(120 days)
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Not Found
No
The document describes a mechanical surgical stapler and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is a surgical stapler/cutter used for transection, resection, and creation of anastomoses, which are surgical procedures, not therapeutic treatments.
No
The device is described as an "Endoscopic Linear Cutter" and "Endoscopic Linear Stapler" used for "transection, resection, [and/or creation of anastomoses]". These are surgical actions, not diagnostic ones. The purpose is to perform a physical surgical procedure, not to identify or assess a medical condition.
No
The device description clearly describes a physical surgical instrument (Endoscopic Linear Cutter/Stapler) with mechanical components (staples, safety lock-out feature, reloadable mechanism). It is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical instrument used for cutting and stapling tissue during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical surgical tool that delivers staples and cuts tissue. It focuses on the physical function of the device in a surgical setting.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue samples) to provide information about a patient's health status, disease, or condition. IVDs are designed for in vitro (outside the body) examination of these samples.
Therefore, the ENDOPATH® EZ45 Endoscopic Linear Cutter and Stapler are surgical instruments, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
Product codes (comma separated list FDA assigned to the subject device)
KOG
Device Description
The ENDOPATH® EZ45 Endoscopic Linear Cutter is a sterile, single patient use instrument that delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. [The ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler is a sterile, single patient use instrument that delivers two, double-staggered rows of staples.] The instrument is designed for use in procedures that do not require insufflation. The instruments' safety lock-out feature is designed to prevent firing an unloaded instrument or prevent a used reload from being refired. The instruments have a staple line that is approximately 45 mm long and a cut line [linear cutter only] that is approximately 41 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument is reloadable with a thin (vascular), white reload; a standard, blue reload; or a thick tissue, green reload. Do not reload the instrument more than seven times for a maximum of eight firings per instrument. The use of the instrument with staple line buttressing materials may reduce the number of firings.
Mentions image processing
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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
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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 devices can be used as designed. The studies demonstrated acceptable performance in transecting, resecting, and/or creation of anastomoses and for use with buttressing materials.
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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Appendix A: 510(k) Summary of Safety and Effectiveness
ﻤﺴﻪ
| 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® EZ45 Endoscopic Linear Cutter is a sterile, single patient use instrument that delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. [The ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler is a sterile, single patient use instrument that delivers two, double-staggered rows of staples.] The instrument is designed for use in procedures that do not require insufflation. The instruments' safety lock-out feature is designed to prevent firing an unloaded instrument or prevent a used reload from being refired. The instruments have a staple line that is approximately 45 mm long and a cut line [linear cutter only] that is approximately 41 mm long. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument is reloadable with a thin (vascular), white reload; a standard, blue reload; or a thick tissue, green reload. Do not reload the instrument more than seven times for a maximum of eight firings per instrument. The use of the instrument with staple line buttressing materials may reduce the number of firings. |
| Intended use | For transection, resection, [and/or the creation of anastomoses]. |
| Indications statement | The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium. |
Continued on next pageContinued on next page
1
Appendix A: 510(k) Summary of Safety and Effectiveness,
Continued
)
| 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
devices can be used as designed. The studies demonstrated acceptable
performance in transecting, resecting, and/or creation of anastomoses and
for use with buttressing materials. |
| 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 | February 25, 1997 |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lorri Chavez Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. . . . . . . . . . . . . . 4545 Creek Road Cincinnati, Ohio 45242-2839
JUN 27 1997
Re: K970720
Trade Name: ENDOPATH® EZ45 Endoscopic Linear Cutter and ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler Regulatory Class: II Product Code: KOG Dated: May 21, 1997 Received: June 10, 1997
Dear Ms. Chavez:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Lorri Chavez
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. " -----
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Stephen Rhodes
Celia'M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix B: Indications for Use Statement
Statement
Indications for Use Statement:
510(k) Number: K 770720
Device Names: The ENDOPATH® EZ45 Endoscopic Linear Cutter and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler.
Indications for Use: The ENDOPATH® EZ45 Endoscopic Linear Cutter [and the ENDOPATH® EZ45 No Knife Endoscopic Linear Stapler] has application in multiple open and other minimally invasive surgical procedures for transection, resection, [and/or creation of anastomoses] and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
Hypt Rhodes
(Division Sign-Off Division of General Restorative Devices 1970720 310(k) Number
Prescription Use
(Per 21 CFR 801.109)