(133 days)
Not Found
No
The summary describes a surgical device utilizing ultrasound for cutting and coagulation, with no mention of AI or ML in its operation or intended use.
No.
The device is used for surgical incisions and bleeding control, which are surgical procedures, not therapeutic treatments.
No
The device description and intended use indicate it is a surgical instrument for cutting and coagulating soft tissue, not for diagnosing medical conditions.
No
The device description explicitly states it consists of a power module, reusable handset part, and disposable handset part, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the LOTUS system is for "soft tissue surgical incisions" and is used "during laparoscopic or open surgery." This describes a surgical tool used directly on the patient's body for treatment, not a device used to examine samples (like blood, urine, or tissue) outside the body to diagnose a condition.
- Device Description: The description confirms it's a surgical system that uses ultrasound to "cut and coagulate soft tissue." This is a direct surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or being used in a laboratory setting.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The LOTUS system is a surgical instrument used for therapeutic purposes.
N/A
Intended Use / Indications for 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.
Product codes
LFL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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. 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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
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