Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.

AI/ML Overview

The provided document is a 510(k) summary for the LapBag®, a sterile specimen retrieval pouch. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a novel device or AI algorithm.

Therefore, many of the requested fields related to AI performance, expert ground truth, adjudication, and clinical study details cannot be filled directly from this document. The document describes engineering and biocompatibility tests to ensure the device itself is safe and performs as intended compared to a predicate, not clinical accuracy or AI performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table for performance similar to how an AI algorithm would be evaluated. Instead, it lists the types of tests performed and states that the "test results support that the subject device is substantially equivalent to the predicate devices."

Test Category	Specific Test	Reported Performance / Outcome (Implicit Acceptance)
Sterilization Validation	In accordance with ISO 11737-1	Results support substantial equivalence.
Shelf Life Validation	Not specified (assumed to be per standard)	Results support substantial equivalence.
Biocompatibility	Cytotoxicity (ISO 10993-5)	Results support substantial equivalence.
	Ethylene Oxide Sterilization Residuals (ISO 10993-7)	Results support substantial equivalence.
	Skin Sensitization (ISO 10993-10)	Results support substantial equivalence.
	Systemic Toxicity (ISO 10993-11)	Results support substantial equivalence.
	Irritation (ISO 10993-10)	Results support substantial equivalence.
Performance Tests	Appearance	Results support substantial equivalence.
	Measurement	Results support substantial equivalence.
	Extraction Test	Results support substantial equivalence.
	Puncture Resistance	Results support substantial equivalence.
	Tensile Strength	Results support substantial equivalence.
	Bag Leak Test	Results support substantial equivalence.
	Ring Pull Test	Results support substantial equivalence.

Study Proving Device Meets Acceptance Criteria:
The study described is a series of laboratory and bench tests comparing the LapBag® to a predicate device (MGB Disposable Retrieval Bag/LAPBAG, K093194). The objective was to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a novel medical AI algorithm. The tests show the LapBag® is comparable in physical, mechanical properties, and biocompatibility. The main difference highlighted is that LapBag® has a wider range of pouch sizes, and comparison tests (Puncture Resistance, Tensile Strength, Bag Leak Test, and Ring Pull Test) were performed to confirm equivalence despite this difference.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a "test set" in the context of clinical data or AI evaluation. The "tests" mentioned are engineering and material verification tests.

Sample Size: Not explicitly stated for each test, but standard statistical sampling would be used for material and product testing.
Data Provenance: Not applicable in the context of clinical data. The tests are laboratory-based and conducted by the manufacturer, Sejong Medical Co., Ltd. (Republic of Korea).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. "Ground truth" in the context of expert consensus for imaging or clinical diagnosis is not relevant to this type of device (a surgical retrieval bag). The "ground truth" for the material and performance tests would be the established scientific and engineering principles and standards (e.g., ISO standards).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in clinical studies, typically for diagnostic or screening devices. This is a material and performance validation for a surgical device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this device. This is a surgical accessory, not a diagnostic imaging device or AI algorithm intended to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the engineering and biocompatibility tests, the "ground truth" is defined by:

International standards (e.g., ISO 11737-1, ISO 10993 series).
Established scientific and engineering principles for material strength, leak integrity, and biocompatibility.
Comparison to the performance characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/machine learning device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 25, 2017

Sejong Medical Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA. Inc. 690 Roosevelt Irvine, California 92620

Re: K171726

Trade/Device Name: LapBag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 12, 2017 Received: September 19, 2017

Dear Priscilla Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv. Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S.

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171726

Device Name

LapBag®

Indications for Use (Describe)

LapBag® is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Summary

(K171726)

This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 09/12/2017

1. Submitter/Applicant

Sejong Medical Co., Ltd. 11, Sinchon 2-ro Paju-si, Gyeonggi-do Republic of Korea 10880

Tel: +82-31-945-8191 Fax: +82-31-945-8190

2. U.S Agent/Contact Person

Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: LapBag®
Common Name: Tissue Bags ●
Classification: Class II
Classification regulation: 21 CFR 876.1500 ●
. Product Code: GCJ

Predicate Devices: 4.

Predicate Device:

MGB Disposable Retrieval Bag/LAPBAG (K093194) by MGB Endoskopische Gerate GmbH Berilin

5. Description:

Sterile Specimen Retrieval Pouch, LapBag®, is a single use specimen container. It is

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designed for use in retrieving specimens during laparoscopic surgery. The LapBag® single use specimen retrieval pouch is supplied sterile in a dispensing tube for ease of insertion through a standard 5, 10, 11,12mm trocar cannula (sleeve). There are 4 types: metal type, non-metal type, metal locking type, and non-metal locking type.

Indication for use: 6.

LapBag® is intended for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

7. Performance Data

The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.

· Sterilization Validation Test in accordance with ISO11737-1
· Shelf Life Validation Test
· Biocompatibility Tests in accordance with ISO 10993

Cytotoxicity	ISO 10993-5
Ethylene Oxide SterilizationResiduals	ISO 10993-7
Skin Sensitization	ISO 10993-10
Systemic Toxicity	ISO 10993-11
Irritation	ISO 10993-10

· Performance Tests: Appearance, Measurement, Extraction Test, Puncture Resistance and Tensile Strength tests, Bag Leak Test, and Ring Pull Test

8. Basis for Substantial Equivalence

The subject device, LapBag® incorporates the same intended use with the predicate device. The devices are similar in physical & mechanical properties and dimensions.

The major difference between the subject device and the predicate device is the sizes of pouch. LapBag® has a wider range of size than the predicate devices. We have performed the comparison test for Puncture Resistance, Tensile Strength, Bag Leak Test, and Ring Pull Test, and the test results support that the subject device is substantially equivalent to the predicate devices.

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9. Conclusion

Upon reviewing the information including testing data provided in this submission and comparing intended use, principle of operation and overall technological characteristics, we conclude that the LapBag® is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 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.