← Product Code LFL · K032424 # LOTUS (K032424) _Sra Developments, Ltd. · LFL · Dec 16, 2003 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K032424 ## Device Facts - **Applicant:** Sra Developments, Ltd. - **Product Code:** LFL - **Decision Date:** Dec 16, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## 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. ## Device Story The LOTUS system is an ultrasonic surgical instrument used for cutting and coagulating soft tissue during laparoscopic or open surgery. It consists of a power module, a reusable handset, and a disposable handset component. The device operates by delivering torsional mode ultrasound at 36 kHz to the surgical site. It is intended for use by surgeons as an alternative or adjunct to traditional scalpels, electrosurgery, or laser surgery. By utilizing torsional ultrasound, the device aims to achieve effective hemostasis while minimizing thermal damage to surrounding tissues, potentially improving patient outcomes during surgical procedures. ## Clinical Evidence Evidence includes bench testing for electrical safety and electromagnetic compatibility, biocompatibility testing of patient-contacting components, performance testing in an animal model, and an experiential clinical study confirming device performance. ## Technological Characteristics System utilizes torsional mode ultrasound at 36 kHz for tissue cutting and coagulation. Components include a power module, reusable handset, and disposable handset. Device is designed for laparoscopic or open surgery. Technological differences from longitudinal-mode predicates were validated via performance testing. ## Predicate Devices - UltraCision Laparoscopic Coagulating Shears ([K980099](/device/K980099.md)) - AutoSuture Ultrasonic Surgical Instrument ([K971861](/device/K971861.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. 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. ### 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 {1}------------------------------------------------ # 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. {2}------------------------------------------------ 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. {3}------------------------------------------------ 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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use 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. 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 Page 1 of 1 --- **Source:** [https://fda.innolitics.com/device/K032424](https://fda.innolitics.com/device/K032424) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com