(245 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical properties, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is described as an accessory for general laparoscopic surgical procedures requiring monopolar electrosurgical cutting and/or coagulation, meaning it is an instrument used during surgery rather than providing therapy itself.
No
Explanation: The device description states it is a family of instruments used for "general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation." These are surgical tools for treatment, not diagnostic purposes.
No
The device description clearly outlines physical instruments (forceps, scissors, probes) made of biocompatible materials with handles, shafts, and tips, designed for physical manipulation and connection to electrosurgical generators. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation." This describes a surgical tool used on the patient during a procedure.
- Device Description: The description details surgical instruments like forceps, scissors, and probes used for cutting and coagulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical instrument used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The Monopolar Laparoscopic Accessories is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Monopolar Laparoscopic Accessories includes Grasping Forceps, Monopolar Scissors, and Monopolar Probe/Electrodes. The devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. Probes/Electrodes have an an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.
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 Monopolar Laparoscopic Accessories.
The safety tests were conducted in accordance with IEC 60601-1 ,IEC 60601-1-2,IEC 60601-2-2, IEC 60601-2-18,10993-5,10993-7,10993-10,10993-11,10993-12,11135-1. The performance testing was conducted including the items listed below:
- Drop Testing
- law Clamping Test
- Blade Sharpness Test
- Arcing Test
- Charring Test
- Thermal Spread Test ●
All the test results demonstrate the performance of Monopolar Laparoscopic Accessories meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Monopolar Laparoscopic Accessories 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three human profiles incorporated into its design. The profiles are arranged in a row, suggesting a sense of community or collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2015
Unimicro Medical Systems % Mr. Long Yang Shenzhen Hlongmed Biotech Company, Ltd. R1508, East Building, Yihai Plaza, Chuangye Road, Nanshan District Shenzhen, Guangdong 518054 People's Republic of China
Re: K142208
Trade/Device Name: Monopolar Laparoscopic Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 13, 2015 Received: February 23, 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,
Jennifer R. Stevenson -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
Monopolar Laparoscopic Accessories .Models : Disposable Laparoscopic Scissors, Disposable Laparoscopic Forceps, Disposable Laparoscopic Electrodes
Indications for Use (Describe)
The Monopolar Laparoscopic Accessories is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.
Type of Use (Select one or both, as applicable)
X 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)
ર-I
3
O Unimicro Medical Systems (ShenZhen) Co., Ltd.
510(K) SUMMARY
This 510(k) summary is being submitted in accordance with 21 CFR §807.92.
Type of submission :Traditional
The assigned 510(K) number is:_ K142208_
Prepared date: April9,2015
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: Monopolar Laparoscopic Accessories
Model: Disposable Laparoscopic Scissors
Disposable Laparoscopic Forceps
Disposable Laparoscopic Electrodes
4
O Unimicro Medical Systems (ShenZhen) Co., Ltd.
Common Name: Electrosurgical, Cutting & Coagulation & Accessories
Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number:878.4400
Device Classification: II
Product Code:GEI
4. Identification of the Predicative Device
| Device Name | Common
Name | Manufacturer | Classification
n and Code | Classification
n regulation | 510(k)
number |
|--------------------------------------|------------------------------------------------------------------|--------------------------------|------------------------------|--------------------------------|------------------|
| Unimax
Laparoscopic
Instrument | Electrosurgical,
Cutting &
Coagulation
&
Accessories | Unimax Medical
Systems Inc. | Class II,
GEI | 21CFR
878.4400 | K103508 |
Table 1: Predicative Device Information
5. Intended Use and Indications for Use of the subject device
The Monopolar Laparoscopic Accessories is a family of instruments which includes forceps,scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.
6. Device Description
The Monopolar Laparoscopic Accessories includes Grasping Forceps, Monopolar Scissors, and Monopolar Probe/Electrodes. The devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different
5
UNIIIIIIIIET O Unimicro Medical Systems (ShenZhen) Co., Ltd.
tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.
7. Non-clinical Testing
A series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Monopolar Laparoscopic Accessories.
The safety tests were conducted in accordance with IEC 60601-1 ,IEC 60601-1-2,IEC 60601-2-2, IEC 60601-2-18,10993-5,10993-7,10993-10,10993-11,10993-12,11135-1. The performance testing was conducted including the items listed below:
- Drop Testing
- law Clamping Test
- Blade Sharpness Test
- Arcing Test
- Charring Test
- Thermal Spread Test ●
All the test results demonstrate the performance of Monopolar Laparoscopic Accessories meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Monopolar Laparoscopic Accessories 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.
9. Substantial Equivalence Determination
The Monopolar Laparoscopic Accessories submitted in this 510(k) file is substantially
6
Unilllifer □ Unimicro Medical Systems (ShenZhen) Co., Ltd.
equivalent in intended use, design, principles of operation and performance to the cleared Unimax Laparoscopic Instrument which is the subject of K103508.
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 |
|---|---|---|
| Monopolar Laparoscopic | ||
| Accessories | Unimax Laparoscopic | |
| Instrument(K103508) | ||
| Indications for Use | a family of instruments which | |
| includes forceps, scissors, and | ||
| probes which are intended to | ||
| be used in general | ||
| laparoscopic surgical | ||
| procedures requiring the use | ||
| of Monopolar electrosurgical | ||
| cutting and/or coagulation. | a family of instruments which | |
| includes forceps, scissors, and | ||
| probes which are intended to | ||
| be used in general | ||
| laparoscopic surgical | ||
| procedures requiring the use | ||
| of Monopolar electrosurgical | ||
| cutting and/or coagulation. | ||
| Consisted | ||
| Instruments | Standard insulated monopolar handles, Insulated Shafts, Class I inserts (forceps, scissors) Electrodes | Standard insulated monopolar handles, Insulated Shafts, Class I inserts (forceps, scissors) Electrodes |
Table 2 : Comparison to Predicate Device
7
| Models | ||
|---|---|---|
| Forceps: Grasper | Grasping Forceps: | |
| Forceps Babcock | Straight grasping forceps | |
| Forceps Clinch | Babcock grasping forceps | |
| Forceps | Clinch grasping forceps | |
| Rat Tooth Forceps | Rat tooth grasping forceps | |
| Dissector Forceps | Maryland dissecting forceps | |
| Duckbill grasping forceps | ||
| Johan grasping forceps | ||
| Scissors | Scissors | |
| Electrodes: | Electrodes: | |
| Monopolar J hook probe | Monopolar J hook probe | |
| Monopolar L hook probe | Monopolar L hook probe | |
| Monopolar Spatula probe | Monopolar Spatula probe | |
| Dimension | 5mm/33cm | 5mm/33cm |
| 5mm/26cm | ||
| 5mm/45cm | ||
| Safety standards | ISO 10993-5 | ISO 10993-5 |
| ISO 10993-7 | ISO 10993-7 | |
| ISO 10993-10 | ISO 10993-10 | |
| ISO 10993-11 | ISO 10993-11 | |
| ISO 10993-12 | ISO 10993-12 | |
| IEC 60601 -1 | IEC 60601 -1 | |
| IEC 60601-2-2 | IEC 60601-2-2 | |
| IEC 60601-1-2 | IEC 60601-1-2 | |
| ISO 11135-1 | ISO 11135-1 | |
| IEC 60601-2-18 | IEC 60601-2-18 | |
| Sterilization | EO | EO |
| Disposable | Yes | Yes |
| Compared | Drop Testing | Drop Testing |
| performance testing | Jaw Clamping Test | Jaw Clamping Test |
| Blade Sharpness Test | Blade Sharpness Test | |
| Arcing Test Arcing Test | Arcing Test Arcing Test | |
| Charring Test | Charring Test | |
| Thermal Spread Test | Thermal Spread Test | |
| N/A | Bending Test | |
| N/A | Pulling Test | |
| N/A | Torque Test |
LIGHUJICCO Unimicro Medical Systems (ShenZhen) Co., Ltd
8
UMillliiCroo Unimicro Medical Systems (ShenZhen) Co., Ltd.
10. Conclusion
After analyzing bench tests, safety testing data, it can be concluded that: Monopolar Laparoscopic Accessories is as safe and effective as the predicate device.