The GYNECARE Morcellex Tissue Morcellator is intended for gynecologic, urologic and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers.
The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

Device Description

The GYNECARE Morcellex Tissue Morcellator is a singlepatient-use device. The device is inserted into the patient with the use of the provided single-patient-use Obturator. The device allows tissue to be grasped with a standard grasping instrument extended through its central lumen. The tissue can be drawn up inside the device's central lumen into the inner stationary sheath as the exposed blade cuts the tissue. The physician can activate the GYNECARE Morcellex Tissue Morcellator via a foot pedal or via the dual-function Blade Guard/Activation Trigger on the device's Detachable Handle. The device can operate in either coring or peeling mode based on the degree of exposure of the blade and placement of the rotatable Coreguard. The device is packaged with a single-patient-use reducer cap to allow the optional use of a 5mm instrument.
The variable-speed, reversible GYNECARE Motor Drive Unit (MDU) drives the rotation of the blade of the GYNECARE Morcellex Tissue Morcellator at a controlled speed and torque after connection of the device to the MDU via the Flexible Drive Cable. An operating room staff member outside of the sterile field controls the direction and speed of rotation on the MDU.

AI/ML Overview

The provided text is a 510(k) summary for the GYNECARE MORCELLEX Tissue Morcellator. It contains information about the device's technical characteristics and intended use, as well as a statement about performance data. However, it does not provide specific acceptance criteria or an in-depth study report with the level of detail requested for AI/medical device performance evaluation.

Here’s a breakdown of why this information is not available in the provided text, and what can be extracted:

Type of Device: The GYNECARE MORCELLEX Tissue Morcellator is a mechanical surgical device for cutting and extracting tissue, not an AI or diagnostic imaging device. Therefore, the typical metrics and study designs (like sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment by experts, etc.) that apply to AI-based medical devices are not relevant or described here.
Nature of "Performance Data": The document states: "The bench testing provided in this 510(k) shows that there is less force required to pull simulated tissue through the Morcellex device than is required for the existing device." This is a very high-level summary of a bench test comparing the new device to a predicate device based on a mechanical performance characteristic (force required to pull simulated tissue). It's not a clinical performance study with human subjects, diagnostic accuracy metrics, or AI algorithm evaluation.

Given the limitations of the provided document, I cannot create the table or answer most of the questions as they pertain to AI/diagnostic device performance. However, I can extract the following information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric (Implied)	Acceptance Criteria (Implied)	Reported Device Performance
Force required to pull simulated tissue	Not explicitly stated, but implies performance at least as good as the predicate or better.	"less force required to pull simulated tissue through the Morcellex device than is required for the existing device."

Explanation: The document does not explicitly state numerical acceptance criteria. The claim is comparative: the new device requires "less force" than the predicate. This implies that "less force" was the performance goal, and achieving it was considered sufficient for substantial equivalence in this aspect.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. (The term "simulated tissue" suggests a lab/bench test, not clinical data from patients).
Data Provenance: Bench testing, likely conducted internally by the manufacturer (Ethicon, Inc.). No country of origin for clinical data is applicable as it was simulated tissue.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for a mechanical force measurement is typically objective, measured by instruments, not established by expert consensus.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert opinions.

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 not an AI device or a diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This is a mechanical surgical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Objective measurement of force using simulated tissue, likely defined by engineering specifications.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/machine learning device.

Summary of what the document does convey:

Device: GYNECARE MORCELLEX Tissue Morcellator.
Predicate Device: GYNECARE X-TRACT Tissue Morcellator.
Intended Use: Gynecologic, urologic, and general surgical endoscopic use.
Indications for Use: Cutting, coring, and extracting tissue during operative laparoscopy.
Technological Characteristics: The modified device has the same technological characteristics as the predicate device (form, fit, function, method of operation are similar).
Performance Claim: Bench testing showed "less force required to pull simulated tissue through the Morcellex device than is required for the existing device."
Conclusion: The device is substantially equivalent to the predicate.

Summary

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K061050 page 1 of 2

Section 5

JUL 1 4 2006

510(k) SUMMARY

Statement

Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " .... 510(k) Summaries and 510(k) Statements ...." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

MODIFIED DEVICE NAME:

GYNECARE MORCELLEX* Tissue Morcellator

PREDICATE DEVICE NAME:

GYNECARE X-TRACT* Tissue Morcellator

Device Description

The variable-speed, reversible GYNECARE Motor Drive Unit

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	(MDU) drives the rotation of the blade of the GYNECAREMorcellex Tissue Morcellator at a controlled speed and torque afterconnection of the device to the MDU via the Flexible Drive Cable.An operating room staff member outside of the sterile fieldcontrols the direction and speed of rotation on the MDU.
Intended Use	The GYNECARE Morcellex Tissue Morcellator is intended forgynecologic, urologic and general surgical endoscopic use bytrained professionals in hospital environments and ambulatorysurgery centers.
Indications Statement	The GYNECARE Morcellex Tissue Morcellator is indicated forcutting, coring and extracting tissue during operative laparoscopy,including laparoscopic general surgical procedures, laparoscopicurologic procedures, and laparoscopic gynecologic procedures.
TechnologicalCharacteristics	The modified device has the same technological characteristics asthe predicate device. The form, fit, function and method ofoperation are similar.
Performance Data	The bench testing provided in this 510(k) shows that there is lessforce required to pull simulated tissue through the Morcellexdevice than is required for the existing device.
Conclusion	Based upon the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thesubject device is substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act.
Contact	Bryan LisaSenior Regulatory AssociateETHICON, INC.Rt. 22 WestSomerville, NJ 08876-0151Phone: (908) 218-3392Fax: (908) 218-2595

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms, representing the department's mission to protect the health of all Americans and provide essential human services. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 1 4 2006

Mr. Bryan Lisa Senior Regulatory Affairs Associate Ethicon, Inc. Ethicon Women's Health & Urology P.O. Box 151, Route 22 West SOMERVILLE NJ 08876

Re: K061050

Trade/Device Name: GYNECARE MORCELLEX* Tissue Morcellator Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: April 14, 2006 Received: April 17, 2006

Dear Mr. Lisa:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image shows a logo with the text "1906-2006" at the top. Below that is the text "FDA" in large, bold letters. Underneath "FDA" is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a circular border with text.

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Page 2 -

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.

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 one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): --

Koblo50 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name:

GYNECARE MORCELLEX* Tissue Morcellator

Indications for Use:

The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __	OR	Over-The Counter Use _
(Per 21 CFR 801.109)		(Optional Eormat 1-2-9G)
		(Division Sign-Off)
		Division of Reproductive, Abdominal,and Radiological Devices
		510(k) Number _

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.