(190 days)
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.
Reprocessed Electrosurgical Instruments mav consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The distal end of the Ethicon device consists of a scissor distal end configuration. The U.S Surgical device consists of a dissector distal end configuration. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The end effectors are operated by the handpiece handles may be designed to be suppressed and released to activate the instruments end-effector. 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.)
This document describes the validation and acceptance criteria for reprocessed electrosurgical instruments by SISS Inc. (d.b.a. MediSISS). This is NOT a study of an AI/ML device, but rather a submission for a 510(k) premarket notification for a medical device. Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance metrics for individual reprocessed instruments. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices and compliance with established standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate devices. |
| Technological Characteristics | Same as predicate devices (materials, design, energy, performance specifications, methods of operation). |
| Functional Characteristics | Bench testing demonstrated appropriate functional characteristics. |
| Cleaning Validation | Process validation performed. |
| Sterilization Validation | Process validation performed, complying with ANSI/AAMI/ISO 11135-1994, ANSI/AAMI/ISO 10993-7:1995. |
| Packaging Validation | Process validation performed. |
| Biocompatibility | Testing demonstrated equivalence and safety, complying with ANSI/AAMI/ISO 10993-1:1997. |
| Safety and Effectiveness | Demonstrated to be equivalent to predicate devices. |
| Manufacturing Process | Includes 100% visual and mechanical testing of all products prior to packaging, labeling, and sterilization. |
| Compliance with Standards | Complies with ANSI/AAMI/ISO 11135-1994, ANSI/AAMI/ISO 10993-7:1995, ANSI/AAMI/ISO 10993-1:1997. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "representative samples of reprocessed electrosurgical instruments underwent bench testing." It does not specify the exact sample size for these tests. The provenance of the data is prospective, as it involves testing of the reprocessed devices themselves. The country of origin for the testing is not explicitly stated but can be inferred as the U.S. where the company is based and seeking FDA approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device submission. The "ground truth" for reprocessed medical instruments is typically established through adherence to validated cleaning, sterilization, and functional performance protocols, and comparison to validated predicate devices, rather than expert consensus on individual "cases."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of human evaluation of data, often in clinical trials or image interpretation studies, which are not described here. The evaluation of reprocessed instruments primarily involves engineering and microbiological testing.
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
This is not applicable. This submission is for a physical medical device (reprocessed electrosurgical instruments), not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance, safety, and effectiveness of the original, legally marketed predicate devices, as well as compliance with relevant international standards for medical device reprocessing (cleaning, sterilization, biocompatibility). It also includes the manufacturer's own validated internal functional and mechanical testing results. The goal is to demonstrate that the reprocessed devices meet these established benchmarks.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of reprocessed physical medical instruments as there's no AI/ML algorithm being developed or trained.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
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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(a MediSISS.com
| Contact Person: | Mary Ann Barker |
|---|---|
| Device Trade Names: | Reprocessed Electrosurgical Instruments and Accessories |
| Common Names: | Reprocessed Electrosurgical Instruments and Accessories |
| Classification Names: | Electrosurgical, Cutting and Coagulation and Accessories |
| Classification and Code: | CFR §878.4400, GEI |
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:
Ethicon U.S.Surgical
These devices are legally marketed and distributed pursuant to 510(k)'s K984240, K951589, and K934784 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, K012625. Likewise, SterilMed, Inc. Reprocessed Laparascopic Electric Instruments: -510(k) K012598; and Vanguard Medical Concepts, Inc Vanguard Reprocessed Endoscopic Instruments, 510(k) K012700.
Device Description
Reprocessed Electrosurgical Instruments mav consist of hand-manipulated devices with electrocautery capability and with or without rotation capability.
The distal end of the Ethicon device consists of a scissor distal end configuration. The U.S Surgical device consists of a dissector distal end configuration. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The end
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effectors are operated by the handpiece handles may be designed to be suppressed and released to activate the instruments end-effector.
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.)
Intended Use
The SISS Inc. (d.b.a. MediSIS) 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.
Functional and Safety Testing
Reprocessed Instrument samples underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and packaging and sterilization procedures. In addition, the manufacturing process includes visual and functional testing of all products produced.
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 clectrosurgical 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
Performance data demonstrates that the Reprocessed Instruments perform as originally intended.
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 Ethelene Oxide Sterilization
- ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical De-. vices Part 7: Ethylene oxide steritization residuals
- ANSEAAMI/ISO 10993-1: 1997 (1999 Edition). Biological Evaluation of . Medical Devices Part 1 : Evaluation and Testing.
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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 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.
Substantial equivalence has been established with respect to intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. The SISS Inc. (d.b.a. MediSISS) Reprocessed Electrosurgical Instruments are therefore substantially equivalent to the identified predicate devices.
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Conclusion
Since the Reprocessed Electrosurgical Instruments meet the requirements of the stated standards and embody technological characteristics substantially equivalent 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 QSR good manufacturing practices that ensure the device is safe and effective for its intended use.
The reprocessed device have the:
- same intended use as the predicate; and .
- has the same technological characteristics as the predicate device .
- and can meet the same performance standards as the predicates �
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 Fridant Process" 5/10/95, we conclude that the SISS Inc. (d.b.a. MediSISS) reprocessed clectrosurgical 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 shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Public Health Service
DEC 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surgical Instruments Service and Savings, Inc. c/o Mr. Marc M. Mouser Project Engineer, Medical Devices Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607-8542
Re: K031869
Trade/Device Name: SISS Inc. Reprocessed Electrosurgical Instruments and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 10, 2003 Received: December 12, 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 prodicate 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 classificd (see above) into either class II (Special Controls) or class III (PMA), 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.
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Marc M. Mouser
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 (301) 594-4659. 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,
sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K031869
SISS Inc. (d.b.a. MediSISS) Reprocessed Electrosurgical Instruments and Device Name: Accessories
Indications for Use:
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.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Preseription Use (Per 21 CFR 801.109)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
al. Restorative
§ 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.