(101 days)
The Equipment Pouch is intended for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic surgical procedures.
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.
The provided text describes a 510(k) premarket notification for a medical device called "Equipment Pouch". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's de novo clinical effectiveness. Therefore, the information provided does not pertain to studies typically conducted for AI-powered devices or diagnostic tools that require a deep analysis of performance criteria against expert-established ground truth or clinical outcomes.
The testing described is primarily non-clinical bench testing to assess the physical performance and biocompatibility of the device, which is a sterile surgical pouch. There is no mention of a study involving human readers, AI assistance, or complex diagnostic tasks.
Given this context, I will address your specific points based on the available information, noting when information is not applicable or not provided in the document.
1. A table of acceptance criteria and the reported device performance
The document lists non-clinical (bench) tests and states that the device 'meets the requirements of its pre-defined acceptance criteria and intended uses.' However, the specific numerical acceptance criteria and the exact reported performance values for each test are not quantitatively detailed in this summary. Instead, a qualitative description of what each test demonstrates is given.
| Test | Acceptance Criteria (Qualitative) | Reported Performance (Qualitative) |
|---|---|---|
| Opening force | Sufficient smoothness | Demonstrates sufficient smoothness |
| Rope tension test | Can withstand at least 2kg of weight | Equipment Pouch rope can withstand at least 2kg of weight |
| Bag load-bearing | Can bear 1Kg weight and keep integrity | Demonstrates bag body can bear 1Kg weight and keep integrity |
| Tensile strength | Adequate weld strength | Demonstrates adequate weld strength |
| Bag Leak Test | No leaks | Demonstrates that the Pouch has no leaks |
Biocompatibility tests (ISO 10993 series) were performed, and the document implies they met acceptance criteria, but specific results or quantitative criteria are not listed here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable or not provided for this type of device and testing. The tests are benchtop physical and chemical tests of the device itself, not studies on a patient population with specific data provenance.
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 or not provided. The 'ground truth' for these tests relates to engineering specifications (e.g., a bag holding 1kg, a rope withstanding 2kg), not clinical diagnoses or expert interpretations of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are relevant for studies involving human interpretation (e.g., reviewing medical images), which is not the nature of the testing described here.
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
This information is not applicable. This device is a surgical pouch, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device does not involve an algorithm. The "performance" refers to the physical characteristics of the pouch.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing described is based on engineering specifications and direct measurements of physical properties (e.g., weight capacity, tensile strength, leak integrity) as well as the results of standardized biocompatibility tests. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set (for AI), there is no ground truth established for one. The "ground truth" for the device's design and testing is based on established engineering principles and medical device standards.
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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);
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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
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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.
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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:
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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
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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,
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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 DisposableRetrieval Endo-Pouch | Equipment Pouch |
| 510(K) Submitter | Unimicro MedicalSystems (ShenZhen)Co.,Ltd. | WickiMed(Huizhou)Medical EquipmentManufacturing Co.,Ltd |
| 510(K) Number | K141593 | - |
| Classificationregulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classificationand Code | Classll,GCJ | Classll,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. |
| Contraindication | The device is notintended for use whenendoscopictechniquesare contraindicated | The device is notintended for use whenendoscopictechniquesare contraindicated |
| Model | Endo-Pouch WithIntroducerAuto RetrievalEndo-Pouch | WEP010306A;WEP010507AWEP010306B;WEP010507B |
| Specification | consists of a flexible | consists of a flexible |
| polymer bag and anintroducer structure thatfits through a trocar port | polymer bag and anintroducer structure thatfits through a trocar port | |
| Endo-Pouch | 3"x6" | 3"x6" |
| Dimension | 5"x7" | 5"x7" |
| PatientContactingMaterial | PTFETPUABS | NitinolABSTPU |
| Safety standards | ISO 10993-1:2003ISO 10993-5:2009ISO 10993-7 :2008ISO 10993-10:2010ISO 10993-12 :2012ISO 11135-1 :2007 | ISO 10993-1ISO 10993-5ISO 10993-7ISO 10993-10ISO 10993-11ISO 10993-12ISO 11135 |
| Sterilization | EO Sterilized | EO Sterilized |
| Disposable | Yes | Yes |
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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.
§ 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.