ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER

K980815 · Ethicon Endo-Surgery, Inc. · OCW · May 1, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980815
• Device Name: ENDOPATH EZ45 ENDOSCOPIC LINEAR CUTTER
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: OCW · Gastroenterology, Urology
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for transection, resection, and / or the creation of anastomoses.

Device Story

ENDOPATH® EZ45 Endoscopic Linear Cutter is a surgical instrument used for tissue transection, resection, and anastomosis creation. It is designed for use in both open and minimally invasive surgical procedures, such as radical prostatectomy. The device functions by delivering staples to tissue and may be used in conjunction with buttressing materials like bovine pericardium to reinforce the staple line. It is operated by surgeons in clinical settings (OR). The device is a mechanical surgical cutter/stapler; it does not involve electronic processing, software, or AI/ML algorithms.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design and performance characteristics to the predicate device.

Technological Characteristics

Mechanical endoscopic linear cutter. Materials, design, and physical properties are identical to 510(k) #970720. No electronic, software, or energy-based components.

Indications for Use

Indicated for transection, resection, and/or creation of anastomoses in open or minimally invasive surgical procedures, including radical prostatectomy. Compatible with staple line or tissue buttressing materials, such as bovine pericardium.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 510(k) #970720

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

| MAY | 1 1998<br>Statement | Information supporting claims of substantial equivalence, as defined under the<br>Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is<br>summarized below. For the convenience of the Reviewer, this summary is<br>formatted in accordance with the Agency's final rule "...510(k) Summaries<br>and 510(k) Statements..." (21 CFR §807) and can be used to provide a<br>substantial equivalence summary to anyone requesting it from the Agency. |
|-----|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device<br>description | All device functions, scientific concepts, significant physical and performance<br>characteristics (i.e. device design, materials, physical properties, etc.) are<br>identical to the design and manufacture described in 510(k) #970720. |
| | Intended use | The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for<br>transection, resection, and / or the creation of anastomoses. |
| | Indications<br>statement | The ENDOPATH® EZ45 Endoscopic Linear Cutter is intended for<br>transection, resection, and / or creation of anastomoses, has application in<br>multiple open or minimally invasive surgical procedures, including radical<br>prostatectomy, and can be used with staple line or tissue buttressing materials,<br>such as bovine pericardium. |
| | Technological<br>characteristics | The technological characteristics of the ENDOPATH® EZ45 Endoscopic<br>Linear Cutter are identical to those described in 510(k) #970720. |
| | Performance<br>data | The ENDOPATH® EZ45 Endoscopic Linear Cutter performance is identical<br>to 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

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| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the<br>information provided herein, we conclude that the ENDOPATH® EZ45<br>Endoscopic Linear Cutter is substantially equivalent to the Predicate Device<br>under the Federal Food, Drug and Cosmetic Act. |
|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Edwin O. Billips, RAC<br>Senior Associate<br>Regulatory Affairs Department<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Date | April 29, 1998 |

ENDOPATH®EZ45 Endoscopic Linear Cutter

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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