CARBODISSECTING ENDOSCOPE by ENDO SURGICAL DEVICES, INC.

The Carbodissecting Endoscope is designed for use in intraluminal tissue separation during a femoro-popliteal endarterectomy procedure intended to achieve vascular reconstruction. The device is an adjunctive aid in the separation of vessel layers.

Device Description

The Carbodissecting Endoscope, sterile and single-use, consists of two components: The spatula is a surgical tool used with carbon dioxide (CO2) and saline for atherectomy using carbodissection. The scope is a flexible fiberscope intended for use with the Carbodissecting Endoscope Spatula to provide visual feedback.

AI/ML Overview

The provided 510(k) summary for the "Carbodissecting Endoscope" does not contain information related to acceptance criteria or a study proving the device meets performance criteria in the context of an AI/ML medical device.

This document details the regulatory pathway for a surgical device (an intraluminal artery stripper) and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "Performance Testing" section primarily refers to compliance with an electrical safety standard (IEC 601-2-18) and mentions "additional bench testing and biocompatibility testing," but provides no specifics on acceptance criteria or detailed study results for functional performance.

Therefore, for almost all the requested information, the answer will be "Not Applicable" or "Not Provided in the document" because the device is a physical surgical tool, not an AI/ML algorithm requiring performance metrics like sensitivity, specificity, or human-in-the-loop studies.

Here's a breakdown based on the provided text, indicating why most items cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

| Criterion | Acceptance Criteria | Reported Device Performance |
| :-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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|
| Electrical Safety | Compliance with IEC 601-2-18 | Device meets the requirements of IEC 601-2-18 (Safety of Medical Electrical Equipment: Particular Requirements for Endoscopes). |
| Biocompatibility | Not explicitly stated, but implied as part of safety testing | Biocompatibility testing has been completed. |
| Bench Testing (Functional) | Not explicitly stated | Additional bench testing has been completed. (No specific functional criteria or results provided in this document). |

2. Sample size used for the test set and the data provenance

Not Applicable. This is a physical surgical device, not an AI/ML algorithm that uses a test set of data. The document does not describe any clinical studies involving patient data for performance evaluation in a hypothesis-testing manner, but rather mentions "bench testing" and "biocompatibility testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No ground truth or expert review process as described for AI/ML models is mentioned in relation to proving the device's performance for this surgical tool.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication process as typically defined for AI/ML models is described.

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 is a surgical instrument, not an AI-assisted diagnostic or interpretive device. No MRMC study or AI assistance is mentioned.

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

Not Applicable. This is a manual surgical instrument, not an algorithm.

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

Not Applicable. Ground truth in the context of AI/ML performance evaluation is not relevant to this device's regulatory submission, which focuses on substantial equivalence based on prior predicate devices and safety testing.

8. The sample size for the training set

Not Applicable. This is a physical device, not an AI/ML algorithm. There is no concept of a "training set."

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

Not Applicable. Consistent with item 8.

Summary regarding AI/ML related questions:

The provided 510(k) summary is for a traditional surgical device and predates the common regulatory framework for AI/ML medical devices. Therefore, the questions related to AI/ML specific performance criteria, data sets, ground truth, and human-in-the-loop studies are not applicable to the information contained within this document. The "Performance Testing" section primarily refers to compliance with an electrical safety standard, bench testing (without specifics), and biocompatibility testing, which are standard for physical medical devices.

Summary

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APR 2 9 2003

510K Summary of Safety and Effectiveness

KO20925

1. Sponsor Name Endo Surgical Devices, Inc. 4400 Rte 9 So., Suite 1000 Freehold, NJ 07728 Telephone: 732 409-5151
1. Device Name

Proprietary Name: Carbodissecting Endoscope Common/Usual Name: Intraluminal Artery Stripper Classification Name: : Intraluminal Artery Stripper

Panel Cardiovascular Device 870.4875 Product Code DWX

1. Identification of Predicate or Legally Marketed Device
- Sobel-Kaplitt-Sawyer Gas Spatula Becton Dickenson and O Company - Preamendments Device
- Endo Surgical Device Carbodissecting Endoscope O
- CardioVacular Concepts, Inc. Moll Ring Cutter O

4. Device Description

The Carbodissecting Endoscope, sterile and single-use, consists of two components:

The spatula is a surgical tool used with carbon dioxide (CO2) and saline for atherectomy using carbodissection.

The scope is a flexible fiberscope intended for use with the Carbodissecting Endoscope Spatula to provide visual feedback.

న్. Intended Use
The Carbodissecting Endoscope is designed for use in intraluminal tissue separation during a femoro-popliteal endarterectomy procedure intended to achieve vascular reconstruction. The device is an adjunctive aid in the separation of vessel layers.

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Comparison of Technological Characteristics 6.
The Carbodissecting Endoscope is similar to the Sobel-Kaplitt-Sawyer Gas Spatula and the Endo Surgical Devices Carbodissecting Endoscope in function.

The Carbodissecting Endoscope uses carbon dioxide gas to perform the dissection of the vessel whereas the Moll Ring Cutter uses mechanical means. Although the operating principal is different from the Moll Ring cutter, gas dissection has been performed for many years and is well documented. The operating principal is however, the same as the BD Gas Spatula and the Endo Surgical Devices Carbodissecting Endoscope cleared under K013680.

The differences between the BD Gas Spatula and the Carbodissecting Endoscope are the following:

Integration of the Scope to provide visualization .
CO2 controls (as opposed to free flow) to limit CO2 inflow to only during ● dissection
Fanned CO2 from the head for more effective dissection .
Handle for easier manipulation during surgery .

The Carbodissecting Endoscope is substantially equivalent to the predicate devices. The intended use, technological characteristics of the device materials and design of the Carbodissecting Endoscope support the concept of substantial equivalence.

7. Performance Testing

The Carbodissecting Endoscope meets the requirements of the following standard:

IEC 601-2-18 Safety of Medical Electrical Equipment: Particular Requirements for Endoscopes

Additional bench testing and biocompatibility testing has been completed on the Carbodissecting Endoscope.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2003

Endo Surgical Devices. Inc. c/o Ms. Debbie Iampietro 7 Tiffany Trail Hopkinton, MA 01748

Re: K020925

Trade Name: Carbodissecting Endoscope Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (two) Product Code: DWX Dated: January 28, 2003 Received: February 3, 2003

Dear Ms. Iampietro:

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

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Page 2 – Ms. Debbie Iampietro

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. 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) 594-4646. 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,

Ralph Tiller

am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of of a س

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K020925

Device Name :

Carbodissecting Endoscope

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qalther

(Optional Format 3-

10-98)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K020925

Prescription Use Only

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).