The provided text describes a 510(k) submission for the NTERO RF Sleeve, a Class II electrosurgical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a new type of device.

Therefore, much of the requested information regarding acceptance criteria, specific test results, ground truth, and expert involvement is not present in the provided document. The device's safety and effectiveness were primarily established through comparison to legally marketed predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not list specific numerical acceptance criteria. The "Reported Device Performance" is a general statement of positive test results and biocompatibility.

Acceptance Criteria	Reported Device Performance
	Performance: Results of in vitro and in vivo testing demonstrate that the NTERO RF Sleeve is safe and effective for its intended function.
	Biocompatibility: The materials used in the NTERO Probe have been shown to be biocompatible.

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

The document states "Results of in vitro and in vivo testing" but does not specify the sample sizes for these tests.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable. The document describes performance testing, but there is no mention of an expert panel establishing a "ground truth" for diagnostic or analytical performance, as would be typical for image analysis or AI devices. The evaluation focuses on the functional performance and safety of the surgical device.

4. Adjudication Method for the Test Set

Not applicable. As there's no mention of expert-established ground truth, there's no adjudication method described.

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

Not applicable. The device is a surgical instrument, not an AI diagnostic tool that would typically involve a MRMC study to assess reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a manual surgical tool and does not involve an algorithm with standalone performance.

7. Type of Ground Truth Used

Not applicable/Not specified in the context of diagnostic "ground truth." The testing focused on functional performance and biocompatibility through in vitro and in vivo methods, rather than establishing a diagnostic ground truth against which an algorithm would be measured. The "ground truth" for a surgical device would be its ability to perform its intended function safely and effectively within biological systems, observed during these tests.

8. Sample Size for the Training Set

Not applicable. This device is hardware (a surgical sleeve) and does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable. As there is no training set, this query is irrelevant for this device.

Summary

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This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: July 30, 1999

510(k) number: K992572

Applicant Information:

NTERO Surgical, Inc. 1137D San Antonio Rd Palo Alto, CA 94303

Contact Person:	D. Bommi Bommannan
Phone Number:	(650) 428-1000 ext. 101
Fax Number:	(650) 428-0700

Device Information:

Classification: Class II Trade Name: NTERO RF Sleeve Classification Name: Electrosurqical Device and accessories (21 CFR 870,4400)

Equivalent Device:

The subject device is substantially equivalent in intended use and/or method of operation to the USSC Versaport Sleeve (K954108), the Surgical Laser SLT Hemosleeve Bipolar Sheath (K984018) and the Dorsal Orthopedic Coaqulating Cannula (K953696).

Intended Use:

The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coaqulate tissue.

Test Results:

Performance

Results of in vitro and in vivo testing demonstrate that the NTERO RF Sleeve is safe and effective for its intended function.

Biocompatibility

The materials used in the NTERO Probe have been shown to be biocompatible.

Summary:

Based on the intended use, product, performance and biocompatability information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three lines representing the head, body, and legs. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 4 1999

Mr. D. Bommi Bommannan President NTERO Surgical, Inc. 1137D San Antonio Road Palo Alto, California 94303

Re: K992572 Trade Name: NTERO RF Sleeve Regulatory Class: II Product Code: GEI Dated: July 30, 1999 Received: August 2, 1999

Dear Mr. Bommannan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 – Mr. D. Bommi Bommannan

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

to welle

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K992572 ---------

Device Name:

NTERO RF Sleeve . . . . . . . . . . . .

Indications for Use:

The NTERO RF Sleeve is intended for use during laparoscopic surgery to maintain a port of entry and to coagulate tissue.

・

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992572

Prescription Use(Per 21 CFR 801.109)	✓	OR	Over-the Counter Use
------------------------------------------	-----------------------------------------	----	----------------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.