(245 days)
LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal injury are important. They may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)
LOTUS Series 4 Enhanced Shears: The LOTUS Series 4 Enhanced Shears consist of a reusable Transducer and a Single use Handpiece and are designed to use torsional ultrasound in the 35.4-36.6kHz range to cut and coagulate soft tissue during laparoscopic, open or bariatric surgery. The 2 types of LOTUS Series 4 Enhanced Shears subject to this application are the ES4-200CT transducer (with DS4-200CD Handpiece) that is designed for use in open surgery and the ES4-500CT transducer (with DS4-500CD Handpiece) that is designed for bariatric surgery. The new LOTUS Series 4 Enhanced Shears transducers have a similar waveguide and blade form to that of the ES4-400CT that was previously cleared as part of the Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101). The LOTUS Series 4 Enhanced shears use an identical transducer stack and casing and the same LG4 generator cleared as part of K151101. The Handpieces are identical in function as those cleared as part of K151101. They are identical to the DS4-200SD and DS4-500SD except that they use the same curved jaw as the DS4-400CD. All of these devices are described in detail in K151101. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.
LOTUS Series 5: The LOTUS Series 5 is a modification to the Lotus Series 4 Ultrasonic Surgical System and Accessories. LOTUS Series 5 consists of new Transducers and Handpieces but are driven by the same generator as in the predicate - the LG4. The Transducers and Handpieces offer the improved feature of 360° rotation, whereas the predicate has rotation limited to 240°. To facilitate this feature, it has been necessary to redesign the transducer so that it sits axially in the plane of the waveguide. It still uses torsional ultrasound in the 35.4-36.6kHz range at the waveguide blade to perform its surgical function. The output at the waveguide blade is substantially equivalent to that of the predicate. The Handpieces of LOTUS Series 5 have had the area where the transducer fits to the Handpiece altered to allow for the 360° rotation, but the outer appearance of the Handpieces remains unchanged from the predicate. All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile.
The provided text describes two medical devices, LOTUS Series 4 Enhanced Shears and LOTUS Series 5, and their substantial equivalence to a predicate device (Lotus Series 4 Ultrasonic Surgical System and Accessories, K151101). The document details the devices' intended use, technological characteristics, and performance testing, but it does not provide traditional acceptance criteria in the form of numerical thresholds or comparative statistics that are typically found in studies for AI/ML devices or diagnostic tools.
Instead, the acceptance criteria are implicitly defined by demonstrating that the new devices are "substantially equivalent" to an existing predicate device, meaning they perform as safely and effectively. The studies conducted are primarily bench testing to confirm this equivalence in performance.
Here's the breakdown based on your request, focusing on what can be extracted from the document:
LOTUS Series 4 Enhanced Shears & LOTUS Series 5
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit numerical acceptance criteria for performance metrics (like sensitivity, specificity, accuracy, or effect size) are not provided in this regulatory document, the table reflects the comparison points used to establish substantial equivalence. The "Acceptance Criteria" column indicates that the performance should be "Equivalent to Predicate," meaning it must meet or not negatively deviate from the established performance of the legally marketed predicate device (LOTUS Series 4 Ultrasonic Surgical System and Accessories K151101).
| Acceptance Criteria (Implicit) | Reported Device Performance (LOTUS Series 4 Enhanced Shears) | Reported Device Performance (LOTUS Series 5) |
|---|---|---|
| Intended Use: Equivalent to Predicate | Equivalent to Predicate | Equivalent to Predicate |
| Energy Source: Equivalent to Predicate | No Change (Ultrasound) | No Change (Ultrasound) |
| Ultrasound Mode: Equivalent to Predicate | No Change (Torsional mode) | No Change (Torsional mode) |
| Generator: Equivalent to Predicate | Uses same generator as predicate | Uses same generator as predicate |
| Electrical Safety: Equivalent to Predicate | Uses same generator as predicate | Uses same generator as predicate (leakage testing performed) |
| Electromagnetic Compatibility: Equivalent to Predicate | Uses same generator as predicate | Uses same generator as predicate |
| Sterilization: Equivalent to Predicate | No Change (EO for handpiece, Autoclave for transducer) | No Change for sterilization method, study on density change in handpiece, reprocessing validated |
| Material Biocompatibility: Equivalent to Predicate | No Change (Hastelloy, PTFE, Titanium 6AI/4V Stainless Steel) | No Change (Hastelloy, PTFE, Titanium 6AI/4V Stainless Steel) |
| Tangential peak to peak displacement (distal tip): Within acceptable range compared to predicate | ES4-200CT Max 185 µm, ES4-500CT Max 188 µm (compared to predicate models ranging from 158-400 µm) | ES5-200CT/360° Max 158 µm, ES5-400CT/360° Max 218 µm, ES5-500CT/360° Max 210 µm, LR5-200ST/360° Max 106 µm, LR5-400ST/360° Max 94 µm (compared to predicate models ranging from 158-400 µm) |
| Temperature of transducer back plate (after 20s): ≤50°C | No Change (≤50°C) | No Change (≤50°C) |
| Temperature of shroud away from distal end (after 20s): ≤40°C | No Change (≤40°C) | No Change (≤40°C) |
| Intermittent Use Duration: 5 hours | No Change (5 hours) | No Change (5 hours) |
| Duty Cycle: 3s on 30s off (Series 4 predicate) | Uses same generator as predicate | Uses same generator as predicate |
| Life in Service (acoustics part): 50 uses | No Change (Survive 50 uses) | No Change (Survive 50 uses) |
| Performance Testing (cut times): Comparable to Predicate | Results included in submission (Confirmed comparable) | Results included in submission (Confirmed comparable) |
| Performance Testing (thermal spread): Comparable to Predicate | Not specified as performed | In 3 types of tissue (muscle, kidney, liver) - Results included (Confirmed comparable) |
| Performance Testing (length of dissection): Comparable to Predicate | Not specified as performed | Results included in submission (Confirmed comparable) |
| Performance Testing (maximum average power & frequency tracking): Comparable to Predicate | Not specified as performed | Results included in submission (Confirmed comparable) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of samples in the typical sense (e.g., patient cases). The testing involved bench testing of the devices themselves.
- For LOTUS Series 4 Enhanced Shears: "Performance testing cut times" and "Transducer lifetime" were tested.
- For LOTUS Series 5: "Acoustic performance cut times, maximum average power and frequency tracking," "Thermal spread in 3 types of tissue (muscle, kidney and liver)," "Length of dissection," and "Transducer lifetime" were tested.
- Data Provenance: The document only mentions "bench testing" and "No animal testing has been undertaken." This suggests testing performed in a laboratory setting on the physical devices or tissue models, rather than clinical data from specific countries or patient populations. The tests were likely conducted by the manufacturer, SRA Developments Ltd (United Kingdom).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This submission is for surgical instruments, not for diagnostic or AI/ML devices that require ground truth established by human experts. The performance is assessed through objective engineering and biological bench tests (e.g., cut times, thermal spread in tissue).
4. Adjudication Method for the Test Set:
- Not Applicable. As there are no human experts establishing a "ground truth" for diagnostic or AI/ML performance, no adjudication method is relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 (ultrasonic shears), not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for these devices is established by objective physical measurements and biological effects (e.g., precise timing of cuts, calibrated temperature measurements for thermal spread in animal tissues, mechanical displacement measurements) as compared to the performance of the legally marketed predicate device. It's not expert consensus, pathology, or outcomes data in the typical sense, but rather engineering and pre-clinical performance data.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set, there is no ground truth establishment for it.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
December 15, 2022
SRA Developments Ltd Phillipa Frewin Regulatory Affairs and Quality Assurance Manager Bremridge Ashburton, Devon TQ13 7JX United Kingdom
Re: K221102
Trade/Device Name: LOTUS Series 4 Enhanced Shears, LOTUS Series 5 Regulatory Class: Unclassified Product Code: LFL Dated: October 11, 2022 Received: October 17, 2022
Dear Phillipa Frewin:
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 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
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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,
Jessica Carr -S
for 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221102
Device Name LOTUS Series 4 Enhanced Shears LOTUS Series 5
Indications for Use (Describe)
LOTUS Series 4 Enhanced Shears
LOTUS Enhanced Shears are indicated for soft tissue surgical incisions when bleeding control and minimal injury are important. They may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
LOTUS Series 5
The Lotus Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)
| 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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510(k) Summary
| Company Information: | SRA Developments LtdBremridgeAshburtonDevonUKTQ13 7JXT: +44 1364 652426F: +44 1364 653589 |
|---|---|
| Contact: | Phillipa FrewinRAQA ManagerSRA Developments Ltd |
| Phillipa.Frewin@bowa-medical.com | |
| Date Prepared: | 28th October 2022 |
| Trade Name: | LOTUS Series 4 Enhanced ShearsLOTUS Series 5 |
| Common: | Ultrasound Surgical Instrument |
| Classification Name: | Unclassified |
| Product Code: | LFL |
REASON FOR SUBMISSION A.
This 510(k) is being filed to add 2 variants of the LOTUS Series 4 Enhanced Shears and also includes an application for an updated version of LOTUS, LOTUS Series 5
B. LEGALLY MARKETED PREDICATE DEVICES
The new LOTUS Series 4 Enhanced Shears and LOTUS Series 5 device are substantially equivalent to those registered as part of Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101).
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DEVICE DESCRIPTION C.
LOTUS Series 4 Enhanced Shears
The LOTUS Series 4 Enhanced Shears consist of a reusable Transducer and a Single use Handpiece and are designed to use torsional ultrasound in the 35.4-36.6kHz range to cut and coagulate soft tissue during laparoscopic, open or bariatric surgery. The 2 types of LOTUS Series 4 Enhanced Shears subject to this application are the ES4-200CT transducer (with DS4-200CD Handpiece) that is designed for use in open surgery and the ES4-500CT transducer (with DS4-500CD Handpiece) that is designed for bariatric surgery. The new LOTUS Series 4 Enhanced Shears transducers have a similar waveguide and blade form to that of the ES4-400CT that was previously cleared as part of the Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101). The LOTUS Series 4 Enhanced shears use an identical transducer stack and casing and the same LG4 generator cleared as part of K151101. The Handpieces are identical in function as those cleared as part of K151101. They are identical to the DS4-200SD and DS4-500SD except that they use the same curved jaw as the DS4-400CD. All of these devices are described in detail in K151101.
All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile
LOTUS Series 5
The LOTUS Series 5 is a modification to the Lotus Series 4 Ultrasonic Surgical System and Accessories. LOTUS Series 5 consists of new Transducers and Handpieces but are driven by the same generator as in the predicate - the LG4. The Transducers and Handpieces offer the improved feature of 360° rotation, whereas the predicate has rotation limited to 240°. To facilitate this feature, it has been necessary to redesign the transducer so that it sits axially in the plane of the waveguide. It still uses torsional ultrasound in the 35.4-36.6kHz range at the waveguide blade to perform its surgical function. The output at the waveguide blade is substantially equivalent to that of the predicate. The Handpieces of LOTUS Series 5 have had the area where the transducer fits to the Handpiece altered to allow for the 360° rotation, but the outer appearance of the Handpieces remains unchanged from the predicate.
All Transducers are reusable up to 50 times and the Handpieces are single use and provided sterile
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D. INTENDED USE
LOTUS Series 4 Enhanced Shears
LOTUS Enhanced Shears are indicated for soft tissue surqical incisions when bleeding control and minimal thermal injury are important. They may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
LOTUS Series 5
The LOTUS Series 5 is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
ய் TECHNOLOGICAL CHARACTERISTICS
LOTUS Series 4 Enhanced Shears
The fundamental technological characteristics (i.e. design, material, chemical composition, energy source) of the LOTUS Series 4 Enhanced Shears are equivalent to the predicate.
LOTUS Series 5
The LOTUS Series 5 is the same as the predicate in that it uses the same fundamental mode of operation i.e. torsional ultrasound in the 35.4-36.6kHz range. All patient contacting materials are the same i.e. Ti 6Al/4V, Hastelloy, PTFE and stainless steel. It has the same indications for use and target population. It also uses the same generator as the predicate. The main difference between the subject and predicate devices is that the subject device allows for 360° rotation whereas the predicate was limited to 240° rotation.
SUBSTANTIAL EQUIVALENCE SUMMARY F.
LOTUS Series 4 Enhanced Shears
| Series 4 (K151101) | Enhanced Shears | |
|---|---|---|
| Intended Use | The Lotus Series 4Ultrasonic Surgical System | LOTUS Enhanced Shearsare indicated for soft tissue |
| and Accessories areindicated for soft tissuesurgical incisions whenbleeding control and minimalthermal injury are important.Lotus Series 4 UltrasonicSurgical System andAccessories may be used asan adjunct to or substitutefor electrosurgery, lasersurgery, and traditionalscalpels in general,gynecological, thoracicsurgery, and exposure toorthopedic structures (suchas hip joint). | surgical incisions whenbleeding control andminimal thermal injury areimportant. They may beused as an adjunct to orsubstitute forelectrosurgery, lasersurgery, and traditionalscalpels in general,gynecological, thoracicsurgery, and exposure toorthopedic structures (suchas hip joint). | |
| Energy Source | Ultrasound | No Change |
| Ultrasound mode | Torsional mode | No Change |
| Axis of transducerstack | Perpendicular to waveguide | No Change |
| Generator | 1 Channel | Uses same generator aspredicate therefore nochange |
| Control System | Digital | Uses same generator aspredicate therefore nochange |
| Frequency Control | Digital frequency control | Uses same generator aspredicate therefore nochange |
| Power Mode | Continuous | Uses same generator aspredicate therefore nochange |
| Electrical Safety | EN 60601-1IEC 60601-1TÜV SÜD marked | Uses same generator aspredicate therefore nochange |
| ElectromagneticCompatibility | EN 60601-1-2FCC Part 18 | Uses same generator aspredicate therefore nochange |
| Function Control | Finger switches orfootswitch | No Change |
| Sterilization | EO for handpieceAutoclave for transducer &waveguide | No Change |
| Sterile Packaging | Single wrapped in heatsealed pouches | No Change |
| manufactured from Tyvek1073B and BOPA | ||
| Handset Design | Trigger operated jaw action designed. Handset may be rotated for optimal cutting angle | No Change |
| Types of Probes Included | Jaw-type, double blade, Liver Resector | Jaw-type |
| Size of Probe Barrel | 5.5mm | No Change |
| Biocompatibility of patient contacting materials | Hastelloy, PTFE, Titanium 6AI/4VStainless Steel | No Change |
| Shears blade type | Laparoscopic shears Curved tipLaparoscopic shears slim Curved tipOpen shears Straight TipBariatric shears Straight Tip | Open shears Curved TipBariatric shears Curved Tip |
| Liver Resector blade type | Open Liver Resector Straight TipLaparoscopic Liver Resector Straight Tip | Not applicable |
| Lengths of shears waveguides | 510mm, 430mm, 255mm | No Change |
| Lengths of Liver Resector waveguides | 430mm, 255mm | No Change |
| Transducer/Handpiece rotation | All shears and Liver Resectors - 240° | 240° |
| Reusable components | Transducer & Waveguide | No Change |
| Power levels | High, Low, Ultra-low | Uses same generator as predicate therefore no change |
| Prescription Device? | Yes | No Change |
| Frequency / Excitation of single torsional mode in the bandwidth; | 35.4-36.6kHz | Uses same generator as predicate therefore no change |
| Lock to torsional resonance, followed by continuous tracking of the frequency; | Yes | Uses same generator as predicate therefore no change |
| Automatic return to last frequency if switch off-switch on; | < 2 seconds | Uses same generator as predicate therefore no change |
| Power into matchingcircuit with waveguide(un)loaded in air; | ≤ 20W | Uses same generator aspredicate therefore nochange |
| Power into handsetwith waveguide(un)loaded in air; | ≤ 10W | Uses same generator aspredicate therefore nochange |
| Tangential peak topeak displacement(including tolerance) ofwaveguide distal tip at10W into matchingcircuit in µm; | CV3-400 Max 250SV3-200 Max 229SV3-500 Max 240ES4-400CT Max 201LR3-200 Max 158LR3-400 Max 192DB3-100 Max 400DB3-400 Max 400 | ES4-200CT Max 185ES4-500CT Max 188 |
| Tangentialdisplacement | May vary as blade is loaded.As a load is added to theblade energy is absorbed bythe resistance. This in turnnaturally reduces thetangential displacement ofthe waveguide | No Change |
| Temperature oftransducer back plateafter 20s continuous | ≤50°C | No Change |
| Temperature ofshroud away fromdistal end after 20s.continuous; | ≤40°C | No Change |
| For intermittent useover a maximumduration of; | 5 hours | No Change |
| Duty cycle will bedetermined by 'appliedpart' temperature; | Series 4 marked as 3s on30s off | Uses same generator aspredicate therefore nochange |
| Life in Service(disposable part,acoustics part,reusable part); | Acoustics part: All types ofTransducer unit (waveguideon torsion horn, sealedinside its plastic casing withhard-wired cable andEeprom potted plug) mustsurvive 50-off standard (fiveminute on-time) uses ie. 250minutes or 4.16 hours of on- | No Change |
| time including 50-off vacuum autoclave lumened load cycles, each at 134°C for three minutes Disposable part: must survive a single (extreme duration) clinical procedure of 1200s. or 20 minutes ON-time with no observable change in performance characteristics. | ||
| Cable length; | 2.9m | No Change |
| Weight Handset including acoustics and disposable; | < 300g | No Change |
| Ergonomic (power activation); | Must be able to be used single handed.Two finger operated switches to activate and toggle between high/normal power | No Change |
| Fuse Type | Internal fuses only | Uses same generator as predicate therefore no change |
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Conclusion: In establishing substantial equivalence of the subject LOTUS Series 4 Enhanced Shears to the predicate device SRA Developments Ltd evaluated the indications for use, intended use and technological characteristics. The LOTUS Series 4 Enhanced Shears are substantially equivalent to the predicate device. They share the same intended use and equivalent technological characteristics. The subject device is as safe and effective as the predicate device.
LOTUS Series 5
| Series 4 (K151101) | LOTUS Series 5 | |
|---|---|---|
| Intended Use | The Lotus Series 4 | The LOTUS Series 5 is |
| Ultrasonic Surgical | ||
| System and Accessories | ||
| are indicated for soft | ||
| tissue surgical incisions | ||
| when bleeding control | ||
| and minimal thermal | ||
| injury are important. | ||
| Lotus Series 4 Ultrasonic | ||
| Surgical System and | ||
| Accessories may beused as an adjunct to orsubstitute forelectrosurgery, lasersurgery, and traditionalscalpels in general,gynecological, thoracicsurgery, and exposure toorthopedic structures(such as hip joint). | scalpels in general,gynecological, thoracicsurgery, and exposure toorthopedic structures(such as hip joint). | |
| Energy Source | Ultrasound | No Change |
| Ultrasound mode | Torsional mode | No Change |
| Axis of transducerstack | Perpendicular towaveguide | Axially aligned towaveguide |
| Generator | 1 Channel | Uses same generator aspredicate therefore nochange |
| Control System | Digital | Uses same generator aspredicate therefore nochange |
| Frequency Control | Digital frequency control | Uses same generator aspredicate therefore nochange |
| Power Mode | Continuous | Uses same generator aspredicate therefore nochange |
| Electrical Safety | EN 60601-1IEC 60601-1TÜV SÜD marked | Uses same generator aspredicate therefore nochange |
| ElectromagneticCompatibility | EN 60601-1-2FCC Part 18 | Uses same generator aspredicate therefore nochange |
| Function Control | Finger switches orfootswitch | No Change |
| Sterilization | EO for handpieceAutoclave for transducer& waveguide | No Change |
| Sterile Packaging | Single wrapped in heatsealed pouchesmanufactured fromTyvek 1073B and BOPA | No Change |
| Handset Design | Trigger operated jawaction designed.Handset may be rotatedfor optimal cutting angle | No Change |
| Types of ProbesIncluded | Jaw-type, double blade,Liver Resector | Jaw-type, Liver Resector |
| Size of Probe Barrel | 5.5mm | No Change |
| Biocompatibility ofpatient contactingmaterials | Hastelloy, PTFE,Titanium 6AI/4VStainless Steel | No Change |
| Shears blade type | Laparoscopic shearsCurved tipLaparoscopic shearsslim Curved tipOpen shears Straight TipBariatric shears StraightTip | Open shears Curved TipLaparoscopic shearsCurved tipBariatric shears CurvedTip |
| Liver Resector bladetype | Open Liver ResectorStraight TipLaparoscopic LiverResector Straight Tip | Open Liver ResectorStraight TipLaparoscopic LiverResector Straight Tip |
| Lengths of shearswaveguides | 510mm, 430mm, 255mm | No Change |
| Lengths of LiverResector waveguides | 430mm, 255mm | No Change |
| Transducer/Handpiecerotation | All shears and LiverResectors - 240° | 360° |
| Reusable components | Transducer &Waveguide | No Change |
| Power levels | High, Low, Ultra-low | Uses same generator aspredicate therefore nochange |
| Prescription Device? | Yes | No Change |
| Frequency / Excitationof single torsionalmode in thebandwidth; | 35.4-36.6kHz | Uses same generator aspredicate therefore nochange |
| Lock to torsionalresonance, followedby continuous trackingof the frequency; | Yes | Uses same generator aspredicate therefore nochange |
| Automatic return tolast frequency if switchoff-switch on; | < 2 seconds | Uses same generator aspredicate therefore nochange |
| Power into matchingcircuit with waveguide(un)loaded in air; | ≤ 20W | Uses same generator aspredicate therefore nochange |
| Power into handsetwith waveguide(un)loaded in air; | ≤ 10W | Uses same generator aspredicate therefore nochange |
| Tangential peak topeak displacement(including tolerance) ofwaveguide distal tip at10W into matchingcircuit in µm; | CV3-400 Max 250SV3-200 Max 229SV3-500 Max 240ES4-400CT Max 201LR3-200 Max 158LR3-400 Max 192DB3-100 Max 400DB3-400 Max 400 | ES5-200CT/360° Max 158ES5-400CT/360° Max 218ES5-500CT/360° Max 210LR5-200ST/360° Max 106LR5-400ST/360° Max 94 |
| Tangentialdisplacement | May vary as blade isloaded.As a load is added to theblade energy isabsorbed by theresistance. This in turnnaturally reduces thetangential displacementof the waveguide | No Change |
| Temperature oftransducer back plateafter 20s continuous | ≤50°C | No Change |
| Temperature ofshroud away fromdistal end after 20s.continuous; | ≤40°C | No Change |
| For intermittent useover a maximumduration of; | 5 hours | No Change |
| Duty cycle will bedetermined by 'appliedpart' temperature; | Series 4 marked as 3son 30s off | Uses same generator aspredicate therefore nochange |
| Life in Service(disposable part,acoustics part,reusable part); | Acoustics part: All typesof Transducer unit(waveguide on torsionhorn, sealed inside itsplastic casing with hard-wired cable and Eeprompotted plug) mustsurvive 50-off standard(five minute on-time)uses ie. 250 minutes or4.16 hours of on-time | No Change |
| including 50-off vacuumautoclave lumened loadcycles, each at 134°C forthree minutesDisposable part: mustsurvive a single (extremeduration) clinicalprocedure of 1200s. or20 minutes ON-time withno observable change inperformancecharacteristics. | ||
| Cable length; | 2.9m | No Change |
| Weight Handsetincluding acousticsand disposable; | < 300g | < 320g |
| Ergonomic (poweractivation); | Must be able to be usedsingle handed.Two finger operatedswitches to activate andtoggle betweenhigh/normal power | No Change |
| Fuse Type | Internal fuses only | Uses same generator aspredicate therefore nochange |
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Conclusion: In establishing substantial equivalence of the subject LOTUS Series 5 to the predicate device SRA Developments Ltd evaluated the indications for use, intended use and technological characteristics. The LOTUS Series 5 are substantially equivalent to the predicate device. They share the same intended use and equivalent technological characteristics. The subject device is as safe and effective as the predicate device.
TESTING G.
LOTUS Series 4 Enhanced Shears
LOTUS Series 4 Enhanced Shears use the same generator as the predicate and, therefore, no further Electromagnetic compatibility testing or electrical safety testing was carried out. All patient contacting materials are the same as in the predicate device and so further biocompatibility testing was not deemed necessary.
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Performance testing was carried out using bench testing. Testing undertaken:
Performance testing cut times
Transducer lifetime
The results of the testing are included in this submission.
No animal testing has been undertaken.
LOTUS Series 5
All patient contacting materials are the same as in the predicate device and so further biocompatibility testing was not deemed necessary.
LOTUS Series 5 uses the same generator as the predicate.
Electrical safety leakage testing was undertaken.
Performance testing was carried out using bench testing.
Performance testing undertaken:
Acoustic performance cut times, maximum average power and frequency tracking.
Thermal spread in 3 types of tissue (muscle, kidney and liver).
Length of dissection.
Transducer lifetime of the LOTUS Series 5.
All testing showed that the LOTUS Series 5 is equivalent to the predicate.
The results of the testing are included in this submission.
No animal testing has been undertaken.
H. STERILIZATION
LOTUS Series 4 Enhanced Shears
The single-use Handpieces are supplied sterile in heat sealed pouches. As the Handpieces are made to the same design and of the same materials, use the same packaging, sealing process and parameters, and the same EO sterilization cycle at the same sub-contract sterilizing company as the devices
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listed in the predicate further sterilization, residuals and ageing testing was not required. The devices have the same SAL of 10 °, residuals are still within acceptable limits and the shelf life remains 3 years.
The Transducers have not changed from those listed in the predicate and so the validations remain the same. No further validations were conducted on this device.
LOTUS Series 5
The single-use Handpieces are supplied sterile in heat sealed pouches and have an SAL of 106. The changes to the Handpiece do not present any greater challenge to the EO gas path. A study was undertaken to see whether any change in product density affected the sterilization evaluation. The overall change in density was well within limits established in the existing sterilization validation. As there were changes to some internal components, testing for residual levels will be performed prior to marketing. These tests will ensure that residuals remained within safe limits. The sterile barrier and sealing method remain the same as the predicate, however, accelerated ageing was still undertaken to ensure that the device itself would still function for the entirety of its stated lifetime.
Reprocessing validation has been performed on the new Transducers. The validated cleaning and autoclave sterilization process is included in the Instructions for Use.
l. CONCLUSION
LOTUS Series 4 Enhanced Shears
The conclusions drawn from the subject device indications for use, technological characteristics and performance testing demonstrates that the subject device is as safe and effective as, and is substantially equivalent to, the legally marketed predicate devices.
LOTUS Series 5
The conclusions drawn from the subject device indications for use, technological characteristics and performance testing demonstrates that the subject device is as safe and effective as, and is substantially equivalent to, the legally marketed predicate devices.
N/A