(423 days)
No
The device description and performance studies focus on the mechanical aspects and safety of the trocar kit, with no mention of AI or ML capabilities.
No
The device provides a port of entry for endoscopic instruments, which are used for diagnosis or treatment, but the trocar itself does not perform therapy.
No
Explanation: The device, a trocar kit, is described as providing a "port of entry for endoscopic instruments" during procedures. Its function is to facilitate access for other instruments, not to diagnose conditions.
No
The device description clearly details physical components like cannula assemblies, seals, valves, stopcocks, and tips, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in endoscopic procedures to provide a port of entry for surgical instruments. This is a surgical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details the physical components and function of a surgical trocar, which is used to create access during minimally invasive surgery.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and functional aspects of the device (compatibility, stability, air leakage), which are relevant to a surgical instrument, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Unimicro Trocar kit,Model: Auto-Locking Trocar, and Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
Product codes
GCJ
Device Description
The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal ,a valve,and a stopcock.This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered.
The Hasson Trocar has application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The Hasson Trocar is available in two (2) sizes: 10mm and 12mm.This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
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 safety tests were performed to assess the safety and effectiveness of the Unimicro Trocar kit. The safety tests were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-12, and ISO 11135-1. The performance testing conducted on subject device and predicate device are listed below:
- Obturator Compatibility
- Insertion&Cannula Stability
- Air Leakage
All the test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria and intended uses.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 10, 2015 Unimicro Medical Systems (ShenZhen) Company, Ltd. % Mr. Long Yang Shenzhen Hlongmed Biotech Company, Ltd. R15-08, East Building, Yihai Plaza, Chuangye Road, Nanshan District 518054 Shenzhen, Guangdong 518054 P.R.China
Re: K141594
Trade/Device Name: Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 19, 2015 Received: June 29, 2015
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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,
Joshua
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K141594
Device Name
Unimicro Trocar Kit, models: Auto-Locking Trocar,Hasson Trocar,Bladeless Trocar
Indications for Use (Describe)
The Unimicro Trocar kit,Model: Auto-Locking Trocar, and Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
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)
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.
Type of submission :Traditional
The assigned 510(K) number is:K141594
The date the summary was prepared: Jun 9,2014
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 Trocar Kit Model: Auto-Locking Trocar,Hasson Trocar,Bladeless Trocar Common Name: Disposable Surgical Trocar /Cannla Classification Name: Laparoscope, General & Plastic Surgery Regulation Number:876.1500 Device Classification: II
5
□ Unimicro Medical Systems (ShenZhen) Co., Ltd.
Product Code:GCJ
4. Identification of the Predicative Device
| Device Name | Common
Name | Manufacturer | Classification
and Code | Classification
regulation | 510(k)
number |
|----------------------------|---------------------------------------------|-----------------------------------|----------------------------|------------------------------|------------------|
| Unimax
Trocar
System | Disposable
Surgical
Trocar
/Cannla | Unimax
Medical
Systems Inc. | Class II,
GCJ | 21CFR
876.1500 | K112358 |
Table 1: Predicative Device Information
5. Intended Use and Indications for Use of the subject device
The Unimicro Trocar kit.Model: Auto-Locking Trocar.Hasson Trocar, and Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
6. Device Description
The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal ,a valve,and a stopcock.This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered.
The Hasson Trocar has application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The Hasson Trocar is available in two (2) sizes: 10mm and 12mm.This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.
The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.
6
Unitifier □ Unimicro Medical Systems (ShenZhen) Co., Ltd.
7. Non-clinical Testing
A series of safety tests were performed to assess the safety and effectiveness of the Unimicro Trocar kit. The safety tests were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-12, and ISO 11135-1. The performance testing conducted on subject device and predicate device are listed below:
- Obturator Compatibility
- Insertion&Cannula Stability
- Air Leakage
All the test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria and intended uses.
8. Substantial Equivalence Determination
The Unimicro Trocar kit (Model: Auto-Locking Trocar,Hasson Trocar,Bladeless Trocar) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Unimax Trocar System which is the subject of K112358. 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 |
|---|---|---|
| Unimicro Trocar kit | Unimax Trocar System | |
| K112358 | ||
| 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 |
Table 2 : Comparison to Predicate Device
7
| | Indications for
Use | Applicate in a variety of
endoscopic procedures to
provide a port of entry for
endoscopic instruments. | Applicate in a variety of
endoscopic procedures to
provide a port of entry for
endoscopic instruments. | |
|--|-----------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | Safety standards | ISO 10993-1
ISO 10993-5
ISO 10993-7
ISO 10993-10
ISO 10993-12
ISO 11135-1 | ISO 10993-1
ISO 10993-5
ISO 10993-7
ISO 10993-10
ISO 10993-12
ISO 11135-1 | |
| | Compared elements | Cannula
Tip of obturator
Obturator compatibility | Cannula
Tip of obturator
Obturator compatibility | |
| | Performance
testing item | Insertion & cannula
stability
Air leakage | Insertion & cannula
stability
Air leakage | |
| | Sterilization | EO Sterilized | EO Sterilized | |
| | Disposable | Yes | Yes | |
| | Model | Auto-Locking Trocar
Hasson Trocar
Bladeless Trocar
/
/
/
/ | Auto-Locking Trocar
Hasson Trocar
Bladeless Trocar
Visible Trocar
Dilating Trocar
Secondary Trocar
Thoracic Trocar | |
| | | Dimension | Diameter :5-12mm
Length :70-120mm | Diameter :3-15mm
Length :65-150mm |
പ്രസിച്ചിത്രത്തി Unimicro Medical Systems (ShenZhen) Co., Ltd.
9. Conclusion
After analyzing bench tests, safety testing data, it can be concluded that: Unimicro Trocar kit is as safe and effective as the predicate device.