The ClearMedical Reprocessed Used, Disposable Endoscopic Scissors and Graspers have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue.

Device Description

The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic Scissors and Graspers) is a sterilized SUD. The reprocessed Endopath endoscopic instruments are sterile, single patient use instruments that have a rotating insulated shaft and are designed for use through appropriate surgical trocars. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Some instruments have a monopolar cautery connector extending from the top of the handle and can be used for electosurgery when properly attached to standard cautery cables and appropriate generators. Other instruments have rachet handles, which allow the instrument jaws to be locked in place. The instrument jaws or scissor blades are activated by compression and release of the ring handles. See instructions for complete mode of operation details. The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic details. The Reprosesses Coasted using EtO sterilization.

AI/ML Overview

The provided text is a 510(k) summary for a reprocessed medical device, the "Reprocessed Used, Disposable Endoscopic Scissors and Graspers." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the way a new device would.

Therefore, much of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC studies is not present in this document. This document is a regulatory submission for substantial equivalence based on similarity to an existing device.

Here's an analysis of what can be extracted and what is missing:

Description of Acceptance Criteria and Study to Prove the Device Meets Them:

The document does not describe specific acceptance criteria and a detailed study designed to quantitatively prove the reprocessed device meets those criteria with performance metrics (e.g., accuracy, sensitivity, specificity, mechanical performance thresholds). Instead, the submission argues for substantial equivalence to a predicate device based on similar design, materials, intended use, and technological characteristics. The "study" here is implicitly the comparison made to the predicate device to satisfy the FDA's regulatory requirements for substantial equivalence.

1. A table of acceptance criteria and the reported device performance

Not provided. The document does not contain a table of acceptance criteria or quantitative performance metrics for the reprocessed device. The submission relies on the concept that if the reprocessed device is substantially equivalent to a legally marketed predicate device, its performance is implicitly acceptable for its intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not specified. The document does not describe a "test set" in the context of performance evaluation with a specific sample size. The substantial equivalence argument is based on a comparison to a predicate device's characteristics, not an independent performance study on a separate dataset of reprocessed devices.

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)

Not applicable/Not specified. This type of information is pertinent to performance studies involving expert review (e.g., for image analysis algorithms). For a reprocessed surgical instrument, "ground truth" would typically relate to functional performance, sterility, and material integrity, which are assessed through engineering and quality control tests, not expert interpretation of data. The document does not detail such specific testing experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. Adjudication methods are typically used in clinical or imaging studies where multiple readers interpret data and discrepancies need to be resolved. This is not relevant to the type of substantial equivalence argument presented for a reprocessed surgical instrument.

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

No such study was done or reported. MRMC studies are relevant for evaluating the impact of AI or new diagnostic tools on human reader performance. This device is a surgical instrument, not an AI-powered diagnostic tool, so an MRMC study is inapplicable here.

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

Not applicable. This device is a manual surgical instrument. It does not operate as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implied Regulatory Ground Truth: The "ground truth" for this submission is the legally marketed predicate device (Ethicon Endoscopic Surgical Instruments, K930933). The substantial equivalence argument posits that the reprocessed device is functionally equivalent to this predicate, thus implicitly sharing its established "ground truth" performance and safety profile from its original approval. Specific, independent "ground truth" data for the reprocessed device's performance, as would be generated for a novel device, is not described.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no training set in that context. The "training" for the reprocessed device would be in the quality control processes and procedures established for reprocessing, but this is not discussed in terms of a "training set" for statistical analysis.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary of available information from the document:

Device Name: Reprocessed Used, Disposable Endoscopic Scissors and Graspers
Predicate Device: Ethicon Endoscopic Surgical Instruments (K930933), cleared June 22, 2003.
Basis for Equivalence: Similarities in intended use, material, design, performance, and physical characteristics to the predicate device.
Reprocessing Method: Ethylene Oxide (EtO) sterilization.
Intended Use: "indicated for use in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transaction of tissue."

Summary

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JUL 27 2004 033592 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

This 510(k) Summary details sufficient information to provide an understanding of the This of othy Cammary actalle causes antilal equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to romide a substantial equivalence summary to anyone requesting it from the Agency.

21 CFR §807.92 a (1)

Submitter:
FALL PROPERTY LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAST LEAS

ClearMedical, Inc 1776 136 Place NE Bellevue, Washington 98005 Contact person: Mike Kovacs Ph: 425-460-2718 Fax: 425-401-1515

Date prepared: 29 June 2004

21 CFR §807.92 a (2)

Trade name:

Reprocessed Used, Disposable Endoscopic Scissors and Graspers

Common name:		Laparoscopic/Endoscopic Surgical Instruments
Classification name:		79GCJ, Manual Laparoscopic Surgical Instruments
		79GEI, Endoscopic Electrosurgical Instruments

21 CFR §807.92 a (3)

Identification of predicate(s): Substantial equivalence for the Reprocessed Used, Disposable Endoscopic Scissors and Graspers is based on its similarities to the predicate devices, Ethicon Endoscopic Surgical Instruments (K930933) 22 June 2003. The Reprocessed Used, Disposable Endoscopic Scissors and Graspers is substantially equivalent to the predicates in intended use, material, design, performance, and physical characteristics.

21 CFR §807.92 a (4)

Device Description-parts and function/concept: The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic Scissors and Graspers) is a sterilized SUD. The reprocessed Endopath endoscopic instruments are sterile, single patient use instruments that have a rotating insulated shaft and are designed for use through appropriate surgical trocars. The rotation knob located on the handle rotates the shaft 360 degrees in either direction. Some instruments have a monopolar cautery connector extending from the top of the handle and can be used for electosurgery when properly attached to standard cautery cables and appropriate generators. Other instruments have rachet handles, which allow the instrument jaws to be locked in place. The instrument jaws or scissor blades are activated by compression and release of the ring handles. See instructions for complete mode of operation

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details. The Reprocessed SUD (Reprocessed Used, Disposable Endoscopic details. The Reprosesses Coasted using EtO sterilization.

21 CFR §807.92 a (5)

21 CFR §807.92 a (5)
Intended use and relationship to predicate(s): The Reprocessed Used, Disposable Intended use and relationship to predicated for use in a variety of minimally invasive
Endoscopic Scissors and Graspers is indicated for use in a variety of tissue Endoscopic Scissols and Graspers is indication, dissection, and transaction of tissue.

CFR §807.92 a (6)

Of IX 9601:52 a (0) Lechnological characteristics and follations on Scissors and Graspers is similar in
The Reprocessed Used, Disposable Endoscopic Scissors and Graspers is similar in The Reprocessed Osed, Disposable Endooseph Solors
design, material, intended use and technological characteristics to the predicate devices.

21 CFR §807.92 b

21 CFR §807.92 b
This substantial equivalence is based on similarities to the predicate devices in terms of This Substantial oquivalor oquivalism characteristics.

21 CFR §807.92 c

21 CFR 8007.32 €
In accordance with the specifications of this subsection, this summary in accordance with the speomsations of a learly identified as such.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of an eagle with three lines representing its wings and three wavy lines representing its body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 2004

Mr. Mike Kovacs Vice President, Engineering and Production ClearMedical, Inc. 1776 136th Place, NE Bellevue, Washington 98005

Re: K033592

Trade/Device Name: Reprocessed Used, Disposable Endoscopic Scissors Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 29, 2004 Received: June 30, 2004

Dear Mr. Kovacs:

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 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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Page 2 - Mr. Mike Kovacs

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,

Miriam C. Provost

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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Indication Statement

Page _ 1 _ of __ 1__

510(k) Number (if known): K033592

Device Name: Reprocessed Used, Disposable Endoscopic Scissors

Indications for Use

The ClearMedical Reprocessed Used, Disposable Endoscopic Scissors The CleanMedical Neprocessou Good, Displantinally invasive procedures
and Graspers have application in a variety of minimaly in a finance and Graspers have application in a varies)
to facilitate grasping, mobilization, dissection, and transaction of tissue...

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use Optional Format 1-

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uriam C. Provost

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K033592

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.