The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue.

Device Description

Reprocessed Electrosurgical Instruments may consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The handpiece handles are connected to the distal end-effector by a narrow-diameter insulated barrel or shaft. The distal end of the device consists of a variety of distal end configurations including: dissectors (straight or curved), graspers, scissors (curved, hooked, or metzenbaum), shears, and cutting or dissecting forceps. The devices may be monopolar, bipolar, or tripolar. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. If the instrument has a scissor or jaw end-effector these are opened and closed using the handles. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (using a knob on the handle.) The jaws of some models may be rotated by manipulating controls on the handpiece. Grasper and clamp models may have manipulating jaws operated at the handpiece to lock and hold tissue.

AI/ML Overview

The provided text describes a 510(k) premarket notification for reprocessed electrosurgical instruments. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical efficacy studies with specific acceptance criteria as would be found for novel devices or AI/software as a medical device (SaMD).

Therefore, many of the requested categories for acceptance criteria and study details are not applicable (N/A) in this context, as the focus is on process validation and demonstrating that the reprocessed device performs identically to its original counterpart.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Reported Device Performance
Functional Equivalence	The reprocessed devices undergo mechanical testing to demonstrate that "the parts do not change in function" and that they have "appropriate functional characteristics." The manufacturer states "The technological characteristics of the reprocessed electrosurgical devices are the same as those of the legally marketed predicate devices."
Cleaning Validation	"Process validation testing was done to validate the cleaning procedures." Cleaning validations "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use."
Sterilization Validation	"Process validation testing was done to validate the sterilization procedures." Sterilization validations "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." Compliance with ANSI/AAMI/ISO 11135-1994 (Ethylene Oxide Sterilization) and ANSI/AAMI/ISO 10993-7:1995 (Ethylene oxide sterilization residuals) is stated.
Packaging Validation	"Process validation testing was done to validate... the device's packaging." Packaging validations "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use."
Biocompatibility	"Biocompatibility testing (or certification of the replacement insulation material)" is mentioned as part of the demonstrations for safety and effectiveness. Compliance with ANSI/AAMI/ISO 10993-1: 1997 (Biological Evaluation of Medical Devices Part 1) is stated.
Visual/Mechanical testing	"100 % visual and mechanical testing of all products prior to packaging, labeling, and sterilization" is part of the manufacturing process. "Visual and functional testing of all products produced" is also mentioned. Visual/mechanical testing "demonstrate that the devices are equivalent and continue to be safe and effective for their intended use."
Materials & Design	"Both the reprocessed devices(s) and the predicate device(s) have the same materials and product design."
Indications for Use	"The intended use... of the reprocessed devices do not differ from the legally marketed predicate device(s)." The uses are for "manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue" in minimally invasive surgical procedures.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: The document mentions "Representative samples of reprocessed electrosurgical instruments underwent bench testing." However, a specific numerical sample size for the test set is not provided.
- Data Provenance: The testing appears to be internal "bench testing" conducted by SISS Inc. (d.b.a. MediSISS) in the US, as part of their manufacturing and re-processing validation. It is prospective as it's part of a manufacturing validation process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This type of study (demonstrating substantial equivalence for reprocessed medical devices) does not typically involve expert review for ground truth in the same way an AI/CADe system would. The ground truth here is derived from objective measurements against established specifications for electrosurgical instrument function, cleaning, and sterilization.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are typically relevant for subjective assessments or discrepancy resolution in clinical trials or expert-labeled datasets. This premarket notification relies on objective bench testing and compliance with standards.
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:
- N/A. This is a reprocessed medical device, not an AI/CADe system. No human reader studies or AI assistance are involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a reprocessed medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on objective performance specifications and compliance with recognized standards (e.g., ISO for sterilization and biocompatibility) for electrosurgical instruments, along with visual and mechanical factory acceptance testing. The "truth" is that the reprocessed device functions identically and safely (e.g., cleaned, sterile, biocompatible) to the original predicate device.
The sample size for the training set:
- N/A. This device does not involve machine learning or AI, so there is no "training set." The reprocessing "process validation" itself is akin to a training phase in a manufacturing context, ensuring the process consistently yields acceptable products.
How the ground truth for the training set was established:
- N/A. As there is no AI training set, this is not applicable. The "ground truth" for the reprocessing process validation was established by adherence to industry standards and internal quality control specifications for device functionality, cleanliness, and sterility, verified through scientific methodologies like sterilization validation protocols.

Summary

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3 2003 JUL

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence starts with the letter 'K', followed by the numbers '030919'. The characters are written in a casual, cursive style, with varying stroke thicknesses. The image has a simple composition, focusing solely on the legibility of the characters.

510(k): SISS Inc. (d.b.a. MediSISS) Reprocessed Electrosurgical Instruments and Accessories

Page 41 of 44

Summerer of Stiller The Price Differ 201 231 2 2011 10:00 10 10 10 10 10 10 10 10 10 10 1

submitted by

SISS Inc. (d.b.a. MediSISS) P.O. 2060 723 Curtis Court Sisters, OR 97759 Phone: (800)-860-9482 Fax: (541) 549-4527 Email: mabarker@MediSISS.com

Contact Person: Device Trade Names: Common Names: Classification Names:

Mary Ann Barker Reprocessed Electrosurgical Instruments Reprocessed Electrosurgical Instruments Electrosurgical cutting and coagulation device and accessories. CFR §876.4300

Identification of a Legally Marketed Predicate Device

The SISS Inc. (d.b.a. MediSISS) Reprocessed Electrosurgical Instruments are substantially equivalent to the electrosurgical instruments manufactured by:

Circon/ACMI Weck (Pilling Surgical)

These devices are legally marketed and distributed pursuant to 510(k)'s K884306, K932293, and K965176 and the counterpart devices from the original manufacturers.

They are also similar to the reprocessed electrosurgical instruments and accessories reprocessed by Alliance Corporation and legally marketed and distributed pursuant to 510(k)'s K012608, K012638, K012603. Likewise, Adven Medical, Inc Reprocessed Used Disposable Endoscopic Scissors and Graspers - 510(k) K012696; SterilMed, Inc. Reprocessed Laparoscopic Electric Instruments: - 510(k) K012598; Vanguard Medical. Concepts, Inc Vanguard Reprocessed Endoscopic Instruments, 510(k) K012700; and SISS, Inc Electrosurgical Electrodes - 510(k) K012669.

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Device Description

Reprocessed Electrosurgical Instruments may consist of hand-manipulated devices with electrocautery capability and with or without rotation capability.

The handpiece handles are connected to the distal end-effector by a narrow-diameter insulated barrel or shaft. The distal end of the device consists of a variety of distal end configurations including: dissectors (straight or curved), graspers, scissors (curved, hooked, or metzenbaum), shears, and cutting or dissecting forceps. The devices may be monopolar, bipolar, or tripolar. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula.

If the instrument has a scissor or jaw end-effector these are opened and closed using the handles. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360°) either direction (using a knob on the handle.) The jaws of some models may be rotated by manipulating controls on the handpiece. Grasper and clamp models may have manipulating jaws operated at the handpiece to lock and hold tissue.

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 electrosurgical devices are the same as those of the legally marketed predicate devices. The technological characteristics of the reprocessed electrosurgical device(s) are the same as those of the legally marketed predicate devices. In addition the MediSISS™ manufacturing process includes 100 % visual and mechanical testing of all products prior to packaging, labeling, and sterilization.

Summary of Performance Data

The SISS Inc. (d.b.a. MediSISS) Reprocessed Electrosurgical Instruments comply with the following standards, practices, and guidance's:

ANSI/AAMI/ISO 11135-1994, Medical Devices-Validation and Routine ● Control of Ethylene Oxide Sterilization
ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical ● Devices-Part 7: Ethylene oxide sterilization residuals

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ANSVAAMI/ISO 10993-1: 1997 (1999 Edition). Biological Evaluation of ● Medical Devices Part 1: Evaluation and Testing.
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.

MediSISS™ Reprocessed Electrosurgical 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.

Cleaning, sterilization, and packaging validations, functional/performance testing, (product certification,) and (biocompatibility) testing (or certification of the replacement insulation material) demonstrate that the devices are equivalent and continue to be safe and effective for their intended use.

Representative samples of reprocessed electrosurgical instruments underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.

The SISS Inc. (d.b.a. MediSISS) Reprocessed Electrosurgical Instruments are substantially equivalent to the identified predicate devices. This has been demonstrated through bench testing and comparative analysis of features.

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Conclusion

Since the Reprocessed Electrosurgical 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 Reprocessed Electrosurgical Instruments will be reprocessed per specifications and good manufacturing practices 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 information provided in this Premarket notification, SISS Inc. (d.b.a. MediSISS) concludes that the modified devices (Reprocessed Electrosurgical Instruments) are safe, effective and substantially equivalent to the predicate devices described herein.

Based on the information provided herein, the 510(k) "Substantial Equivalence" Decision Making Process Chart, and the FDA - "510(k) Guidance Document for General Surgical Electrosurgical Devices" 5/10/95, we conclude that the SISS Inc. (d.b.a. MediSISS) reprocessed electrosurgical instruments are substantially equivalent to the predicate devices under the Federal Food and Drug, and Cosmetic Act.

This conclusion is based upon the devices' similarities in functional design, materials, indications for use, and methods of construction.

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Image /page/4/Picture/1 description: The image is a black and white logo. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. In the center of the circle is a stylized image of an eagle's head with three lines representing the feathers.

Public Health Service

3 2003 JUL

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siss. Inc. (d.b.a. MediSiSS") Mr. Marc M. Mouser Project Engineer, Medical Devices FDA Office Coordinator UL Conformity Assessment Services Underwriters Laboratory, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

Re: K030919

Trade/Device Name: See Attachment Regulation Number: 876.4300 Regulation Name: Reprocessed Endoscopic Electrosurgical Unit (with or without Accessories) Regulatory Class: II Product Code: NLR Dated: June 16, 2003 Received: June 20, 2003

Dear Mr. Mouser:

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 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 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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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Brogdon

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

Enclosure ,

l'age 2

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Device	Manufacturer	Model No.
Dolphin Nose Dissector	Weck (Pilling Surgical)	722420a
Maryland Dissector	Weck (Pilling Surgical)	722425a
Straight Dissector	Weck (Pilling Surgical)	725401a
Fenestrated Dissector	Weck (Pilling Surgical)	725430a
Mixter Dissector 90° angle	Weck (Pilling Surgical)	727210a
Mixter Dissector 45° angle	Weck (Pilling Surgical)	727211a
Maryland Dissector	Weck (Pilling Surgical)	727425a
Cone Tip Dissector with spoon	Weck (Pilling Surgical)	725405a
Dolphin Nose Dissector	Weck (Pilling Surgical)	725420a
Maryland Dissector	Weck (Pilling Surgical)	725425a
Tri-polar Cutting Forceps,10 mm, 32 cm	Circon ACMI	006689-90
Tri-polar Cutting Forcepsw/rotation, 10 mm, 32 cm	Circon ACMI	006689-90
Tri-polar Cutting Forcepsfor open procedures, 10 mm, 15 cm	Circon ACMI	008140-90
Tri-polar Cutting Forceps,5 mm, 32 cm	Circon ACMI	008593-90

K030919 Premarket Notification of MediSISS Reprocessed Electrosurgical Devices

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Page 5 of 44

Indications for Usa

	Page 1 of 1
510(k) Number (if known):
Device Name:	SISS Inc. (d.b.a. MediSISS) Reprocessed Electrosurgical Instruments and Accessories.
Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)	OR (Division Sign-Off)	Over-The-Counter Use (Optional Format 1-2-96)
---------------------------------------	------------------------	-----------------------------------------------

Nancy c Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices K030919

510(k) Number

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).