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 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).

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets those criteria.

Based on the provided text, the device in question (HydroCision TenJet Device) is a medical device and not an AI/ML enabled device. Therefore, a significant portion of the requested information, specifically regarding AI/ML related studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone performance, etc.), is not applicable and cannot be extracted from this document.

The document details a 510(k) premarket notification for a medical device that uses high-pressure saline for tissue debridement. The "acceptance criteria" and "proof" in this context are related to demonstrating substantial equivalence to a previously cleared predicate device, rather than performance metrics of an AI model.

The "studies" are primarily non-clinical bench testing, biocompatibility testing, human factors/usability studies, and electrical/EMC testing, all aimed at confirming the device's safety and effectiveness compared to the predicate and applicable standards.

Breakdown of Applicable Information from the Provided Text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a single, concise table of acceptance criteria with corresponding performance for each. Instead, it describes general conformance to standards and internal test protocols to prove substantial equivalence. The "acceptance criteria" can be inferred from the types of tests conducted and their successful completion.

Acceptance Criterion (Inferred)	Reported Device Performance / Proof
Performance (Substantial Equivalence to Predicate)
TenJet Weldment Burst Strength	Testing verified performance is substantially equivalent to predicate and performs as intended.
TenJet Weldment Strength	Testing verified performance is substantially equivalent to predicate and performs as intended.
TenJet Sharp Tip Testing	Testing verified performance is substantially equivalent to predicate and performs as intended.
TenJet Tissue Differentiation- Safety and Efficacy (Bovine and Cadaver)	Testing verified performance is substantially equivalent to predicate and performs as intended.
Biocompatibility (per ISO 10993-1:2009 and FDA guidance)	All tests passed: Cytotoxicity, Sensitization, EO Residual, Irritation / Intracutaneous reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity.
Sterilization Efficacy (Ethylene Oxide)	Validation performed and passed.
Human Factors / Usability (per IEC 62366-1:2015)	Device found in conformance.
Electromagnetic Compatibility (EMC) & Electrical Safety (per IEC 60601-1, IEC 60601-1-2)	Device found to comply with applicable parts of the standards.
Software Development & Validation	Software developed, verified, tested, and validated to company's documented procedures.
Risk Analysis (per ISO 14971)	Carried out, hazards identified and evaluated; no safety and efficacy issues raised.
Overall Safety and Effectiveness	Adequately supported by Non-Clinical performance data, substantial equivalence information, materials information, and comparison of design characteristics.

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size:
- For TenJet Tissue Differentiation- Safety and Efficacy, the text mentions "Bovine and Cadaver" tissue. It does not specify the number of bovine or cadaver samples used.
- For other bench tests, biocompatibility, human factors, and electrical testing, specific sample sizes are not provided.
Data Provenance:
- The studies appear to be non-clinical, laboratory-based tests. The country of origin for the data is implied to be the US, as the company (HydroCision, Inc.) and consultants are based in the US, and it's a submission to the US FDA.
- The data is inherently prospective in nature, as it was generated specifically for this 510(k) submission to demonstrate compliance and substantial equivalence before market clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not Applicable / Not Provided. This type of information is relevant for AI/ML performance studies, not for the types of non-clinical device performance studies described here for a mechanical/fluidic device. The "ground truth" for these tests are objective measurements, pass/fail criteria based on standards, or comparison to the predicate device's established performance.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or expert review processes, especially for image analysis or diagnostic tasks, which are not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-enabled device. Therefore, no MRMC comparative effectiveness study involving AI assistance would have been conducted or is mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an AI-enabled device. Software is mentioned for the console's functionality (touch-screen LCD display, graphical user interface), and it states "The HydroCision console software has been developed, verified, tested and validated to the company's documented development and test procedures." This refers to standard medical device software validation, not standalone AI algorithm performance.

7. The Type of Ground Truth Used:

The "ground truth" for the various tests were:
- Bench Testing: Objective physical measurements, comparison to predicate device characteristics, and observed performance on specific tissue types (bovine and cadaver).
- Biocompatibility: Established ISO standards (ISO 10993-1:2009) and FDA guidance for toxicology and material safety.
- Sterilization: Industry standards for ethylene oxide sterilization validation.
- Human Factors/Usability: Conformance to IEC 62366-1:2015.
- EMC/Electrical Safety: Conformance to IEC 60601-1 and IEC 60601-1-2.
- Software: Conformance to the company's documented development and test procedures.
- The document explicitly states: "Clinical evidence was not necessary to show substantial equivalence." This means that ground truth from patient outcomes or extensive clinical trials was not used for this submission.

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device. No training set for an algorithm is mentioned.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no AI/ML training set, this question is not relevant.

Summary

{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 (100) 445-6740 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: +1(978)289-1333 Email: mlewis@hydrocision.com
1. Regulatory Correspondent/ 510(k) Submission Contact: Mr. Yashesh Rawal, MS Regulatory Affairs Specialist MAE Consulting Group, LLC 119 North Road, Deerfield, NH 03037 Phone: +1(603)340-7081 Email: yasheshr@maegroups.com
Date Prepared: March 27, 2019 4.
1. 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.

1. 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).

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

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

1. 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.
1. 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.

ComparativeCharacteristics	Proposed Device:HydroCision TenJet Device	Predicate Device:HydroCision ArthroJet with Cautery,TurboBurr and Curette
510(k) Number	N/A	K041233
Indication forUse	The HydroCision TenJet Device isindicated for orthopedic surgical	The HydroCision ArthroJet System withCautery, TurboBurr, and Curette is
Comparative	Proposed Device:	Predicate Device:
Characteristics	HydroCision TenJet Device	HydroCision ArthroJet with Cautery,TurboBurr and Curette
	procedures where the cutting,debridement and removal of soft andhard tissue is required in a variety ofopen, arthroscopic, and minimallyinvasive surgical procedures	indicated for orthopedic surgicalprocedures where the cutting andremoval of soft tissue and the ablationand removal of hard tissue or bone isrequired with control of bleeding duringthose procedures as needed. Specificfunctions include cutting, ablation andshaping of the soft tissue, and drilling,reaming, decorticating and smoothing ofbone, cartilage and other bone relatedtissue in a variety of surgical proceduresincluding open and minimally invasivespinal surgeries and small and large jointarthroscopic procedures.
Principle ofOperation	The TenJet device uses a high-pressuresaline to act as a cutting medium todebride and remove targeted tissuematerial in the intended procedures.As the high-pressure saline flows fromthe one needle lumen nozzle toanother at the distal tip of the TenJetdevice, a Venturi effect createslocalized suction pulling nearby targettissue into the path of the high-pressure saline stream where it is cut,debrided and then passes into theevacuation tube to be removed.	The ArthroJet device uses a high-pressure saline to act as a cuttingmedium to debride and removetargeted tissue material in the intendedprocedures. As the high pressure salineflows from the one needle lumen nozzleto another at the distal tip of theArthroJet device, a Venturi effectcreates localized suction pulling nearbytarget tissue into the path of the highpressure saline stream where it is cut,debrided and then passes into theevacuation tube to be removed.
Single Use	Yes	Yes
Principle DeviceComponents(Sterile,Disposable,Single Use)	Handpiece, Pump Cartridge and TubingAssembly	Handpiece, Pump Cartridge and TubingAssembly
Other devices forinterfacing	HydroCision Console Unit, Foot Pedal	HydroCision Console Unit, Foot Pedal
Accessories/Convenience Kit	Yes, an accessory kit is provided withthe TenJet device. The accessory kitcontains 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 inthe surgical site preparation andclosure. These include a syringe andneedle, scalpel, an ultrasound probecover, gauze, chloraprep, closure stripsand dressing.
Sterilization	Supplied Sterile, EtO Sterilization	Supplied Sterile, EtO Sterilization
Materials
HandpieceHandle	ABS	ABS
HandpieceNeedle	Stainless Steel	Stainless Steel
Pump Cartridge	Stainless Steel	Stainless Steel
High PressureTubing Assembly	Polyamide	Polyamide
EvacuationTubing Assembly	Polyurethane	Polyurethane
Medical Adhesive	Loctite #4011	Loctite #4011
Biocompatibilityof Materials	Meets ISO 10993-1 requirements	Meets ISO 10993-1 requirements
Technical Features/Design
Tubing AssemblyDimension(DisposableHose)	High Pressure Hose - 0.143"OD, 0.050"IDEvacuation Tube Hose - 0.125"OD,0.059" ID	Identical.High Pressure Hose - 0.143"OD, 0.050"IDEvacuation Tube Hose - 0.125"OD,0.059" ID
Pump CartridgeDimension	Handle Cartridge - Length - 2.00"Piston Body- Length- 1.860Suction Connector- Length- 1.6"	Identical.Handle Cartridge - Length - 2.00"Piston Body- Length- 1.860Suction Connector- Length- 1.6"
HandpieceDimension	Handle:Device Handle Weldment Length- 5.41"	Handle:Device Handle Weldment Length- 4.593"
	Needle:Two-Lumen Needle Length- 5.224"High Pressure lumen/jet tube- 0.025 OD, 0.013 ID	Needle:Two-Lumen Needle Length- 9.832"High Pressure lumen/jet tube- 0.045 OD, 0.020 ID
ComparativeCharacteristics	Proposed Device:HydroCision TenJet Device	Predicate Device:HydroCision ArthroJet with Cautery,TurboBurr and Curette
Device Needle	The TenJet handpiece needle consistsof two lumens: high pressure tubelumen and evacuation tube lumen,which are welded together. The high-pressure tube lumen delivers highpressure saline to the target tissue site.The evacuation tube lumen evacuatesthe saline and debrided tissue materialfrom the target tissue site.The TenJet two-lumen needle tipalso includes pointed cap, which iswelded at the top of the twolumens. The high-pressure lumen nozzle is at50-degree angle to the evacuationlumen, so as to accommodate thepointed cap at the top and that high-pressure saline jet is directed intothe evacuation lumen when in use.	The ArthroJet handpiece needle consistsof two lumens: high pressure tubelumen and evacuation tube lumen,which are welded together. The high-pressure lumen delivers high pressuresaline to the target tissue site. Theevacuation lumen evacuates the salineand debrided tissue material from thetarget tissue site.The ArthroJet handpiece needle doesnot include a pointed cap. The high-pressure lumen nozzle is at0-degree angle to the evacuationlumen, so that high pressure salinejet is directed into the evacuationlumen when in use.
High PressureSaline Flow Rate(at the pumpcartridge)	230 ml/min at 15,000 psi156 ml/min at 7,500 psi	230 ml/min at 15,000 psi156 ml/min at 7,500 psi
HydroCisionConsole	Dimensions: 8.7" W x 17.5" D x 11.5" HWeight: 30lbsPower: 100-240 V ~ 6A 50/60 HzSoftware driven	Dimensions: 16" W x 13" D x 7" HWeight: 28lbsPower: 100-240 V ~ 6A 50/60 HzNot Software Driven
PackagingDescription	Blister tray, Tyvek led seal, Tyvekpouch, unit box.	Sealed mylar/Tyvek pouch or a PETGtray with a sealed Tyvek lid.
Do the DevicesHave the SameIndication forUse andTechnologicalCharacteristicsand aresubstantiallyequivalent?	Indications for Use Statement: 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}------------------------------------------------

ComparativeCharacteristics	Proposed Device:HydroCision TenJet Device	Predicate Device:HydroCision ArthroJet with Cautery,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.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.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.