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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the ENDOPOUCH PRO Specimen Retrieval Bag. It outlines its intended use, technological characteristics, and a brief summary of performance data. However, the document does NOT contain the detailed information required to answer all the questions in your request, particularly those related to specific acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this device is not an AI/ML algorithm.

Here's an analysis of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
(Not explicitly stated in terms of specific, quantifiable criteria)	"It was determined that the device has greater bag strength than either predicate device."

Explanation: The document states that "Pre-clinical in vivo as well as bench top testing has been performed to verify that the product meets the performance requirements described." However, it does not explicitly list the acceptance criteria (e.g., "bag strength must be X Newtons") nor provides quantitative reported device performance other than the qualitative statement about greater bag strength.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Information Not Provided: The document mentions "Pre-clinical in vivo as well as bench top testing," but it does not specify the sample size for these tests, the type of data (e.g., if it involved human subjects or materials), or the provenance of any 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)

Information Not Provided: This question is more relevant to studies involving interpretation by human experts, such as medical image analysis. For a specimen retrieval bag, the "ground truth" would likely relate to objective physical properties or functional performance, not expert consensus on interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Information Not Provided: Adjudication methods are typically associated with resolving disagreements in expert interpretations, which is not applicable to the type of testing described for this device.

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

No, an MRMC study was not done.
Explanation: An MRMC study is relevant for AI/ML-based diagnostic devices that assist human readers (e.g., radiologists interpreting images). The ENDOPOUCH PRO is a surgical instrument, not an AI/ML diagnostic aid. The document does not describe any such study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done.
Explanation: This question also pertains to AI/ML algorithms. The ENDOPOUCH PRO is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implied Ground Truth: For the "bag strength" testing, the ground truth would likely be established through objective physical measurements (e.g., tensile strength testing) rather than expert consensus, pathology, or outcomes data, as it's a mechanical property. The document doesn't specify the exact metrics or methods for establishing this.

8. The sample size for the training set

Information Not Applicable/Provided: As this device is not an AI/ML algorithm, there is no "training set."

9. How the ground truth for the training set was established

Information Not Applicable/Provided: As this device is not an AI/ML algorithm, there is no "training set" and thus no ground truth established for one.

Summary of Study (as described for the ENDOPOUCH PRO Specimen Retrieval Bag):

The study referenced is "Pre-clinical in vivo as well as bench top testing." The purpose of this testing was to "verify that the product meets the performance requirements described." The key finding reported is that the device "has greater bag strength than either predicate device."

This documentation focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and functional performance testing, which is typical for a 510(k) submission of a conventional medical device. It does not involve AI/ML components or associated study methodologies like MRMC, standalone algorithm performance, or extensive details on ground truth establishment relevant to AI.

Summary

{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

. . . . . .

_ 27

{1}------------------------------------------------

510(k) Summary of Safety and Effectiveness, Continued

PerformanceData	Pre-clinical in vivo as well as bench top testing has been performed to verifythat the product meets the performance requirements described. It wasdetermined that the device has greater bag strength than either predicatedevice.
Conclusion	Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) andthe information provided herein, we conclude that the new device issubstantially equivalent to the predicate devices under the Federal Food,Drug, Cosmetic Act.
Contact	Gregory R. JonesDirector of Regulatory AffairsETHICON, Inc.Rt. #22 WestSomerville, New Jersey 08876-0151
Date	May 1, 1998

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

and the comments of the comments of

. :

{2}------------------------------------------------

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 __

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.