The SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments are intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel instruments. The instruments are used in general, pediatric, thoracic, gynecologic, urologic, and other open and endoscopic surgeries for the transection, dissection, and coagulation of tissue(s).

Device Description

Reprocessed Ultrasonic Surgical Instruments consist of hand-manipulated devices, with or without rotation capability, with or without cutting ability.

The handpiece handles are connected to the distal end-effector by a narrow-diameter metal barrel or shaft. The distal end of the device consists of a scalpel with a variety of end configurations including Flat, Cutting, and Blunt or a combination of the same. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula or used to be used in open surgery. The end-effectors are usually operated by the handpiece handles. The handles may be designed to be suppressed and released to activate the instruments end-effector. Similarly the handle may incorporate a button or switch to activate the end-effectors.

The device's shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (by manipulating controls located on the handle.)

AI/ML Overview

This document describes the regulatory clearance for reprocessed ultrasonic surgical instruments, not a study evaluating an AI device or a new medical device's performance. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and comparative effectiveness studies is not applicable.

The document discusses the substantial equivalence of reprocessed devices to legally marketed predicate devices. The "performance data" section focuses on validation of the reprocessing methods (cleaning, sterilization, packaging) and demonstrating that the reprocessed devices maintain their mechanical function.

Here's a breakdown of the relevant information from the provided text, and an explanation of why other requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Reprocessed Devices)	Reported Device Performance (Summary)
Sterilization Validation:	Complies with ANSI/AAMI/ISO 11135-1994 (Medical Devices—Validation and Routine Control of Ethylene Oxide Sterilization) and ANSI/AAMI/ISO 10993-7:1995 (Biological Evaluation of Medical Devices-Part 7: Ethylene oxide sterilization residual).
Cleaning Validation:	Complies with AAMI RDS0TIR No. 12-1994 (Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities) and FDA Reviewer Guidance (1996) for Labeling Reusable Medical Devices.
Mechanical Testing:	Undergoes mechanical testing to demonstrate that parts do not change in function.
Visual Inspection:	100% visual inspection of all products prior to packaging, labeling, and sterilization.
Substantial Equivalence:	Devices are safe, effective, and substantially equivalent to predicate devices based on similarities in functional design, materials, indications for use, and methods of construction.

Explanation of Non-Applicability for other sections:

The document focuses on the regulatory clearance of reprocessed medical devices (ultrasonic surgical instruments), not the development or evaluation of a new diagnostic or therapeutic device, especially not one involving AI. Therefore, the traditional "acceptance criteria" and "study" framework relevant to a novel device's performance often includes metrics like sensitivity, specificity, AUC, etc., which are not present here.

2. Sample size used for the test set and data provenance: Not applicable. The document discusses process validations for cleaning, sterilization, and mechanical function, not a test set for diagnostic accuracy or clinical outcomes of a novel device. The "data" refers to validation reports from these processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be related to the effectiveness of the reprocessing steps (e.g., sterility, cleanliness, mechanical integrity), which are assessed through standardized validation protocols, not expert consensus on diagnostic images or clinical conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no "test set" in the sense of a set of cases requiring adjudication for a diagnostic outcome.
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 document is about reprocessed surgical instruments, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm or AI component in the described device or its reprocessing validation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the reprocessing validation, the "ground truth" is defined by the established standards and methods for assessing sterility, cleanliness, and mechanical function. For example, sterility is confirmed by microbiological tests according to established protocols, and mechanical integrity by predefined engineering tests. This is not 'expert consensus' on clinical data, pathology, or outcomes data in the usual sense for a diagnostic device.
8. The sample size for the training set: Not applicable. There is no AI model or "training set" involved.
9. How the ground truth for the training set was established: Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird-like shape, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 2004 NOV

Mike Sammon, Ph.D. Senior Director of Research and Development MediSISS. Inc. 2747 SW 6th Street Redmond, Oregon 97756

K030598 - Supplemental Validation Submission Re: Trade/Device Name: Ethicon, CS-14C, LCS-C5 (see enclosed list) Regulation Name: Ultrasonic Surgical Instruments Regulatory Class: Unclassified Product Code: NLQ Dated: December 30, 2003 Received: December 31, 2003

Dear Dr. Sammon:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on January 23, 2004. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices 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 devices comply 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 applicable 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.

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Page 2 - Mike Sammon, Ph.D.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Stupt Rhodes

Colin M. Wittmer, M.D., Ph.D.

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

Enclosure

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Reprocessed Ultrasonic Surgical Instruments found to be Substantially Equivalent:

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Ethicon, CS-14C Ethicon, LCS-C5

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AND / OR Prescription Use Use (Part 21 CFR 801 Subpart D)

Over-The-Counter

(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)

Stist ludu

(Division Sign-Off)

Division of General, Restorative,
and Neurological Devices

Page 1 of 1

510(k) Number K030598

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Company

510(k) #

Ethicon Endo-Surgery (Ultracision)	K980099, K993054, and K010898
U.S.Surgical	K971861
Olympus Optical	K972114

They are also similar to the Reprocessed Ultrasonic Surgical Instruments reprocessed by SterilMed Corporation and legally marketed and distributed pursuant to Reprocessed Harmonic Scalpels 510(k) K012571 and likewise, Vanguard's 510(k) 022780 Vanguard Reprocessed Ultrasonic Scalpel.

K030598

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510(k): SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments

Page 41 of 42

Device Description

Reprocessed Ultrasonic Surgical Instruments consist of hand-manipulated devices, with or without rotation capability, with or without cutting ability.

The device's shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (by manipulating controls located on the handle.)

Intended Use

Summary of Technological Characteristics

The intended use and technological features of the reprocessed devices do not differ from the legally marketed predicate device(s). Both the reprocessed devices(s) and the predicate device(s) have the same materials and product design. There are no changes to the claims, intended use, clinical applications, patient populations, performance specifications, or methods of operation. The technological characteristics of the Reprocessed UItrasonic Surgical Instruments are the same as those of the legally marketed predicate devices. In addition the SISS d.b.a. MediSISS™ manufacturing process includes 100 % visual and mechanical testing of all products prior to packaging, labeling, and sterilization.

Summary of Performance Data

The SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments comply with the following standards, practices, and guidance's:

Sterilization Validation and EO Residuals:

ANSI/AAMI/ISO 11135-1994, Medical Devices—Validation and Routine Control of � Ethylene Oxide Sterilization
SISS d.b.a. MediSISS™

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Page 42 of 42

510(k): SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments

ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices-Part 7: Ethylene oxide sterilization residual.

Cleaning Validation:

AAMI RDS0TIR No. 12-1994. Designing, Testing, and Labeling Reusable Medical . Devices for Reprocessing in Health Care Facilities: A guide for Device Manufactures. Association for the Advancement of Medical Instrumentation, Arlington, VA.Food and Drug Administration. 1996.
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA . Reviewer Guidance, Office of Device Evaluation. FDA, Washington, D.C.

Cleaning, sterilization, packaging validations, and visual/mechanical testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use.

SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments undergo mechanical testing to demonstrate that the parts do not change in function. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging.

Conclusion

Since the SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments meet the requirements of the stated standards and embody technological characteristics identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments will be reprocessed per specifications, good manufacturing practices, and QSR (Quality System Regulations) that ensure the device is safe and effective for its intended use.

In Accordance with the Federal Food, Drug, and cosmetic Act, 21 CFR Part 807, and based on the 510(k) "Substantial Equivalence" Decision Making Process Chart and the information provided in this premarket notification, SISS d.b.a. MediSISS™ concludes that the device(s)(Reprocessed Ultrasonic Instruments) are safe, effective, and substantially equivalent to the predicate devices as described herein.

This conclusion is based upon the SISS d.b.a. MediSISS™ Reprocessed Ultrasonic Surgical Instruments similarities in functional design, materials, indications for use, and methods of construction to the predicate devices.

Regulation Number and Section

N/A