UNMIAX LAPAROSCOPIC INSTRUMENT
Device Facts
| Record ID | K103508 |
|---|---|
| Device Name | UNMIAX LAPAROSCOPIC INSTRUMENT |
| Applicant | Unimax Medical Systems, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Dec 20, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Unimax Laparoscopic Instrument 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
Unimax Laparoscopic Instrument family includes grasping forceps, monopolar scissors, and monopolar probe/electrodes. Devices are disposable, single-use, and individually packaged. Construction features insulated shafts with rotating tips and handles; male cautery connector attaches to standard monopolar cautery cables and generators. Probes/electrodes utilize thermally conductive metal tip electrodes. Operated by surgeons in laparoscopic surgical settings. Device functions by delivering monopolar electrosurgical energy to tissue for cutting or coagulation. Output is controlled by the surgeon via the generator interface. Benefits include precise tissue manipulation and electrosurgical control during minimally invasive procedures.
Clinical Evidence
Bench testing only. No clinical data presented. Testing included mechanical performance (drop, bending, pulling, torque, jaw clamping, blade sharpness) and electrical/thermal safety (arcing, charring, thermal spread) in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 standards. Biocompatibility testing performed per ISO 10993 series.
Technological Characteristics
Disposable, single-use laparoscopic instruments. Materials: biocompatible, medical-grade injection-molded plastic handles, insulated shafts, metal tip electrodes. Energy: Monopolar electrosurgical. Connectivity: standard monopolar cautery cable interface. Sterilization: Ethylene Oxide (EO). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, 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. Intended for prescription use.
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
- AED Monopolar Lap Accessories (K081503)
Submission Summary (Full Text)
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Unimax Laparoscopic Instrument
# 510(k) Summary
| 5.1 Type of Submission: | Traditional |
|-------------------------|-------------|
|-------------------------|-------------|
| | 5.2 Submitter: | Unimax Medical Systems Inc. |
|--|----------------|---------------------------------------------------------|
| | Address: | 8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien City, |
| | | Taipei, Taiwan |
| | Phone: | 886-2-89191698 |
| | Fax: | 886-2-89191528 |
| | Contact: | Sophia Chiu |
| | | Establishment Registration Number: |
#### 5.3 Identification of the Device:
| Proprietary/Trade name: | Unimax Laparoscopic Instrument |
|-------------------------|------------------------------------------------------|
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Device Classification: | II |
| Regulation Number: | 878.4400 |
| Panel: | General & Plastic Surgery |
| Product Code: | GEI |
### 5.4 Identification of the Predicate Device:
| Predicate Device Name: | AED Monopolar Lap Accessories |
|-----------------------------------------|-------------------------------------------|
| Manufacturer: | National Advanced Eedoscopy Devices, INC. |
| 510(k) Number or Clearance Information: | K081503 |
## 5.5 Intended Use and Indications for Use of the subject device.
The Unimax Laparoscopic Instrument 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 clectrosurgical cutting and/or coagulation.
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K10 3508
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#### Unimax Laparoscopic Instrument
#### 5.6 Device Description
The Unimax Laparoscopic Instrument 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 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.
#### 5.7 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 Unimax Laparoscopic Instrument. The safety tests were conducted in accordance with IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995, IEC 60601-1-2: 2001 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility -Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)), IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3), ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-7 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals, ISO 10993-10 Biological evaluation of medical devices -Part 10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity, ISO 10993-12 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials, and ISO 11135-1 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
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Unimax Laparoscopic Instrument
The comparative performance testing was conducted on the subject device and the predicate device including the items listed below:
- Drop Testing
- · Bending Test
- Pulling Test
- · Torque Test
- · Jaw Clamping Test
- · Blade Sharpness Test
- Arcing Test
- · Charring Test
- · Thermal Spread Test
All the test results demonstrate the performance of Unimax Laparoscopic Instrument meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Unimax Laparoscopic Instrument is as safe and effective as the predicate devices.
### 5.8 Safety and Effectiveness
The result of bench testing indicates that the new device is as safe and effective as the predicate device.
#### 5.9 Substantial Equivalence Determination
The Unimax Laparoscopic Instrument submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared AED Monopolar Lap Accessories which is the subject of K081503. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
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K103508
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### Unimax Laparoscopic Instrument
| Item | Proposed Device<br>(Unimax Medical Systems Inc.<br>Laparoscopic Instrument) | Predicate Device<br>(National Advanced Endoscopy<br>Devices, Inc. AED Monopolar Lap<br>Accessories) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Unimax Laparoscopic Instrument is<br>a family of instruments which includes<br>forceps, scissors, and probes which are<br>intended to be used in general<br>laparoscopic surgical procedures<br>requiring the use of Monopolar<br>electrosurgical cutting and/or<br>coagulation. | AED Monopolar Lap Accessories are<br>reusable devices (forceps and<br>electrodes) intended to be used in<br>general laparoscopic surgical<br>procedures requiring the use of<br>electrosurgical cutting and/or<br>coagulation. |
| Consisted<br>Instruments | - Standard insulated monopolar handles<br>- Insulated Shafts<br>- Class I inserts (forceps, scissors)<br>- Electrodes | - Standard insulated monopolar handles<br>- Insulated Shafts<br>- Class I inserts (forceps, scissors)<br>- Probes/Electrodes |
| Models | Grasping Forceps:<br>- Straight grasping forceps<br>- Babcock grasping forceps<br>- Clinch grasping forceps<br>- Maryland dissecting forceps<br>- Rat tooth grasping forceps<br>- Duckbill grasping forceps<br>- Johan grasping forceps<br>Scissors<br>Probe/Electrode:<br>- Monopolar J hook probe<br>- Monopolar L hook probe<br>- Monopolar Spatula probe | Grasping Forceps:<br>- Graspers, with spoon<br>- Babcock Grasping Forceps<br>- Endo Clinch Forceps<br>- Maryland Forceps<br>- Cobra Style Toothed Grasper<br>- Duckbill Forceps<br>- Johan Grasping Forceps<br>Scissors<br>Probe/Electrode:<br>- J hook<br>- L hook |
| Dimension | 5mm/33cm<br>5mm/26cm<br>5mm/45cm | 5mm/33cm<br>5mm/26cm<br>5mm/45cm |
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Unimax Laparoscopic Instrument
| Sterilization | EO Sterility | EO Sterility |
|---------------|--------------------------|--------------------------|
| Safety | IEC 60601-1 | IEC 60601-1 |
| standards | IEC 60601-1-2 | IEC 60601-1-2 |
| | IEC 60601-2-2 | IEC 60601-2-2 |
| | ISO 10993-5 | ISO 10993-5 |
| | ISO 10993-10 | ISO 10993-10 |
| | ISO 10993-11 | ISO 10993-11 |
| | ISO 10993-12 | ISO 10993-12 |
| | ISO 10993-7 | ISO 14937 |
| | ISO 11135-1 | |
| Performance | No performance standards | No performance standards |
| standards | | |
| Compared | Drop Testing | Drop Testing |
| performance | Bending Test | Bending Test |
| testing | Pulling Test | Pulling Test |
| | Torque Test | Torque Test |
| | Jaw Clamping Test | Jaw Clamping Test |
| | Blade Sharpness Test | Blade Sharpness Test |
| | Arcing Test | Arcing Test |
| | Charring Test | Charring Test |
| | Thermal Spread Test | Thermal Spread Test |
# 5.10 Conclusion
After analyzing bench tests, electrical safety testing data, it can be concluded that Unimax Laparoscopic Instrument is as safe and effective as the predicate device.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 20 2011
Unimax Medical Systems, Inc. % AcmeBiotechs Co., Ltd. Mr. Michael Lee No. 45, Minshen Rd. Danshui Town Taipei County China (Taiwan) 251
Re: K103508
Trade/Device Name: Unimax Laparoscopic Instrument Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 16, 2011 Received: December 16, 2011
Dear Mr. Lee:
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
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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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
for Dlo. Dacus
Mark N. Mel Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K103508
Unimax Laparoscopic Instrument
Indications for Use
510(k) Number (if known):
Device Name: Unimax Laparoscopic Instrument
Indications for Use:
The Unimax Laparoscopic Instrument 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.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
.510(k) Number K103508
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