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).

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.

AI/ML Overview

The provided text describes the Series 3 LOTUS Laparoscopic Ultrasound Surgery System (K063531). However, the document is a 510(k) summary and not a detailed study report. Therefore, it discusses testing performed but does not provide specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria in the format requested.

Here's a breakdown of what can be extracted and what information is missing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary states that "Performance testing was carried out for some characteristics. The data from this testing was available and was presented in this 510(k)." but it does not detail:

Specific quantitative acceptance criteria (e.g., "device must achieve X % reduction in bleeding").
The exact results of the performance tests against such criteria.

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

The document mentions three types of testing:

Animal study: "Performance testing was carried out in an animal study in Portugal".
Ex-vivo testing: "Ex-vivo testing was also completed both in Portugal and the UK".
User trials: "User trials were undertaken at a number of UK hospitals."

However, the sample sizes for any of these test sets are not specified. The data provenance states Portugal and the UK, but it does not specify if the studies were retrospective or prospective, though animal and ex-vivo studies are typically prospective. User trials would also typically be prospective.

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

This information is not provided. The document makes no mention of "ground truth" or the use of experts in establishing it for any of the performance tests.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided. Such a study would typically involve human readers interpreting images or data, which is not the primary function of this surgical instrument. The user trials might involve clinicians' feedback on device performance, but not in an MRMC comparative effectiveness study context as typically understood for diagnostic AI.

6. Standalone Performance

The device itself is a surgical instrument (ultrasound shear & hook), not primarily a diagnostic algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not directly applicable in the same way as it would be for an AI diagnostic device. The performance tests described (animal, ex-vivo, user trials) inherently test the device's function directly.

7. Type of Ground Truth Used

This information is not explicitly provided. Since it's a surgical instrument, the 'ground truth' in performance testing would likely relate to objective measures of tissue cutting, coagulation, thermal injury, and functional outcome in the animal and ex-vivo studies. For user trials, it would be subjective feedback from surgeons. The document does not specify how these outcomes were definitively assessed or by whom.

8. Sample Size for the Training Set

This device is a physical surgical instrument and not an AI algorithm that undergoes "training" in the computational sense. Therefore, the concept of a "training set" and its sample size is not applicable.

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

As above, this concept is not applicable to this device.

Summary of available information regarding testing:

While specific acceptance criteria and detailed study results are absent, the document indicates that the following testing was performed to support the device's substantial equivalence:

Electromagnetic compatibility testing: Successfully carried out to EN 60601-1-2 and FCC Part 18.
Electrical safety testing: Carried out in-house to EN 60601-1, with plans for UL60601-1 testing before US marketing.
Biocompatibility issues: Covered by the predicate device's application (K032424).
Performance testing:
- Animal study in Portugal (results included in Exhibit 21 of the 510(k)).
- Ex-vivo testing in Portugal and the UK (results included in Exhibit 21).
- User trials in a number of UK hospitals (summary included as Exhibit 22).

The 510(k) concludes that based on this testing, the device demonstrates substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for its intended use.

Summary

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Ko635-3/

510(k) Summarv

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Series 3 LOTUS Laparoscopic Ultrasound Surgery System

FEB 2 2 2007

Common:	Ultrasound Surgical Instrument
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories (21 C.F.R. 878.4400)
Product Code:	LFL
Sponsor:	SRA Developments LtdBremridgeAshburtonDevon TQ13 7JXT: +44 1364 652426F: +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

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K06353/

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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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Page 3 of 3

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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Page 2 - Mr. Alan Chivers

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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K06353/

Indications for Use

510(k) Number (if known): K063531

Device Name: Series 3 LOTUS Laproscopic Ultrasound Surgery System

Indications For Use:

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

Page 1 of

Regulation Number and Section

N/A