HydroCision TenJet Device

K190804 · Hydrocision, Inc. · HRX · Jun 5, 2019 · Orthopedic

Device Facts

• Record ID: K190804
• Device Name: HydroCision TenJet Device
• Applicant: Hydrocision, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Jun 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HydroCision TenJet Device is indicated for orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures.

Device Story

TenJet device; single-use disposable orthopedic surgical instrument. System components: handpiece, pump cartridge, tubing assembly; used with HydroCision Console and foot pedal. Principle of operation: high-pressure saline jet creates Venturi effect at distal tip; localized suction pulls target tissue into saline stream for cutting/debridement; debrided tissue and saline evacuated through waste tube. Used in open, arthroscopic, or minimally invasive procedures; surgeon-operated under ultrasound visualization. Console provides pressurized saline; includes touch-screen LCD and GUI. Benefits: precise tissue removal via high-pressure fluid stream; minimally invasive access reduces surgical trauma.

Clinical Evidence

Bench testing only. Performance testing included weldment burst/strength, sharp tip testing, and tissue differentiation (bovine/cadaver). Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity). Human factors/usability study per IEC 62366-1. Electrical safety/EMC per IEC 60601-1/1-2. No clinical data.

Technological Characteristics

Materials: ABS handle, stainless steel needle/pump cartridge, polyamide high-pressure tubing, polyurethane evacuation tubing. Principle: high-pressure saline jet (up to 15,000 psi). Connectivity: console-based. Sterilization: Ethylene Oxide (EtO). Software: console-driven GUI.

Indications for Use

Indicated for orthopedic surgical procedures requiring cutting, debridement, and removal of soft and hard tissue in open, arthroscopic, and minimally invasive procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• HydroCision ArthroJet with Cautery, TurboBurr and Curette (K041233)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 5, 2019

HydroCision, Inc. % Mr. Yashesh Rawal MAE Consulting Group, LLC 119 North Road Deerfield, New Hampshire 03037

Re: K190804

Trade/Device Name: HydroCision TenJet Device Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: March 28, 2019 Received: March 29, 2019

Dear Mr. Rawal:

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. 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/cfpmp/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.

{1}------------------------------------------------

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 and Part 809); 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Jennifer R. Stevenson Acting Division Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Devices

Enclosure

{2}------------------------------------------------

# Section 4- Indication for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190804

Device Name HydroCision TenJet Device

Indications for Use (Describe)

HydroCision Tenlet Device is indicated for orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

POC Publishing Survices [phone] EF

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

# 510(k) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the HydroCision TenJet Device.

- 1. Applicant: HydroCision, Inc. 267 Boston Rd, North Billerica, MA 01862
- Sponsor Contact Person: 2. Mr. Mark Lewis Vice President Operations and Regulatory Affairs HydroCision, Inc. 267 Boston Rd, North Billerica, MA 01862 Phone: [phone] Email: [e-mail]
- 3. Regulatory Correspondent/ 510(k) Submission Contact: Mr. Yashesh Rawal, MS Regulatory Affairs Specialist MAE Consulting Group, LLC 119 North Road, Deerfield, NH 03037 Phone: [phone] Email: [e-mail]
- Date Prepared: March 27, 2019 4.
- 5. Device Information:

Proprietary Name: HydroCision TenJet Device

| Device: | HydroCision TenJet Device |
|--------------------|---------------------------|
| Panel: | Orthopedic |
| Regulatory Number: | 21 CFR 880.1100 |
| Regulation Name: | Arthroscope |
| Product Code: | HRX |
| Device Class: | Class II |

{4}------------------------------------------------

## 6. Predicate Device:

HydroCision ArthroJet with Cautery, TurboBurr and Curette (K041233). HydroCision ArthroJet device has been rebranded to HydroCision SpineJet device, no other changes made to the device.

- 7. Device Description:
The TenJet device is a single use disposable device intended for use in orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures. The TenJet device is constructed from various biocompatible materials. The TenJet device is designed to be used in combination with HydroCision Console and Foot Pedal, which are sold and package separately. The Accessory Kit, also known as supply kit is packaged along with each HydroCision TenJet Device. The supply kit contains sterile packaged, single use, OEM surgical supply items for use in the surgical site preparation and closure. The itemized contents of the kit with their manufacturer and regulatory information are provided in section 11.7.3 of this 510(k).

The components of TenJet device consists of a pump cartridge, handpiece and tubing assembly, which is used in combination with HydroCision Console. The TenJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the TenJet device and pressurizes the saline to deliver to the tip of the TenJet handpiece through high pressure saline tube. The TenJet handpiece consists of a plastic handle and a two-lumen needle: high pressure tube lumen and evacuation tube lumen, which are welded together in the handle. As the high-pressure saline passes from one lumen nozzle to another lumen nozzle, the targeted tissues are cut, debrided and removed into the evacuation tube lumen, passing into the waste container. The TenJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of TenJet handpiece and (iii) Evacuation tube (waste hose) - which removes debrided tissue, along with saline from tip of the handpiece and delivers it to waste container, which is provided by the facility.

The Hydrocision Console is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the TenJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface. The detailed software description and associated documentation is included in Section 16 of the TenJet 510(k).

{5}------------------------------------------------

To perform an open, arthroscopic or minimally invasive surgical procedure, the TenJet handpiece needle is inserted into the body through a small incision and guided toward the targeted diseased tissue under ultrasound visualization. Once the Tenlet handpiece needle is in position, the surgeon activates the high-pressure saline of TenJet device using the Hydrocision console and foot pedal. Using ultrasound visual guidance, the surgeon uses the TenJet handpiece to cut, debride and remove the targeted diseased tissue. When the procedure is complete, the handpiece is withdrawn and the incision is closed using steri-strips for a closed, minimally invasive, ultrasound guided procedure.

The TenJet device is provided sterile, via ethylene oxide sterilization.

- 8. Indication for Use:
HydroCision TenJet Device is indicated for orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required in a variety of open, arthroscopic, and minimally invasive surgical procedures.

- 9. Comparison of Technological Characteristics:
The HydroCision TenJet Device is substantially equivalent in intended use, design, performance and principles of operation to the predicate device- HydroCision Arthrolet with Cautery, TurboBurr and Curette (K041233). Both devices include similar principle components: a pump cartridge, handpiece and tubing assembly (disposable hose). The handpiece component of both devices consists of a plastic handle and a two-lumen needle welded in the handle. Both devices are designed to be connected with the HydroCision console, foot pedal, a sterile bag of saline (which is supplied by the facility), and a waste container (supplied by the facility) prior to operation. The differences between the HydroCision Tenlet device and the predicate device are minor and raise no new issues of safety or efficacy. The HydroCision TenJet device and the predicate device consist of the same technology and are sterilized with same acceptable method. Both the devices are made up of same biocompatible materials.

Below is a comparison table that provides a top-level overview of the substantial equivalent comparison between proposed and predicate devices.

| Comparative<br>Characteristics | Proposed Device:<br>HydroCision TenJet Device | Predicate Device:<br>HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K041233 |
| Indication for<br>Use | The HydroCision TenJet Device is<br>indicated for orthopedic surgical | The HydroCision ArthroJet System with<br>Cautery, TurboBurr, and Curette is |
| Comparative | Proposed Device: | Predicate Device: |
| Characteristics | HydroCision TenJet Device | HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
| | procedures where the cutting,<br>debridement and removal of soft and<br>hard tissue is required in a variety of<br>open, arthroscopic, and minimally<br>invasive surgical procedures | indicated for orthopedic surgical<br>procedures where the cutting and<br>removal of soft tissue and the ablation<br>and removal of hard tissue or bone is<br>required with control of bleeding during<br>those procedures as needed. Specific<br>functions include cutting, ablation and<br>shaping of the soft tissue, and drilling,<br>reaming, decorticating and smoothing of<br>bone, cartilage and other bone related<br>tissue in a variety of surgical procedures<br>including open and minimally invasive<br>spinal surgeries and small and large joint<br>arthroscopic procedures. |
| Principle of<br>Operation | The TenJet device uses a high-pressure<br>saline to act as a cutting medium to<br>debride and remove targeted tissue<br>material in the intended procedures.<br>As the high-pressure saline flows from<br>the one needle lumen nozzle to<br>another at the distal tip of the TenJet<br>device, a Venturi effect creates<br>localized suction pulling nearby target<br>tissue into the path of the high-<br>pressure saline stream where it is cut,<br>debrided and then passes into the<br>evacuation tube to be removed. | The ArthroJet device uses a high-<br>pressure saline to act as a cutting<br>medium to debride and remove<br>targeted tissue material in the intended<br>procedures. As the high pressure saline<br>flows from the one needle lumen nozzle<br>to another at the distal tip of the<br>ArthroJet device, a Venturi effect<br>creates localized suction pulling nearby<br>target tissue into the path of the high<br>pressure saline stream where it is cut,<br>debrided and then passes into the<br>evacuation tube to be removed. |
| Single Use | Yes | Yes |
| Principle Device<br>Components<br>(Sterile,<br>Disposable,<br>Single Use) | Handpiece, Pump Cartridge and Tubing<br>Assembly | Handpiece, Pump Cartridge and Tubing<br>Assembly |
| Other devices for<br>interfacing | HydroCision Console Unit, Foot Pedal | HydroCision Console Unit, Foot Pedal |
| Accessories/<br>Convenience Kit | Yes, an accessory kit is provided with<br>the TenJet device. The accessory kit<br>contains sterile packaged, single use | No |
| Comparative | Proposed Device: | Predicate Device: |
| Characteristics | HydroCision TenJet Device | HydroCision ArthroJet with Cautery, TurboBurr and Curette |
| | OEM surgical supply items for use in<br>the surgical site preparation and<br>closure. These include a syringe and<br>needle, scalpel, an ultrasound probe<br>cover, gauze, chloraprep, closure strips<br>and dressing. | |
| Sterilization | Supplied Sterile, EtO Sterilization | Supplied Sterile, EtO Sterilization |
| Materials | | |
| Handpiece<br>Handle | ABS | ABS |
| Handpiece<br>Needle | Stainless Steel | Stainless Steel |
| Pump Cartridge | Stainless Steel | Stainless Steel |
| High Pressure<br>Tubing Assembly | Polyamide | Polyamide |
| Evacuation<br>Tubing Assembly | Polyurethane | Polyurethane |
| Medical Adhesive | Loctite #4011 | Loctite #4011 |
| Biocompatibility<br>of Materials | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements |
| Technical Features/Design | | |
| Tubing Assembly<br>Dimension<br>(Disposable<br>Hose) | High Pressure Hose - 0.143"OD, 0.050"<br>ID<br>Evacuation Tube Hose - 0.125"OD,<br>0.059" ID | Identical.<br>High Pressure Hose - 0.143"OD, 0.050"<br>ID<br>Evacuation Tube Hose - 0.125"OD,<br>0.059" ID |
| Pump Cartridge<br>Dimension | Handle Cartridge - Length - 2.00"<br>Piston Body- Length- 1.860<br>Suction Connector- Length- 1.6" | Identical.<br>Handle Cartridge - Length - 2.00"<br>Piston Body- Length- 1.860<br>Suction Connector- Length- 1.6" |
| Handpiece<br>Dimension | Handle:<br>Device Handle Weldment Length- 5.41" | Handle:<br>Device Handle Weldment Length- 4.593" |
| | Needle:<br>Two-Lumen Needle Length- 5.224"<br>High Pressure lumen/jet tube- 0.025 OD, 0.013 ID | Needle:<br>Two-Lumen Needle Length- 9.832"<br>High Pressure lumen/jet tube- 0.045 OD, 0.020 ID |
| Comparative<br>Characteristics | Proposed Device:<br>HydroCision TenJet Device | Predicate Device:<br>HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
| Device Needle | The TenJet handpiece needle consists<br>of two lumens: high pressure tube<br>lumen and evacuation tube lumen,<br>which are welded together. The high-<br>pressure tube lumen delivers high<br>pressure saline to the target tissue site.<br>The evacuation tube lumen evacuates<br>the saline and debrided tissue material<br>from the target tissue site.<br>The TenJet two-lumen needle tip<br>also includes pointed cap, which is<br>welded at the top of the two<br>lumens. The high-pressure lumen nozzle is at<br>50-degree angle to the evacuation<br>lumen, so as to accommodate the<br>pointed cap at the top and that high-<br>pressure saline jet is directed into<br>the evacuation lumen when in use. | The ArthroJet handpiece needle consists<br>of two lumens: high pressure tube<br>lumen and evacuation tube lumen,<br>which are welded together. The high-<br>pressure lumen delivers high pressure<br>saline to the target tissue site. The<br>evacuation lumen evacuates the saline<br>and debrided tissue material from the<br>target tissue site.<br>The ArthroJet handpiece needle does<br>not include a pointed cap. The high-pressure lumen nozzle is at<br>0-degree angle to the evacuation<br>lumen, so that high pressure saline<br>jet is directed into the evacuation<br>lumen when in use. |
| High Pressure<br>Saline Flow Rate<br>(at the pump<br>cartridge) | 230 ml/min at 15,000 psi<br>156 ml/min at 7,500 psi | 230 ml/min at 15,000 psi<br>156 ml/min at 7,500 psi |
| HydroCision<br>Console | Dimensions: 8.7" W x 17.5" D x 11.5" H<br>Weight: 30lbs<br>Power: 100-240 V ~ 6A 50/60 Hz<br>Software driven | Dimensions: 16" W x 13" D x 7" H<br>Weight: 28lbs<br>Power: 100-240 V ~ 6A 50/60 Hz<br>Not Software Driven |
| Packaging<br>Description | Blister tray, Tyvek led seal, Tyvek<br>pouch, unit box. | Sealed mylar/Tyvek pouch or a PETG<br>tray with a sealed Tyvek lid. |
| Do the Devices<br>Have the Same<br>Indication for<br>Use and<br>Technological<br>Characteristics<br>and are<br>substantially<br>equivalent? | <b>Indications for Use Statement:</b> The indications for use statements are nearly identical for the two devices except that the predicate device is also indicated for use in ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures. Although worded differently, the indications for use of the HydroCision TenJet device is a subset of the predicate device indication for use. Both the HydroCision TenJet device and the predicate device are single use disposable devices indicated for use in orthopedic surgical procedures where the cutting. | |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

{10}------------------------------------------------

| Comparative<br>Characteristics | Proposed Device:<br>HydroCision TenJet Device | Predicate Device:<br>HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------|
| In terms of difference in packaging, packaging validation studies have been conducted by HydroCision on the final packaged TenJet device in compliance to ISO 11607-1:2006 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems. The test results demonstrate that the sterile barrier system and the device package is able to maintain its strength, integrity, and microbial barrier until the end of the intended shelf life. The full test reports are provided in Section 14.6.<br><br>Although there are slight differences in the design features of the proposed device and the predicate device, these differences were found to be insignificant overall and the principle of operation remains the same. The HydroCision TenJet Device is considered substantially equivalent to the predicate device in indication for use and technological characteristics (design and materials) based on the above evaluation. | | |

## 10. Summary of Testing

To ensure that the proposed device design and construction are suitable for the intended use and is substantially equivalent, the HydroCision TenJet device has been evaluated in the following tests:

- . Performance Bench testing has been conducted to verify that the performance of the proposed TenJet device is substantially equivalent to the predicate device, and the TenJet device will perform as intended. The following bench-top testing were conducted to assure conformance to the specifications:
- O TenJet weldment burst testing
- o TenJet weldment strength testing
- o TenJet Sharp Tip Testing
- o TenJet Tissue Differentiation- Safety and Efficacy (Bovine and Cadaver)
- The following Biocompatibility testing was performed in accordance with ISO 10993-1:2009 and FDA guidance on Use of International Standard ISO 10993-1
- o Cytotoxicity
- o Sensitization
- o EO Residual
- o Irritation / Intracutaneous reactivity
- Material Mediated Pyrogenicity
- o Acute Systemic Toxicity
- Sterilization by ethylene oxide has been validated for HydroCision TenJet device.

{11}------------------------------------------------

- . A Human Factors / Usability Study was conducted and the HydroCision TenJet device was found to be in conformance with the IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices
- . Additionally, the electromagnetic compatibility and electrical safety of the device were tested and found to comply with applicable parts of the following international standards:
- o IEC 60601-1
- o IEC 60601-1-2
- Clinical evidence was not necessary to show substantial equivalence
- The HydroCision console software has been developed, verified, tested and validated to the company's documented development and test procedures. The detailed software description and associated documentation is included in Section 16 of the TenJet 510(k)
- . A risk analysis according to ISO standard "14971 Medical Devices – Application of risk management to medical devices" was carried out for the HydroCision TenJet Device. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode and Effect Analysis" technique.

#### 11. Conclusion:

The HydroCision TenJet device met all predetermined acceptance criteria as specified by the applicable standards, FDA guidance documents and internal test protocols. No safety and efficacy issues were raised during the testing program. Therefore, the HydroCision TenJet device is considered substantially equivalent to the predicate device.

The safety and effectiveness of the HydroCision TenJet device are adequately supported by the Non-Clinical performance data, substantial equivalence information, materials information, and comparison of design characteristics provided within this premarket notification.