(90 days)
Not Found
No
The description focuses on mechanical articulation and accessory channels, with no mention of AI/ML or related concepts.
No.
The device is described as a "supplemental conduit" and an "accessory channel" that attaches to an endoscope to improve access and enable the use of multiple accessory devices, but it does not directly treat or diagnose a disease or condition.
No
The device is an accessory that attaches to an endoscope to improve access and enable the use of multiple accessory devices simultaneously. It does not perform any diagnostic functions itself.
No
The device description clearly describes a physical, sterile, single-use, disposable accessory that attaches to an endoscope. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as a "supplemental conduit that attaches to an endoscope to enable improved access." This describes a device used during a medical procedure to facilitate access, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical accessory that attaches to an endoscope to improve access and allow for the use of additional instruments. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information
- Reagents or test kits
The device is clearly an accessory for an endoscopic procedure, designed to improve the mechanics and access during the procedure itself.
N/A
Intended Use / 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.
Product codes
ODC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
2
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.
3
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.
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.
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.