The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Specimen Retrieval Bag. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for a novel medical device.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study was not presented in this document.

Here's what can be extracted and what cannot:

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

The document provides a comparison of the proposed device against a predicate device, focusing on technological characteristics and compliance with general standards. It does not explicitly state "acceptance criteria" for a study to prove performance but rather lists the tests performed to demonstrate substantial equivalence to the predicate.

Test Item	Acceptance Criteria (Implicit - achieved SE to predicate)	Reported Device Performance (Proposed Device)
Biocompatibility	Conform with ISO 10993 requirements (for predicate)
Cytotoxicity	No cytotoxicity	No cytotoxicity
Skin Sensitization		No skin sensitization
Irritation	No irritation	No irritation
Physical Performance Tests	Met design specifications and demonstrated SE to predicate
Retracted Bag Peeling Force Test	(Not explicitly stated, but performed)	Test performed (results not detailed, but implied to be sufficient for SE)
String Tensile Strength Test	(Not explicitly stated, but performed)	Test performed (results not detailed, but implied to be sufficient for SE)
Force to Withdraw Retracted Bag Test	(Not explicitly stated, but performed)	Test performed (results not detailed, but implied to be sufficient for SE)
Force to Push out Retracted Bag Test	(Not explicitly stated, but performed)	Test performed (results not detailed, but implied to be sufficient for SE)
Penetration Force Test	(Not explicitly stated, but performed)	Test performed (results not detailed, but implied to be sufficient for SE)
Leak Test	(Not explicitly stated, but performed)	Test performed (results not detailed, but implied to be sufficient for SE)
Standards Compliance	Compliance with relevant ISO and ASTM standards	Complies with ISO 10993-1, -5, -7, -10; ASTM F88/F88M-15; ASTM F 1929-15
Label/Labeling	Complied with 21 CFR part 801	Complied with 21 CFR part 801

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

The document does not provide details on the sample sizes used for the non-clinical tests or the data provenance. It only states that "performance tests were performed on both proposed device and predicate device."

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)

This information is not applicable and not provided. The study is a non-clinical, bench-testing evaluation designed to demonstrate substantial equivalence, not a clinical study involving human readers or expert ground truth for interpretation.

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

This information is not applicable and not provided, as there was no clinical study or expert adjudication described.

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 MRMC or clinical study was done. The document explicitly states: "No clinical study is included in this submission."

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

This concept is not applicable as the device is a physical specimen retrieval bag, not an AI algorithm. The tests performed are non-clinical, bench tests.

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

For the non-clinical performance tests, the "ground truth" would be the established scientific and engineering principles and the performance of the predicate device, as well as compliance with recognized standards (e.g., ISO, ASTM). It's not a clinical "ground truth."

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set." The device is a physical medical device, not an AI or machine learning model that requires training data.

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

Not applicable as there is no training set mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 1, 2018

Beijing HangTian KaDi Technology R&D Institute % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K172789

Trade/Device Name: Specimen Retrieval Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 5, 2018 Received: January 11, 2018

Dear Diana Hong:

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 Act include requirements for annual registration, listing of devices, good manufacturing, 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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good

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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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Jennifer R. Stevenson -S 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

510(k) Number (if known)

K172789

Device Name

Specimen Retrieval Bag

Indications for Use (Describe)

The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic 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)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172789

1. Date of Preparation: 01/05/2018
1. Sponsor Identification

Beiiing HangTian KaDi Technology R&D_Institute

Room 301-08, 09, 10, 11, Third floor, Building No.13, No.15 Jing Sheng Nan Er Street, TongZhou District, 101102 Beijing, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: Not yet registered

Contact Person: Liying Zhang Position: General Manager Tel: +86-10-56407751 Fax: +86-10-56407795-803 Email: zly1110@139.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co.. Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 3609253199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Specimen Retrieval Bag Common Name: Specimen Retrieval Bag

Regulatory Information

Classification Name: Laparoscope, General& Plastic Surgery Classification: II; Product Code: GCJ Regulation Number: CFR 876.1500 Review Panel: General& Plastic Surgery

Intended Use Statement:

The device is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic procedures.

Device Description

ર. Identification of Predicate Device
510(k) Number: K100959 Product Name: Specimen Retrieval System
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.

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ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
A ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

The performance tests were performed on both proposed device and predicate device. The test items include follow items

Retracted Bag Peeling Force Test
String Tensile Strength Test
Force to Withdraw Retracted Bag Test
Force to Push out Retracted Bag Test
Penetration Force Test
Leak Test
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Item	Proposed Device	Predicate Device
		K100959
Product Code	GCJ	Same
Regulation Number	21 CFR 876.1500	Same
Class	CLASS II	Same
Intended Use	The specimen retrieval bag is indicated for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.	Same
Configuration	Retracted Bag	Same
	Outer Introducer Shaft
	Outer Introducer Handle
	Inner Introducer Shaft
	Inner Introducer Handle
	String
	Opening Support
	Pull loop
Single Use	Single Use	Same
Label/Labeling	Complied with 21 CFR part 801	Same
Sterilization	EO sterilization	Irradiation Sterilization
Biocompatibility
Cytotoxicity	No cytotoxicity	Conform with ISO 10993requirements
Skin Sensitization	No skin sensitization
Irritation	No irritation

8. Substantially Equivalent (SE) Comparison

Table 1 Comparison of Technology Characteristics
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) 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.