Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a simple specimen retrieval pouch and the summary contains no mention of AI, ML, image processing, or data analysis beyond basic physical performance tests.

Therapeutic

No
The device is described as a specimen container for collecting tissue, organs, and calculi during surgical procedures, which serves a containment or retrieval function rather than directly treating or preventing a disease or condition.

Diagnostic

No
The device is described as a "receptacle for the collection of tissue, organs and calculi" and a "specimen container," indicating its function is for collection and retrieval of biological materials during surgery, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "sterile and single-use specimen container" and describes physical characteristics and performance tests related to material properties and structural integrity, indicating it is a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to collect tissue, organs, and calculi during surgical procedures. This is a collection device for specimens, not a device used to perform tests on those specimens to diagnose a condition.
Device Description: The description focuses on its function as a container for retrieving specimens during surgery.
Lack of Diagnostic Function: There is no mention of the device being used to analyze or test the collected specimens for diagnostic purposes. The performance studies focus on the physical integrity and safety of the pouch itself, not on its ability to provide diagnostic information.

IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device's function is solely for the collection and containment of specimens during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

GCJ

Device Description

The Equipment Pouch is a sterile and single-use specimencontainer designed for use in retrieving specimens during endoscopic surgery. The Equipment Pouch is supplied in a dispending tube for ease of insertion through a standard 10, 11, or 12mm trocar sheath.
consists of a flexible polymer bag and an introducer structure that fits through a trocar port

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

A series of safety tests were performed to assess the safety and effectiveness of the Equipment Pouch. The safety tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, ISO 10993-12:2012, and ISO 11135:2014. The test items are Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemictoxicity and Material-Mediated Pyrogenicity.

The tests listed below demonstrate the performance of Equipment Pouch meets the requirements of its pre-defined acceptance criteria and intended uses.

· Opening force Demonstrates sufficient smoothness.
Rope tension test Equipment Pouch rope can withstand at least 2kg of weight.
Bag load-bearing Demonstrates bag body can bear 1Kg weight and keep integrity.
Tensile strength Demonstrates adequate weld strength.
Bag Leak Test Demonstrates that the Pouch has no leaks.

The Comparative testing results of the non-clinical testing demonstrate that the Equipment Pouch is as safe and effective as the predicate device in performance.

Key Metrics

Not Found

Predicate Device(s)

K141593

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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.

December 7, 2017

WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. Haobin Li General Manager TangJiao XingWang Street, Lilin Town ZhongKai Hi-Tech Zone Huizhou, GuangDong, China

Re: K172578

Trade/Device Name: Equipment Pouch, Models: WEP010306A, WEP010306B, WEP010507A, WEP010507B Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: November 15, 2017 Received: November 20, 2017

Dear Haobin Li:

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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

1

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 medical devices and radiation-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 -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

2

Indications for Use

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

510(k) Number (if known)

K172578

Device Name

Equipment Pouch, models : WEP010306A, WEP010306B, WEP010507A, WEP010507B

Indications for Use (Describe)

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

× 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

"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."

3

WickiMed (Huizhou) Medical Equipment Manufacturing 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.

Type of submission: Traditional

The assigned 510(K) number is: K172578

The date the summary was prepared: November 15,2017

l. Submitter information:

Manufacturer Name: WickiMed (Huizhou) Medical Equipment Manufacturing Co. , Ltd. Address: TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone,

HuiZhou,GuangDong, China.

Tel : 0086-0752-3860807

Fax : 0086-0752-3863017

Establishment Registration Number:3010601992

2. Contact person:

Haobin Li (General Manager) WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone, HuiZhou, GuangDong, China. Tel: 0086-0752-3860807 Fax: 0086-0752-3863017 E-mail:mac lai@wickimed.com

3. Identification of the Device:

Trade Name: Equipment Pouch Model: WEP010306A, WEP010507A, WEP010306B, WEP010507B Common Name: Tissue Bags

4

WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.

Classification Name	Laparoscope, General & Plastic Surgery
Product Code	GCJ
Regulation Number	21 CFR 876.1500
Regulatory Class	II
Review Panel	General & Plastic Surgery

4. Identification of the Predicate Device

	Table I: Predicate Device Information

Device Name	Unimicro Disposable Retrieval Endo-Pouch
Common Name	Tissue Bags
Manufacturer	Unimicro Medical Systems (ShenZhen) Co., Ltd.
Classification and Code	Class II, GCJ
Classification regulation	21 CFR 876.1500
510(k) number	K141593

5. Intended Use and Indications for Use

The Equipment 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. Device Description

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

7. Non-clinical Testing

A series of safety tests were performed to assess the safety and effectiveness of the Equipment Pouch. The safety tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, ISO 10993-12:2012, and ISO 11135:2014. The test items are Cytotoxicity, Sensitization,

5

WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Intracutaneous reactivity, Acute systemictoxicity and Material-Mediated Pyrogenicity.

The tests listed below demonstrate the performance of Equipment Pouch meets the requirements of its pre-defined acceptance criteria and intended uses.

· Opening force
Demonstrates sufficient smoothness.
Rope tension test
Equipment Pouch rope can withstand at least 2kg of weight.
Bag load-bearing
Demonstrates bag body can bear 1Kg weight and keep integrity.
Tensile strength
Demonstrates adequate weld strength.
Bag Leak Test
Demonstrates that the Pouch has no leaks.

The Comparative testing results of the non-clinical testing demonstrate that the Equipment Pouch is as safe and effective as the predicate device in performance.

8. Substantial Equivalence Determination

The Equipment Pouch submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, performance to the cleared Unimicro Disposable Retrieval Endo-Pouch which is the subject of K141593. There are no differences between the two devices and no any new issues of safety or effectiveness.

The comparison to predicate device as below Table 2.

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WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Table 2 : Comparison to Predicate Device

Item	Predicate Device	Proposed Device
Trade Name	Unimicro Disposable
Retrieval Endo-Pouch	Equipment Pouch
510(K) Submitter	Unimicro Medical
Systems (ShenZhen)
Co.,Ltd.	WickiMed(Huizhou)Medic
al Equipment
Manufacturing Co.,Ltd
510(K) Number	K141593	-
Classification
regulation	21 CFR 876.1500	21 CFR 876.1500
Classification
and Code	Classll,
GCJ	Classll,
GCJ
Device
Classification
Name	Laparoscope, General &
Plastic Surgery	Laparoscope, General &
Plastic Surgery
Indications for
Use	Indicated for use as a
receptacle for the
collection and extraction
of tissue, organs and
calculi during general and
laparoscopic surgical
procedures.	Indicated for use as a
receptacle for the
collection and extraction
of tissue, organs and
calculi during general and
laparoscopic surgical
procedures.
Contraindication	The device is not
intended for use when
endoscopictechniques
are contraindicated	The device is not
intended for use when
endoscopictechniques
are contraindicated
Model	Endo-Pouch With
Introducer

Auto Retrieval
Endo-Pouch | WEP010306A;
WEP010507A

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WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.

9. Conclusion

After analyzing bench tests and safety testing data, it can be concluded that the Equipment Pouch is as safe and effective as the predicate device.