The LOTUS Laproscopic Ultrasound Surgery System is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important, LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecologic, and thoracic surgery.

Device Description

The LOTUS (Laparosopic Operation by Torsional UltraSound) system consists of the power module, the reusable part of the handset, and the disposable part of the handset. The Lotus system employs torsional mode ultrasound at 36 kHz to cut and coagulate soft tissue during laparoscopic or open surgery.

AI/ML Overview

Here's an analysis of the provided text regarding the LOTUS Laparoscopic Ultrasound Surgery System (K032424) and the requested information about its acceptance criteria and supporting studies.

Based on the provided documents, comprehensive details about specific acceptance criteria and a structured study proving it are largely absent. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through general performance testing rather than against pre-defined quantitative acceptance criteria.

However, I will extract what can be inferred and explicitly stated from the text.

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria are not explicitly stated, this table will reflect the general areas of performance testing mentioned and the outcome reported.

Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Electrical Safety Standard Compliance	Successfully carried out
Electromagnetic Compatibility Standard Compliance	Successfully carried out
Biocompatibility	Conducted on some patient-contacting parts of the system; results not detailed but implied to meet requirements.
Performance in Animal Model	Confirmed
Performance in Experiential Clinical Study	Confirmed
Ability to cut and coagulate soft tissue (functional equivalence)	Demonstrated equivalence to predicate devices

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the provided documents. The text mentions "an animal model" and "an experiential clinical study" and "performance testing," but no numbers are given for the number of animals or human subjects, nor the number of cases or procedures performed.
Data Provenance:
- Country of Origin: Not explicitly stated, but the company (SRA Developments Ltd) is located in Ashburton, Devon, UK, suggesting the studies could have taken place there or in another undisclosed location.
- Retrospective or Prospective: Not specified. Animal studies are typically prospective, and "experiential clinical study" could be prospective, but no details are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The nature of the device (surgical tool) implies evaluation by surgeons or clinical specialists, but this is an inference, not an explicit statement.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the type of device and testing (surgical performance), it's highly likely that direct observation and assessment by the surgical team or researchers were used, but no formal adjudication process like 2+1 or 3+1 is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported. This type of study is more common for diagnostic imaging devices where multiple readers interpret cases. The LOTUS device is a surgical instrument.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. The LOTUS device is a physical surgical tool that requires human operation. It does not have a standalone algorithmic component that can be evaluated without human interaction.

7. The Type of Ground Truth Used

Ground Truth: The "ground truth" for performance seems to be based on direct observation of surgical outcomes in animal models and experiential clinical studies. This would likely include:
- Assessment of tissue cutting efficacy.
- Assessment of coagulation effectiveness (hemostasis).
- Evaluation of minimal thermal injury.
- Comparison of these outcomes with predicate devices.
- Biocompatibility testing provided "ground truth" on material safety.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The LOTUS device is a physical surgical instrument, not an AI/ML algorithm that requires a training set. There is no mention of any AI or machine learning components.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary of Device Performance as Reported in the Study

The provided 510(k) summary (K032424) indicates that the LOTUS Laparoscopic Ultrasound Surgery System underwent several types of testing to demonstrate its substantial equivalence to predicate devices:

Electrical Safety and Electromagnetic Compatibility: "Successfully carried out." This implies compliance with relevant standards.
Biocompatibility: "Conducted on some patient-contacting parts of the system." The conclusion of substantial equivalence implies these tests were successful.
Performance Testing:
- "Performance testing in an animal model was conducted."
- "Performance was confirmed in an experiential clinical study."
- The combined results from this performance testing "demonstrate equivalence" to the predicate devices in terms of its ability to cut and coagulate soft tissue, with considerations for bleeding control and minimal thermal injury. The key difference noted is its torsional mode of operation compared to the predicate's longitudinal mode, but this difference was shown not to impact equivalence negatively.

The overall conclusion is that "The data do, in fact, demonstrate equivalence," supporting the substantial equivalence claim.

Summary

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DEC 1 6 2003

K032424 (pg 1 of 2)
510(k) Summary

LOTUS Laparoscopic Ultrasound Surgery System

Common Name: Ultrasound Surgical Instrument Common/Classification Name: Unclassified SRA Developments Ltd Bremridge House Ashburton Devon TQ13 7JX nk

Contact: Dr. Michael J. R. Young, Prepared: July 31, 2003

LEGALLY MARKETED PREDICATE DEVICES A.

The LOTUS Laparoscopic Ultrasound Surgery System is substantially equivalent to the UltraCision Laparoscopic Coagulating Shears cleared by FDA as K980099), and to the AutoSuture Ultrasonic Surgical Instrument (K971861).

DEVICE DESCRIPTION в.

C. INTENDED USE

The LOTUS Laparoscopic Ultrasound Surgery System is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecologic, and thoracic surgery.

SUBSTANTIAL EQUIVALENCE SUMMARY D.

The LOTUS Laparoscopic Ultrasound Surgery System is a medical device, and it has the same indications for use and target population as the legally marketed predicate device.

The LOTUS Laparoscopic Ultrasound Surgery System has the same

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KO32424 (pg 2 of 2)

technological characteristics as the predicate device. However, the descriptive characteristics may not be sufficiently precise to assure substantial equivalence. Therefore, performance testing was carried out for some characteristics. The data from this testing was available and was presented in this 510(k). The data do, in fact, demonstrate equivalence.

TECHNOLOGICAL CHARACTERISTICS E.

The basic technological characteristics of the LOTUS device are the same as those of the predicate devices. The only difference is that the LOTUS is a torsional mode device, while the predicate devices are longitudinal-mode devices.

TESTING F.

Testing to electrical safety and electromagnetic compatibility standards was successfully carried out. Biocompatibility testing was conducted on some patient-contacting parts of the system. Performance testing in an animal model was conducted and performance was confirmed in an experiential clinical study.

G. CONCLUSIONS

This premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three faces in profile, stacked on top of each other, with flowing lines underneath. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2003

SRA Developments, Ltd c/o T. Whit Athey, Ph.D. The Health Policy Resources Group, LLC 2305 Gold Mine Road, Suite 200 Brookeville, Maryland 20833-2233

Re: K032424

Trade/Device Name: LOTUS Laparoscopic Ultrasound Surgery System Regulatory Class: Unclassified Product Code: LFL Dated: November 6, 2003 Received: November 6, 2003

Dear Dr. Athey:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - T. Whit Athey, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) (Division Sign-On), Restorative Division of egical Devices

510(k) Number K032424

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Regulation Number and Section

N/A