PROPLATE

K073360 · Bio Protech, Inc. · GEI · Dec 19, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K073360
• Device Name: PROPLATE
• Applicant: Bio Protech, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended 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.

Device Story

PROPLATE is a disposable, single-use, neutral (dispersive) electrode for monopolar electrosurgery. It functions as a return path for high-frequency electrical current from the active electrode back to the electrosurgical unit (ESU). The device features a large surface area to maintain low current density, preventing tissue damage or burns at the contact site. It consists of a conductive hydrogel layer on an aluminum foil base, with an adhesive backing to ensure skin contact during procedures. It is supplied either uncorded or with an integrated 3-meter PVC-coated cable and MSB-female connector. Used in clinical settings by healthcare professionals, the device ensures safe current return, mitigating the risk of electrosurgical burns to the patient.

Clinical Evidence

Bench testing only. Performance verified through contact impedance testing, maximum safe temperature rise testing, adherence (pull and conformability) tests, and fluid tolerance testing. Biocompatibility confirmed per ISO 10993-1.

Technological Characteristics

Flexible, conductive adhesive grounding plate. Materials: conductive hydrogel, aluminum foil, non-woven fabric/PE foam substrate, PET-coated silicon release liner. Connectivity: integrated 3m PVC-coated cable with MSB-female connector. Non-sterile, single-use. Complies with HF-18 electrical safety and ISO 10993 biocompatibility standards.

Indications for Use

Indicated for use as a neutral electrode (return path) for high-frequency electrical current in electrosurgical procedures for adult and pediatric patients. Contraindicated for use with anything other than monopolar instruments.

Regulatory Classification

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.

Predicate Devices

• Leonhard Lang GmbH (K030362)

Submission Summary (Full Text)

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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

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DEC 1 9 2007

December 12, 2007

Mr. Kevin Han Contact: 17962 Sky Park Circle Suite G Irvine, CA 92614 Phone: [phone]

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 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

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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 | Electrosurgical<br>grounding<br>plate | Electrosurgical<br>grounding<br>plate | |
| 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-woven<br>Fabric) and PE Foam | Cloth (Non-woven<br>Fabric) and PE Foam |
| | Gel | Sticky conductive gel<br>with<br>thin Aluminum Foil | Sticky conductive gel<br>with<br>thin Aluminum Foil |
| | Release Liner | PET coated Silicon | PET coated Silicon |
| | Connector<br>(compatible) | REM (Valleylab) | REM (Valleylab),<br>6.3mm jack (standard) |
| | Cable | Blue PVC cable | Blue PVC cable |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | |
| Technical | Maximum safe<br>temperature rise | Pass | Pass |
| | Contact impedance | Pass | Pass |
| | Adherence | Pull test | Pass |
| | | Conformability<br>test | 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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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)

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

510(k) Numbe