UNIMAX VERESS NEEDLE

K111441 · Unimax Medical Systems, Inc. · HIF · Aug 19, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K111441
• Device Name: UNIMAX VERESS NEEDLE
• Applicant: Unimax Medical Systems, Inc.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Aug 19, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

Device Story

The Unimax Veress Needle is a sterile, single-use surgical instrument used to establish pneumoperitoneum. It features a spring-loaded blunt stylet mechanism that retracts during insertion and advances upon entering the peritoneal cavity to protect internal structures. Available in 120mm and 150mm lengths, the device is operated by surgeons or trained clinicians in a clinical or OR setting. The device is inserted percutaneously; once the peritoneal cavity is reached, carbon dioxide is insufflated through the needle to create space for subsequent trocar and cannula placement. This process facilitates safe access for laparoscopic surgery, reducing the risk of injury to abdominal organs during initial entry.

Clinical Evidence

No clinical data. Evidence consists of bench testing only, including physical, mechanical, and biocompatibility evaluations. Biocompatibility testing followed ISO 10993 standards (cytotoxicity, intracutaneous reactivity, sensitization). Performance testing (tip pull, switch operation, spring obturator operation, needle puncture force) demonstrated that the device meets pre-defined acceptance criteria and performs as well as the predicate device.

Technological Characteristics

Sterile, single-use Veress needle with spring-loaded blunt stylet mechanism. Available in 120mm and 150mm lengths. Materials evaluated per ISO 10993. Sterilization via ethylene oxide (EO) per ISO 11135-1. Mechanical design includes a spring-loaded obturator for safety during insertion. No electronic components or software.

Indications for Use

Indicated for patients undergoing laparoscopic procedures, including gynecological laparoscopy, requiring percutaneous insertion into the peritoneal cavity for carbon dioxide insufflation to establish pneumoperitoneum prior to trocar placement.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• GeniCon Pneumo-Needle (K993625)

Submission Summary (Full Text)

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Unimax Medical Systems Inc. 510(k) Notification

AUG 1 9 2011

Unimax Veress Needle

# 510(k) Summary

| 5.1 | Type of Submission: | Traditional |
|-----|------------------------------------|----------------------------------------------------------------------|
| 5.2 | Preparation Date: | Apr 29, 2011 |
| 5.3 | Revised Date: | Jul 27, 2011 |
| 5.4 | Submitter: | Unimax Medical Systems Inc. |
| | Address: | 8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien,<br>Taipei, Taiwan |
| | Phone: | 886-2-89191698 |
| | Fax: | 886-2-89191528 |
| | Contact: | Sophia Chiu |
| | Establishment Registration Number: | 3007791595 |

#### 5.5 Identification of the Device:

| Proprietary/Trade name: | Unimax Veress Needle |
|-------------------------|---------------------------|
| Common Name: | Veress Needle |
| Classification Name: | Insufflator, Laparoscopi- |
| Device Classification: | 2 |
| Regulation Number: | 884.1730 |
| Panel: | Obstetrics/Gynecology |
| Product Code: | HIF |

# 5.6 Identification of the Predicate Device:

| Predicate Device Name: | GeniCon Pneumo-Needle |
|-----------------------------------------|-----------------------|
| Manufacturer: | GeniCon, L.C. |
| 510(k) Number or Clearance Information: | K993625 |

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Unimax Veress Needle

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#### 5.7 Intended Use and Indications for Use of the subject device.

The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

#### 5.8 Device Description

510(k) Notification

い

The Unimax Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120mm and 150mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

#### 5.9 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 Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing, ISO 10993-5 Biological Evalustion of medical devices- Part 5: Test 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- Part10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-12 Biological evaluation of medical devices- PArt12: Sample preparation and reference material, ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

- · Cytotoxicity Test
- · Intracutaneous Reactivity Test
- · Maximization Sensitization Test
- · EO Sterilization Validation Study Report
- · Ethylene Oxide Sterilization Residuals Study Report

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Unimax Veress Needle

Unimax Medical Systems Inc. 510(k) Notification

> The tests listed below have demonstrated that the subject device performs at least same performance as the predicate device.

- Tip Pull Test
- · Switch Operation
- · Spring Obturator Operation
- · Needle Puncture Force Test

All the test results demonstrate the performance of Unimax Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses.

The results of the non-clinical testing demonstrate that the Unimax Veress Needle is as safe and effective as the predicate devices.

### 5.10Substantial Equivalence Determination

The Unimax Veress Needle submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared GeniCon Pneumo-Needle which is the subject of K993625. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

| Item | Proposed Device<br>(Unimax Medical Systems Inc. Veress<br>Needle) | Predicate Device<br>(GeniCon L.C. Pneumo-Needle) | |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Intended Use | The Unimax Veress Needle is intended<br>for percutaneous insertion into the<br>peritoneal cavity for the purpose of<br>insufflation with carbon dioxide to<br>establish pneumoperitoneum prior to the<br>placement of trocars during laparoscopic<br>procedures. | The GeniCon Pneumo-Needle is<br>intended for percutaneous insertion into<br>the peritoneal cavity for the purpose of<br>insufflation with carbon dioxide to<br>establish pneumoperitoneum prior to<br>the placement of trocars during<br>laparoscopic procedures. | |
| | Consisted | Veress Needle | Veress Needle |
| | Instruments | Obturator | Obturator |
| | Models | xVN Series | Model 900-200 |
| | Dimension | 120mm, 150mm | 120mm, 150mm |

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## Unimax Medical Systems Inc. 510(k) Notification

Unimax Veress Needle

| Sterilization | EO Sterilized | EO Sterilized |
|----------------------------|------------------------------------|----------------------------|
| Safety<br>standards | ISO 10993-1 | ISO 10993-1 |
| | ISO 10993-5 | ISO 10993-5 |
| | ISO 10993-7 | ISO 10993-7 |
| | ISO 10993-10 | ISO 10993-10 |
| | ISO 10993-12 | ISO 10993-12 |
| | ISO 11135-1 | ISO 11135-1 |
| Performance<br>standards | Not Applicable | Not Applicable |
| | Compared<br>performance<br>testing | Tip Pull Test |
| Switch Operation | | Switch Operation |
| Spring Obturator Operation | | Spring Obturator Operation |
| Needle Puncture Force Test | | Needle Puncture Force Test |

# 5.11 Conclusion

After analyzing bench tests, safety testing data, it can be concluded that Unimax Veress Needle is as safe and effective as the predicate device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Unimax Medical Systems Inc. % Mr. Michael Lee. President AcmeBiotechs Co., Ltd. No.45, Minsheng Rd. Danshui Town TAIPEI COUNTY 251 TAIWAN

Re: K111441

Trade/Device Name: Unimax Veress Needle Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated: May 20, 2011 Received: May 24, 2011

AUG 1 9 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 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 of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lehman MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K111441

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Unimax Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

Prescription Use × (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)

Hulda Gunn

(Division Sign-Off) Division of Reproductive, Gastro-Rep Urological Devices 510(k) Number

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