← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K172578 # Equipment Pouch (K172578) _Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · GCJ · Dec 7, 2017 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K172578 ## Device Facts - **Applicant:** Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Dec 7, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended 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. ## Device Story Equipment Pouch is a sterile, single-use specimen retrieval bag for endoscopic surgery. Device consists of a flexible polymer bag and an introducer structure; supplied in a dispensing tube for insertion through standard 10, 11, or 12mm trocar sheaths. Used in OR by surgeons during general and laparoscopic procedures to collect and extract tissue, organs, or calculi. Operation involves inserting the pouch through a trocar, deploying the bag, placing the specimen inside, and withdrawing the pouch through the port. Facilitates safe specimen removal, minimizing risk of contamination or tissue loss during extraction. ## Clinical Evidence Bench testing only. Performance validated via opening force, rope tension (min 2kg), bag load-bearing (1kg), tensile strength, and leak testing. Biocompatibility testing conducted per ISO 10993-1, -5, -7, -10, -11, and -12, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity. ## Technological Characteristics Materials: Nitinol, ABS, TPU. Form factor: Flexible polymer bag with introducer tube for 10-12mm trocars. Sterilization: Ethylene Oxide (EO). Standards: ISO 10993 series (biocompatibility), ISO 11135 (sterilization). ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Unimicro Disposable Retrieval Endo-Pouch ([K141593](/device/K141593.md)) ## Related Devices - [K141593](/device/K141593.md) — UNIMICRO DISPOSABLE RETRIEVAL ENDO-POUCH · Unimicro Medical Systems (Shenzhen) Co., Ltd. · Nov 13, 2014 - [K222828](/device/K222828.md) — Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · Mar 20, 2023 - [K171726](/device/K171726.md) — LapBag · Sejong Medical Co., Ltd. · Sep 25, 2017 - [K201243](/device/K201243.md) — Disposable Specimen Retrieval Bag · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Jul 10, 2020 - [K103510](/device/K103510.md) — UNIMAX SPECIMEN RETRIEVAL SYSTEM · Unimax Medical Systems, Inc. · May 6, 2011 ## Submission Summary (Full Text) {0}------------------------------------------------ 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. {6}------------------------------------------------ # WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Table 2 : Comparison to Predicate Device | Item | Predicate Device | Proposed Device | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Unimicro Disposable<br>Retrieval Endo-Pouch | Equipment Pouch | | 510(K) Submitter | Unimicro Medical<br>Systems (ShenZhen)<br>Co.,Ltd. | WickiMed(Huizhou)Medic<br>al Equipment<br>Manufacturing Co.,Ltd | | 510(K) Number | K141593 | - | | Classification<br>regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | | Classification<br>and Code | Classll,<br>GCJ | Classll,<br>GCJ | | Device<br>Classification<br>Name | Laparoscope, General &<br>Plastic Surgery | Laparoscope, General &<br>Plastic Surgery | | Indications for<br>Use | Indicated for use as a<br>receptacle for the<br>collection and extraction<br>of tissue, organs and<br>calculi during general and<br>laparoscopic surgical<br>procedures. | Indicated for use as a<br>receptacle for the<br>collection and extraction<br>of tissue, organs and<br>calculi during general and<br>laparoscopic surgical<br>procedures. | | Contraindication | The device is not<br>intended for use when<br>endoscopictechniques<br>are contraindicated | The device is not<br>intended for use when<br>endoscopictechniques<br>are contraindicated | | Model | Endo-Pouch With<br>Introducer<br><br>Auto Retrieval<br>Endo-Pouch | WEP010306A;<br>WEP010507A<br><br>WEP010306B;<br>WEP010507B | | Specification | consists of a flexible | consists of a flexible | | | polymer bag and an<br>introducer structure that<br>fits through a trocar port | polymer bag and an<br>introducer structure that<br>fits through a trocar port | | Endo-Pouch | 3"x6" | 3"x6" | | Dimension | 5"x7" | 5"x7" | | Patient<br>Contacting<br>Material | PTFE<br>TPU<br>ABS | Nitinol<br>ABS<br>TPU | | Safety standards | ISO 10993-1:2003<br>ISO 10993-5:2009<br>ISO 10993-7 :2008<br>ISO 10993-10:2010<br>ISO 10993-12 :2012<br>ISO 11135-1 :2007 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-7<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-12<br>ISO 11135 | | Sterilization | EO Sterilized | EO Sterilized | | Disposable | Yes | Yes | {7}------------------------------------------------ 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K172578](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K172578) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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