ENDOPATH ULTRA VERESS NEEDLE

K983925 · Ethicon Endo-Surgery, Inc. · HIF · Feb 3, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K983925
• Device Name: ENDOPATH ULTRA VERESS NEEDLE
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Feb 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The intended use of the New Device is the establishment of pneumonperitoneum.

Device Story

The ENDOPATH® Ultra Veress Insufflation Needle is a 14-gauge stainless steel needle with a plastic handle, stopcock, and luer lock connector. It features a spring-loaded, blunt stylet that extends beyond the needle tip. During insertion through abdominal tissue, the stylet retracts; once the peritoneum is reached, the stylet automatically advances forward to protect internal structures. Used by clinicians to establish pneumoperitoneum prior to abdominal endoscopy. The device facilitates gas insufflation into the abdominal cavity. It is a mechanical instrument requiring manual operation by a physician.

Clinical Evidence

Bench testing only. Studies evaluated flow rate, spring force to deflect stylet, audible rate, and needle penetration to ensure design reliability and performance equivalence to the predicate device.

Technological Characteristics

14-gauge stainless steel needle; plastic handle with stopcock and luer lock connector; spring-loaded blunt stylet mechanism. Mechanical device; no software or electronic components.

Indications for Use

Indicated for use in gynecologic laparoscopy and other minimally invasive abdominal procedures for the establishment of pneumoperitoneum. Not intended for use when minimally invasive techniques are contraindicated.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Submission Summary (Full Text)

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## Appendix A: 510(k) Summary of Safety and Effectiveness

| 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 | The ENDOPATH® Ultra Veress Insufflation Needle is a spring-loaded, blunt<br>stylet safety mechanism similar in function to a Veress needle. It is used to<br>establish pneumoperitoneum prior to abdominal endoscopy. The 14 gauge<br>stainless steel needle is attached at its proximal end to a plastic handle. The<br>handle is shaped for comfort in the hand and contains a stopcock and a luer<br>lock connector for insufflating the abdominal cavity.<br>Inside the needle sleeve and extending beyond the needle tip is a spring-<br>loaded, blunt stylet. The stylet retracts as the needle is pushed through the<br>abdominal tissue and automatically advances forward once the peritoneum is<br>established. |
| Intended use | The intended use of the New Device is the establishment of<br>pneumonperitoneum. |
| Indications | The ENDOPATH® Ultra Veress Insufflation Needle has applications in<br>gynecologic laparoscopy and other minimally invasive abdominal procedures<br>for establishment of pneumonperitoneum. |
| Contra-<br>indications | The instrument is not intended for use when minimally invasive techniques<br>are contraindicated. |
| Technological<br>characteristics | The technological characteristics of the New Device are the same as the<br>Predicate Device. |
| Performance<br>data | Bench data was used to evaluate the performance to ensure that the device can<br>be used as designed. The studies demonstrated acceptable performance to the<br>Predicate Device in reliability and design. The performance criteria evaluated<br>are flow rate, spring force to deflect stylet, audible rate, and needle<br>penetration. From the data generated, it can be concluded that the New<br>Device performed equivalent to the Predicate Device. |
| Conclusion | Based on the 510(k) summaries and 510(k) statements (21 CFR §807) and the<br>information provided herein, we conclude that the New Device is<br>substantially equivalent to the Predicate Device under the Federal Food, Drug<br>and Cosmetic Act. |
| Contact | Edwin O. Billips, RAC<br>Senior Associate<br>Regulatory Affairs<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Date | November 2, 1998 |

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## Appendix A: 510(k) Summary of Safety and Effectiveness,

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Image /page/2/Picture/2 description: The image shows a black and white seal for the Department of Health & Human Services USA. The seal is circular with text around the perimeter. Inside the circle is an emblem of an eagle with three stylized lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 1999

Edwin O. Billips, RAC Senior Associate, Regulatory Affairs ETHICON ENDO-SURGERY, INC. 4545 Creek Road Cincinnati, OH 45242-2839

Re: K983925

ENDOPATH® Ultra Veress Insufflation Needle Dated: November 2, 1998 Received: November 5, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF

Dear Mr. Billips:

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 legally marketed predicate 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). 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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 Requlation (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 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 510(k) 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 vitro diagnostic devices), please contact the Office of Compirance 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/dsma/dsmamain.html".

Sincerely yours,

J.J.

Capt. Daniel G. Schultz, M.D. Acting 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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K983925

Page 1 of 1

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510(k) Number (if known)

Device Name

Indications for use

ENDOPATH® Ultra Veress Insufflation Needle

The ENDOPATH® Ultra Veress Insufflation Needle has
Insufficial Ultra Veress soony and other The ENDOPATII - Olda - Startoscopy and other applications in gyllectilegie hiparesess for establishment
minimally invasive abdominal procedures for establishment of preumoperitoneum.

(PL): ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K983925 |
| Prescription Use | <div style="display:inline-block;"> <span style="text-decoration: overline;">✓</span> </div> |
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | |
|--------------------------|--|
| (Optional Format 1-2-96) | |