(59 days)
The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for transection, resection, and /or creation of anastomoses, has application in multiple open or minimally invasive surgical procedures, including radical prostatectomy, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) #970720.
This 510(k) submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary simply states that:
- "All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) #970720."
- "The technological characteristics of the ENDOPATH® EZ45 Endoscopic Linear Cutter are identical to those described in 510(k) #970720."
- "The ENDOPATH® EZ45 Endoscopic Linear Cutter performance is identical to that described in 510(k) #970720."
This means that the current device (ENDOPATH® EZ45 Endoscopic Linear Cutter) is being claimed as substantially equivalent to a previously cleared device (referenced by 510(k) #970720). Therefore, the detailed performance data and acceptance criteria would be found in the original 510(k) submission (#970720), not in this summary.
Based on the provided text, I cannot extract the requested information regarding acceptance criteria or a study. All answers to your questions would be "Not provided in this document" or "Information refers to a predicate device's submission."
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510(k) Summary of Safety and Effectiveness
| MAY | 1 1998Statement | Information supporting claims of substantial equivalence, as defined under theFederal Food, Drug and Cosmetic Act, respecting safety and effectiveness issummarized below. For the convenience of the Reviewer, this summary isformatted in accordance with the Agency's final rule "...510(k) Summariesand 510(k) Statements..." (21 CFR §807) and can be used to provide asubstantial equivalence summary to anyone requesting it from the Agency. |
|---|---|---|
| Devicedescription | All device functions, scientific concepts, significant physical and performancecharacteristics (i.e. device design, materials, physical properties, etc.) areidentical to the design and manufacture described in 510(k) #970720. | |
| Intended use | The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended fortransection, resection, and / or the creation of anastomoses. | |
| Indicationsstatement | The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended fortransection, resection, and / or creation of anastomoses, has application inmultiple open or minimally invasive surgical procedures, including radicalprostatectomy, and can be used with staple line or tissue buttressing materials,such as bovine pericardium. | |
| Technologicalcharacteristics | The technological characteristics of the ENDOPATH® EZ45 EndoscopicLinear Cutter are identical to those described in 510(k) #970720. | |
| Performancedata | The ENDOPATH® EZ45 Endoscopic Linear Cutter performance is identicalto that described in 510(k) #970720. | |
| Continued on next page |
ETHICON ENDO-SURGERY, INC. ENDOPATH® EZ45 Endoscopic Linear Cutter
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510(k) Summary of Safety and Effectiveness, continued
ส
:
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and theinformation provided herein, we conclude that the ENDOPATH® EZ45Endoscopic Linear Cutter is substantially equivalent to the Predicate Deviceunder the Federal Food, Drug and Cosmetic Act. |
|---|---|
| Contact | Edwin O. Billips, RACSenior AssociateRegulatory Affairs DepartmentEthicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
| Date | April 29, 1998 |
ENDOPATH®EZ45 Endoscopic Linear Cutter
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized representation of three human figures, one behind the other, with their heads tilted slightly upwards. The figures are depicted in a simple, abstract manner, with flowing lines suggesting movement or progress. The text "DEPARTMENT OF" is vertically oriented and placed to the left of the figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1000 MAY
Ms. Lorri Chavez Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242-2839
Re: K980815
Endopath® EZ45 Endoscopic Linear Cutter Dated: March 2, 1998 Received: March 3, 1998 Regulatory Class: II 21 SCFR 876.1500/Procode: 78 KOG
Dear Ms. Chavez:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device 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 (OS) for Medical Devices: General regulation (2) 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 device in the Federal Register. Please note: this response to your premarket notification submission 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.
This letter will allow you to begin marketing your device as described in your 510ks) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, 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/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K9808/5
Following is the Indications for Use Statement: Statement
510(k) Number: K980815 Device Name: ENDOPATH® EZ45 Endoscopic Linear Cutter
Indications for Use:
The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for transection, resection, and /or creation of anastomoses, has application in multiple open or minimally invasive surgical procedures, including radical prostatectomy, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
Continued on next page
Roder P. Satling/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K 98081 510(k) Number.
ﺳ Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use_
ETHICON ENDO-SURGERY, INC. ENDOPATH® EZ45 Endoscopic Linear Cutter
§ 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.