(182 days)
No
The 510(k) summary describes a physical specimen bag and its performance testing, with no mention of AI or ML technology.
No
The device is a receptacle for collecting specimens during surgical procedures, not an instrument for treating a disease or condition.
No
Explanation: The device is described as a "Specimen Bag" intended for collecting tissue, organs, and calculi during surgical procedures. Its purpose is for collection and retrieval, not for making a diagnosis.
No
The device description clearly indicates it is a physical specimen container made of material, not software. The performance studies also focus on physical properties and biocompatibility.
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 surgical tool for specimen retrieval, not for analyzing a specimen in vitro 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 perform any tests or analyses on the collected specimens to provide diagnostic information. The performance studies focus on the physical properties and safety of the bag itself, not on its ability to aid in diagnosis.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This Specimen Bag's function is purely for the collection and containment of specimens during a surgical procedure.
N/A
Intended Use / Indications for Use
The Specimen Bag 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 Specimen Bag is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Specimen Bag is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.
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
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of safety tests were performed to assess the safety and effectiveness of the Specimen Bag.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 systemic toxicity and Material-Mediated Pyrogenicity.
The tests listed below demonstrate the performance of Specimen Bag meets the requirements of its pre-defined acceptance criteria and intended uses.
- O Tensile strength
- Bag load-bearing
- Opening force
- O Rope tension test
- Puncture Force Test
- 0 Pouch Leakage Test
The results of the non-clinical testing demonstrate that the Specimen Bag is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows 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 is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 20, 2023
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. Mac Lai CEO TangJiao XingWang Street, Lilin Town ZhongKai Hi-Tech Zone HuiZhou, GuangDong 516003 China
Re: K222828
Trade/Device Name: Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: February 21, 2023 Received: February 21, 2023
Dear Mac Lai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
542 of the Act); 21 CFR 1000-1050.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
| Mark
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2023.03.20
12:22:57 -04'00' |
| --------------------- | --------------------------------------------------------------------------------- |
|---|
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality 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)
Device Name Specimen Bag : WEP040306B,WEP010304B,WEP010304B,WEP010304A,WEP010759B,WEP010759A,WEP010709B,WEP010709A
Indications for Use (Describe)
The Specimen Bag is intended for use as a receptacle for the collection 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) |
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3
K222828
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: K222828
The date the summary was prepared: February 5, 2023
1. 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: Specimen Bag Model:WEP040306B,WEP010304B,WEP040304B,WEP010304A,WEP010759B,WEP0107 59A,WEP010709B,WEP010709A Common Name: Tissue Bags
4
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
| Classification Name | Product
Code | Regulation
Number | Regulatory
Class | Review Panel |
|----------------------------------------------|-----------------|----------------------|---------------------|------------------------------|
| Laparoscope,
General & Plastic
Surgery | GCJ | 21CFR
876.1500 | II | General & Plastic
Surgery |
4. Identification of the Predicative Device
Predicate Device name:Equipment Pouch
Manufacturer :WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd.
510(K) number: K172578
Product Code: GCJ
Classification Names: Laparoscope, General & Plastic Surgery
CFR Reference: 21CFR 876.1500
5. Intended Use and Indications for Use of the subject device
The Specimen Bag 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 Specimen Bag is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Specimen Bag is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.
7. Non-clinical Testing
A series of safety tests were performed to assess the safety and effectiveness of the Specimen Bag.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 systemic toxicity and Material-Mediated Pyrogenicity.
5
K222828
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
The tests listed below demonstrate the performance of Specimen Bag meets the requirements of its pre-defined acceptance criteria and intended uses.
- O Tensile strength
- Bag load-bearing
- Opening force
- O Rope tension test
- Puncture Force Test
- 0 Pouch Leakage Test
The results of the non-clinical testing demonstrate that the Specimen Bag is as safe and effective as the predicate device.
8. Substantial Equivalence Determination
The Specimen Bag submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, performance to the cleared Equipment Pouch which is the subject of K172578. The difference in material has been evaluated for biocompatibility does not raise any safety and effectiveness issues.
The comparison to predicate device as below Table 2.
| Item | Predicate Device | Proposed Device |
|---|---|---|
| Trade Name | Equipment Pouch | Specimen Bag |
| 510(K) Submitter | WickiMed(Huizhou)Medic | |
| al Equipment | ||
| Manufacturing Co.,Ltd | WickiMed(Huizhou)Medic | |
| al Equipment | ||
| Manufacturing Co.,Ltd | ||
| 510(K) Number | K172578 | - |
| Classification | ||
| regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification | ||
| and Code | Class II , | |
| GCJ | Class II , | |
| GCJ |
| Table 2 : Comparison to Predicate Device | ||
|---|---|---|
| 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 | ||
| endoscopic techniques | ||
| are contraindicated | The device is not | |
| intended for use when | ||
| endoscopic techniques | ||
| are contraindicated | ||
| Model | Memory Type | |
| Detachable type | Memory Type | |
| Detachable type | ||
| Specification | consists of a flexible | |
| polymer bag and an | ||
| introducer structure that | ||
| fits through a trocar port | consists of a flexible | |
| polymer bag and an | ||
| introducer structure that | ||
| fits through a trocar port | ||
| Endo-Pouch | ||
| Dimension | 3"x6" | |
| 5"x7" | 3"x4" | |
| 3"x6" | ||
| 7"x9" | ||
| 7.5"X9" | ||
| Patient | ||
| Contacting | ||
| Material | Nitinol | |
| ABS | ||
| TPU | Nitinol | |
| ABS | ||
| TPU | ||
| Nylon composite film | ||
| Safety standards | ISO 10993-1 | |
| ISO 10993-5 | ||
| ISO 10993-7 | ISO 10993-1 | |
| ISO 10993-5 | ||
| ISO 10993-7 | ||
| 10993-10 | ||
| ાડિ | 10993-10 | |
| ાડભાગમાં આવેલા ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યન | ||
| 10993-11 | ||
| ાડિ | 10993-11 | |
| ાડભાગમાં આવેલા ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત્પાદન છે | ||
| ISO 10993-12 | 10993-12 | |
| ાડભાગમાં આવેલા ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગુજરાત રાજ્યના ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત્પાદન છે | ||
| ISO 11135 | ISO 11135 | |
| Sterilization | EO Sterilized | EO Sterilized |
| Disposable | Yes | Yes |
6
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
7
K222828
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
9. Conclusion
WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd. believes that the Specimen Bag is substantially equivalent to its predicate device (WickiMed Equipment K172578 . It has substantially equivalent indications and contraindication , Pouch) technological characteristics, and performance characteristics to these of the predicate device , and therefore does not introduce any new safety or effectiveness concerns.