Monopolar Laparascopic Accessories

K142208 · Unimicro Medical Systems (Shenzhen) Co., Ltd. · GEI · Apr 13, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K142208
• Device Name: Monopolar Laparascopic Accessories
• Applicant: Unimicro Medical Systems (Shenzhen) Co., Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Family of disposable, single-use laparoscopic instruments including forceps, scissors, and probes; used in general laparoscopic surgery. Instruments feature insulated shafts, rotating tips, and handles with male cautery connectors for attachment to standard monopolar electrosurgical generators. Probes/electrodes consist of insulated shafts with thermally conductive metal tip electrodes. Operated by surgeons in clinical/OR settings. Device delivers electrosurgical energy to tissue for cutting or coagulation; provides mechanical grasping or dissection capabilities. Benefits include disposable nature ensuring sterility and reducing cross-contamination risk.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included drop, jaw clamping, blade sharpness, arcing, charring, and thermal spread tests. Biocompatibility and electrical safety testing performed per ISO 10993 and IEC 60601 standards.

Technological Characteristics

Biocompatible materials; medical-grade injection-molded plastic handles; thermally conductive metal tip electrodes. Dimensions: 5mm diameter, 33cm length. Connectivity: standard monopolar cautery cable interface. Sterilization: Ethylene Oxide (EO). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 10993-5/7/10/11/12, ISO 11135-1.

Indications for Use

Indicated for use in general laparoscopic surgical procedures requiring monopolar electrosurgical cutting and/or coagulation. No specific age or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• Unimax Laparoscopic Instrument (K103508)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

K142208

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)

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## 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 : [phone]

Fax : [phone]

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: [phone]

Fax: [phone]

E-mail: [e-mail]

#### 3. Identification of the Device :

Trade Name: Monopolar Laparoscopic Accessories

Model: Disposable Laparoscopic Scissors

Disposable Laparoscopic Forceps

Disposable Laparoscopic Electrodes

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## 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<br>Name | Manufacturer | Classification<br>n and Code | Classification<br>n regulation | 510(k)<br>number |
|--------------------------------------|------------------------------------------------------------------|--------------------------------|------------------------------|--------------------------------|------------------|
| Unimax<br>Laparoscopic<br>Instrument | Electrosurgical,<br>Cutting &<br>Coagulation<br>&<br>Accessories | Unimax Medical<br>Systems Inc. | Class II,<br>GEI | 21CFR<br>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

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## 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

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## 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<br>Accessories | Unimax Laparoscopic<br>Instrument(K103508) |
| Indications for Use | a family of instruments which<br>includes forceps, scissors, and<br>probes which are intended to<br>be used in general<br>laparoscopic surgical<br>procedures requiring the use<br>of Monopolar electrosurgical<br>cutting and/or coagulation. | a family of instruments which<br>includes forceps, scissors, and<br>probes which are intended to<br>be used in general<br>laparoscopic surgical<br>procedures requiring the use<br>of Monopolar electrosurgical<br>cutting and/or coagulation. |
| Consisted<br>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

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| 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

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# 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.