LOTUS Series 4 Enhanced Shears, LOTUS Series 5

K221102 · Sra Developments, Ltd. · LFL · Dec 15, 2022 · SU

Device Facts

• Record ID: K221102
• Device Name: LOTUS Series 4 Enhanced Shears, LOTUS Series 5
• Applicant: Sra Developments, Ltd.
• Product Code: LFL · SU
• Decision Date: Dec 15, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

LOTUS Enhanced Shears are indicated for soft tissue surgical 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). 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).

Device Story

LOTUS Series 4 Enhanced Shears and Series 5 are ultrasonic surgical instruments for soft tissue incision and coagulation. They utilize torsional ultrasound (35.4-36.6kHz) generated by an LG4 generator to cut and coagulate tissue. Series 4 includes transducers for open and bariatric surgery; Series 5 features a redesigned transducer for 360° rotation (vs 240° in predicate). Devices are used in laparoscopic, open, or bariatric surgical settings by surgeons. The system provides hemostasis and tissue cutting, potentially reducing thermal injury compared to traditional electrosurgery. Output is controlled via finger switches or footswitch. The device benefits patients by providing precise cutting with simultaneous coagulation, minimizing bleeding and thermal damage.

Clinical Evidence

Bench testing only. Testing included acoustic performance (cut times, frequency tracking), thermal spread in muscle/kidney/liver, dissection length, and transducer lifetime. No clinical or animal data provided.

Technological Characteristics

Energy source: Torsional ultrasound (35.4-36.6kHz). Materials: Ti 6Al/4V, Hastelloy, PTFE, stainless steel. Series 4: Perpendicular transducer stack. Series 5: Axially aligned transducer stack for 360° rotation. Connectivity: Wired to LG4 generator. Sterilization: EO (handpieces), Autoclave (transducers). Software: Digital frequency control/tracking.

Indications for Use

Indicated for soft tissue surgical incisions in general, gynecological, thoracic, and orthopedic (e.g., hip joint) surgery where bleeding control and minimal thermal injury are required. Suitable for use as an adjunct or substitute for electrosurgery, laser surgery, and traditional scalpels.

Predicate Devices

• Lotus Series 4 Ultrasonic Surgical System and Accessories (K151101)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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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K221102

# 510(k) Summary

| Company Information: | SRA Developments Ltd<br>Bremridge<br>Ashburton<br>Devon<br>UK<br>TQ13 7JX<br>T: [phone]<br>F: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact: | Phillipa Frewin<br>RAQA Manager<br>SRA Developments Ltd |
| | [e-mail] |
| Date Prepared: | 28th October 2022 |
| Trade Name: | LOTUS Series 4 Enhanced Shears<br>LOTUS 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 4<br>Ultrasonic Surgical System | LOTUS Enhanced Shears<br>are indicated for soft tissue |
| | and Accessories are<br>indicated for soft tissue<br>surgical incisions when<br>bleeding control and minimal<br>thermal injury are important.<br>Lotus Series 4 Ultrasonic<br>Surgical System and<br>Accessories may be used as<br>an adjunct to or substitute<br>for electrosurgery, laser<br>surgery, and traditional<br>scalpels in general,<br>gynecological, thoracic<br>surgery, and exposure to<br>orthopedic structures (such<br>as hip joint). | surgical incisions when<br>bleeding control and<br>minimal thermal injury are<br>important. They may be<br>used as an adjunct to or<br>substitute for<br>electrosurgery, laser<br>surgery, and traditional<br>scalpels in general,<br>gynecological, thoracic<br>surgery, and exposure to<br>orthopedic structures (such<br>as hip joint). |
| Energy Source | Ultrasound | No Change |
| Ultrasound mode | Torsional mode | No Change |
| Axis of transducer<br>stack | Perpendicular to waveguide | No Change |
| Generator | 1 Channel | Uses same generator as<br>predicate therefore no<br>change |
| Control System | Digital | Uses same generator as<br>predicate therefore no<br>change |
| Frequency Control | Digital frequency control | Uses same generator as<br>predicate therefore no<br>change |
| Power Mode | Continuous | Uses same generator as<br>predicate therefore no<br>change |
| Electrical Safety | EN 60601-1<br>IEC 60601-1<br>TÜV SÜD marked | Uses same generator as<br>predicate therefore no<br>change |
| Electromagnetic<br>Compatibility | EN 60601-1-2<br>FCC Part 18 | Uses same generator as<br>predicate therefore no<br>change |
| Function Control | Finger switches or<br>footswitch | No Change |
| Sterilization | EO for handpiece<br>Autoclave for transducer &<br>waveguide | No Change |
| Sterile Packaging | Single wrapped in heat<br>sealed pouches | No Change |
| | | |
| | manufactured from Tyvek<br>1073B 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/4V<br>Stainless Steel | No Change |
| Shears blade type | Laparoscopic shears Curved tip<br>Laparoscopic shears slim Curved tip<br>Open shears Straight Tip<br>Bariatric shears Straight Tip | Open shears Curved Tip<br>Bariatric shears Curved Tip |
| Liver Resector blade type | Open Liver Resector Straight Tip<br>Laparoscopic 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 matching<br>circuit with waveguide<br>(un)loaded in air; | ≤ 20W | Uses same generator as<br>predicate therefore no<br>change |
| Power into handset<br>with waveguide<br>(un)loaded in air; | ≤ 10W | Uses same generator as<br>predicate therefore no<br>change |
| Tangential peak to<br>peak displacement<br>(including tolerance) of<br>waveguide distal tip at<br>10W into matching<br>circuit in µm; | CV3-400 Max 250<br>SV3-200 Max 229<br>SV3-500 Max 240<br>ES4-400CT Max 201<br>LR3-200 Max 158<br>LR3-400 Max 192<br>DB3-100 Max 400<br>DB3-400 Max 400 | ES4-200CT Max 185<br>ES4-500CT Max 188 |
| Tangential<br>displacement | May vary as blade is loaded.<br>As a load is added to the<br>blade energy is absorbed by<br>the resistance. This in turn<br>naturally reduces the<br>tangential displacement of<br>the waveguide | No Change |
| Temperature of<br>transducer back plate<br>after 20s continuous | ≤50°C | No Change |
| Temperature of<br>shroud away from<br>distal end after 20s.<br>continuous; | ≤40°C | No Change |
| For intermittent use<br>over a maximum<br>duration of; | 5 hours | No Change |
| Duty cycle will be<br>determined by 'applied<br>part' temperature; | Series 4 marked as 3s on<br>30s off | Uses same generator as<br>predicate therefore no<br>change |
| Life in Service<br>(disposable part,<br>acoustics part,<br>reusable part); | Acoustics part: All types of<br>Transducer unit (waveguide<br>on torsion horn, sealed<br>inside its plastic casing with<br>hard-wired cable and<br>Eeprom potted plug) must<br>survive 50-off standard (five<br>minute on-time) uses ie. 250<br>minutes 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.<br>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 be<br>used as an adjunct to or<br>substitute for<br>electrosurgery, laser<br>surgery, and traditional<br>scalpels in general,<br>gynecological, thoracic<br>surgery, and exposure to<br>orthopedic structures<br>(such as hip joint). | scalpels in general,<br>gynecological, thoracic<br>surgery, and exposure to<br>orthopedic structures<br>(such as hip joint). |
| Energy Source | Ultrasound | No Change |
| Ultrasound mode | Torsional mode | No Change |
| Axis of transducer<br>stack | Perpendicular to<br>waveguide | Axially aligned to<br>waveguide |
| Generator | 1 Channel | Uses same generator as<br>predicate therefore no<br>change |
| Control System | Digital | Uses same generator as<br>predicate therefore no<br>change |
| Frequency Control | Digital frequency control | Uses same generator as<br>predicate therefore no<br>change |
| Power Mode | Continuous | Uses same generator as<br>predicate therefore no<br>change |
| Electrical Safety | EN 60601-1<br>IEC 60601-1<br>TÜV SÜD marked | Uses same generator as<br>predicate therefore no<br>change |
| Electromagnetic<br>Compatibility | EN 60601-1-2<br>FCC Part 18 | Uses same generator as<br>predicate therefore no<br>change |
| Function Control | Finger switches or<br>footswitch | No Change |
| Sterilization | EO for handpiece<br>Autoclave for transducer<br>& waveguide | No Change |
| Sterile Packaging | Single wrapped in heat<br>sealed pouches<br>manufactured from<br>Tyvek 1073B and BOPA | No Change |
| Handset Design | Trigger operated jaw<br>action designed.<br>Handset may be rotated<br>for optimal cutting angle | No Change |
| Types of Probes<br>Included | Jaw-type, double blade,<br>Liver Resector | Jaw-type, Liver Resector |
| Size of Probe Barrel | 5.5mm | No Change |
| Biocompatibility of<br>patient contacting<br>materials | Hastelloy, PTFE,<br>Titanium 6AI/4V<br>Stainless Steel | No Change |
| Shears blade type | Laparoscopic shears<br>Curved tip<br>Laparoscopic shears<br>slim Curved tip<br>Open shears Straight Tip<br>Bariatric shears Straight<br>Tip | Open shears Curved Tip<br>Laparoscopic shears<br>Curved tip<br>Bariatric shears Curved<br>Tip |
| Liver Resector blade<br>type | Open Liver Resector<br>Straight Tip<br>Laparoscopic Liver<br>Resector Straight Tip | Open Liver Resector<br>Straight Tip<br>Laparoscopic Liver<br>Resector Straight Tip |
| Lengths of shears<br>waveguides | 510mm, 430mm, 255mm | No Change |
| Lengths of Liver<br>Resector waveguides | 430mm, 255mm | No Change |
| Transducer/Handpiece<br>rotation | All shears and Liver<br>Resectors - 240° | 360° |
| Reusable components | Transducer &<br>Waveguide | No Change |
| Power levels | High, Low, Ultra-low | Uses same generator as<br>predicate therefore no<br>change |
| Prescription Device? | Yes | No Change |
| Frequency / Excitation<br>of single torsional<br>mode in the<br>bandwidth; | 35.4-36.6kHz | Uses same generator as<br>predicate therefore no<br>change |
| Lock to torsional<br>resonance, followed<br>by continuous tracking<br>of the frequency; | Yes | Uses same generator as<br>predicate therefore no<br>change |
| Automatic return to<br>last frequency if switch<br>off-switch on; | < 2 seconds | Uses same generator as<br>predicate therefore no<br>change |
| Power into matching<br>circuit with waveguide<br>(un)loaded in air; | ≤ 20W | Uses same generator as<br>predicate therefore no<br>change |
| Power into handset<br>with waveguide<br>(un)loaded in air; | ≤ 10W | Uses same generator as<br>predicate therefore no<br>change |
| Tangential peak to<br>peak displacement<br>(including tolerance) of<br>waveguide distal tip at<br>10W into matching<br>circuit in µm; | CV3-400 Max 250<br…