The PROPLATE of Bio Protech is a disposable, single use, neutral electrode, which provides a return path for high frequency electrical current to the ESU device.

Device Description

The PROPLATE Electrosurgical Grounding Plate (and as also to be offered for sale under various private label trade names) is a flexible, conductive adhesive electrosurgical grounding plate with integrated 3 meter PVC coated cable and standard MSB-female connector. It is an Electrosurgical Grounding Plate at which no electrosurgical effect is intended. It is also known as the patient plate or inactive, indifferent, neutral, return or dispersive electrode. It is frequently, and sometimes inaccurately, referred to as the ground plate. The Electrosurgical Grounding Plate is for use with monopolar instruments only. The role of the Electrosurgical Grounding Plate is preventing highly current density from doing damage to the patient's tissue. And Electrosurgical Grounding Plate transfer input current from the active electrode to ESU device in operation. The Electrosurgical Grounding Plate is large in area, compared to the active electrode, promoting low current density and thereby reducing the possibility or risk of electrosurgical effect or burns. The PROPLATE is made from conductive hydro gel and aluminum foil. The adhesive on the backing material prevent them from falling off the patient's skin during operation. The plates are supplied either uncorded or corded. The electrodes are packaged with 100 pieces (Uncorded plates) or 25 pieces (Corded plates) per an inner box. The plates are provided non-sterile with an expiration date of 24 months.

AI/ML Overview

The provided document describes a 510(k) submission for the PROPLATE Electrosurgical Grounding Plate, demonstrating its substantial equivalence to a predicate device. This submission focuses on technical specifications and performance testing against established safety standards rather than clinical performance or AI algorithm performance. Therefore, many of the requested categories regarding AI-specific criteria, such as training sets, ground truth establishment for AI, and MRMC studies, are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The device, PROPLATE, meets the acceptance criteria by demonstrating performance equivalent to its predicate device, the Leonhard Lang GmbH electrosurgical grounding plate. The acceptance criteria are based on established technical standards and physiological requirements for such devices.

Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Predicate Performance)	Reported Device Performance (PROPLATE)
Biocompatibility	ISO 10993-1 compliant	Pass (ISO 10993-1 compliant)
Maximum Safe Temperature Rise	Pass	Pass
Contact Impedance	Pass	Pass
Adherence	Pass (Pull test)	Pass (Pull test)
Conformability	Pass	Pass
Fluid Tolerance	Pass	Pass
Electrical Safety	HF-18 requirements met	HF-18 requirements met

Study Details

The study described is a bench testing and substantial equivalence comparison rather than a clinical trial or AI performance study.

Sample Size used for the test set and the data provenance:
- The document does not explicitly state the specific sample sizes for each test (e.g., number of plates tested for adherence, temperature rise, etc.). Instead, it indicates that the PROPLATE was subjected to "Pass" or "met" for each technical requirement.
- Data Provenance: The tests are likely laboratory-based bench tests performed by the manufacturer (Bio Protech, Inc.) and/or certified testing facilities (e.g., those ensuring ISO 10993-1 compliance or HF-18 requirements). The country of origin for these tests is not explicitly stated, but the manufacturer is based in South Korea. The study is prospective in the sense that the tests were conducted specifically to demonstrate compliance for this 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the "ground truth" for electrosurgical grounding plates is based on established engineering and safety standards (e.g., ISO 10993, HF-18) rather than expert clinical consensus or interpretation of complex data. Compliance with these standards serves as the benchmark.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. The performance evaluations are based on objective measurements against predefined technical specifications and standards, not on human interpretation or adjudication of ambiguous cases.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a passive medical device (electrosurgical grounding plate), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device does not incorporate any AI algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is compliance with established technical and safety standards for electrosurgical grounding plates (e.g., maximum safe temperature rise, contact impedance, adherence, biocompatibility as per ISO 10993-1, and electrical safety as per HF-18).
The sample size for the training set:
- This is not applicable. The device does not involve a "training set" as it is not an AI/machine learning product.
How the ground truth for the training set was established:
- This is not applicable. There is no training set for this type of medical device.

Summary

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073360

BIO PROTECH, INC. 1720-26, Taejang 2 - Dong, Wonju Wooniu-Si. Gangwon-Do Republic of South Korea

510(K) Summary

Page 1 of 13

DEC 1 9 2007

December 12, 2007

Mr. Kevin Han Contact: 17962 Sky Park Circle Suite G Irvine, CA 92614 Phone: 310-515-1799

Classification Name:

Common/Usual Name: Proprietary Name: Establishment Registration Number: Classification: Product Code: Regulation Number:

Electrosurgical, Cutting and Coagulation Device and Accessories Electrosurgical Grounding Plate PROPLATE 9710582 Class II GEI 21 CFR 878.440

1. Indications for use

The PROPLATE of Bio Protech is a disposable, single use, neutral electrode, which provides a return path for high frequency electrical current to the ESU device.

2. Description of Product

The role of the Electrosurgical Grounding Plate is preventing highly current density from doing damage to the patient's tissue. And Electrosurgical Grounding Plate transfer input current from the active electrode to ESU device in operation. The Electrosurgical Grounding Plate is large in area, compared to the active electrode, promoting low current density and thereby reducing the possibility or risk of electrosurgical effect or burns. The PROPLATE is made from conductive hydro gel and aluminum foil. The adhesive on the backing material prevent them from falling off the patient's skin during operation. The plates are supplied either uncorded or corded. The

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073360

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electrodes are packaged with 100 pieces (Uncorded plates) or 25 pieces (Corded plates) per an inner box. The plates are provided non-sterile with an expiration date of 24 months.

Parameters	Bio Protech, Inc.	Leonhard Lang GmbH
510(k) Number	Pending	K030362
Intended Use	Electrosurgicalgroundingplate	Electrosurgicalgroundingplate
Uncorded	Yes	Yes
Corded	Yes	Yes
Labeling	Latex free	Yes	Yes
	Intended population	Adult and Pediatric	Adult and Pediatric
	Single Use	Yes	Yes
	Non-sterile	Yes	Yes
Material	Plate size	Various sizes	Various sizes
	Substrate	Cloth (Non-wovenFabric) and PE Foam	Cloth (Non-wovenFabric) and PE Foam
	Gel	Sticky conductive gelwiththin Aluminum Foil	Sticky conductive gelwiththin Aluminum Foil
	Release Liner	PET coated Silicon	PET coated Silicon
	Connector(compatible)	REM (Valleylab)	REM (Valleylab),6.3mm jack (standard)
	Cable	Blue PVC cable	Blue PVC cable
Biocompatibility	ISO 10993-1	ISO 10993-1
Technical	Maximum safetemperature rise	Pass	Pass
	Contact impedance	Pass	Pass
	Adherence	Pull test	Pass
		Conformabilitytest	Pass
	Fluid tolerance	Pass	Pass
	test

Substantial Equivalent Table

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K073360

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The PROPLATE ahs the same intended use, uses the same material and has the same performance characteristics as the predicate device. Both devices have met the HF-18 requirements for electrical safety both meet ISO 10993 Standards for biocompatibility. Based on the similarities of the two devices Bio Protech concludes that no new issues of safety and effectiveness have been raised and thus it is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a distinctive design of intertwined snakes and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2007

Bio Protech, Inc. % Underwriters Laboratories, Inc. Mr. Jeff Rongero Senior Project Engineer 12 Laboratory Drive Research Triangle, North Carolina 27709

Re: K073360

Trade/Device Name: PROPLATE Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: December 13, 2007 Received: December 14, 2007

Dear Mr. Rongero:

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. Jeff Rongero

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millman

Mark N. Melkerson 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

KU73360 510(k) Number (if known):

Device Name: PROPLATE

Indications for Use:

The PROPLATE of Bio Protech is a disposable, single use, neutral electrode, which provides a return path for high frequency electrical current to the ESU device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Page 1 of 1

(Division Sign (Division D-5Division of General, Restorative, and Neurological Devices

510(k) Numbe

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.