(76 days)
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Not Found
No
The device description focuses on mechanical features and surgical procedures, with no mention of AI, ML, or related concepts like image processing or data analysis for decision-making.
No.
The device is described as an endoscopic linear cutter that delivers staples and divides tissue, used for transection, resection, and/or creation of anastomoses during surgery. It is a surgical tool, not a therapeutic device that treats a condition.
No
Explanation: The device description and intended use clearly state that it is a surgical tool for transection, resection, and creating anastomoses, delivering staples and dividing tissue. There is no mention of it being used for diagnosis, imaging, or analyzing bodily functions to identify diseases or conditions.
No
The device description clearly details a physical surgical instrument with mechanical components (staples, cutting blade, articulation lever, safety lock-out feature). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states the device's function is for "transection, resection, and/or creation of anastomoses" in surgical procedures. It physically manipulates tissue within the body using staples and cutting.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze specimens taken from the body. Its action is directly on the tissue within the body.
Therefore, the ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
Intended use: For transection, resection, and/or creation of anastomoses.
Indications statement: The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter have application in general, urologic, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Product codes
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Device Description
The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX Endoscopic Articulating Linear Cutter devices deliver two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows. A "no-knife" version may also be provided. The instrument's safety lock-out feature is designed to prevent a spent reload from being refired. Both the standard and the vascular/thin instruments have a staple line that is 20-60mm long and a cut line of 18-58mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. An articulation lever on the ETS-FLEX Endoscopic Articulating Linear Cutter enables bilateral movement of the instrument jaws.
The instrument is reloadable with either a standard, blue reload for tissue that is compressible to 1.5mm in thickness, a thick, green reload for tissue that is compressible to 2.0mm in thickness, or a vascular/thin, white reload for tissue that is compressible to 1.0mm in thickness. Do not reload the instrument more than seven times for a maximum of eight firings per instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
general, urologic, gynecologic, and thoracic surgery
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical laboratory evaluations were performed to ensure that the device can be used as designed. The studies demonstrated acceptable performance in transecting, resecting, and/or creation of anastomoses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
JUN 2 5 1996
1
K 961390
Appendices
510(k) Summary of Safety and Effectiveness (App. A)
| Statement | Information supporting claims of substantial equivalence, as defined under the
Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is
summarized below. For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule “...510(k) Summaries and
510(k) Statements...” (21 CFR §807) and can be used to provide a substantial
equivalence summary to anyone requesting it from the Agency. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX
Endoscopic Articulating Linear Cutter devices deliver two double-staggered
or two triple-staggered rows of staples while simultaneously dividing the tissue
between the rows. A "no-knife" version may also be provided. The
instrument's safety lock-out feature is designed to prevent a spent reload from
being refired. Both the standard and the vascular/thin instruments have a
staple line that is 20-60mm long and a cut line of 18-58mm long. A staple
retaining cap on the reload protects the staple leg points during shipping and
transportation. An articulation lever on the ETS-FLEX Endoscopic
Articulating Linear Cutter enables bilateral movement of the instrument jaws.
The instrument is reloadable with either a standard, blue reload for tissue that
is compressible to 1.5mm in thickness, a thick, green reload for tissue that is
compressible to 2.0mm in thickness, or a vascular/thin, white reload for tissue
that is compressible to 1.0mm in thickness. Do not reload the instrument more
than seven times for a maximum of eight firings per instrument. |
| Intended use | For transection, resection, and/or creation of anatomoses. |
| Indications
statement | The ENDOPATH® ETS Endoscopic Linear Cutter and ETS-FLEX
Endoscopic Articulating Linear Cutter have application in general, urologic,
gynecologic, and thoracic surgery for transection, resection, and/or creation of
anastomoses. |
| | Continued on next page |
| Technological
characteristics | The technological characteristics of the New Devices are the same as the
Predicate Device. |
| Performance
data | Pre-clinical laboratory evaluations were performed to ensure that the device
can be used as designed. The studies demonstrated acceptable performance in
transecting, resecting, and/or creation of anastomoses. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and
the information provided herein, we conclude that the New Devices are
substantially equivalent to the Predicate Device under the Federal Food,
Drug and Cosmetic Act. |
| Contact | Lorri Chavez
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
| Date | April 9, 1996 |
1
510(k) Summary of Safety and Effectiveness (App. A), Continued
1
. .