The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

Device Description

The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps.

AI/ML Overview

This document is a 510(k) summary, which is a premarket notification submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It is not a detailed study report designed to present specific acceptance criteria and performance data for a novel device, nor an AI device. Therefore, much of the requested information regarding detailed acceptance criteria, study methodologies, and AI-specific metrics is not available in the provided text.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or detailed performance metrics against those criteria in a tabular format as would be found in a study report. Instead, it relies on demonstrating compliance with recognized consensus standards and substantial equivalence to predicate devices.

For "Performance Data," the document states:
"The device complies with applicable requirements of recognized consensus standards IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility) and Medical Device Directive 93/42/EEC, and is manufactured at an ISO 13485 facility."

This indicates that the "acceptance criteria" are compliance with these listed standards. The "reported device performance" is that the device "complies" with these standards.

Acceptance Criteria (Inferred)	Reported Device Performance
IEC 60601-1 (Electrical Safety)	Complies
IEC 60601-1-2 (Electromagnetic Compatibility)	Complies
Medical Device Directive 93/42/EEC	Complies
ISO 13485 (Quality Management System)	Manufactured at an ISO 13485 facility
Substantial Equivalence to Predicate Devices	Determined substantially equivalent

2. Sample size used for the test set and the data provenance
Not applicable. This is a medical device (morcellator), not an AI algorithm. The performance data refers to compliance with safety and compatibility standards, not a clinical test set with a specific sample size of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device, not an AI algorithm requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device, not an AI algorithm requiring adjudication for a test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (morcellator), not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (morcellator), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device, "ground truth" would be compliance with engineering and safety standards, and confirmation that its functional performance is similar to predicate devices, rather than a clinical ground truth for diagnostic accuracy.

8. The sample size for the training set
Not applicable. This is a medical device (morcellator), not an AI algorithm that uses a training set.

9. How the ground truth for the training set was established
Not applicable. This is a medical device (morcellator), not an AI algorithm.

Summary based on the document:

The Trokamed Morcellator is a motorized unit for tissue morcellation during laparoscopic procedures. Its "acceptance criteria" appear to be compliance with established international standards for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and the Medical Device Directive 93/42/EEC, along with manufacturing under ISO 13485. The "study" for these criteria is the testing performed to demonstrate compliance with these standards, the details of which are not provided in this summary but are implied to have been conducted by the manufacturer. The primary method of demonstrating its safety and effectiveness for FDA 510(k) clearance is by showing substantial equivalence to existing predicate devices (K993801, K061180, K041610, K960640), noting that "minor differences in design and dimensions have no effect on the performance, function or intended use of the device and do not raise any new issues of safety and effectiveness." There is no mention of AI or machine learning components in this device or its assessment.

Summary

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K09101C page 1 of 2

ーで

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR - 1 20il

Date:	February 9, 2011
Submitter:
Name:	Trokamed GmbH
Address:	Kleine Breite 1778187 GeisingenGermany
Contact Person:	Harald Merkt
Telephone:	+49.7704.92440
Fax:	+49.7704.924444
Product:
Trade Name:	TROKAMED MORCELLATOR
Classification:	HET, GCJ (Class II)
Common Names:	Morcellator
Classification Names:	Endoscopic Cutting Accessory
Predicate Device:	K993801, Gynecare Laparoscopic MorcellatorK061180, Storz KSEA Rotocut GIK041610, Morce Scope Set - MorcellatorK960640, SEMM Set for Moto Drive WISAP
Device Description:	The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps.
Intended Use:	The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.
Performance Data:	The device complies with applicable requirements of recognized consensus standards IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility) and Medical Device Directive 93/42/EEC, and is manufactured at an ISO 13485 facility.
Sterilization	The control unit, power cable and foot pedals are provided non-sterile for disinfection only.
	The flexible shaft, control cable, grip module, trocar sheaths, trocars, and forceps are provided non-sterile for steam sterilization.
	The cutting modules and the valve unit are provided sterile for single use only.

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KD91010 page 2 of 2

Conclusion: The basic features, design and intended uses of the TROKAMED MORCELLATOR are similar or identical to those of the predicate devices. The minor differences in design and dimensions have no effect on the performance, function or intended use of the device and do not raise any new issues of safety and effectiveness. In summary, the applicant considers the TROKAMED MORCELLATOR to be substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Trokamed GmbH % Ms. Angelika Scherp Regulatory Affairs Consultant Business Support International Amstel 320-I 1017 AP Amsterdam NH 1017AP THE NETHERLANDS

1 2011

Re: K091010

Trade Name: Trokamed Morcellator Regulation Number: 21 CFR 8884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET and GCJ Dated: August 9, 2010 Received: August 19, 2010

Dear Ms. Scherp:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21. CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hichard Lemmer us

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K091010

Device Name: TROKAMED MORCELLATOR

Indications for Use: The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Tom K. Whing

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K091010.

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Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.