(153 days)
Not Found
No
The device description and intended use clearly describe a physical specimen retrieval pouch, with no mention of software, data processing, or any terms related to AI/ML.
No
The device is described as a "specimen container designed for use in retrieving specimens," which indicates it is used for diagnostic or procedural purposes rather than directly treating a disease or condition.
No.
The device is a specimen retrieval pouch used for collecting and extracting tissue during surgical procedures, not for diagnosing conditions.
No
The device description clearly indicates it is a physical specimen container (pouch) and dispensing tube, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures." This describes a device used during a surgical procedure to physically retrieve specimens.
- Device Description: The description reinforces this by stating it's a "specimen container designed for use in retrieving specimens during endoscopic surgery."
- Lack of IVD Characteristics: An IVD is a device used to examine specimens outside the body to provide information about a patient's health. This device is used inside the body to collect the specimen. There is no mention of analysis, testing, or diagnosis being performed by the device itself.
Therefore, based on the provided information, the Unimicro Disposable Retrieval Endo-Pouch is a surgical retrieval device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Unimicro Disposable Retrieval Endo-Pouch is intended for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.
Product codes
GCJ
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.
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 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.
The result of bench testing indicates that the new device is as safe and effective as the predicate device.
Key Metrics
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/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)
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 & Plastic | ||
| Surgery | GCJ | 876.1500 |
5
□ Unimicro Medical Systems (ShenZhen) Co., Ltd.
4. Predicative Device
| Device Name | Common
Name | Manufacturer | Classification
and Code | Classification
regulation | 510(k)
number |
|-------------------------------------------|----------------|-----------------------------------|----------------------------|------------------------------|------------------|
| Unimax
Specimen
Retrieval
System | Tissue
Bags | Unimax
Medical
Systems Inc. | Class II,
GCJ | 21CFR
876.1500 | 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
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.
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 Disposable | |
| Retrieval Endo-Pouch | Unimax Specimen | |
| Retrieval System | ||
| 510(K) | ||
| Submitter | Unimicro Medical | |
| Systems (ShenZhen) | ||
| Co.,Ltd. | Unimax Medical Systems | |
| Inc. | ||
| 510(K) Number | ---------- | K103510 |
| Classification | ||
| regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Classification | ||
| and Code | Class II , | |
| GCJ | Class II , | |
| 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. | ||
| Material | Various polymer | |
| Stainless | Various polymer | |
| Stainless | ||
| 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 | ||
| Biocompatibility | ISO 10993-1:2009 | |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2010 | ||
| ISO 10993-12 :2012 | ISO 10993-1:2003 | |
| ISO 10993-5:2009 | ||
| ISO 10993-10:2002 | ||
| ISO 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.