(27 days)
No
The description focuses on the mechanical and hydraulic aspects of the device for tissue cutting and removal, with software primarily for the user interface. There is no mention of AI or ML for decision-making, image analysis, or automated control.
No.
The device is used for cutting and removing tissue/bone, which is a surgical procedure, not a therapeutic application.
No
The device is described as being used for cutting, ablation, and removal of tissue in surgical procedures, which are therapeutic functions, not diagnostic ones. While it mentions fluoroscopic guidance, this is for real-time visualization during the procedure, not for pre-procedural diagnosis by the device itself.
No
The device description clearly outlines physical components including a sterile disposable tubing assembly (SpineJet device) and a reusable console unit (HydroCision Console), which are hardware. While the console includes software functionality, the device as a whole is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a system that uses high-pressure saline to cut and remove tissue in vivo (within the living body). It involves a handpiece inserted into the spine and a console to control the process.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on surgical intervention and tissue removal during a procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
HRX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic guidance
Anatomical Site
spinal surgeries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, hospital/surgical facility
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 used to support previously 510(k) cleared device has been conducted to verify that the modified SpineJet device safety, functionality, and performance characteristics is substantially equivalent to the predicate device, and the Spinelet device will perform as intended.
- A Human Factors / Usability Study was conducted, and the HydroCision SpineJet System with the HydroCision Console 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 modified SpineJet device and HydroCision Console 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
- A risk analysis according to ISO standard "14971 Medical Devices – Application of risk management to medical devices" was carried out specifically for the changes made between the ArthroJet system and the modified HydroCision SpineJet system. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode and Effect Analysis" technique.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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FORM FDA 3881 (7/17)
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3
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: +1(978)289-1333 Email: mlewis@hydrocision.com
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: +1(603)340-7081 Email: yasheshr@maegroups.com
- 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 |
4
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.
5
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.
6
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 SpineJet System | Predicate Device:
HydroCision ArthroJet with Cautery,
TurboBurr and Curette |
|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K041233 |
| 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. | The HydroCision ArthroJet System with
Cautery, TurboBurr, and Curette is
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 SpineJet 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
SpineJet 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 System
Components | Handpiece, Pump Cartridge and Tubing
Assembly | Handpiece, Pump Cartridge and Tubing
Assembly |
| Comparative
Characteristics | Proposed Device:
HydroCision SpineJet System | Predicate Device:
HydroCision ArthroJet with Cautery,
TurboBurr and Curette |
| (Sterile,
Disposable,
Single Use) | | |
| Principle System
Components/
Other devices for
interfacing
(Reusable) | HydroCision Console Unit, Foot Pedal | HydroCision Console Unit, Foot Pedal |
| Accessories/
Convenience Kit | No | No |
| 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 | 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" |
| Comparative
Characteristics | Proposed Device:
HydroCision SpineJet System | Predicate Device:
HydroCision ArthroJet with Cautery,
TurboBurr and Curette |
| Handpiece
Dimension | Include models of additional length.
The dimensional range of Modified
device is within the dimensional
specification cleared for the predicate
device- ArthroJet system. | |
| | Tubing Assembly:
High Pressure Hose - 0.143"OD, 0.050"
ID | Tubing Assembly: (Identical)
High Pressure Hose - 0.143"OD, 0.050"
ID |
| | Evacuation Tube Hose - 0.125"OD,
0.059" ID | Evacuation Tube Hose - 0.125"OD,
0.059" ID |
| | Handle: (Identical)
Device Handle Weldment Length-
4.593" | Handle: (Identical)
Device Handle Weldment Length- 4.593" |
| | Needle:
High Pressure lumen/jet tube- 0.045
OD, 0.020 ID
Evacuation Tube lumen- 0.072 OD,
0.063 ID | Needle: (Identical)
High Pressure lumen/jet tube- 0.045 OD,
0.020 ID
Evacuation Tube lumen- 0.072 OD, 0.063
ID |
| | Needle Angle:
10 Deg, 20 Deg, 30 Deg, 75 Deg | Needle Angle: (Identical)
10 Deg, 20 Deg, 30 Deg, 75 Deg |
| | Working Shaft Length (Needle Length) -
Additional Models:
6.70", 7.61", 7.62", 7.66", 7.739",
7.76", 8.28", 8.30", 8.92", 8.96", 13.78" | Working Shaft Length (Needle Length):
6.7", 13.78" |
| Comparative
Characteristics | Proposed Device:
HydroCision SpineJet System | Predicate Device:
HydroCision ArthroJet with Cautery,
TurboBurr and Curette |
| Device Needle | The SpineJet 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. | Identical |
| 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
(K190804) | Dimensions: 16" W x 13" D x 7" H
Weight: 28lbs
Power: 100-240 V ~ 6A 50/60 Hz
Not Software Driven
(K041233) |
| 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 drilling and reaming
of bone, cartilage and other bone related tissue in a variety of surgical
procedures. The predicate device includes additional components for drilling
and reaming which are TurboBurr, Cautery and Curette. These components
are obsoleted and removed for the HydroCision SpineJet device. The claims
associated with the obsolete components were removed from the indication
for use of SpineJet device.
● The indications for use of the HydroCision SpineJet device is a subset of the
predicate device indication for use. Both the HydroCision SpineJet device and
the predicate device are single use disposable devices indicated for use
surgical procedures where the cutting and removal of soft tissue and the
ablation and removal of hard tissue or bone is required.
Technological Characteristics
● The HydroCision ArthroJet System has been re-branded to HydroCision
SpineJet system with the dimensional changes to handpiece and removal of
obsolete components. | |
7
8
HydroCision SpineJet System- Special 510(k)
9
10
HydroCision SpineJet System- Special 510(k)
11
5.10. Summary of Testing
To ensure that the modified device design and construction are suitable for the intended use and is substantially equivalent, the HydroCision SpineJet System has been evaluated in the following tests:
- . Performance Bench testing used to support previously 510(k) cleared device has been conducted to verify that the modified SpineJet device safety, functionality, and performance characteristics is substantially equivalent to the predicate device, and the Spinelet device will perform as intended.
- . A Human Factors / Usability Study was conducted, and the HydroCision SpineJet System with the HydroCision Console 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 modified SpineJet device and HydroCision Console 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
- . A risk analysis according to ISO standard "14971 Medical Devices – Application of risk management to medical devices" was carried out specifically for the changes made between the ArthroJet system and the modified HydroCision SpineJet system. Possible hazards and consequences were systematically identified and evaluated by using the "Failure Mode and Effect Analysis" technique.
5.11. Conclusion:
The modified HydroCision SpineJet system 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 Spinelet System is considered substantially equivalent to the predicate device.
The safety and effectiveness of the HydroCision SpineJet system are adequately supported by the Non-Clinical performance data, substantial equivalence information, and comparison of design characteristics provided within this premarket notification.