Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini

K170381 · Medtronic Advanced Energy · GEI · Sep 7, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170381
• Device Name: Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini
• Applicant: Medtronic Advanced Energy
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and Aquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile, single-use bipolar electrosurgical devices 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. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Story

The Aquamantys MIS FLEX and MIS FLEX Mini are single-use, bipolar electrosurgical handpieces designed for use in surgical settings (OR). They utilize Transcollation Technology, which delivers RF energy and saline irrigation simultaneously to achieve hemostatic sealing and coagulation of soft tissue and bone. The device features a malleable shaft, dual electrode tips, and dual saline delivery ports. It connects to a qualified Medtronic Pump Generator (AEX or Aquamantys) via a three-pin electrical connector. A handpiece button activates both RF energy and saline flow. Surgeons use the device to control bleeding during procedures; the saline irrigation helps manage thermal effects on tissue. The device provides a surgical tool for improved hemostasis, potentially reducing blood loss and improving surgical site visibility.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1, IEC 60601-2-2), mechanical testing, and performance testing. Performance was validated via a cadaver study for anatomical access and comparative in-vivo porcine and ex-vivo tissue studies against the predicate device to assess thermal effects.

Technological Characteristics

Sterile, single-use, bipolar electrosurgical device. Features malleable shaft, dual electrode tips, and dual saline delivery ports. Energy source: RF energy via external Pump Generator. Standards: ISO 10993 (biocompatibility), IEC 60601-1 (general safety), IEC 60601-2-2 (HF surgery equipment), ISO 11737-1, ISO 11135 (sterilization).

Indications for Use

Indicated for hemostatic sealing and coagulation of soft tissue and bone in patients undergoing orthopaedic, neurosurgical, spine, endoscopic, abdominal, or thoracic surgery, and epidural vein sealing. 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 SBS 5.0 (K132974)

Reference Devices

• AEX Pump Generator (K143175)
• Aquamantys Pump Generator (K052859)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 7, 2017

Medtronic Advanced Energy Heather Valley Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801

Re: K170381

Trade/Device Name: Aquamantys MIS FLEX and Aquamantys MIS FLEX Mini Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 18, 2017 Received: August 21, 2017

Dear Heather Valley:

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. 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 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 (reporting of medical device

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related adverse events) (21 CFR 803): 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, bold font. The text is arranged vertically, with "Jennifer R." on the top line and "Stevenson -S3" on the bottom line. The background is a light blue color, and the letters are black.

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K170381

#### Device Name

Aquamantys(TM) Minimally Invasive Sealer (MIS) FLEX Aquamantys(TM) Minimally Invasive Sealer (MIS) FLEX Mini

#### Indications for Use (Describe)

The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and Aquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile, single-use bipolar electrosurgical devices 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. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol on the left and the word "Medtronic" in blue on the right. The circular symbol contains three figures in different poses, arranged in a circular pattern.

MIS FLEX

Traditional 510(k) Premarket Notification

# 510(k) Summary

| Submitter: | Medtronic Advanced Energy<br>180 International Drive<br>Portsmouth, NH 03801 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Heather Valley, RAC<br>Principal Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | September 5, 2017 |
| Device Trade Name: | Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and<br>Aquamantys™ Minimally Invasive Sealer (MIS) FLEX Mini |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories<br>(21 CFR 878.4400) |
| Regulatory Class: | Class II |
| Product Code: | GEI |
| Predicate Device: | Aquamantys SBS 5.0 (K132974) |
| Device Description: | MIS FLEX and MIS FLEX Mini are single-use, disposable, bipolar<br>devices. The MIS FLEX and MIS FLEX Mini employ radio-frequency<br>(RF) energy and saline irrigation (termed Transcollation Technology™)<br>for hemostatic sealing and coagulation. The devices are equipped with<br>dual electrode tips while saline and electrical lines exit the opposite end<br>of the handpiece from the electrodes. The handpiece is equipped with an<br>on-off button that simultaneously activates both RF and saline flow. A<br>saline fluid delivery line is provided with the device and includes a<br>section of pump tubing and drip chamber or spike. The three-pin<br>electrical connector is designed to be plugged into either of the FDA<br>cleared AEX (K143175) or Aquamantys (K052859) Pump Generators.<br>The MIS FLEX devices feature a fully malleable shaft, altered saline<br>delivery and dual ports for saline delivery (two for each electrode). The<br>distal end of the device features small, rounded electrode geometry.<br>The MIS FLEX and MIS FLEX Mini differ by the length of the shaft. The<br>MIS FLEX is designed for transsphenoidal and MIS Spine procedures<br>while the MIS FLEX Mini is designed for craniotomies with application in<br>posterial cervical and other spinal procedures. |
| Indications for Use: | The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and<br>Aquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile,<br>single-use bipolar electrosurgical devices intended to be used in |

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K170381 p 2/4

Traditional 510(k) Premarket Notification

conjunction with a qualified Pump Generator for delivery of Radiofrequency (RF) energy and saline for hemostatic sealing and coaqulation of soft tissue and bone at the operative site. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

### Technological Characteristics:

The MIS FLEX devices are similar to the predicate devices as they are sterile, single use, bipolar electrosurgical devices used to provide hemostatic sealing and coagulation of soft tissue and bone at the operative site.

The three major differences between the subject and predicate device are the malleable shaft, altered saline delivery and electrode size. These new features do not impact the safety or effectiveness of the device.

### Summary of Non-Clinical Testing:

The design and performance of the MIS FLEX devices were verified and validated through bench testing. The following performance data were provided in support of the substantial equivalence determination:

- Biocompatibility ●
- Sterilization ●
- Shelf Life
- Electrical Safety ●
- Electromagnetic Compatibility ●
- Mechanical Testing
- Performance Testing .

### Biocompatibility Testing

The Biocompatibility evaluation for MIS FLEX was conducted in accordance with the following International Standard ISO-10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The testing includes the following:

- InVitro Cytotoxicity ●
- . Acute System Toxicity
- Irritation or Intracutaneous Reactivity ●
- Sensitization ●
- . Pyrogenicity

The MIS FLEX devices are considered externally communicating devices (Tissue/Bone/Dentin) with limited exposure of less than 24 hours.

Image /page/4/Picture/24 description: The image shows a logo. The logo has a blue winged figure on the left. To the right of the figure is the word "Mewburn" in blue.

MIS FLEX

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Image /page/5/Picture/0 description: The image contains the Medtronic logo. The logo consists of a blue circle on the left side with a stylized human figure inside. To the right of the circle is the word "Medtronic" in a bold, blue font. The logo is simple and modern, and the use of blue gives it a sense of trustworthiness and reliability.

MIS FLEX

Traditional 510(k) Premarket Notification

## Electrical Safety Testing

Electrical safety and EMC testing were conducted on MIS FLEX devices and were found to be in compliance with associated IEC 60601-1 and IEC 60601-2-2 standards.

## Performance Testing

Two studies were completed in support of the MIS FLEX 510(k). One study was limited to validating anatomical access (Cadaver Study). The second study was a comparative performance test, which was conducted in an in-vivo porcine model. Ex-vivo tissue testing was also completed.

The access study was conducted to ensure that the MIS FELX will be able to access key anatomy and meet customer needs for neurosurgical and spine procedures. The devices met the requirements for access.

The comparative performance testing assessed the thermal effect of the MIS FLEX devices in both the in-vivo and ex-vivo models against the predicate in accordance with the "Premarket Notification (510(k) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff". The subject devices were substantially equivalent.

Testing of the MIS FLEX and MIS FLEX Mini were conducted in accordance with the following FDA recognized standards:

| Recognition<br>Number | Standard | Title of Standard |
|-----------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | ES60601-1:20 X05/(R)2012 And<br>A1:2012 | C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated<br>Text) Medical Electrical Equipment - Part 1: General<br>Requirements For Basic Safety And Essential<br>Performance (IEC 60601-1:2005, MOD) |
| 9-64 | IEC 60601-2-2Ed 5.0 | Medical Electrical Equipment - Part 2-2: Particular<br>Requirements For The Basic Safety And Essential<br>Performance Of High Frequency Surgery Equipment<br>And High Frequency Surgical Accessories |
| 14-407 | 11737-1 Second Edition 2006-<br>04-01 | Sterilization Of Medical Devices - Microbiological<br>Methods - Part 1: Determination Of A Population Of<br>Microorganisms On Products [Including: Technical<br>Corrigendum 1 (2007)] |
| 14-479 | 11135:2014 | Sterilization Of Health Care Products - Ethylene Oxide<br>- Requirements For Development, Validation And<br>Routine Control Of A Sterilization Process For Medical<br>Devices. |
| 2-220 | 10993-1 Fourth Edition 2009-10-<br>15 | Biological Evaluation Of Medical Devices - Part 1:<br>Evaluation And Testing Within A Risk Management<br>Process [Including: Technical Corrigendum 1 (2010)] |

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Image /page/6/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" in blue on the right. The graphic contains three figures in different positions inside of a circle.

K170381 p 4/4

MIS FLEX

Traditional 510(k) Premarket Notification

| 2-235 | 10993-4 Second Edition 2002-<br>10-15 AMENDMENT 1 | Biological Evaluation Of Medical Devices - Part 4:<br>Selection Of Tests For Interaction With Blood<br>[Including: Amendment 1 (2006)]. |
|-------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 2-153 | 10993-5:2009/(R)2014 | Biological Evaluation Of Medical Devices - Part 5:<br>Tests For In Vitro Cytotoxicity |
| 2-174 | 10993-10 Third Edition 2010-08-<br>01 | Biological Evaluation Of Medical Devices - Part 10:<br>Tests For Irritation And Skin Sensitization |
| 2-176 | 10993-11 Second Edition 2006-<br>08-15 | Biological Evaluation Of Medical Devices - Part 11:<br>Tests For Systemic Toxicity |

Summary of Clinical Tests: Clinical testing was not required for this product.

Conclusion: The indications for use, technology and performance characteristics of the MIS FLEX and MIS FLEX Mini are equivalent to that of the predicate device and therefore Medtronic Advanced Energy claims substantial equivalence to the predicate device.