HydroCision SpineJet System

K200729 · Hydrocision, Inc. · HRX · Apr 16, 2020 · Orthopedic

Device Facts

• Record ID: K200729
• Device Name: HydroCision SpineJet System
• Applicant: Hydrocision, Inc.
• Product Code: HRX · Orthopedic
• Decision Date: Apr 16, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HydroCision SpineJet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive in spinal surgeries.

Device Story

HydroCision SpineJet System is a surgical tool for spinal procedures; utilizes high-pressure saline stream to cut, debride, and remove soft/hard tissue. System consists of sterile, single-use disposable handpiece/tubing assembly and reusable HydroCision Console. Handpiece features two-lumen needle; high-pressure saline lumen delivers fluid; evacuation lumen removes debrided tissue/saline via Venturi effect. Operated by surgeon in OR using foot pedal; guided by fluoroscopy. Console provides pressurized saline and features touch-screen GUI. Device enables precise tissue removal; benefits include minimally invasive access to diseased spinal tissue. Output is physical tissue removal; healthcare provider uses visual feedback from fluoroscopy to guide handpiece. System is a modification of ArthroJet (K041233), extending working lengths and removing obsolete cautery/burr components.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing (performance verification), human factors/usability study (IEC 62366-1:2015), electromagnetic compatibility/electrical safety testing (IEC 60601-1, IEC 60601-1-2), and risk analysis (ISO 14971).

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) creating Venturi suction. Connectivity: Console-based with foot pedal. Sterilization: Ethylene oxide (EtO). Software: Console-based GUI.

Indications for Use

Indicated for patients undergoing open or minimally invasive spinal surgery requiring soft tissue cutting/removal and hard tissue/bone ablation, decortication, or smoothing.

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)

Reference Devices

• HydroCision Console (K190804)

Submission Summary (Full Text)

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April 16, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below it.

HydroCision, Inc. % Yashesh Rawal Regulatory Affairs Specialist II MAE Consulting Group, LLC 119 North Road Deerfield, New Hampshire 03037

Re: K200729

Trade/Device Name: HydroCision SpineJet System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: March 15, 2020 Received: March 20, 2020

# Dear Yashesh 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/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 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

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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 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,

Jesse Muir, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

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

510(k) Number (if known) K200729

Device Name

HydroCision SpineJet System

#### Indications for Use (Describe)

The HydroCision Spinelet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive in spinal surgeries.

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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# Section 5- 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 HydroCision Spinelet System.

5.1.Applicant:

HydroCision, Inc. 267 Boston Rd, North Billerica, MA 01862

5.2.Sponsor Contact Person:

Mr. Mark Lewis Vice President Operations and Regulatory Affairs HydroCision, Inc. 267 Boston Rd, North Billerica, MA 01862 Phone: [phone] Email: [e-mail]

5.3.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]

- 5.4.Date Prepared: March 13, 2020
### 5.5.Device Information:

Proprietary Name: HydroCision SpineJet System

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

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### 5.6.Predicate Device:

HydroCision ArthroJet with Cautery, TurboBurr and Curette (K041233). HydroCision ArthroJet System has been rebranded to HydroCision SpineJet System.

The purpose of this Special 510(k) submission is to implement design changes to the predicate ArthroJet System (K041233) to create a product line extensions with additional working length to encompass different configurations of Spinelet handpiece models and remove obsolete components for Cautery, TurboBurr and Curette from the predicate device. These modifications to the 510(k) cleared ArthroJet System do not change the indications for use of the device, nor do they change the fundamental scientific technology of the device.

#### 5.7.Device Description:

The HydroCision SpineJet System comprises of (i) sterile disposable tubing assembly- SpineJet device and (ii) reusable console unit- HydroCision Console. The components of SpineJet device consists of a pump cartridge, handpiece and tubing assembly (also known as disposable hose). The SpineJet device is provided sterile, via ethylene oxide sterilization. The reusable HydroCision Console are packaged and sold separately. The SpineJet device is designed to be used in combination with the HydroCision console as a SpineJet system. The SpineJet system is connected with a foot pedal, a sterile bag of saline, and a waste container prior to operation.

The SpineJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the SpineJet device and pressurizes the saline to deliver to the tip of the SpineJet handpiece through high pressure saline tube. The SpineJet 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 SpineJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline from saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of Spinelet 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.

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The Hydrocision Console (K190804) is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the SpineJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface.

To perform an open or minimally invasive spinal procedure, the SpineJet handpiece needle is inserted into the spine through cannula access set and guided toward the targeted diseased tissue under fluoroscopic guidance. Once the Spinelet handpiece needle is in position, the surgeon activates the high-pressure saline of Spinelet device using the Hydrocision console and foot pedal. Using fluoroscopic guidance, the surgeon uses the Spinelet handpiece to cut 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 procedure.

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

- 5.8.Indication for Use:
The HydroCision SpineJet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive spinal surgeries.

### 5.9.Comparison of Technological Characteristics:

The HydroCision SpineJet System is substantially equivalent in intended use, design, performance and principles of operation to the predicate device- HydroCision ArthroJet with Cautery, TurboBurr and Curette (K041233). Both systems include same principle components- (i) Spinelet device consisting of a pump cartridge, handpiece and tubing assembly (disposable hose) and (ii) HydroCision console. 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 in the design of the HydroCision SpineJet device and the predicate device are minor and raise no new issues of safety or efficacy. The HydroCision SpineJet 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.

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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 SpineJet System | Predicate Device:<br>HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K041233 |
| Indication for<br>Use | The HydroCision SpineJet System is<br>indicated for surgical procedures where<br>the cutting and removal of soft tissue<br>and the ablation and removal of hard<br>tissue or bone is required. Specific<br>functions include cutting, ablation and<br>shaping of soft tissue, and decorticating<br>and smoothing of bone, cartilage and<br>other bone related tissue in open and<br>minimally invasive spinal surgeries. | The HydroCision ArthroJet System with<br>Cautery, TurboBurr, and Curette is<br>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 SpineJet 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<br>nozzle to another at the distal tip of the<br>SpineJet 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. | 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 System<br>Components | Handpiece, Pump Cartridge and Tubing<br>Assembly | Handpiece, Pump Cartridge and Tubing<br>Assembly |
| Comparative<br>Characteristics | Proposed Device:<br>HydroCision SpineJet System | Predicate Device:<br>HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
| (Sterile,<br>Disposable,<br>Single Use) | | |
| Principle System<br>Components/<br>Other devices for<br>interfacing<br>(Reusable) | HydroCision Console Unit, Foot Pedal | HydroCision Console Unit, Foot Pedal |
| Accessories/<br>Convenience Kit | No | No |
| 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 | 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" |
| Comparative<br>Characteristics | Proposed Device:<br>HydroCision SpineJet System | Predicate Device:<br>HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
| Handpiece<br>Dimension | Include models of additional length.<br>The dimensional range of Modified<br>device is within the dimensional<br>specification cleared for the predicate<br>device- ArthroJet system. | |
| | Tubing Assembly:<br>High Pressure Hose - 0.143"OD, 0.050"<br>ID | Tubing Assembly: (Identical)<br>High Pressure Hose - 0.143"OD, 0.050"<br>ID |
| | Evacuation Tube Hose - 0.125"OD,<br>0.059" ID | Evacuation Tube Hose - 0.125"OD,<br>0.059" ID |
| | Handle: (Identical)<br>Device Handle Weldment Length-<br>4.593" | Handle: (Identical)<br>Device Handle Weldment Length- 4.593" |
| | Needle:<br>High Pressure lumen/jet tube- 0.045<br>OD, 0.020 ID<br>Evacuation Tube lumen- 0.072 OD,<br>0.063 ID | Needle: (Identical)<br>High Pressure lumen/jet tube- 0.045 OD,<br>0.020 ID<br>Evacuation Tube lumen- 0.072 OD, 0.063<br>ID |
| | Needle Angle:<br>10 Deg, 20 Deg, 30 Deg, 75 Deg | Needle Angle: (Identical)<br>10 Deg, 20 Deg, 30 Deg, 75 Deg |
| | Working Shaft Length (Needle Length) -<br>Additional Models:<br>6.70", 7.61", 7.62", 7.66", 7.739",<br>7.76", 8.28", 8.30", 8.92", 8.96", 13.78" | Working Shaft Length (Needle Length):<br>6.7", 13.78" |
| Comparative<br>Characteristics | Proposed Device:<br>HydroCision SpineJet System | Predicate Device:<br>HydroCision ArthroJet with Cautery,<br>TurboBurr and Curette |
| Device Needle | The SpineJet 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. | Identical |
| 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…