The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.

Device Description

Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.

AI/ML Overview

The provided text is a 510(k) summary for ClearMedical Reprocessed Trocars. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than reporting on a clinical or performance study of an AI/algorithm-driven device. Therefore, much of the requested information regarding acceptance criteria for an AI device, sample sizes for training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.

However, I can extract the general acceptance criteria and the type of information provided to "prove" the device meets them in the context of this 510(k) submission.

Acceptance Criteria and Device Performance (based on the provided 510(k) summary):

Acceptance Criteria Category	Reported Device Performance (ClearMedical Reprocessed Trocars)
Intended Use	Reprocessed trocars are used in thoracic, gynecologic, laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.
Technological Characteristics	The technological characteristics of design, material, and functional performance of reprocessed trocars are unchanged and remain equivalent to the predicate devices.
Safety & Effectiveness	Validation of cleaning, performance, and packaging, and sterilization, as well as biocompatibility testing, demonstrate that reprocessed trocars perform as intended and are safe and effective.
Substantial Equivalence	Based on information provided in this submission, ClearMedical Reprocessed Trocars are substantially equivalent to the identified predicate devices.

Study Information (Based on the provided document):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not specified. This document describes a 510(k) submission for reprocessed medical devices, not an AI or algorithm-driven device that would typically involve a "test set" in the computational sense. The "test data" mentioned refers to validation of cleaning, performance, packaging, sterilization, and biocompatibility, which are laboratory/engineering tests on the reprocessed devices themselves. The specific sample sizes for these validation tests are not detailed in this summary.
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. Ground truth, in the context of AI/algorithm performance, is not relevant to this submission. The "truth" for reprocessed devices is assessed through engineering and biological safety tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not specified.
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, not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the typical AI sense. For this device, the "ground truth" equivalent would be the objective standards and specifications for the original predicate devices, and the established regulatory requirements for reprocessing, cleaning, sterilization, and biocompatibility. The performance (e.g., integrity, functionality) of the reprocessed devices is compared against these engineering and safety benchmarks.
The sample size for the training set:
- Not applicable / Not specified. This is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable / Not specified.

Summary

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JUN 3 - 2005

A CLDF 3

510(k) SUMMARY

Submitter:	ClearMedical, Inc.1776 136th Place NEBellevue, WA 98005
Contact:	Gene LimPh: 425-460-2779Fax: 425-401-1515
Date:	June 2, 2005
Trade name:	ClearMedical Reprocessed Trocars
Common name:	Bladed and Non-Bladed Trocars
Classification name:	Endoscope and Accessories (Class II, 21 CFR 876-1500)
Product Code:	NLM - Laparoscope, General & Plastic Surgery, Reprocessed

Predicate Device(s):

The trade names of current legally marketed predicate devices are:

Ethicon Endopath® Dilating Tip Trocar (5mm-12mm) .
. Ethicon Endopath® Tristar® Trocar (5mm-12mm)
Ethicon Endopath® Tristar® Blunt Tip Trocar (10mm-12mm) .

The 510(k) Premarket Notification numbers for these devices are:

K020428 Endopath® Dilating Tip Trocar .
. K011538 Endopath® Non-Bladed Solid Obturator (with sleeve)
K011257 Endopath® Non-Bladed Obturator Trocar System (5mm) .

Device description:

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Intended use:

Reprocessed trocars are used in thoracic, gynecologic, laparoscopy, and other abdominal procedures to establish a path of entry for endoscopic instruments.

Technological characteristics:

Reprocessed trocars are used devices that are cleaned, inspected, tested, packaged, and sterilized for an additional single patient use. The technological characteristics of design, material, and functional performance of reprocessed trocars are unchanged and remain equivalent to the predicate devices.

Test data:

Validation of cleaning, performance, and packaging, and sterilization, as well as biocompatibility testing, demonstrate that reprocessed trocars perform as intended and are safe and effective.

Conclusion:

Based on information provided in this submission. ClearMedical Reprocessed Trocars are substantially equivalent to the identified predicate devices and are safe and effective for their intended use.

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Image /page/2/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 an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 - 2005

Mr. Gene Lim Director of Product Development ClearMedical Incorporated 1776 136" Place NE Bellevue, Washington 98005

Re: K033591

Trade/Device Name: Reprocessed Trocars (see additional list) Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: II Product Code: KBG Dated: April 4, 2005 Received: April 5, 2005

Dear Mr. Lim:

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. Ilsting 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 (OS) 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. Gene Lim

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 (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/industry/support/index.html.

Sincerely vours.

Miriam C. Provost

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Listing of device being cleared in K033591:

Ethiconmodel	ClearMedicalPart Number
355S	10154-S-1
355T	10154-S-2
355L	10154-S-3
511S	10154-S-4
512S	10154-S-5
355SM	10155-S-1
355SD	10155-S-2
355TM	10155-S-3
355LM	10155-S-4
355LD	10155-S-5
578SD	10155-S-6
511SM	10155-S-7
511SD	10155-S-8
512SM	10155-S-9
512SD	10155-S-10
512B	10157-S

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Indications for Use

510(k) Number (if known): K033591

Device Name: Reprocessed Trocars

Indications for Use:

Contraindications:

These instruments are not intended for use when minimally invasive techniques are contraindicated.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

Page 1 of 1

K033591 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.