(262 days)
Ultrasonic System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone. osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:
- · Otolaryngology
- Oral/maxillofacial
- · Hand and foot
- · Neurosurgery
- · Spine
- · Plastic/reconstructive.
Ultrasonic Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve).
The console has a touch panel that allows the surgeon to control device operation. The console activates and controls the ultrasound vibration, controls irrigation flow, and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module, and the micro-processor electronic board that controls and supervises the functional parameters of the device.
The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are activated by pressing the footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.
Ultrasonic Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.
The tips are used to fragment and reshape bone and soft tissue through longitudinal and (for bone drilling) rotational vibration at high frequency and small amplitude, while keeping the soft tissues with elastic properties free of damage.
Ultrasonic Surgical System comes with separate handpieces for Ultrasonic Surgical Bone Cutting and Ultrasonic Surgical Bone Drilling.
The handpieces are reprocessed through cleaning and disinfection before each use. The ultrasonic tips, irrigation tubing, and water injection sleeves are provided sterile for single use.
The provided text is a 510(k) summary for the MediSonic Technology Co's "Ultrasonic Surgical System." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria for device performance in a clinical or AI-assisted context.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them in the context of device performance as understood in questions 1-9 (e.g., accuracy, effect size with human readers, standalone performance, ground truth establishment). The document describes non-clinical bench testing for aspects like electrical safety, biocompatibility, sterilization, and software validation, which are about assuring the device itself is safe and functions as designed, not about its clinical efficacy or how it assists human users.
Here's what can be extracted based on the provided text, addressing the points where information is available or noting its absence:
Acceptance Criteria and Device Performance (Based on "Performance Testing" section):
The document lists various non-clinical bench tests performed according to FDA-recognized standards. The description states that "the device passed each test." This implies that the acceptance criterion for each of these tests was simply compliance with the respective FDA-recognized standard. The "reported device performance" is implicitly that it met these standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1-2 Edition 4:2014 (EMC) | Passed |
| Compliance with IEC 60601-1:2015, Mod (Electrical Safety) | Passed |
| Compliance with ISO 10993-1:2009 (Biocompatibility) | Passed (materials biocompatible) |
| Compliance with ISO 10993-5:2009 (Biocompatibility - Cytotoxicity) | Passed |
| Compliance with ISO 10993-10:2009 (Biocompatibility - Irritation/Sensitization) | Passed |
| Compliance with ISO 10993-7:2008 (Biocompatibility - EO residuals) | Passed |
| Compliance with ISO 10993-11:2017 (Biocompatibility - Systemic Toxicity) | Passed |
| Compliance with ISO 11135:2007 (Sterilization Validation) | Passed |
| Compliance with ISO 11607-1:2006 (Sterilization Packaging) | Passed |
| Compliance with ISO 11607-2:2006 (Packaging Validation) | Passed |
| Compliance with ASTM F1980-16 (Shelf Life) | Passed (2 Years) |
| Compliance with IEC 62366-1:2015 (Usability Engineering) | Passed |
| Compliance with IEC 61847:1998 (Ultrasonic Surgical Systems performance) | Passed |
| Compliance with IEC 62304:2006 (Software Life Cycle) | Software verification and validation reports included |
| Compliance with ISO 14971:2007 (Risk Management) | Passed |
Here's a breakdown of the specific questions based only on the provided text:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: As detailed in the table above, the acceptance criteria were compliance with the specified FDA-recognized standards for non-clinical bench testing.
- Reported Device Performance: The document states that "the device passed each test" and that "all necessary testing has been performed and the results support the conclusion that Ultrasonic Surgical System is substantially equivalent."
-
Sample sizes used for the test set and the data provenance:
- This document describes non-clinical bench testing (e.g., electrical, biocompatibility, sterilization, software validation). It does not involve a "test set" in the sense of patient data or clinical images.
- Sample size: Not applicable for this type of testing (no human or patient data samples).
- Data provenance: Not applicable. The tests are laboratory-based demonstrations against engineering and safety standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of clinical device performance, usually refers to a definitive diagnosis or outcome confirmed by expert consensus, pathology, or long-term follow-up. This document focuses on demonstrating the safety and fundamental functionality of the surgical system itself through non-clinical testing, not diagnostic or clinical accuracy.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of human adjudication for a test set.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is an "Ultrasonic Surgical System" for cutting bone, osteotomy, osteoplasty, and drilling. It is a surgical tool, not an AI-powered diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware surgical device, not a standalone algorithm. Its "performance" refers to its physical and functional capabilities, not an algorithmic output.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the tests performed relates to compliance with engineering and safety standards rather than clinical outcomes. For example, for biocompatibility, the ground truth is whether the materials elicit specific biological responses as defined by ISO standards. For electrical safety, it's whether the device meets insulation and leakage current limits. This is established by specific test methodologies outlined in the referenced standards.
-
The sample size for the training set:
- Not applicable. This device is not an AI/ML product developed with a training set.
-
How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
October 31, 2019
MediSonic Technology Co % John Gillespy FDA 510k Consultants, LLC 1100 Del Lago Cir #104 Palm Beach Gardens, Florida 33410
Re: K190281
Trade/Device Name: Ultrasonic Surgical System Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic Surgical Instrument and Accessories/Attachments Regulatory Class: Class II Product Code: JDX Dated: February 4, 2019 Received: February 11, 2019
Dear John Gillespy:
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
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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); 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.
Digitally signed by Long H. Chen Long H. Chen -S -s Date: 2019.10.31 13:24:47 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190281
Device Name Ultrasonic Surgical System
Indications for Use (Describe)
Ultrasonic System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone. osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to:
- · Otolaryngology
- Oral/maxillofacial
- · Hand and foot
- · Neurosurgery
- · Spine
- · Plastic/reconstructive.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X | 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 (K190281)
| 1. 510(k) Submitter: | MediSonic Technology Co11411 Southern Highlands Parkway, Suite 300Las Vegas, NV 89141Phone: 770-377-6365Email: rbwilliams@medisonictech.com |
|---|---|
| 2. Company Contact: | Reginald Bart-Williams, CEO |
| 3. Date of Submission: | October 29, 2019 |
| 4. 510(k) Preparer: | John F. Gillespy, MBAFDA 510k Consulting, LLCPalm Beach Gardens, FL 33410Phone: 386-243-4332Email: john@fda510kconsultants.com |
| 5. Device Classification: | Trade name: Ultrasonic Surgical SystemCommon name: Ultrasonic Surgical Bone Cutter, Ultrasonic Surgical Bone DrillDevice: Instrument, Surgical, Sonic & AccessoryClass: 2Regulation #: 888.4580Product Code: JDX |
| 6. Predicate: | Applicant: SMTP Technology Co, Ltd (China)Device: XD880A Ultrasonic Osteotomy Surgical System510(k) Number: K172464 |
-
- Device Description... Ultrasonic Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve).
The console has a touch panel that allows the surgeon to control device operation. The console activates and controls the ultrasound vibration, controls irrigation flow, and displays system condition. Inside the console are located the ultrasonic generator, the electrical power supply module, and the micro-processor electronic board that controls and supervises the functional parameters of the device.
- Device Description... Ultrasonic Surgical System consists of a console (control unit) with an integrated peristaltic pump, a handpiece with a connecting cord, a range of tip inserts, a torque wrench, a footswitch, and an irrigation set (liquid-flow tube and liquid-flow sleeve).
The console is connected to the main power by an electrical cord. It includes connectors for the handpiece and for the footswitch. The console incorporates a peristaltic pump which provides, through the irrigation tubing set, a sterile fluid supply to the surgical site. Ultrasonic power and irrigation flow to the handpiece are activated by pressing the
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footswitch. The handpiece contains a piezoelectric ultrasonic transducer which attaches to the generator (inside the console) by a cable at one end of the handpiece. Tip inserts are attached to the other end of the handpiece.
Ultrasonic Surgical System uses ultrasonic technology to generate mechanical microvibrations of the tip insert connected to the handpiece, the piezoelectric transducer converting the electrical voltage supplied by the ultrasonic generator into mechanical energy that induces vibration of the tip insert at the resonant frequency of the tip insert.
The tips are used to fragment and reshape bone and soft tissue through longitudinal and (for bone drilling) rotational vibration at high frequency and small amplitude, while keeping the soft tissues with elastic properties free of damage.
Ultrasonic Surgical System comes with separate handpieces for Ultrasonic Surgical Bone Cutting and Ultrasonic Surgical Bone Drilling.
The handpieces are reprocessed through cleaning and disinfection before each use. The ultrasonic tips, irrigation tubing, and water injection sleeves are provided sterile for single use.
-
- Indications For Use... Ultrasonic Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: otolaryngology, oral/maxillofacial, hand and foot, neurosurgery, spine, plastic/reconstructive.
The device is intended for prescription use only.
- Indications For Use... Ultrasonic Surgical System is an ultrasonic surgical system consisting of a handpiece and associated tips for cutting bone, osteotomy, osteoplasty and drilling in a variety of surgical procedures, including but not limited to: otolaryngology, oral/maxillofacial, hand and foot, neurosurgery, spine, plastic/reconstructive.
-
- Accessories and Components... The device comes with various ultrasonic cutting blades or "tips," water injection sleeves, and irrigation tubing, depending on the model and desired application. Other accessories include a foot switch (single or double), separate wrenches for handpiece and tips, and a user manual.
Ultrasonic Tips – Each model (Bone Cutter and Bone Drill) offers three series of tips, 80mm Standard Length ("STD"), 140mm Extended Length ("EXT"), and 200mm or 330mm Minimally Invasive ("MINI"). The Bone Cutter provides five different tip shapes—tooth, toothless, hook, dome, and spoon, while the Bone Drill uses only the tooth-shaped blade. The Bone Cutter offers 14 STD, 11 EXT, and 6 MINI tips; meanwhile, the Bone Drill offers 5 STD, 4 EXT, and 4 MINI blades.
- Accessories and Components... The device comes with various ultrasonic cutting blades or "tips," water injection sleeves, and irrigation tubing, depending on the model and desired application. Other accessories include a foot switch (single or double), separate wrenches for handpiece and tips, and a user manual.
Water Injection Sleeves – The Bone Cutter and Bone Drill offer 22 and 11 models of sleeves, respectively, for water injection during operation.
Irrigation Tubing – The device comes with two irrigation tubes to remove fluid and debris from the surgical site.
-
- Comparison To Predicate Device... See Table 5 on the following pages.
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Table 5 Comparison Table
| Characteristics | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Name | Ultrasonic Surgical System | XD880A UltrasonicOsteotomy SurgicalSystem | NA |
| Manufacturer | MediSonic Technology Co(USA) | SMTP Technology Co, Ltd(China) | NA |
| 510k Number | K190281 | K172464 | NA |
| Device Photo | Image: Subject Device | Image: Predicate Device | NA |
| Class | II | II | Same |
| Regulation # | 21 CFR 888.4580 | 21 CFR 888.4580 | Same |
| Product Code | JDX | JDX | Same |
| CommonDescription | Sonic Surgical Instrument &Accessories/Attachments | Sonic Surgical Instrument& Accessories/Attachment | Same |
| Intended Use | Ultrasonic Surgery of Hardand Soft Tissue | Ultrasonic Surgery of Hardand Soft Tissue | Same |
| Indications ForUse | An ultrasonic surgical systemthat includes a handpiece andassociated cutting tipsintended for cutting bone,osteotomy, osteoplasty anddrilling in a variety of surgicalprocedures, including but notlimited to: otolaryngology,oral/maxillofacial, hand andfoot, neurosurgery (boneonly), spine, andplastic/reconstructive surgery. | An ultrasonic surgical systemthat includes a handpiece andassociated cutting tipsintended for cutting bone,osteotomy, osteoplasty anddrilling in a variety of surgicalprocedures, including but notlimited to: otolaryngology,oral/maxillofacial, hand andfoot, neurosurgery (boneonly), spine, andplastic/reconstructive surgery | Same |
| Anatomical Site | Various hard & soft tissuelocations | Various hard & soft tissuelocations | Same |
| System Design | Uses ultrasonic technology togenerate mechanical micro-vibrations of tip insertconnected to handpiece inconjunction with irrigationsystem and aspiration. Twohandpieces. | Uses ultrasonic technologyto generate mechanicalmicro-vibrations of tipinsert connected tohandpiece in conjunctionwith irrigation system.Single handpiece. | Handpieces differ foruser preference |
| Energy Use | Transducer in handpiececonverts electrical voltagesupplied by ultrasonicgenerator in console intomechanical energy thatinduces vibration of tip insertat resonant frequency of tipinsert. | Transducer in handpiececonverts electrical voltagesupplied by ultrasonicgenerator in console intomechanical energy thatinduces vibration of tipinsert at resonant frequencyof tip insert. | Same |
| Handpiece Tech | Piezoelectric | Piezoelectric | Same |
| Bone Cutting | Tips are used to fragment andreshape bone tissue throughlongitudinal vibration at high(low ultrasonic) frequency andsmall amplitude (less than0.12mm), keeping soft tissueswith elastic properties free ofdamage. | Tips are used to fragmentand reshape bone tissuethrough longitudinalvibration at high (lowultrasonic) frequency andsmall amplitude (less than0.12mm), keeping softtissues with elasticproperties free of damage. | Same |
| Bone Drilling | Same as above except usesboth longitudinal & torsionalvibration. | Same as above (longitudinalvibration only). | Torsional is common inultrasonic bone drills(e.g., K010309) |
| Handpieces | Bone Cutter & Bone Drillmodels | Single straight model | Handpieces differ foruser preference |
| Ultrasonic Freq | 40 kHz | 40 kHz | Same |
| Maximum TipAmplitude | 250 um +/- 20% | Not available | Not available |
| Operating Temp | 55-95F (10-35C) | Not available | Not available |
| Relative Humidity | 30-75% (non-condensing) | Not available | Not available |
| Material--PatientContact | Tips - TC4 Titanium Alloy;Irrigation Sleeve - PTFE;Irrigation Tube - PVC | Tips - TC4 Titanium Alloy;Irrigation Sleeve & Tube -Medical Silicone Rubber | Tips same as P1;materials passedbiocompatibility testing |
| Components | |||
| Console | Houses electronics, pumps, and mechanical parts. Includes touch screen to control system. | Houses electronics, pumps, and mechanical parts. Includes touch screen to control system. | Same |
| Handpiece | Handheld surgical device with tip that is applied to patient hard and soft tissue. | Handheld surgical device with tip that is applied to patient hard tissue. | Same |
| Footswitch | Connected to console; controls ultrasonic power and irrigation fluid. | Connected to console; controls ultrasonic power and irrigation fluid. | Same |
| Accessories | |||
| Tip | Range of tips | Range of tips | Same |
| Irrigation Set(Tubing &Surgical TipSleeve) | Provides user-supplied sterile irrigation fluid from IV set to peristaltic pump in console to distal end of surgical tip. | Provides user-supplied sterile irrigation fluid from IV set to peristaltic pump in console to distal end of surgical tip. | Same |
| Torque Wrench | To tighten or loosen tip | To tighten or loosen tip | Same |
| Bench Testing | |||
| SterilizationValidation | ISO 11135:2014 | No mention in 510k | |
| Package Integrity | ISO 11607:2006 | Summary | |
| Shelf Life | ASTM F1980-16 (2 Years) | ||
| Biocompatibility | ISO 10993-1:2008; ISO10993-5:2009; ISO 10993-10:2010; ISO 10993-11:2017; ISO 10993-7:2008 | Biocompatibility Testing | |
| Software | IEC 62304:2006 | Software Testing | Testing performed tocurrent FDA-recognized standards |
| RiskManagement | EN ISO 14971:2012 | ISO 14971 likely (in SW) | |
| Electrical Safety | IEC 60601-1:2005+C1:2006+C2:2007+A1:2012 | IEC 60601-1:2006 | |
| EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2007/2010 | |
| Usability | IEC 62366-1:2015 | Not provided | |
| MechanicalSafety | IEC 61847:1998 | Mechanical & Acoustic(standard not provided) |
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Physical Characteristics
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All components of Ultrasonic Surgical System were included in bench testing, which included sterilization validation, biocompatibility, software verification and validation, EMC and electrical safety, usability, and mechanical safety.
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-
- Performance Testing... Ultrasonic Surgical System was subjected to the following nonclinical bench tests. All testing standards are currently FDA recognized, and the device passed each test:
- . EMC – IEC 60601-1-2 Edition 4:2014... Medical Electrical Equipment – Part 1-2: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements And Tests
- . Electrical Safety – IEC 60601-1:2015, Mod... Medical Electrical Equipment – Part 1: General Requirements For Basic Safety And Essential Performance
- . Biocompatibility - ISO 10993-1:2009... Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process
- . Biocompatibility - ISO 10993-5:2009... Biological evaluation of medical devices -Part 5: Test methods to assess the in vitro cytotoxicity of medical devices
- . Biocompatibility - ISO 10993-10:2009... Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- . Biocompatibility - ISO 10993-7:2008... Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
- Biocompatibility - ISO 10993-11:2017... Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
- . Sterilization Validation – ISO 11135:2007 (1st Edition)... Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
- Sterilization Packaging ISO 11607-1:2006... Packaging for terminally sterilized . medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
- Packaging Validation ISO 11607-2:2006... Packaging for terminally sterilized . medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
- Shelf Life ASTM F1980-16... Standard guide for accelerated aging of sterile barrier . systems for medical devices
- Usability Engineering IEC 62366-1:2015... Medical Devices Part 1: Application of . Usability Engineering to Medical Devices
- . Ultrasonic Surgical Systems - IEC 61847:1998... Ultrasonics - Surgical Systems -Basic Output Characteristics
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- Software Life Cycle IEC 62304:2006... Medical Device Software Software Life ● Cycle Processes
- Risk Management ISO 14971:2007... Medical Device Application of Risk ● Management to Medical Devices
-
- Patient-Contacting Materials... Ultrasonic Surgical System components that come into direct contact with patients during surgical procedures include the ultrasonic surgical tips. According to ISO 10993-1, these components are classified as "external communicating devices," as they get in contact with "tissue/bone" for a duration less than 24 hours. The cutting tips are made of Titanium Alloy TC4.
The other system components that can have indirect contact with the surface of patient's body during surgery are water injection sleeves and irrigation tubing, and the duration of their contact is also less than 24 hours. The sleeves and tubing are made of PTFE and PVC, respectively.
As shown in "Performance Testing" above, biocompatibility studies have been conducted on the tips, sleeves, and tubing, and test results showed that all materials are biocompatible.
-
- Software Verification and Validation... Software verification and validation testing were conducted in line with the requirements of FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (2005). The software for this device was considered as a "moderate level of concern" and software verification and validation reports have been included in this submission.
-
- Substantial Equivalence... Many of the features and technical characteristics of Ultrasonic Surgical System (subject device) are identical to those of the predicate device, and where there are differences, such differences do not have an impact on the safety or effectiveness of the subject device.
Ultrasonic Surgical System successfully followed the pathway to Substantial Equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (2014). The steps are summarized below:
- The predicate is legally marketed and was found substantially equivalent through 510(k) premarket submission.
- . The subject and predicate device have the same intended use.
- . Technological differences between the subject and predicate were evaluated; none of the differences raised different issues of safety and effectiveness.
- . The following methods for evaluation of the effects of different characteristics on safety and effectiveness were deemed acceptable-electrical safety, EMC, biocompatibility, sterilization, package integrity, shelf life, usability
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engineering, and ultrasonic surgical systems performance testing. All tests were conducted to FDA-recognized standards.
- . Data from these tests demonstrated equivalence and support the indications for use.
In conclusion, all necessary testing has been performed and the results support the conclusion that Ultrasonic Surgical System is substantially equivalent to the legally marketed predicate based on both (a) comparison of intended use, materials, technology, and design and (b) testing to FDA-recognized standards, and the device thus does not raise any concerns of safety or effectiveness.
Based on the information contained within this submission, it is concluded that Ultrasonic Surgical System is substantially equivalent to the identified predicate device and warrants clearance for marketing activities.
N/A