The Unimicro Disposable Retrieval Endo-Pouch is intended for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

Device Description

The Unimicro Disposable Retrieval Endo-Pouch is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimicro Disposable Retrieval Endo-Pouch is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.

AI/ML Overview

The document is a 510(k) premarket notification for the Unimicro Disposable Retrieval Endo-Pouch. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria based on outcome measures.

Therefore, the information typically requested in your prompt (such as acceptance criteria for device performance in terms of accuracy, sensitivity, specificity, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth for training data was established) is not applicable to this 510(k) submission for a medical device that retrieves tissues, organs, and calculi during surgical procedures.

Instead, the submission relies on demonstrating similarity in intended use, design, principles of operation, materials, performance, and sterilization to a predicate device. The "acceptance criteria" here refers to the successful completion of non-clinical (bench) testing to ensure the device performs as expected and meets safety requirements.

Here's a breakdown of the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "A series of preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimicro Disposable Retrieval Endo-Pouch. All the test results demonstrate the performance of Unimicro Disposable Retrieval Endo-Pouch meets the requirements of its predefined acceptance criteria and intended uses."

While the specific acceptance criteria and detailed quantitative results for each test are not provided in this summary document, the general categories of tests and the conclusion are stated.

Category of Test	Acceptance Criteria (Implicit)	Reported Device Performance
Physical Tests	Device functions as intended without physical failure during simulated use or applicable stress.	Meets requirements of predefined acceptance criteria and intended uses.
Mechanical Tests	Device maintains structural integrity and performs mechanical actions (e.g., deployment, retrieval strength) as designed.	Meets requirements of predefined acceptance criteria and intended uses.
Biocompatibility Tests (ISO 10993 series)	Device materials are non-toxic, non-irritating, and non-sensitizing as per the specified ISO standards: ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) ISO 10993-5:2009 (Tests for in vitro cytotoxicity) ISO 10993-10:2010 (Tests for irritation and skin sensitization) ISO 10993-12:2012 (Sample preparation and reference materials)	Meets requirements of predefined acceptance criteria (by adhering to ISO standards) and intended uses.
Sterilization (EO Sterilized)	Device achieves and maintains sterility.	EO Sterilized (implies successful sterilization validation).

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. Standard practice for non-clinical bench testing generally involves a sufficient number of units to demonstrate reproducibility and robustness, but specific numbers are not typically included in a 510(k) summary.
Data Provenance: Not explicitly stated, but these are bench tests conducted by the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd., in China. The data would therefore be prospective in the sense that the tests were conducted specifically for this submission, but not in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a non-clinical device that collects specimens. There is no "ground truth" to be established by clinical experts in the context of the described bench tests. The tests evaluate physical, mechanical, and biological properties according to engineering and biocompatibility standards.

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

Not Applicable. As these are non-clinical bench tests evaluating device properties, there is no need for expert adjudication of results in the way it would be applied to a diagnostic imaging algorithm. Test results are typically objective measurements.

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:

Not Applicable. This is a device for specimen retrieval, not a diagnostic AI device.

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

Not Applicable. This is a medical device, not an algorithm. Bench testing evaluates the device itself.

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

Not Applicable. For non-clinical bench testing, the "ground truth" or reference standard would be the pre-defined engineering specifications, material properties, and biocompatibility standards (e.g., ISO 10993 suite). These are objective criteria.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not Applicable. (See point 8).

Summary of Equivalence (rather than direct performance against clinical criteria):

The submission demonstrates substantial equivalence by comparing the Unimicro Disposable Retrieval Endo-Pouch to the predicate device, Unimax Specimen Retrieval System (K103510), across several parameters:

Intended Use: Identical ("receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.")
Design: Both consist of a flexible polymer bag and an introducer structure that fits through a trocar port.
Principles of Operation: Implied to be identical given design and intended use.
Materials: Both use "Various polymer Stainless."
Performance: Supported by the statement "The result of bench testing indicates that the new device is as safe and effective as the predicate device" and that the non-clinical tests "demonstrate the performance... meets the requirements of its predefined acceptance criteria and intended uses."
Sterilization: Both are EO Sterilized.
Biocompatibility: Both adhere to ISO 10993 standards (with slightly updated versions for the proposed device, reflecting current standards).

In conclusion, this 510(k) submission establishes equivalence through non-clinical testing against predefined engineering and biocompatibility standards, rather than through clinical studies with performance metrics like sensitivity/specificity or expert-adjudicated ground truth.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

November 13, 2014

Unimicro Medical Systems (ShenZhen) Company, Ltd. % Mr. Long Yang Shenzhen Hlongmed Biotech Company, Ltd. R 15-08, East Building, Yihai Plaza, Chuangye Road, Nanshan District Shenzhen, Guangdong 518054 People's Republic of China

Re: K141593

Trade/Device Name: Unimicro Disposable Retrieval Endo-Pouch, models: Auto Retrieval Endo-Pouch, Endo-Pouch With Introducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 17, 2014 Received: October 23, 2014

Dear Mr. Yang:

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 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

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

Page 2 - Mr. Long Yang

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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.

Sincerely yours.

David Krause -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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141593

Device Name

Unimicro Disposable Retrieval Endo-Pouch, models: Auto Retrieval Endo-Pouch, Endo-Pouch With Introducer

Indications for Use (Describe)

The Unimicro Disposable Retrieval Endo-Pouch is intended for the collection and extraction 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

{3}------------------------------------------------

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

| | Unimicro Medical Systems (ShenZhen) Co., Ltd. 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.

The assigned 510(K) number is:

1. Submitter information:

Manufacturer Name: Unimicro Medical Systems (ShenZhen) Co.,Ltd. Address: 2/F, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District, ShenZhen City,Guangdong Province, China Tel : 0086-755-27111581 Fax : 0086-755-27111580 Establishment Registration Number:3010806467

2. Contact person:

Long Yang (COO)

Shenzhen Hlongmed Biotech Co., Ltd.

R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District,Shenzhen, P.R. China

Tel: 0086-755-86664986

Fax: 0086-755-86664933

E-mail: yanglong@hlongmed.com

3. Device Information:

Trade Name: Unimicro Disposable Retrieval Endo-Pouch

Model: Auto Retrieval Endo-Pouch, Endo-Pouch With Introducer

Common Name: Tissue Bags

Regulatory Class: II

Classification Name	Product Code	Regulation Number
Laparoscope, General & PlasticSurgery	GCJ	876.1500

{5}------------------------------------------------

□ Unimicro Medical Systems (ShenZhen) Co., Ltd.

4. Predicative Device

Device Name	CommonName	Manufacturer	Classificationand Code	Classificationregulation	510(k)number
UnimaxSpecimenRetrievalSystem	TissueBags	UnimaxMedicalSystems Inc.	Class II,GCJ	21CFR876.1500	K103510

Table 1: Predicative Device Information

5. Intended Use and Indications for Use of the subject device

The Unimicro Disposable Retrieval Endo-Pouch is intended for use as a receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

6. Description

7. Non-clinical Testing

A series of preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimicro Disposable Retrieval Endo-Pouch. All the test results demonstrate the performance of Unimicro Disposable Retrieval Endo-Pouch meets the requirements of its predefined acceptance criteria and intended uses. The results of the non-clinical testing demonstrate that the Non-clinical Testing is as safe and effective as the predicate devices.

8. Safety and Effectiveness

The result of bench testing indicates that the new device is as safe and effective as the predicate device.

{6}------------------------------------------------

பரி///////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////

9. Substantial Equivalence Determination

The Unimicro Disposable Retrieval Endo-Pouch submitted in this 510(k) file is substantially equivalent in intended use, design, principles of operation, materials ,performance and sterilization to the cleared Unimax Specimen Retrieval System which is the subject of K103510.There are no difference between the Proposed Device and Predicate Device, see Table 2.

Item	Proposed Device	Predicate Device
Trade Name	Unimicro DisposableRetrieval Endo-Pouch	Unimax SpecimenRetrieval System
510(K)Submitter	Unimicro MedicalSystems (ShenZhen)Co.,Ltd.	Unimax Medical SystemsInc.
510(K) Number	----------	K103510
Classificationregulation	21 CFR 876.1500	21 CFR 876.1500
Classificationand Code	Class II ,GCJ	Class II ,GCJ
DeviceClassificationName	Laparoscope, General &Plastic Surgery	Laparoscope, General &Plastic Surgery
Indications forUse	Indicated for use as areceptacle for thecollection and extractionof tissue, organs andcalculi during general andlaparoscopic surgicalprocedures.	Indicated for use as areceptacle for thecollection and extractionof tissue, organs andcalculi during general andlaparoscopic surgicalprocedures.
Material	Various polymerStainless	Various polymerStainless
Specification	consists of a flexiblepolymer bag and anintroducer structure thatfits through a trocar port	consists of a flexiblepolymer bag and anintroducer structure thatfits through a trocar port
Biocompatibility	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010ISO 10993-12 :2012	ISO 10993-1:2003ISO 10993-5:2009ISO 10993-10:2002ISO 10993-12 :2007
Sterilization	EO Sterilized	EO Sterilized

Table 2 : Comparison to Predicate Device

{7}------------------------------------------------

UNilllifer

10. Conclusion

After analyzing bench tests, it can be concluded that Unimicro Disposable Retrieval Endo-Pouch is as safe and effective as the predicate device.

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.