K981579 · ETHICON, Inc. · MDM · Jul 9, 1998 · General, Plastic Surgery
Device Facts
Record ID
K981579
Device Name
ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG
Applicant
ETHICON, Inc.
Product Code
MDM · General, Plastic Surgery
Decision Date
Jul 9, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4800
Device Class
Class 1
Indications for Use
The ENDOPOUCH PRO Specimen Retrieval Bag is intended for use during general laparoscopic surgical procedures as well as the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi.
Device Story
ENDOPOUCH PRO is a disposable specimen retrieval bag for laparoscopic surgery. Device consists of flexible plastic bag, push rod handle, and introducer tube. Designed for single-hand deployment by surgeons during minimally invasive procedures. Surgeon inserts device through laparoscopic port, deploys bag to capture tissue specimen, and extracts bag containing tissue from body. Provides secure containment of specimens during removal, preventing contamination or tissue loss. Benefits include simplified retrieval process and improved bag strength compared to predicate devices.
Clinical Evidence
No clinical data. Evidence consists of pre-clinical in vivo and bench top testing verifying performance requirements, specifically demonstrating greater bag strength than predicate devices.
Technological Characteristics
Disposable specimen retrieval bag; flexible plastic construction; includes push rod handle and introducer tube; manual deployment mechanism.
Indications for Use
Indicated for collection and extraction of tissue specimens (e.g., appendix, gall bladder, ovaries, fibroid tumors, calculi) during laparoscopic surgical procedures.
Regulatory Classification
Identification
A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.
Predicate Devices
ENDOPOUCH II Specimen Retrieval Bag
Auto Suture ENDO CATCH Specimen Retrieval Bag
Submission Summary (Full Text)
{0}------------------------------------------------
5981579
റി 1698 JUL
# SECTION 7
## 510(k) Summary of Safety and Effectiveness
| 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. |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | MODIFIED DEVICE NAME: ENDOPOUCH PRO Specimen Retrieval Bag |
| | PREDICATE DEVICE NAME: ENDOPOUCH II Specimen Retrieval Bag and Auto Suture ENDO CATCH Specimen Retrieval Bag |
| Device Description | The ENDOPOUCH PRO device is comprised of a flexible plastic bag with a large, easily accessible opening, a push rod handle and an introducer tube. The push rod and handle allow for single hand deployment. |
| Intended Use | The ENDOPOUCH PRO Specimen Retrieval Bag is intended for use during general laparoscopic surgical procedures as well as the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi. |
| Indications Statement | The ENDOPOUCH PRO Specimen Retrieval Bag is a disposable device used as a receptacle for the collection and extraction of tissue specimens such as the appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures. |
| Technological characteristics | The modified device has the same technological characteristics as the predicate devices. The form, fit and function is similar. |
| | Continued on next page |
s
. . . . . .
_ 27
{1}------------------------------------------------
## 510(k) Summary of Safety and Effectiveness, Continued
| Performance<br>Data | Pre-clinical in vivo as well as bench top testing has been performed to verify<br>that the product meets the performance requirements described. It was<br>determined that the device has greater bag strength than either predicate<br>device. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and<br>the information provided herein, we conclude that the new device is<br>substantially equivalent to the predicate devices under the Federal Food,<br>Drug, Cosmetic Act. |
| Contact | Gregory R. Jones<br>Director of Regulatory Affairs<br>ETHICON, Inc.<br>Rt. #22 West<br>Somerville, New Jersey 08876-0151 |
| Date | May 1, 1998 |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
and the comments of the comments of
:
. :
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
d 1008 JUL
Mr. Gregory R. Jones Director, Regulatory Affairs Ethicon, Inc. Route 22, West Somerville, New Jersey 08876
Re: K981579 Trade Name: Endopouch Pro Specimen Retrieval Bag Regulatory Class: II Product Code: MDM Dated: May 1, 1998 Received: May 4, 1998
Dear Mr. Jones:
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 (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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality 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 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.
{3}------------------------------------------------
Page 2 - Mr. Gregory R. Jones
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 Compliance at (301) 594-4595. 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/dsmamain.html".
Sincerely yours,
Cella 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}------------------------------------------------
#### INDICATIONS FOR USE
981/579
510(k) Number (if known):
Device Name:
ENDOPOUCH PRO Specimen Retrieval Bag
Indications for Use:
ENDOPOUCH PRO Specimen Retrieval Bag is a disposable device used as a receptacle for the collection and extraction of tissue specimens such as appendix, gall bladder, ovaries, fibroid tumors, other tissues and calculi during laparoscopic surgical procedures.
#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use **__** OR Over-The-Counter Use X
(Optional Format 1-2-9G)
(Division Sign-Off)
Division of General Restorative Devices (4981579
510(k) Number **__**
4
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