(245 days)
No
The device description focuses on the mechanical and ultrasonic aspects of the surgical shears and does not mention any AI or ML components or functionalities.
No
The device is described as an ultrasonic surgical tool used for cutting and coagulating tissue during surgery, which makes it a surgical tool rather than a therapeutic device.
No
Explanation: The device is described as surgical shears indicated for "soft tissue surgical incisions when bleeding control and minimal injury are important." Its function involves cutting and coagulating tissue using torsional ultrasound, which are therapeutic actions, not diagnostic ones. There is no mention of it being used to detect or identify medical conditions.
No
The device description clearly outlines physical hardware components including transducers, handpieces, and a generator, which are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the LOTUS Enhanced Shears and LOTUS Series 5 are surgical devices used for cutting and coagulating soft tissue during surgical procedures. They operate using torsional ultrasound to achieve this.
- Intended Use: The intended use is for soft tissue surgical incisions, not for analyzing samples taken from the body.
- Device Description: The description focuses on the mechanical and ultrasonic aspects of the device for surgical use.
- Performance Studies: The performance studies described involve bench testing related to cutting times, transducer lifetime, thermal spread in tissue, and length of dissection – all related to surgical performance, not diagnostic analysis of samples.
The device is a surgical instrument used directly on the patient's tissue during surgery, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, Hip joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
LOTUS Series 4 Enhanced Shears
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
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
1
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
2
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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3
510(k) Summary
| Company Information: | SRA Developments Ltd
Bremridge
Ashburton
Devon
UK
TQ13 7JX
T: +44 1364 652426
F: +44 1364 653589 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Contact: | Phillipa Frewin
RAQA Manager
SRA Developments Ltd |
| | Phillipa.Frewin@bowa-medical.com |
| Date Prepared: | 28th October 2022 |
| Trade Name: | LOTUS Series 4 Enhanced Shears
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).
4
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
5
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 | |
| Ultrasonic Surgical System | LOTUS Enhanced Shears | |
| are indicated for soft tissue | ||
| 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 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). | 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). | ||
| Energy Source | Ultrasound | No Change |
| Ultrasound mode | Torsional mode | No Change |
| Axis of transducer | ||
| stack | Perpendicular to waveguide | No Change |
| Generator | 1 Channel | Uses same generator as |
| predicate therefore no | ||
| change | ||
| Control System | Digital | Uses same generator as |
| predicate therefore no | ||
| change | ||
| Frequency Control | Digital frequency control | Uses same generator as |
| predicate therefore no | ||
| change | ||
| Power Mode | Continuous | Uses same generator as |
| predicate therefore no | ||
| change | ||
| Electrical Safety | EN 60601-1 | |
| IEC 60601-1 | ||
| TÜV SÜD marked | Uses same generator as | |
| predicate therefore no | ||
| change | ||
| Electromagnetic | ||
| Compatibility | EN 60601-1-2 | |
| FCC Part 18 | Uses same generator as | |
| predicate therefore no | ||
| change | ||
| Function Control | Finger switches or | |
| footswitch | No Change | |
| Sterilization | EO for handpiece | |
| Autoclave for transducer & | ||
| waveguide | No Change | |
| Sterile Packaging | Single wrapped in heat | |
| sealed pouches | No Change | |
| manufactured from Tyvek | ||
| 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 | |
| Stainless Steel | No Change | |
| Shears blade type | Laparoscopic shears Curved tip | |
| Laparoscopic shears slim Curved tip | ||
| Open shears Straight Tip | ||
| Bariatric shears Straight Tip | Open shears Curved Tip | |
| Bariatric shears Curved Tip | ||
| Liver Resector blade type | Open Liver Resector Straight Tip | |
| 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; |