Green OR Reprocessed Aquamantys Bipolar Sealer
Device Facts
| Record ID | K211203 |
|---|---|
| Device Name | Green OR Reprocessed Aquamantys Bipolar Sealer |
| Applicant | Green Or, LLC |
| Product Code | NUJ · General, Plastic Surgery |
| Decision Date | Apr 7, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.
Device Story
Reprocessed single-use bipolar electrosurgical device; delivers RF energy and saline to soft tissue and bone for hemostasis. Input: RF energy and saline flow from qualified Pump Generator. Output: Coagulated tissue at operative site. Operated by surgeons in OR. Device features on-off button for simultaneous RF and saline activation; includes saline delivery line, pump tubing, and drip chamber/spike. Connects to generator via three-pin electrical connector. Benefits: Provides hemostatic sealing during surgical procedures. Device is reprocessed version of original OEM equipment.
Clinical Evidence
Bench testing only. No clinical data. Performance testing included: sterilization validation, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity), bacterial endotoxin/LAL, EMC/electrical safety (IEC 60601-2-2), functional performance (RF power output, saline flow rate), cleaning, residual protein, and residual total organic carbon.
Technological Characteristics
Bipolar electrosurgical device; RF energy and saline delivery. Three-pin electrical connector. Includes saline fluid delivery line, pump tubing, and drip chamber/spike. Sterilization validation performed. Electrical safety per IEC 60601-2-2. Reprocessed single-use device.
Indications for Use
Indicated for hemostatic sealing and coagulation of soft tissue and bone in orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. Contraindicated for contraceptive tubal coagulation.
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
- Aquamantys 2.3 Bipolar Sealer (K132974)
- Aquamantys 9.5 XL Bipolar Sealer (K120537)
- Aquamantys 6.0 Bipolar Sealer (K111285)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
April 7, 2022
Green OR, LLC. % Aaron Rogers Director of Regulatory and Quality Pathway LLC 8779 Cottonwood Ave. Suite 105 Santee, California 92071
Re: K211203
Trade/Device Name: Green OR Reprocessed Aquamantys Bipolar Sealer Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: March 7, 2022 Received: March 8, 2022
Dear Aaron Rogers:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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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): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# K211203 - Aaron Rogers
| Reprocessed Single-Use Device Models Included in Submission: | | |
|--------------------------------------------------------------|--------------|----------------------------------|
| OM | Model Number | Device Name/Description |
| OEM | Model Number | Device Name/Description |
| Medtronic | 23-113-1 | Aquamantys 2.3 Bipolar Sealer |
| Medtronic | 23-112-1 | Aquamantys 6.0 Bipolar Sealer |
| Medtronic | 23-313-1 | Aquamantys 9.5 XL Bipolar Sealer |
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## Indications for Use
510(k) Number (if known) K211203
#### Device Name
Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer, Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer, Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer
#### Indications for Use (Describe)
The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.
| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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K211203
Image /page/4/Picture/2 description: The image shows the logo for GreenOR. The word "Green" is written in green font, and the letters "OR" are written in blue font. A green and blue circular arrow surrounds the word "Green" and connects to the letters "OR".
Reprocessed Aquamantys Bipolar Sealers
# K211203 Summary
| SUBMITTER | Green OR, LLC.<br>John Zehren<br>4200 Dahlberg Drive #300<br>Golden Valley, MN 55422 | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------|
| CONTACT | Aaron Rogers<br>Pathway, LLC.<br>8779 Cottonwood Ave. #105<br>Santee, CA 92071<br>619-415-0103 x704<br>arogers@pathwaynpi.com | | |
| DATE PREPARED | April 6, 2022 | | |
| DEVICE NAME | Green OR Reprocessed Aquamantys Bipolar Sealer | | |
| CLASSIFICATION | Electrosurgical cutting and coagulation device and accessories<br>Regulation: 21 CFR 878.4400<br>Device Class: Class II<br>Product Code: NUJ | | |
| | Predicate<br>Manufacturer | Device Name | 510(k) |
| PREDICATE<br>DEVICE | Medtronic | Aquamantys 2.3 Bipolar Sealer | K132974 |
| | Medtronic | Aquamantys 9.5 XL Bipolar Sealer | K120537 |
| | Medtronic | Aquamantys 6.0 Bipolar Sealer | K111285 |
| REFERENCE<br>DEVICE | No reference devices were used in this submission. | | |
| | with an on-off button that simultaneously activates both RF and saline<br>flow. A saline fluid delivery line is provided with the device, and<br>includes a section of pump tubing and a drip chamber or spike. The<br>three-pin electrical connector is designed to be plugged into a<br>qualified Pump Generator. The generator is not included in the scope<br>of the study and will not be reprocessed. | | |
| | The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile,<br>single-use bipolar electrosurgical device intended to be used in<br>conjunction with a qualified Pump Generator for delivery of RF energy<br>and saline for hemostatic sealing and coagulation of soft tissue and<br>bone at the operative site. The device is not intended for<br>contraceptive tubal coagulation (permanent female sterilization). | | |
| INTENDED USE | The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is<br>intended for, but not limited to orthopaedic, neurosurgical, spine,<br>thoracic, and open abdominal surgery. | | |
| | The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is<br>intended for, but not limited to orthopaedic, spine, thoracic, and open<br>abdominal surgery. | | |
| | The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is<br>intended for, but not limited to, open abdominal, orthopaedic, and<br>thoracic surgery. | | |
| TECHNOLOGICAL<br>CHARACTERISTICS | The technological characteristics and the fundamental scientific<br>technology of the subject devices are identical to the predicate<br>device. The subject devices are a reprocessed version of the<br>predicate. The predicate devices were used to support intended use,<br>technological characteristics, and functional performance<br>specifications. | | |
| | The functional characteristics of the subject devices have been<br>evaluated and found to be equivalent to the predicate devices based<br>on the following tests: | | |
| PERFORMANCE<br>TESTING | Sterilization Validation Biocompatibility Cytotoxicity Sensitization Irritation: Intracutaneous Reactivity Acute systemic toxicity Material mediated pyrogenicity Bacterial Endotoxin / LAL EMC and Electrical Safety IEC 60601-2-2 Functional Performance RF Power Output Saline Flow Rate | | |
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| | • Cleaning |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Residual Protein |
| | • Residual Total Organic Carbon |
| CONCLUSION | Based on comparisons of the indications for use, intended use, technological characteristics, and performance data to the predicate devices, the Green OR Reprocessed Aquamantys Bipolar Sealer is substantially equivalent to the predicate devices. |
