(350 days)
No reference devices were used in this submission.
No
The summary describes a reprocessed electrosurgical device for hemostatic sealing and coagulation, with no mention of AI or ML in its intended use, device description, or performance studies.
Yes.
The device is intended for hemostatic sealing and coagulation of soft tissue and bone, which are therapeutic actions.
No
The device is an electrosurgical device intended for hemostatic sealing and coagulation of soft tissue and bone, which are therapeutic functions, not diagnostic ones.
No
The device description and performance studies clearly indicate this is a physical electrosurgical device with hardware components (bipolar sealer, generator, pump) and not a software-only device.
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 for "hemostatic sealing and coagulation of soft tissue and bone at the operative site" using radio-frequency energy and saline. This is a therapeutic and surgical application, not a diagnostic one.
- Mechanism of Action: The device works by applying RF energy and saline directly to tissue during surgery to control bleeding. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
NUJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and bone at the operative site (for all models); orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery (for 2.3 model); orthopaedic, spine, thoracic, and open abdominal surgery (for 6.0 model); open abdominal, orthopaedic, and thoracic surgery (for 9.5 XL model).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 functional characteristics of the subject devices have been evaluated and found to be equivalent to the predicate devices based on the following tests:
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
Cleaning
Residual Protein
Residual Total Organic Carbon
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
1
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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Reprocessed Aquamantys Bipolar Sealers
K211203 Summary
| SUBMITTER | Green OR, LLC.
John Zehren
4200 Dahlberg Drive #300
Golden Valley, MN 55422 | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|---------|
| CONTACT | Aaron Rogers
Pathway, LLC.
8779 Cottonwood Ave. #105
Santee, CA 92071
619-415-0103 x704
arogers@pathwaynpi.com | | |
| DATE PREPARED | April 6, 2022 | | |
| DEVICE NAME | Green OR Reprocessed Aquamantys Bipolar Sealer | | |
| CLASSIFICATION | Electrosurgical cutting and coagulation device and accessories
Regulation: 21 CFR 878.4400
Device Class: Class II
Product Code: NUJ | | |
| | Predicate
Manufacturer | Device Name | 510(k) |
| PREDICATE
DEVICE | Medtronic | Aquamantys 2.3 Bipolar Sealer | K132974 |
| | Medtronic | Aquamantys 9.5 XL Bipolar Sealer | K120537 |
| | Medtronic | Aquamantys 6.0 Bipolar Sealer | K111285 |
| REFERENCE
DEVICE | No reference devices were used in this submission. | | |
| | with an on-off button that simultaneously activates both RF and saline
flow. A saline fluid delivery line is provided with the device, and
includes a section of pump tubing and a drip chamber or spike. The
three-pin electrical connector is designed to be plugged into a
qualified Pump Generator. The generator is not included in the scope
of the study and will not be reprocessed. | | |
| | 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 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). | | |
| INTENDED USE | 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. | | |
| TECHNOLOGICAL
CHARACTERISTICS | The technological characteristics and the fundamental scientific
technology of the subject devices are identical to the predicate
device. The subject devices are a reprocessed version of the
predicate. The predicate devices were used to support intended use,
technological characteristics, and functional performance
specifications. | | |
| | The functional characteristics of the subject devices have been
evaluated and found to be equivalent to the predicate devices based
on the following tests: | | |
| PERFORMANCE
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. |