(92 days)
Not Found
No
The summary describes a surgical device using ultrasonic energy for cutting and coagulation. There is no mention of AI, ML, image processing, or any data-driven decision-making processes typically associated with AI/ML in the device description or performance studies.
Yes
The device is indicated for soft tissue surgical incisions for cutting and coagulation, which qualifies it as a therapeutic device.
No
The device description clearly states it "cut[s] and coagulate[s] soft tissue" and is used for "soft tissue surgical incisions," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it consists of a power module, reusable handset part, and disposable handset part, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue surgical incisions when bleeding control and minimal thermal injury are important." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a "Laparoscopic Ultrasound Surgery System" that uses "torsional mode ultrasound at 35-40kHz to cut and coagulate soft tissue during laparoscopic or open surgery." This is a surgical instrument.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not perform any such analysis of specimens.
The device is clearly a surgical instrument used for cutting and coagulating tissue during surgery, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Series 3 LOTUS shear & hook are 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, 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
The SRA Developments Series 3 LOTUS Laparoscopic Ultrasound Surgery System consists of the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset; and the disposable part of the handset. The Series 3 LOTUS system employs torsional mode ultrasound at 35-40kHz 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electromagnetic compatibility testing was successfully carried out to EN 60601-1-2 and to FCC Part 18. Electrical safety testing has been carried out in-house to EN 60601-1 and SRA Developments will have the system tested to comply with UL60601-1 including Clause 19 Patient Auxillany Current by UL UK Itd. before they are marketed in the US. Biocompatibility issues were covered by the LOTUS Laparoscopic Ultrasound Surgery System (K032424) application.
Performance testing was carried out in an animal study in Portugal and the results are included in this 510(k) in Exhibit 21. Ex-vivo testing was also completed both in Portugal and the UK, the results of this testing is also included in Exhibit 21. User trials were undertaken at a number of UK hospitals. A summary of this testing is included as Exhibit 22.
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.
K032424, K060245, K971302, K021502
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
Ko635-3/
510(k) Summarv
Rage 1 of 3
Series 3 LOTUS Laparoscopic Ultrasound Surgery System
FEB 2 2 2007
| Common: | Ultrasound Surgical Instrument |
|---|---|
| Classification Name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories (21 C.F.R. 878.4400) | |
| Product Code: | LFL |
| Sponsor: | SRA Developments Ltd |
| Bremridge | |
| Ashburton | |
| Devon TQ13 7JX | |
| T: +44 1364 652426 | |
| F: +44 1364 653589 |
Dr. Michael J. R. Young
A. REASON FOR SUBMISSION
Contact:
This 510(k) is being filed for three main reasons. Firstly, it is to cover improvements in the existing LOTUS (K032424) which includes a new generator and ergonomically improved handsets. Secondly there are new hook handsets available that were not covered in the original 510(k). Thirdly is a change to the intended use that now includes its use in orthopedic surgery.
B. LEGALLY MARKETED PREDICATE DEVICES
The SRA Developments Series 3 LOTUS Laparoscopic Ultrasound Surgery System is substantially equivalent to the LOTUS Laparoscopic Coagulation and Cutting System cleared for marketing under K032424, the Ultracision Harmonic Scalpel Blades and Shears cleared for marketing under K060245, the Ultracision 5mm Hard Sheath Laparoscopic Blade and Ultracision HS2 Blade (K971302) and Orthosonics OSCAR System for Cemented Arthroplasty Revision (K021502).
C. DEVICE DESCRIPTION
The SRA Developments Series 3 LOTUS Laparoscopic Ultrasound Surgery System consists of the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset; and the disposable part of the handset. The Series 3 LOTUS system employs torsional mode ultrasound at 35-40kHz to cut and coagulate soft tissue during laparoscopic or open surgery.
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D. INTENDED USE
Series 3 LOTUS shear & hook are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. IOTUS 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
The Series 3 LOTUS Laparoscopic Coagulation and Cutting System has the same technological characteristics as the predicate device LOTUS Laparoscopic Coagulation and Cutting System. The only difference with the predicate device Ethicon Ultracision Harmonic Scalpel Blades and Shears is that the LOTUS is a torsional mode device whereas the harmonic scalpel is longitudinal.
F. SUBSTANTIAL EQUIVALENCE SUMMARY
The Series 3 LOTUS Laparoscopic Coagulation and Cutting System is a medical device, and it has the same indications for use and target population as the legally marketed predicate devices.
The Series 3 LOTUS Laparoscopic Coagulation and Cutting System has the same technological characteristics as the predicate devices. 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).
G. TESTING
Electromagnetic compatibility testing was successfully carried out to EN 60601-1-2 and to FCC Part 18. Electrical safety testing has been carried out in-house to EN 60601-1 and SRA Developments will have the system tested to comply with UL60601-1 including Clause 19 Patient Auxillany Current by UL UK Itd. before they are marketed in the US. Biocompatibility issues were covered by the LOTUS Laparoscopic Ultrasound Surgery System (K032424) application.
Performance testing was carried out in an animal study in Portugal and the results are included in this 510(k) in Exhibit 21. Ex-vivo testing was also completed both in Portugal and the UK, the results of this testing is also
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included in Exhibit 21. User trials were undertaken at a number of UK hospitals. A summary of this testing is included as Exhibit 22.
H. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" and is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SRA Developments, Ltd. % Mr. Alan Chivers Regulatory Affairs Manager Bremridge House Ashburton, South Devon, United Kingdom TQ13 7JX
FEB 2 2 2007
Re: K063531
Trade/Device Name: Series 3 LOTUS Laproscopic Ultrasound Surgery System Regulatory Class: Unclassified Product Code: LFL Dated: January 26, 2007 Received: February 5, 2007
Dear Mr. Chivers:
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
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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.
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milkerson
Mark N. Melkerson 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): K063531
Device Name: Series 3 LOTUS Laproscopic Ultrasound Surgery System
Indications For Use:
Series 3 LOTUS shear & hook are 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, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
Signature
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millikan
(Division Sign-Off) Division of General, Restorative, and Neurolacical Devices
510(k) Number
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