The Ethicon Endo Surgery Sheath and Articulating External Accessory Channel accessory product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access.

Device Description

The Ethicon Endo Surgery® Sheath and External Accessory Channel is a supplemental articulating accessory channel that attaches to an endoscope to enable improved access. The sterile, single-use, disposable device is available in two (2) basic configurations: a shorter gastroscope compatible system, and a longer colonoscope compatible system.

The flexible Sheath is installed over the insertion tube of the endoscope. The Sheath contains a track (C-Channel) along which the Articulating External Accessory Channel can be can be introduced and removed without removing and re-introducing the endoscope, allowing for multiple intubations and/or specimen retrieval independent of the endospor, The Articulating External Accessory Channel enables the use of two accessory devices simultaneously - one in the Articulating External Accessory Channel and the other in the endoscope working channel. The Articulating External Accessory Channel provides off axis articulation to off the shelf accessory devices, thereby allowing than user to more effectively direct devices to the targeted tissue.

AI/ML Overview

The provided text is a 510(k) summary for the Ethicon Endo Surgery Sheath and Articulating External Accessory Channel. It describes the device, its intended use, and its similarities to and differences from predicate devices. It also mentions performance data, but it does not contain specific acceptance criteria or detailed study results needed to complete the requested table and answer many of the questions directly.

Based on the provided text, here's what can be extracted and what information is missing:

Missing Information: The document states "Bench testing was performed to demonstrate that the new device performs as intended" and "Animal testing was performed to evaluate the tissue effects associated with the new device relative to the predicate devices." However, it does not provide:

Specific quantitative acceptance criteria (e.g., a certain force, a specific range of motion, a defined success rate).
The actual results of these performance tests against specified criteria.
The sample sizes for these tests.
Details about the experts, ground truth, adjudication methods, or reader studies related to these tests.

Therefore, the table below will reflect the absence of this detailed information.

Acceptance Criteria and Device Performance Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in the provided document. The text broadly indicates "the new device performs as intended" and "evaluate the tissue effects associated with the new device relative to the predicate devices.")	Bench Testing: "Bench testing was performed to demonstrate that the new device performs as intended." (No specific quantitative performance metrics reported in this document.) Animal Testing: "Animal testing was performed to evaluate the tissue effects associated with the new device relative to the predicate devices." (No specific quantitative tissue effect metrics or comparative results reported in this document beyond implying equivalence or safety.) Biocompatibility: "Device materials have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1." (Implicitly, the device passed ISO 10993-1 requirements, which would be the acceptance criterion.)

Acceptance Criteria

Reported Device Performance

(Not explicitly stated in the provided document. The text broadly indicates "the new device performs as intended" and "evaluate the tissue effects associated with the new device relative to the predicate devices.")

Bench Testing: "Bench testing was performed to demonstrate that the new device performs as intended." (No specific quantitative performance metrics reported in this document.) Animal Testing: "Animal testing was performed to evaluate the tissue effects associated with the new device relative to the predicate devices." (No specific quantitative tissue effect metrics or comparative results reported in this document beyond implying equivalence or safety.) Biocompatibility: "Device materials have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1." (Implicitly, the device passed ISO 10993-1 requirements, which would be the acceptance criterion.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size (Test Set): Not specified in the provided text for either bench or animal testing.
* Data Provenance: Not specified. The document is a US FDA 510(k) submission, so it's likely the studies were conducted to US standards or within the US, but this is not explicitly stated. The studies are described as performance data to support substantial equivalence, implying prospective testing for this submission.

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. The performance data described ("Bench testing" and "Animal testing") do not inherently require human expert ground truth in the way medical image analysis or diagnostic studies would. Details on how "tissue effects" were evaluated in animal studies are not provided, so the role or qualifications of any experts involved in that assessment are unknown from this text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable/Not specified.

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. This is a medical device (endoscopic accessory), not an AI diagnostic algorithm. An MRMC study or AI assistance is not relevant to the described performance testing.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* For Bench testing: Implied to be engineering specifications and design requirements (e.g., functional performance, mechanical properties).
* For Animal testing: Implied to be histological or clinical assessment of tissue effects. The text doesn't specify if this was pathology-confirmed.
* For Biocompatibility: Ground truth is adherence to ISO 10993-1 standards, which involves specific chemical, physical, and biological tests.

8. The sample size for the training set
* Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established
* Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Ethicon Endo-Surgery, Inc. Ms. Renee Rowe Staff Project Manager, Quality Systems & Regulatory Affairs 4545 Creek Road Cincinnati, OH 45242

JUL 2 7 2015

K073484 Re:

Trade/Device Name: Ethicon Endo Surgery® Sheath and Articulating External Accessory Channel Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated (Date on orig SE ltr): December 7, 2007 Received (Date on orig SE ltr): December 11, 2007

Dear Ms. Rowe,

This letter corrects our substantially equivalent letter of March 10, 2008.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting of medical device-related adverse events} (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm_ Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): / 0 7 34 8 4

Device Name: Ethicon Endo Surgery Sheath and Articulating External Accessory Channel

Indications for Use:

The Ethicon Endo Surgery Sheath and Articulating External Accessory Channel accessory product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access.

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)

Page 1 of 1

(Posted November 13, 2003)

Heidi Heitner

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

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K073484

510(k) Summary

Company Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242

MAR 1 0 2000

Contact Renee Rowe Staff Project Manager, Quality Systems & Regulatory Affairs Telephone: (513) 337-8243 Fax: (513) 337-2243 Email: rrowel @eesus.jnj.com

Date Prepared December 7, 2007

Device Name Trade Name: The trademark name has not vet been determined Common or Usual Name: Endoscopes and/or Accessories Classification Name: Endoscopes and accessories [21 CFR 876.1500 (KOG)]

Predicate Devices LSI Endoscopic External Accessory Channel and Accessories Product (K024301) US Endoscopy Disposable Overtube (K040835)

Olympus Splinting Tube, ST-C4 (510(k) unknown).

Indications for Use

The Ethicon Endo Surgery Sheath and Articulating External Accessory Channel accessory product is intended for use as a supplemental conduit that attaches to an endoscope to enable improved access.

Device Description The Ethicon Endo Surgery® Sheath and External Accessory Channel is a supplemental articulating accessory channel that attaches to an endoscope to enable improved access. The sterile, single-use, disposable device is available in two (2) basic configurations: a shorter gastroscope compatible system, and a longer colonoscope compatible system.

Technological Characteristics The new device, the Ethicon Endo-Surgery® Sheath and Articulating External Accessory Channel, is similar in functionality and design to the

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predicate devices. The key similarities between the Ethicon Endo-Surgery® Sheath and Articulating External Accessory Channel and the predicate devices are as follows:

The Indications and Contraindications for Use are similar. .
All are mounted/installed external to or over the endoscope. .
The functionality of the new device and the LSI Solutions Endoscopic External . Accessory Channel predicate device is similar in that both provide a supplemental accessory channel that allows for the passage of additional endoscopic instruments.
The new device and the US Endoscopy Disposable Overtube and the Olympus Splinting . Tube predicates facilitate multiple endoscopic intubations.
The maximum width of the insertion portion of the new device is similar to the predicate t devices.

The new device offers features not provided by the predicates, as follows:

The external accessory channel of the new device is not fixed to the scope and can be . introduced and removed without a need to remove or re-introduce the endoscope. The LSI Solutions Endoscopic External Accessory Channel predicate device is fixed to the endoscope and must be must be removed and re-introduced with the endoscope.
t The new device enables articulation of compatible commercially available endoscopic accessory devices for improved ability to reach the target tissue.

A comprehensive assessment of the Ethicon Endo-Surgery® Sheath and Articulating External Accessory Channel versus the predicates indicates the new features do not raise any new issues relating to safety and effectiveness.

Performance Data. Bench testing was performed to demonstrate that the new device performs as intended. Animal testing was performed to evaluate the tissue effects associated with the new device relative to the predicate devices. Device materials have been evaluated for biocompatibility and comply with the requirements of ISO 10993-1. These data, combined with intended use and design information, indicate the Ethicon Endo-Surgery® Sheath and Articulating External Accessory Channel - is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes 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 (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.