(52 days)
Not Found
No
The device description and intended use focus on mechanical suction and irrigation functions during laparoscopic surgery. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
A therapeutic device actively treats a condition or disease. This device aids in visualization during surgery by clearing the surgical site, which is a supportive function rather than a direct therapeutic one.
No
The device is described as assisting in surgery by providing suction and irrigation to clear the surgical site for better visualization, which is a therapeutic and visualization aid function, not a diagnostic one.
No
The device description clearly outlines physical components such as a hand piece, probe, tubing, and valves, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Unimicro Suction Irrigation Tubing set is a surgical device used during laparoscopic procedures to physically irrigate and suction the operative site. Its purpose is to clear the surgical field for better visualization, not to analyze biological specimens for diagnostic purposes.
- Intended Use: The intended use clearly states its function is to "facilitate lavage during laparoscopic surgery" and "flush blood and tissue debris from the operative site... to aid visualization." This is a surgical aid, not a diagnostic tool.
- Lack of Diagnostic Metrics: The description does not mention any diagnostic metrics like sensitivity, specificity, AUC, etc., which are typical for IVDs.
- Performance Studies: The performance studies described are focused on physical, mechanical, and biocompatibility testing, which are relevant for surgical devices, not diagnostic accuracy.
In summary, the Unimicro Suction Irrigation Tubing set is a surgical instrument used to manage the surgical field during laparoscopic procedures. It does not perform any diagnostic testing on biological specimens.
N/A
Intended Use / Indications for Use
The Unimicro Suction Irrigation Tubing set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
Product codes
GCJ
Device Description
The Unimicro Suction Irrigation Tubing set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site.
The suction irrigation set consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimicro Suction Irrigation Tubing set.
All the test results demonstrate the performance of Unimicro Suction Irrigation Tubing set meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Unimicro Suction Irrigation Tubing set is as safe and effective as the predicate devices.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2014
Unimicro Medical Systems Company, Ltd. % Mr. Long Yang Shenshen Hlongmed Biotech Company Ltd. R15-08, East Building, Yihai Plaza, Chuangye Road, Nanshan District Shenzhen, Guangdong 518054 People's Republic China
Re: K141592
Trade/Device Name: Unimicro Suction Trigation Tubing set, models: Suction Irrigation Tubing Set A, Suction Irrigation Tubing Set B Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 20, 2014 Received: June 25, 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
Page 2 - Mr. Long Yang
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) K141592
Device Name
Unimicro Suction Irrigation Tubing set, models : Suction Trigation Tubing Set A , Suction Irrigation Tubing Set B
Indications for Use (Describe)
The Unimicro Suction Irrigation Tubing set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
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 FDA 3881 (1/14)
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."
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□ 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.
Type of submission :Traditional
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. Identification of the Device :
Trade Name: Unimicro Suction Irrigation Tubing set Model: Suction Irrigation Tubing Set A. Suction Irrigation Tubing Set B. Common Name: Suction Irrigation Classification Name: Laparoscope, General & Plastic Surgery Regulation Number:876.1500 Device Classification: II Product Code:GCJ
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□ Unimicro Medical Systems (ShenZhen) Co., Ltd.
4. Identification of the Predicative Device
| Device Name | Common
Name | Manufacturer | Classification
and Code | Classification
regulation | 510(k)
number |
|-------------------------------------|-----------------------|-----------------------------------|----------------------------|------------------------------|------------------|
| Unimax
Suction
Irrigation Set | Suction
Irrigation | Unimax
Medical
Systems Inc. | Class II,
GCJ | 21CFR
876.1500 | K103509 |
Table 1: Predicative Device Information
5. Intended Use and Indications for Use of the subject device
The Unimicro Suction Irrigation Tubing set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.
6. Device Description
The Unimicro Suction Irrigation Tubing set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site.
The suction irrigation set consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.
The hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.
7. Non-clinical Testing
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests
6
UMilllifer
were performed to assess the safety and effectiveness of the Unimicro Suction Irrigation Tubing set.
All the test results demonstrate the performance of Unimicro Suction Irrigation Tubing set meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Unimicro Suction Irrigation Tubing set is as safe and effective as the predicate devices.
8. Substantial Equivalence Determination
The Unimicro Suction Irrigation Tubing set submitted in this 5 10(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Unimax Suction Irrigation Set which is the subject of K103509.
Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
The comparison to predicate device as below Table 2.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Unimicro Suction | |
| Irrigation Tubing set | Unimax Suction Irrigation Set | |
| 510(K) | ||
| Submitter | Unimicro Medical | |
| Systems (ShenZhen) | ||
| Co.,Ltd. | Unimax Medical Systems | |
| Inc. | ||
| 510(K) Number | ---------- | K103509 |
| 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 | This device is available with | This device is available with |
| Use | an array of probe designs to facilitate lavage during laparoscopic surgery. | |
| This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization. | an array of probe designs to facilitate lavage during laparoscopic surgery. | |
| This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization. | ||
| Sterile | Yes | Yes |
| Disposable | Yes | Yes |
| Biocompatibility | Cytotoxicity Test; | |
| Intracutaneous Reactivity Test; | ||
| Maximization Sensitization Test; | Cytotoxicity Test; | |
| Intracutaneous Reactivity Test; | ||
| Maximization Sensitization Test; | ||
| Specification | The device consists of a hand piece equipped with two trumpet style,valves, a probe, and connecting lines of tubing | The device consists of a hand piece equipped with two trumpet style,valves, a probe, and connecting lines of tubing |
| Function | The tubing one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. |
The valves allow controlled irrigation and aspiration during a surgical procedure | The tubing one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump.
The valves allow controlled irrigation and aspiration during a surgical procedure |
Table 2 : Comparison to Predicate Device
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பார்!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
8
പ്രസിച്ചിത്രത്തി Unimicro Medical Systems (ShenZhen) Co., Ltd.
| Additional
accessories | / | Reusable Monopolar Probe:
Description Size: |
|---------------------------|---|------------------------------------------------|
| | | Spatula Probe:5mm×33mm |
| | | J-Hook Probe:5mm×33mm |
| | | L-Hook Probe:5mm×33mm |
9. Conclusion
After analyzing bench tests, safety testing data, it can be concluded that: Unimicro Suction Irrigation Tubing set is safe and effective as the predicate device.