(68 days)
Not Found
No
The description focuses on the mechanical and fluid dynamics of the device for tissue cutting and removal, controlled by a console with basic software for display and user interface. There is no mention of AI/ML in the intended use, device description, or performance studies.
Yes.
The device is used for cutting, debridement, and removal of soft and hard tissue in orthopedic surgical procedures, which are therapeutic interventions.
No.
The device is designed for cutting, debridement, and removal of tissue in surgical procedures, not for diagnosing conditions. While it is used with ultrasound visualization, the ultrasound is for guidance during the surgical procedure, not for diagnostic purposes by the device itself.
No
The device description clearly outlines physical components like a pump cartridge, handpiece, tubing assembly, and console, which are hardware. While the console includes software functionality, the device as a whole is not software-only.
Based on the provided text, the HydroCision TenJet Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "orthopedic surgical procedures where the cutting, debridement and removal of soft and hard tissue is required." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a device that uses pressurized saline to cut and remove tissue in vivo (within the body). It is used in conjunction with a console and foot pedal to perform surgical procedures.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The TenJet device does not perform any such analysis of specimens.
Therefore, the HydroCision TenJet Device is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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 TenJet 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Orthopedic surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- TenJet weldment burst testing
- TenJet weldment strength testing
- TenJet Sharp Tip Testing
- 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
- Cytotoxicity
- Sensitization
- EO Residual
- Irritation / Intracutaneous reactivity
- Material Mediated Pyrogenicity
- Acute Systemic Toxicity
Sterilization by ethylene oxide has been validated for HydroCision TenJet device.
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:
- IEC 60601-1
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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.
-
- 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
-
- 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.
-
- 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.
-
- 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).
- Device Description:
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.
-
- 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.
- Indication for Use:
-
- 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.
- Comparison of Technological Characteristics:
Below is a comparison table that provides a top-level overview of the substantial equivalent comparison between proposed and predicate devices.
| Comparative
Characteristics | Proposed Device:
HydroCision TenJet Device | Predicate Device:
HydroCision ArthroJet with Cautery,
TurboBurr and Curette |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K041233 |
| Indication for
Use | The HydroCision TenJet Device is
indicated for orthopedic surgical | The HydroCision ArthroJet System with
Cautery, 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 and
hard tissue is required in a variety of
open, arthroscopic, and minimally
invasive surgical procedures | indicated for orthopedic surgical
procedures where the cutting and
removal of soft tissue and the ablation
and removal of hard tissue or bone is
required with control of bleeding during
those procedures as needed. Specific
functions include cutting, ablation and
shaping of the soft tissue, and drilling,
reaming, decorticating and smoothing of
bone, cartilage and other bone related
tissue in a variety of surgical procedures
including open and minimally invasive
spinal surgeries and small and large joint
arthroscopic procedures. |
| Principle of
Operation | The TenJet device uses a high-pressure
saline to act as a cutting medium to
debride and remove targeted tissue
material in the intended procedures.
As the high-pressure saline flows from
the one needle lumen nozzle to
another at the distal tip of the TenJet
device, a Venturi effect creates
localized suction pulling nearby target
tissue into the path of the high-
pressure saline stream where it is cut,
debrided and then passes into the
evacuation tube to be removed. | The ArthroJet device uses a high-
pressure saline to act as a cutting
medium to debride and remove
targeted tissue material in the intended
procedures. As the high pressure saline
flows from the one needle lumen nozzle
to another at the distal tip of the
ArthroJet device, a Venturi effect
creates localized suction pulling nearby
target tissue into the path of the high
pressure saline stream where it is cut,
debrided and then passes into the
evacuation tube to be removed. |
| Single Use | Yes | Yes |
| Principle Device
Components
(Sterile,
Disposable,
Single Use) | Handpiece, Pump Cartridge and Tubing
Assembly | Handpiece, Pump Cartridge and Tubing
Assembly |
| Other devices for
interfacing | HydroCision Console Unit, Foot Pedal | HydroCision Console Unit, Foot Pedal |
| Accessories/
Convenience Kit | Yes, an accessory kit is provided with
the TenJet device. The accessory kit
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
the surgical site preparation and
closure. These include a syringe and
needle, scalpel, an ultrasound probe
cover, gauze, chloraprep, closure strips
and dressing. | |
| Sterilization | Supplied Sterile, EtO Sterilization | Supplied Sterile, EtO Sterilization |
| Materials | | |
| Handpiece
Handle | ABS | ABS |
| Handpiece
Needle | Stainless Steel | Stainless Steel |
| Pump Cartridge | Stainless Steel | Stainless Steel |
| High Pressure
Tubing Assembly | Polyamide | Polyamide |
| Evacuation
Tubing Assembly | Polyurethane | Polyurethane |
| Medical Adhesive | Loctite #4011 | Loctite #4011 |
| Biocompatibility
of Materials | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements |
| Technical Features/Design | | |
| Tubing Assembly
Dimension
(Disposable
Hose) | High Pressure Hose - 0.143"OD, 0.050"
ID
Evacuation Tube Hose - 0.125"OD,
0.059" ID | Identical.
High Pressure Hose - 0.143"OD, 0.050"
ID
Evacuation Tube Hose - 0.125"OD,
0.059" ID |
| Pump Cartridge
Dimension | Handle Cartridge - Length - 2.00"
Piston Body- Length- 1.860
Suction Connector- Length- 1.6" | Identical.
Handle Cartridge - Length - 2.00"
Piston Body- Length- 1.860
Suction Connector- Length- 1.6" |
| Handpiece
Dimension | 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 |
| Comparative
Characteristics | Proposed Device:
HydroCision TenJet Device | Predicate Device:
HydroCision ArthroJet with Cautery,
TurboBurr and Curette |
| Device Needle | The TenJet handpiece needle consists
of two lumens: high pressure tube
lumen and evacuation tube lumen,
which are welded together. The high-
pressure tube lumen delivers high
pressure saline to the target tissue site.
The evacuation tube lumen evacuates
the saline and debrided tissue material
from the target tissue site.
The TenJet two-lumen needle tip
also includes pointed cap, which is
welded at the top of the two
lumens. The high-pressure lumen nozzle is at
50-degree angle to the evacuation
lumen, so as to accommodate the
pointed cap at the top and that high-
pressure saline jet is directed into
the evacuation lumen when in use. | The ArthroJet handpiece needle consists
of two lumens: high pressure tube
lumen and evacuation tube lumen,
which are welded together. The high-
pressure lumen delivers high pressure
saline to the target tissue site. The
evacuation lumen evacuates the saline
and debrided tissue material from the
target tissue site.
The ArthroJet handpiece needle does
not include a pointed cap. The high-pressure lumen nozzle is at
0-degree angle to the evacuation
lumen, so that high pressure saline
jet is directed into the evacuation
lumen when in use. |
| High Pressure
Saline Flow Rate
(at the pump
cartridge) | 230 ml/min at 15,000 psi
156 ml/min at 7,500 psi | 230 ml/min at 15,000 psi
156 ml/min at 7,500 psi |
| HydroCision
Console | Dimensions: 8.7" W x 17.5" D x 11.5" H
Weight: 30lbs
Power: 100-240 V ~ 6A 50/60 Hz
Software driven | Dimensions: 16" W x 13" D x 7" H
Weight: 28lbs
Power: 100-240 V ~ 6A 50/60 Hz
Not Software Driven |
| Packaging
Description | Blister tray, Tyvek led seal, Tyvek
pouch, unit box. | Sealed mylar/Tyvek pouch or a PETG
tray with a sealed Tyvek lid. |
| Do the Devices
Have the Same
Indication for
Use and
Technological
Characteristics
and are
substantially
equivalent? | 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
| Comparative
Characteristics | 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.