(19 days)
Not Found
No
The device description and performance studies focus on the physical properties and electrical safety of a passive electrosurgical grounding plate, with no mention of AI or ML capabilities.
No.
The device prevents harm during an electrosurgical procedure by dissipating electrical current, but it does not directly treat a disease or condition.
No
Explanation: The device is an electrosurgical grounding plate designed to return electrical current to an electrosurgical unit (ESU) and prevent tissue damage during electrosurgical procedures. It is not used to diagnose a medical condition or disease.
No
The device description clearly details physical components like a flexible, conductive adhesive plate, cable, and connector, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "neutral electrode, which provides a return path for high frequency electrical current to the ESU device." This describes a device used during a surgical procedure to manage electrical current flow within the patient's body.
- Device Description: The description further elaborates on its function in electrosurgery, preventing burns and transferring current. It is applied to the patient's skin.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with biological samples for diagnostic purposes.
The device described is an electrosurgical accessory used in conjunction with an electrosurgical unit (ESU) during surgical procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The PROPLATE has 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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
1
073360
Page 2 of 2
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 | ||
| grounding | |||
| plate | Electrosurgical | ||
| grounding | |||
| 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 | ||
| Fabric) and PE Foam | Cloth (Non-woven | ||
| Fabric) and PE Foam | |||
| Gel | Sticky conductive gel | ||
| with | |||
| thin Aluminum Foil | Sticky conductive gel | ||
| with | |||
| thin 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 safe | ||
| temperature rise | Pass | Pass | |
| Contact impedance | Pass | Pass | |
| Adherence | Pull test | Pass | |
| Conformability | |||
| test | Pass | ||
| Fluid tolerance | Pass | Pass | |
| test |
Substantial Equivalent Table
2
Page 3 of 3
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.
3
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.
4
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
5
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