use in Argon Plasma Coagulation (APC). The devices are used to treat many conditions in endoscopy for various surgical procedures.

Device Description

The APC Integrated Filter Probes incorporate a filter similar to the APC Membrane Filter and the hose (specifically the length) of an APC Connector Hose into one device. The Probes are flexible. They are provided in various lengths, diameter sizes, and tip configurations to accommodate the various size/types of endoscopes for a variety of applications (i.e., the treatment of various target tissues inside a patient). The working lengths of the APC Integrated Filter Probes are 4.9ft. (1.5m) to 9.8ft. (3m). The working diameters of the Probes are 4.5 French (1.5mm) to 9.6 French (3.2mm). The Probes have either an axial (straight fire), lateral (side fire), or circumferential opening allowing the energy to be delivered straight, at a 45 to 90 degree angle, or directly to target tissue regardless of the probe's position. The three types of openings for the APC Integrated Filter Probes allow the physician a choice in the direction or the option not to have to consider the direction (just proximity) of delivering the argon plasma to the treatment site which is based upon tissue resistance.

The APC Integrated Filter Probe Adapter is a flexible connecting cable. It connects the APC Integrated Filter Probe to an ERBE Argon Plasma Coagulator. The Adapter is a conduit for both electrosurgical current and argon gas. It is approximately 13-1/2" in length.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (ERBE APC Integrated Filter Probes and Adapter). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a novel device meets specific acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding acceptance criteria, extensive studies, sample sizes, expert ground truth, MRMC studies, and standalone performance is not typically found or required in a 510(k) submission of this nature.

However, based on the document, I can provide information on what was verified/validated to show the device is safe and effective and substantially equivalent to its predicate.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical trial or performance study. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device. The performance is assessed by confirming that the modified device functions similarly to the predicate and that modifications do not raise new safety or efficacy concerns.

The core "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Implicit Acceptance Criteria and Reported Device Performance (based on substantial equivalence claims):

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (from the 510(k))
Functional Equivalence: Performs like the predicate.	Probes: "The APC Integrated Filter Probes have the same performance, working dimensional and tip specifications... as the predicate APC Probes. The Integrated Filter Probes incorporate a filter similar to and performs like the predicate APC Membrane Filter."Adapter: "The [Adapter's] performance was validated via Recognized Standards."
Material Biocompatibility: No new biocompatibility issues.	Probes: "All added or modified materials... were evaluated for biocompatibility with no problem found." "The materials were found via validation testing and the materials are biocompatible."Adapter: "Biocompatibility testing was not necessary because the Adapter doesn't come in contact with the patient."
Sterilization Efficacy: Maintains sterility.	Probes: "The sterilization cycle has been validated."
Structural Integrity & Safety: No new safety/efficacy concerns from modifications.	Probes: "The structural modifications of changing the connector end didn't raise any safety or efficacy issues." "No negative impact was found with the dimensional modification of installing a filter." "The filter... was found to be sufficient in keeping backflow fluid from reaching the Adapter or Coagulator."Adapter: "No safety or efficacy concerns for the Adapter." "Found to function properly through validated testing and using Recognized Standards."
Instrument Recognition System Functionality: Correctly communicates with coagulator.	Probes: "Instrument recognition system. If attached directly... Coagulator recognizes the Probe diameter size and automatically sets conservative default settings." (EPROM-based is more specific and recognized "in real-time").Adapter: "The Adapter has a resistor instrument recognition system. If the Adapter is used, it overrides specific probe recognition... no safety or efficacy issues are expected because the Adapter's resistor sets the lowest/most conservative default settings."

Study Details Not Provided (typical for 510(k) premarket notifications)

The document is a 510(k) summary, not a clinical study report. Therefore, it does not contain the following information as these are generally not required for substantial equivalence claims of this nature, especially for Class II accessories to an existing system:

Sample size used for the test set and the data provenance: Not applicable or provided. Performance was demonstrated through "validation testing" and adherence to "Recognized Standards," but specific sample sizes for these tests are not detailed. These are likely internal engineering and bench tests, not large-scale clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would relate to clinical outcomes, which were not directly assessed through clinical trials for this 510(k).
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrosurgical accessory, not an AI-driven diagnostic or treatment planning tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device accessory.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's safety and effectiveness relies on its performance against engineering specifications, biocompatibility standards, and functional equivalence to its predicate, rather than clinical outcomes data from a de novo study.
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Approach in the 510(k):

The manufacturer relied on the following to demonstrate substantial equivalence:

Bench Testing and Validation: "Functionality and reliability of the Probes were demonstrated through validation testing using Recognized Standards."
Biocompatibility Testing: "All added or modified materials... were evaluated for biocompatibility with no problem found."
Sterilization Validation: "The sterilization cycle has been validated."
Predicate Comparison: Detailed comparison of materials, dimensions, intended use, performance specifications, and other characteristics to legally marketed predicate devices, highlighting similarities and explaining differences.
Risk Analysis: Stating that modifications "didn't raise any safety or efficacy issues" and "no negative impact was found."
Design Controls: Stating, "All the changes have been verified or validated in design control."

In essence, the "study" for this 510(k) involved engineering verification and validation, materials testing, and a comprehensive comparison to established predicate devices, rather than a clinical trial with acceptance criteria for patient outcomes.

Summary

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EB 1 6 2006 26018:

510K SUMMARY

Submitted By:

ERBE USA. Inc. 2225 Northwest Parkway Marietta, GA 30067

Tel: 770-955-4400 Fax: 770-955-2577

John Tartal Contact Person:

01/23/06 Date Prepared:

Argon Plasma Coagulation (APC) Integrated Filter Probes Common Name: and Adapter

ERBE APC Integrated Filter Probes and Adapter Trade/Proprietary Name:

and device and coagulation Electrosurgical cutting Classification Name: accessories (21CFR878.4400)

GEI Product Code:

Legally Marketed Device: APC Connector Hose and Probes submitted in the ERBE 510(k) Number K013348 as well as APC Membrane Filter (as an Accessory) in ERBE 510(k) Number K024047

The APC Integrated Filter Probes and Adapter are being submitted in this Note: premarket notification are modified from the accessories in the above 510(k)s. The modifications were determined to require a 510(k) submission.

Device Description:

The APC Integrated Filter Probes incorporate a filter similar to the APC Membrane Filter and the hose (specifically the length) of an APC Connector Hose into one device. See Section IV, Appendix 1, Product Pictures (IV-2). The Probes are flexible. They are provided in various lengths, diameter sizes, and tip configurations to accommodate the various size/types of endoscopes for a variety of applications (i.e., the treatment of various target tissues inside a patient). The working lengths (i.e., the segment of the Probe that would go down a scope) of the APC Integrated Filter Probes are 4.9ft. (1.5m) to 9.8ft. (3m). The working diameters of the Probes are 4.5 French (1.5mm) to 9.6 The Probes have either an axial (straight fire), lateral (side fire), or French (3.2mm). circumferential opening allowing the energy to be delivered straight, at a 45 to 90 degree angle, or directly to target tissue regardless of the probe's position. The three types of openings for the APC Integrated Filter Probes allow the physician a choice in the direction or the option not to have to consider the direction (just proximity) of delivering the argon plasma to the treatment site which is based upon tissue resistance.

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K060183

Page 2 of 5

Note: Since the last 510(k), two (2) additional APC Probes became apart of the product Note: "Since the last of of(i), two (=) ticant. One involved a different outer diameter and line. The modificulture were within the ranges of dimensions that were already included in approved Probes. The other involved modifying the tip of a side fire probe included in application. Besides the modification to the tip shape, the bonding for circumici application. "Backlower, the material difference in the tip did not raise any biocompatibility issues.

For each Probe, the blue connector/filter end is made of plastics (including the ron Cath Probo, the brass contact pins coated with nickel. The filter is 0.45 µm and mombrane filter) was a Coagulator (the Equipment) from contamination if there is a protote the Arger. I have other fluid contaminant. The hose part of the Probe is made of baoklow of brood of any the tube portion of the Probe is made of polyurethane, PTFE rond a stainless steel wafer shape electrode close to the tip for terminating electrical current. Various glues/adhesives are used to secure all of the Probe's parts. Ceramic tips are bonded on the APC Integrated Filter Side Fire and Circumferential Probes. Functionality and reliability of the Probes were demonstrated through validation testing using Recognized Standards. All added or modified materials in the APC Integrated Filter Probes were evaluated for biocompatibility with no problem found (See Section III, Biocompatibility, III-10 to III-19).

The APC Integrated Filter Probes are provided sterile by means of ethylene oxide and are disposable (Single Use) [Note: The sterilization cycle has been validated. See Section III, Sterilization Information, III-20.].

The APC Integrated Filter Probe Adapter is a flexible connecting cable. See Section IV, Appendix 1, Product Pictures (IV-3). It connects the APC Integrated Filter Probe to an ERBE Argon Plasma Coagulator. The Adapter is a conduit for both electrosurgical current and argon gas. It is approximately 13-1/2" in length. The connector ends of the Adapter are made of plastics. The cable portion of the Adapter is silicone. The Adapter's performance was validated via Recognized Standards. The APC Integrated Filter Probe Adapter is provided non-sterile and is reusable (Note: The Adapter only needs to be externally cleaned/disinfected unless it is contaminated.).

The APC Integrated Filter Probes and Adapter are accessories of the ERBE Argon Plasma Coagulator Models APC 300 and APC 2 [Note: The Coagulator is used with an associated ERBE ElectroSurgical Unit (ESU)]. The APC Integrated Filter Probe Adapter attaches to gas as well as electrical inputs of the Coagulator and then to an APC Integrated Filter Probe [Note: It is possible to connect an APC Integrated Filter probe directed to ERBE Coagulator APC 2 Model if it has an FiAPC Receptacle). An endoscope is manipulated inside the patient to locate tissue that requires treatment. Upon finding the target tissue, the Probe is threaded into the working channel of the endoscope, until the tip of the APC Integrated Filter Probe slightly protrudes from the end of the scope. The opening of the Probe is positioned towards/in close proximity of the area to be treated (Note: The APC Integrated Filter Probes have depth marker rings close to the tip for positioning purposes.). The APC/ESU system is activated via a

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K060183

Page 3 of (5)

footswitch. When high frequency voltage reaches the critical level and the proximity to tissue is close enough, electrically conductive argon plasma forms in the gas stream. tissue is close chough, colochiany contractly contract of the tissue. Current density upon Trills allows the burrent to how asses coagulation. The application of the energy to the tissue is uniform and contact free.

Intended Use:

The APC Integrated Filter Probes are intended for use in Argon Plasma Coagulation (APC). The devices are used to treat many conditions in endoscopy for various surgical procedures.

Note: The APC Integrated Filter Probe Adapter is just the attachment piece to connect Note: "The Ar of the Probe to an ERBE Coagulator Model APC 300. The Adapter is only needed for the ERBE APC 2 Model if a FiAPC Receptacle is not installed.

Similarities and Differences of the Modified Device to the Current Device (Predicate Comparison/Substantial Equivalence):

APC Integrated Filter Probes and Adapter

Similarities

The APC Integrated Filter Probes have the same performance, working dimensional and tip specifications (i.e., working diameter and lengths as well as tip configurations), intended use, labeling, and packaging specifications as the predicate APC Probes. The Interabled Filter Probes incorporate a filter similar to and performs like the predicate APC Membrane Filter. Also like the predicates, the Filter Probes are provided sterile by ethylene oxide and are single use. Furthermore, the hose length of the APC Integrated Filter Probes is the same as the APC Connector Hose. Like the predicate Integrated the APC Integrated Filter Probes have an instrument recognition system. If attached directly into an ERBE Argon Plasma Coagulator Model APC 2 via an FiAPC receptacle, the Coagulator recognizes the Probe diameter size and automatically sets conservative default settings.

The APC Integrated Filter Probe Adapter is basically the connectors of the APC Connector Hose. The connectors that attach to an ERBE Coagulator are the same as the connectors on the APC Connector Hose. The APC Integrated Filter Probe Adapter has the same type of materials (plastics and silicone), performance specifications, intended use, labeling, and packaging specifications as the predicate APC Connector Hose. Also like the predicate, it is provided non-sterile and is reusable.

Differences

The APC Integrated Filter Probes have a different connector end as well as incorporates a filter and length of hose (Note: Due to having the filter at the end of the Probes. the connector was modified. This was also done so that it only fits its designated Adapter.). The structural modifications of changing the connector end didn't

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K060183

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raise any safety or efficacy issues. The connector fits snugly on the designated Adapter raise any saicty of emodor locator). Also no negative impact was found with the (f.e., the condunt to the ERDE obagana filter and the hose in the Probes. The filter in the diffiensional modification of installing a filter stand alone APC Membrane Filter size being 0.2 I robe is 0.45 pm as ound to be sufficient in keeping backflow fluid from pin. The farger port of Coachator. The slight materials changes (i.e., in plastics, the readling the Nadptor or Sougalaton be acceptable in producing a functionally reliable dror in grace/ nore recognition system in the APC Integrated Filter Probes are Probe. chipped (EPROM) based as compared to the predicate APC Probes which are chipped (LI (Chi) based as semped based recognition system is more specific and recognized 'na rolletereration. Finally; slightly different plastics, metals, and adheswes can provide more information. This and Membrane Filter, Probes, and Connector Hose. The materials were found via validation Membrano Filter Recognized Standards to work well in the APC Integrated Filter testing and the materials are biocompatible. See Section III, Biocompatibility and Summary of Design Control Activities.

The APC Integrated Filter Probe Adapter is different that the APC Connector Hose in that it doesn't have the hose portion and the connector to the Probe was modified so it only attaches to the APC Integrated Filter Probes. The dimensional modification of not having the hose portion and the structural modification to the end that connects to the neving the need portions any safety or efficacy concerns for the Adapter. The APC Integrated Filter Probe Adapter connects snugly to the Filter Probes. It was also found to function properly through validated testing and using Recognized Standards. The Adapter is also different that the predicate APC Connector Hose in that the Adapter has a resistor instrument recognition system. If the Adapter is used, it overrides specific probe recognition. However, no safety or efficacy issues are expected because the Adapter's resistor sets the lowest/most conservative default settings (i.e., gas flow and wattage) on an ERBE Coagulator. As a result for the Probe being used, the settings adiustments on the ERBE Coagulator would only be upward. Setting maximums for the gas flow rate and wattage are specified for each APC Probe in the Notes On Use (NOU) for the Probes. In the "How to Use" section of the NOU, the user is also directed to setting limitations and instructed not to exceed maximums for the APC Probe being used. If the gas flow rate limit is appreciably exceeded when using the Adapter and the smallest diameter APC Probe, then the Coagulator errors preventing activation. With the Adapter and the largest diameter APC Probe the maximum gas flow rate is limited: however, no problem with in the clinical environment is expected. Typically, desired settings are established during test firing of the Probe. Therefore, no problems in regards to not having specific probe recognition are expected. Biocompatibility testing was not necessary because the Adapter doesn't come in contact with the patient.

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K060 183

Image /page/4/Picture/1 description: The image shows the handwritten words "Page 5 of 5". The word "page" is written in cursive, and the numbers are written in a more standard font. The last number 5 is circled.

Note: Incorporating the filter in the Probes eliminates the need to reprocess the Adapter Note. Incorporating the meet in the APC Connector Hose because backflow between "Sacob" and reach the Adapter or Coagulator.

All the changes have been verified or validated in design control.

Conclusion:

The APC Integrated Filter Probes and Adapter have the same intended use, principles The AFC Integration, and technological characteristics as the accessories in the previously of operation, and technological onations were found to have a cicaled predioute action. The APC Integrated Filter Probes and Adapter.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare. The symbol features a staff with two snakes entwined around it, and a pair of wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 6 2006

Mr. John Tartal Manager Quality Assurance and Regulatory Affairs ERBE USA, Inc. 2225 Northwest Parkway Marietta, Georgia 30157

Re: K060183

Trade/Device Name: ERBE APC Integrated Filter Probes and Adapter Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 23, 2006 Received: January 25, 2006

Dear Mr. Tartal:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Tartal

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060183

Device Name: ERBE APC Integrated Filter Probes and Adapter

Indications for Use:

Argon Plasma Coagulation (APC)

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRII. Office of Device Evaluation (ODE)

ivis ் 201-: 11: Jivision of General, Restorative, and Neurological Devices

Page 1 of 1

316(k) Number_________________________________________________________________________________________________________________________________________________________________

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.