(120 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ENDOPATH® EZ45 Endoscopic Linear Cutter and No Knife Endoscopic Linear Stapler:
This document is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed acceptance criteria and statistical analysis as one might find for a novel AI device.
Therefore, the information you're looking for will be limited based on the nature of this submission.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria (e.g., "sensitivity ≥ 90%") are not explicitly stated or quantified. The performance is described in a general qualitative manner.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device can be used as designed for its intended purpose. | "The studies demonstrated acceptable performance in transecting, resecting, and/or creation of anastomoses and for use with buttressing materials." (This addresses the intended use stated as "for transection, resection, [and/or the creation of anastomoses]" and the indication for use including "can be used with staple line or tissue buttressing materials"). |
| Device meets the "Technological characteristics" of the Predicate Device. | "The technological characteristics of the New Devices are the same as the Predicate Device." |
| Device is "substantially equivalent" to an existing predicate device regarding safety and effectiveness. | "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." |
Study Details
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. The document only states "Pre-clinical laboratory evaluations were performed." The number of devices, firings, or tissue samples tested is not mentioned.
- Data Provenance: Not specified. It only mentions "Pre-clinical laboratory evaluations," implying a controlled lab setting rather than clinical patient data. This would typically be regarded as prospective in the sense of designing tests for the device, but not involving human subjects/retrospective patient data.
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. This is a mechanical surgical stapler/cutter, not an AI diagnostic device. "Ground truth" would likely be established through objective measurements of staple line integrity, tissue cutting, and functionality rather than expert consensus on diagnostic images. No experts are mentioned in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI diagnostic device requiring adjudication of interpretations.
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 not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a mechanical surgical device. Performance is inherently "standalone" in the sense that the device performs its function, but it is always used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the "ground truth" methodology. However, given the nature of the device (stapler/cutter), the "acceptable performance" would have been assessed against engineering specifications and functional requirements such as:
- Staple formation and integrity (e.g., proper 'B' shape for staples)
- Cutting completeness
- Lack of tissue damage beyond the intended cut/staple line
- Prevention of misfires or unintended reloads (as per the "safety lock-out feature")
- Tissue-specific performance (thin, standard, thick tissue reloads)
- Performance with buttressing materials
This would likely involve objective measurements and visual inspection in a laboratory setting.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for a mechanical device.
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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
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Appendix A: 510(k) Summary of Safety and Effectiveness,
Continued
)
| Technologicalcharacteristics | The technological characteristics of the New Devices are the same as thePredicate Device. |
|---|---|
| Performancedata | Pre-clinical laboratory evaluations were performed to ensure that thedevices can be used as designed. The studies demonstrated acceptableperformance in transecting, resecting, and/or creation of anastomoses andfor 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 Devicesare substantially equivalent to the Predicate Device under the FederalFood, Drug and Cosmetic Act. |
| Contact | Lorri ChavezEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
| Date | February 25, 1997 |
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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.
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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
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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)
§ 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.