The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.

Device Description

MediSISS Reprocessed Non-electric GI Biopsy Forceps are designed for endoscopic use to retrieve tissue samples for microscopic inspection. Forceps outer diameters range from 2,2mm to 2.5mm and working lengths vary from 160cm. A syringe-like proximal handle opens and closes the distal instrument jaws, that are available in multiple design configurations such as Oval, Alligator, Smooth, or Fenestrated with and without a needle. The working length of the biopsy forceps is coated with a plastic sheath to decrease friction.

AI/ML Overview

The provided document is a 510(k) summary for the MediSISS Reprocessed Non-electric GI Biopsy Forceps. This type of document is for a medical device that processes existing devices, rather than a diagnostic AI device. As such, the specific criteria for AI model performance (like sensitivity, specificity, MRMC studies, ground truth establishment for training/test sets) are not applicable.

Instead, the acceptance criteria and study information provided relate to the reprocessing of surgical instruments to ensure they are safe and effective for reuse, demonstrating substantial equivalence to new, unused predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description	Reported Device Performance (Summary of Validation Data)
Cleaning	Processed device must be adequately cleaned to remove biological and other contaminants, adhering to established standards to ensure patient safety and prevent cross-contamination.	"MediSISS has validated its cleaning...processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization." The conclusion states, "MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to cleanliness..."
Sterilization	Reprocessed device must achieve and maintain sterility to eliminate microbial life, meeting specified Sterility Assurance Levels (SALs) as per regulatory standards. Ethylene Oxide sterilization residuals must also be within acceptable limits.	"MediSISS has validated its...sterilization...processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization." The conclusion states, "MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to...sterility..."
Functional Performance	Reprocessed device must perform its intended function (e.g., retrieving tissue samples) without degradation in performance compared to new devices, for the maximum number of intended uses. This includes mechanical integrity and operational effectiveness.	"MediSISS has validated its...functional performance...processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization. We have demonstrated with a high degree of assurance that MediSISS Reprocessed Non-Electric GI Biopsy Forceps...will continue to be safe and effective for the maximum number of intended uses."
Packaging and Distribution	Packaging must maintain sterility and protect the device during storage and transport. Packaging integrity and seal strength must be validated.	"MediSISS has validated its...packaging and distribution processes Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization." The conclusion states, "MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to...packaging..."
Biocompatibility	Materials in contact with patients after reprocessing should not cause adverse biological reactions due to residuals or material changes. (Implied by sterilization and cleaning standards, especially regarding ETO residuals).	ANSI/AAMI/ISO 10993:1995, Biological Evaluation-Part 7: Ethylene Oxide Sterilization Residuals, is listed as an applicable standard, indicating that residuals were evaluated to ensure biocompatibility.

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

The document does not explicitly state the specific sample sizes for each validation test (cleaning, sterilization, functional performance, packaging). However, it refers to "validation data" and "routine tests" which implies a sampling methodology was used in accordance with the listed standards.

Data provenance refers to the origin and history of data. In this context, it relates to the devices that were reprocessed and tested. The predicate devices are from manufacturers like Bard, Esco Precision, Inc., and Olympus. The MediSISS device itself is a reprocessed version of various OEM models (e.g., Bard 385, Microvasive 1537, Olympus FB-240U, Wilson-Cook SDE 2.5-230). The testing would have been conducted on these reprocessed devices, likely in a controlled laboratory or testing facility ("retrospective" in the sense that the original devices are already manufactured, but "prospective" in the sense that the reprocessing and validation are performed afterward).

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

This type of information (number and qualification of specific experts for ground truth) is typically not applicable to the validation of reprocessed surgical instruments. The "ground truth" here is adherence to established engineering, microbiological, and material science standards. These standards (e.g., ISO, AAMI, ASTM, USP) are developed and maintained by expert committees and are considered the "ground truth" for safe and effective reprocessing. Compliance with these standards is assessed through validated test methods, not by subjective expert consensus on 'cases'.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert disagreement in diagnostic image reading. For device reprocessing validation, objective measurements and adherence to performance specifications of the listed standards dictate acceptance or rejection.

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 device is a reprocessed surgical instrument, not an AI diagnostic tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This refers to AI algorithm performance without human intervention, which is not relevant to a reprocessed surgical instrument.

7. The Type of Ground Truth Used

The "ground truth" for the reprocessed non-electric GI biopsy forceps is defined by:

Adherence to recognized industry standards: ANSI/AAMI/ISO 11737-1, AAMI TIR No. 12, ASTM D4164, ISO 11607, ANSI/AAMI/ISO 11135, ANSI/AAMI/ISO 10993, ASTM F88, ASTM F1980, United States Pharmacopeia 24, ASTM F2096-02. These standards specify acceptable limits for microbial load, sterility, residual levels, functional performance, and packaging integrity.
Substantial equivalence to legally marketed predicate devices: The "ground truth" for safety and effectiveness is benchmarked against new, unused predicate devices (Bard K912549, Esco Precision K900015, Olympus K955065). Validation data confirmed that the reprocessed devices perform equivalently to these new devices.

8. The Sample Size for the Training Set

Not applicable. This concept is relevant for AI models, not for traditional medical device reprocessing validation.

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

Not applicable, as there is no "training set" in the context of this device's validation.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for MediSISS, a surgical instrument service and sterilization company. The logo features the company name in a stylized font, with the letters "MediSISS" in bold, black letters. Above the company name is the trademark symbol. Below the company name is the text "Surgical Instrument Service & Sterilization".

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted by: MediSISS 2747 SW 6th St. Redmond, OR 97756 Telephone: (541) 923-3310 Facsimile: (541) 923-3375 Email: bijames(@medisiss.com September 27, 2004

FEB 1 4 2005

Contact Person Brandi James Proprietary Name MediSISS Reprocessed Non-electric GI Biopsy Forceps Common Name Reprocessed Cold GI Biopsy Forceps Classification Gastroenterology/Urology Forceps, Biopsy, Reprocessed, per 21 CFR 876.1075, Product Code: NON, Regulatory Class II.

Device Description and Technological Characteristics:

Predicate Device 510(k)s

Identification of legally marketed predicate device Original Equipment Manufacturer's 510(k)s:

Manufacturer	510(k)#
Bard	K912549
Esco Precision, Inc.	K900015
Olympus	K955065

Summary of Validation Data: MediSISS has validated its cleaning, sterilization, functional performance and packaging and distribution processed Non-Electric GI Biopsy Forceps. Successful validation, and routine tests monitor the safety and effectiveness of our product post sterilization. We have demonstrated with a high degree of assurance that MediSISS Reprocessed Non-Electric GI Biopsy Forceps are substantially equivalent to the new and unused predicate devices, and will continue to be safe and effective for the maximum number of intended uses.

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Image /page/1/Picture/0 description: The image shows the logo for MediSISS, a surgical instrument service and sterilization company. The logo features the company name in a stylized font, with the letters "MediSISS" in bold, black letters. Above the company name is a trademark symbol. Below the company name is the text "Surgical Instrument Service & Sterilization".

Standards

MediSISS Reprocessed Non-Electric GI Biopsy Forceps are either tested and/or processed in conformance with the applicable parts of the following standards:

ANSVAAMI/ISO 11737-1-1995: Sterilization of Medical Devices-Microbiological Methods-. Part 1: Estimation of population of microorganisms on products.
AAMI TIR No. 12-1994-Designing, Testing, and Labeling Reusable Medical Devices for t Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.
ASTM D4164: 2001 DC 13, AL 1: Performance Testing of Shipping Containers and Systems. .
ISO 11607: 2003-Packaging for terminally sterilized medical devices. ●
ANSI/AAMI/ISO 11135:1994, Medical devices--- Validation and routine control of ethylene oxide . sterilization.
ANSI/AAMI/ISO 10993:1995, Biological Evaluation-Part 7: Ethylene Oxide Sterilization . Residuals.
. ASTM F88-Seal strength of Flexible Barrier Materials.
ASTM F1980: 2002—Standard Guide for Accelerated Aging of Sterile Medical Device Packages .
United States Pharmacopeia 24-Sterility Test �
ASTM F2096-02 Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging ● by Internal Pressurization (Bubble Test).

Intended Use

MediSISS Reprocessed Non-electric GI Biopsy Forceps are to be used during minimally invasive endoscopic procedures to remove polyps and obtain tissue samples for microscopic examination.

Contraindications

The MediSISS Reprocessed Non-electric GI Biopsy Forceps should not be used when GI endoscopic procedures are contraindicated.

Conclusion

MediSISS Reprocessed Non-electric GI Biopsy Forceps are substantially equivalent to the legally marketed predicate devices with respect to cleanliness, sterility, design, packaging and intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2005

Ms. Brandi James Regulatory Specialist MediSISS 2747 SW 6th Street REDMOND OR 97756

K042659 Re: Trade/Device Name: MediSISS Reprocessed Non-Electrical GI Biopsy Forceps (SEE ENCLOSURE) Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: I Product Code: 78 NON Dated: December 23, 2004 Received: December 27, 2004

Dear Ms. James:

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.

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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrl/dsmadsmam.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

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Surgical Instrument Service & Sterilization

Cover Letter for 510(k) Premarket Notification-MediSISS Reprocessed Non-Electric Biopsy Forceps

INDICATIONS FOR USE

. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. א. דער אין א 104265 510(k) Number (if known):

Device Name: MediSISS Reprocessed Non-electric GI Biopsy Forceps

Indications for Use:

The MediSISS Reprocessed Non-electric Biopsy Forceps are intended to be used to remove polyps, and obtain a specimen of tissue for microscopic examination.

PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE OF ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use (Optional Format 1-2-96)

(Division Sign-Off)

David A. Tognozzi

(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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510(k) K042659: MediSISS Reprocessed Non-Electric ("Cold") GI Biopsy Forceps

The following models (and only the following models, with the descriptions below), which are the The following models (and only the tonowing models, with the associated in 1977)
subjects of this application, have been found substantially equivalent to the predicate devic listed in K042659.

OEM Model	Description	Jaw O.D.	Length	Sheath Color
Bard 385	Precisor* EXL Coated Biopsy Forceps, Alligator Cup	2.3 mm	230 cm	Blue
Microvasive 1537	Radial Jaw 3 Biopsy Forcep with Needle	2.2 mm	240 cm	Orange
Microvasive 1597	Radial Jaw, 3 Large Capacity Biopsy Forcep with Needle	2.2 mm	160 cm	Yellow
Microvasive 1599	Radial Jaw 3, Large Capacity Biopsy Forcep with Needle	2.2 mm	240 cm	Orange
Olympus FB-240U	EndoJaw, Biopsy Forcep, Oval Cup, Fenestrated with Needle	2.2 mm	230 cm	Blue
Wilson-Cook SDE 2.5-230	Shark Biopsy Forceps, Fenestrated without Spike (Red Handle)	2.5 mm	230 cm	Grey

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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 § 876.9.