(27 days)
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.
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.
This is a medical device 510(k) summary for the HydroCision SpineJet System. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study of the device's clinical performance against acceptance criteria in the way a novel AI/software medical device might.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number and qualifications of experts, adjudication methods, MRMC studies, type of ground truth) are not applicable or not provided in this type of submission.
Here's a breakdown of the information provided, tailored to your request where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria and corresponding performance metrics for the HydroCision SpineJet System in the context of a clinical study. Instead, the submission focuses on validating that the modified device maintains the safety, functionality, and performance characteristics substantially equivalent to its predicate device.
The "acceptance criteria" are implied to be adherence to various engineering standards and confirmation that the design changes do not negatively impact the device's function or safety.
| Acceptance Criteria Category | Reported Device Performance / Compliance |
|---|---|
| Performance Bench Testing | The modified SpineJet device's safety, functionality, and performance characteristics were verified to be substantially equivalent to the predicate device. The SpineJet device will perform as intended. |
| Human Factors / Usability | Found to be in conformance with IEC 62366-1:2015 Medical devices – Application of usability engineering to medical devices. |
| Electromagnetic Compatibility & Electrical Safety | Tested and found to comply with applicable parts of IEC 60601-1 and IEC 60601-1-2. |
| Risk Analysis | A risk analysis according to ISO 14971 was carried out, systematically identifying and evaluating hazards and consequences using "Failure Mode and Effect Analysis." |
| Overall Conclusion | The modified HydroCision SpineJet system met all predetermined acceptance criteria as specified by applicable standards, FDA guidance documents, and internal test protocols. No safety and efficacy issues were raised. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as there was no clinical test set in the sense of patient data for evaluating a diagnostic or predictive algorithm. The testing described is primarily engineering bench testing and compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of diagnostic performance, is not established for this type of submission.
4. Adjudication Method for the Test Set
Not applicable.
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
Not applicable. This device is a surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, safety standards, and functional equivalence to its predicate device through bench testing rather than clinical outcomes or diagnostic accuracy.
8. The Sample Size for the Training Set
Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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April 16, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below it.
HydroCision, Inc. % Yashesh Rawal Regulatory Affairs Specialist II MAE Consulting Group, LLC 119 North Road Deerfield, New Hampshire 03037
Re: K200729
Trade/Device Name: HydroCision SpineJet System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: March 15, 2020 Received: March 20, 2020
Dear Yashesh Rawal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No, 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K200729
Device Name
HydroCision SpineJet System
Indications for Use (Describe)
The HydroCision Spinelet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive in spinal surgeries.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5- 510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the HydroCision Spinelet System.
5.1.Applicant:
HydroCision, Inc. 267 Boston Rd, North Billerica, MA 01862
5.2.Sponsor Contact Person:
Mr. Mark Lewis Vice President Operations and Regulatory Affairs HydroCision, Inc. 267 Boston Rd, North Billerica, MA 01862 Phone: +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 |
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5.6.Predicate Device:
HydroCision ArthroJet with Cautery, TurboBurr and Curette (K041233). HydroCision ArthroJet System has been rebranded to HydroCision SpineJet System.
The purpose of this Special 510(k) submission is to implement design changes to the predicate ArthroJet System (K041233) to create a product line extensions with additional working length to encompass different configurations of Spinelet handpiece models and remove obsolete components for Cautery, TurboBurr and Curette from the predicate device. These modifications to the 510(k) cleared ArthroJet System do not change the indications for use of the device, nor do they change the fundamental scientific technology of the device.
5.7.Device Description:
The HydroCision SpineJet System comprises of (i) sterile disposable tubing assembly- SpineJet device and (ii) reusable console unit- HydroCision Console. The components of SpineJet device consists of a pump cartridge, handpiece and tubing assembly (also known as disposable hose). The SpineJet device is provided sterile, via ethylene oxide sterilization. The reusable HydroCision Console are packaged and sold separately. The SpineJet device is designed to be used in combination with the HydroCision console as a SpineJet system. The SpineJet system is connected with a foot pedal, a sterile bag of saline, and a waste container prior to operation.
The SpineJet device pump cartridge plugs into the front of the HydroCision Console. This connection provides power to the SpineJet device and pressurizes the saline to deliver to the tip of the SpineJet handpiece through high pressure saline tube. The SpineJet handpiece consists of a plastic handle and a two-lumen needle: high pressure tube lumen and evacuation tube lumen, which are welded together in the handle. As the high-pressure saline passes from one lumen nozzle to another lumen nozzle, the targeted tissues are cut, debrided and removed into the evacuation tube lumen, passing into the waste container. The SpineJet tubing assembly (also known as disposable hose) consists of three tubes: (i) Clear saline supply tube (fluid supply hose) - which delivers saline from saline bag to pump cartridge (ii) High pressure saline tube- which delivers pressurized saline from the pump cartridge to the tip of Spinelet handpiece and (iii) Evacuation tube (waste hose) - which removes debrided tissue, along with saline from tip of the handpiece and delivers it to waste container, which is provided by the facility.
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The Hydrocision Console (K190804) is an electrically powered device. It provides the power to pressurize sterile saline fluid, which is delivered to the distal tip of the SpineJet handpiece. The HydroCision console includes the software functionality to provide touch-screen LCD display and graphical user interface.
To perform an open or minimally invasive spinal procedure, the SpineJet handpiece needle is inserted into the spine through cannula access set and guided toward the targeted diseased tissue under fluoroscopic guidance. Once the Spinelet handpiece needle is in position, the surgeon activates the high-pressure saline of Spinelet device using the Hydrocision console and foot pedal. Using fluoroscopic guidance, the surgeon uses the Spinelet handpiece to cut and remove the targeted diseased tissue. When the procedure is complete, the handpiece is withdrawn, and the incision is closed using steri-strips for a closed, minimally invasive procedure.
The Spinelet device is provided sterile, via ethylene oxide sterilization.
- 5.8.Indication for Use:
The HydroCision SpineJet System is indicated for surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required. Specific functions include cutting, ablation and shaping of soft tissue, and decorticating and smoothing of bone, cartilage and other bone related tissue in open and minimally invasive spinal surgeries.
5.9.Comparison of Technological Characteristics:
The HydroCision SpineJet System is substantially equivalent in intended use, design, performance and principles of operation to the predicate device- HydroCision ArthroJet with Cautery, TurboBurr and Curette (K041233). Both systems include same principle components- (i) Spinelet device consisting of a pump cartridge, handpiece and tubing assembly (disposable hose) and (ii) HydroCision console. The handpiece component of both devices consists of a plastic handle and a two-lumen needle welded in the handle. Both devices are designed to be connected with the HydroCision console, foot pedal, a sterile bag of saline (which is supplied by the facility), and a waste container (supplied by the facility) prior to operation. The differences in the design of the HydroCision SpineJet device and the predicate device are minor and raise no new issues of safety or efficacy. The HydroCision SpineJet device and the predicate device consist of the same technology and are sterilized with same acceptable method. Both the devices are made up of same biocompatible materials.
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Below is a comparison table that provides a top-level overview of the substantial equivalent comparison between proposed and predicate devices.
| ComparativeCharacteristics | Proposed Device:HydroCision SpineJet System | Predicate Device:HydroCision ArthroJet with Cautery,TurboBurr and Curette |
|---|---|---|
| 510(k) Number | N/A | K041233 |
| Indication forUse | The HydroCision SpineJet System isindicated for surgical procedures wherethe cutting and removal of soft tissueand the ablation and removal of hardtissue or bone is required. Specificfunctions include cutting, ablation andshaping of soft tissue, and decorticatingand smoothing of bone, cartilage andother bone related tissue in open andminimally invasive spinal surgeries. | The HydroCision ArthroJet System withCautery, TurboBurr, and Curette isindicated 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 SpineJet 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 lumennozzle to another at the distal tip of theSpineJet 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. | 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 SystemComponents | Handpiece, Pump Cartridge and TubingAssembly | Handpiece, Pump Cartridge and TubingAssembly |
| ComparativeCharacteristics | Proposed Device:HydroCision SpineJet System | Predicate Device:HydroCision ArthroJet with Cautery,TurboBurr and Curette |
| (Sterile,Disposable,Single Use) | ||
| Principle SystemComponents/Other devices forinterfacing(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 | ||
| 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 | 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" |
| ComparativeCharacteristics | Proposed Device:HydroCision SpineJet System | Predicate Device:HydroCision ArthroJet with Cautery,TurboBurr and Curette |
| HandpieceDimension | Include models of additional length.The dimensional range of Modifieddevice is within the dimensionalspecification cleared for the predicatedevice- 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- 0.045OD, 0.020 IDEvacuation Tube lumen- 0.072 OD,0.063 ID | Needle: (Identical)High Pressure lumen/jet tube- 0.045 OD,0.020 IDEvacuation Tube lumen- 0.072 OD, 0.063ID | |
| 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" | |
| ComparativeCharacteristics | Proposed Device:HydroCision SpineJet System | Predicate Device:HydroCision ArthroJet with Cautery,TurboBurr and Curette |
| Device Needle | The SpineJet 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. | Identical |
| 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(K190804) | Dimensions: 16" W x 13" D x 7" HWeight: 28lbsPower: 100-240 V ~ 6A 50/60 HzNot Software Driven(K041233) |
| 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 devicesexcept that the predicate device is also indicated for use drilling and reamingof bone, cartilage and other bone related tissue in a variety of surgicalprocedures. The predicate device includes additional components for drillingand reaming which are TurboBurr, Cautery and Curette. These componentsare obsoleted and removed for the HydroCision SpineJet device. The claimsassociated with the obsolete components were removed from the indicationfor use of SpineJet device.● The indications for use of the HydroCision SpineJet device is a subset of thepredicate device indication for use. Both the HydroCision SpineJet device andthe predicate device are single use disposable devices indicated for usesurgical procedures where the cutting and removal of soft tissue and theablation and removal of hard tissue or bone is required.Technological Characteristics● The HydroCision ArthroJet System has been re-branded to HydroCisionSpineJet system with the dimensional changes to handpiece and removal ofobsolete components. |
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HydroCision SpineJet System- Special 510(k)
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HydroCision SpineJet System- Special 510(k)
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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.
§ 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.