Unimicro Veress Needle

K150068 · Unimicro Medical Systems (Shenzhen) Co., Ltd. · HIF · Jul 31, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150068
• Device Name: Unimicro Veress Needle
• Applicant: Unimicro Medical Systems (Shenzhen) Co., Ltd.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jul 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The Unimicro 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

Sterile, single-use Veress needle; 120mm or 150mm lengths. Incorporates spring-loaded blunt stylet mechanism. Used by surgeons in clinical/OR settings to access peritoneal cavity. Device connects to external CO2 insufflator via tubing. Surgeon inserts needle percutaneously; spring-loaded stylet retracts during puncture and advances upon entering cavity to protect internal structures. CO2 insufflation establishes pneumoperitoneum, creating space for subsequent trocar/cannula placement. Facilitates safe laparoscopic access; reduces risk of injury to internal organs during initial entry.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993 series: cytotoxicity, irritation, sensitization) and mechanical performance (tip pull, switch operation, spring obturator operation, needle puncture force). All tests met pre-defined acceptance criteria.

Technological Characteristics

Sterile, single-use, spring-loaded blunt stylet needle. Lengths: 120mm, 150mm. Materials compliant with ISO 10993. Sterilization: Ethylene Oxide (ISO 11135-1). Mechanical operation via spring-loaded obturator. No software or electronic components.

Indications for Use

Indicated for patients undergoing laparoscopic procedures, including gynecological laparoscopy, requiring percutaneous insertion into the peritoneal cavity for CO2 insufflation to establish pneumoperitoneum.

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

• Unimax Veress Needle (K111441)

Submission Summary (Full Text)

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July 31, 2015

Unimicro Medical Systems (ShenZhen) Co., Ltd. Weizhong Chen Vice General Manager 2/f, Bldg 31, The 3rd Industrial Area, Mashantou, Gongming Street, Guangming New District ShenZhen City, Guangdong 518106 China

Re: K150068 Trade/Device Name: Unimicro Veress Needle Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated: June 17, 2015 Received: June 23, 2015

Dear Weizhong Chen,

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

Public Health Service

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

# Joyce M. Whang -S

for

Benjamin R. Fisher, Ph.D. Director 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) K150068

Device Name

Unimicro Veress Needle, models : MND 11200, MND 11500

Indications for Use (Describe)

The Unimicro 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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### 1 | Unimicro Medical Systems (ShenZhen) Co., Ltd. BIRTHHE 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:_ K150068

Date of Preparation: JULY 1, 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:

Mr. Weizhong Chen (Vice General Manager)

E-mail: [e-mail]

### 3. Identification of the Device :

Trade Name: Unimicro Veress Needle

Common Name: Veress Needle

Model: MND 11200, MND 11500

| Classification<br>Name | Product<br>Code | Regulation<br>Number | Regulatory<br>Class | Review Panel |
|------------------------------|-----------------|----------------------|---------------------|------------------------------|
| Insufflator,<br>Laparoscopic | HIF | 21CFR<br>884.1730 | II | Obstetrics/Gynec<br>ology |
| Pneumoperitoneum<br>Needle | FHO | 21CFR<br>876.1500 | II | Gastroenterology/<br>Urology |

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## O Unimicro Medical Systems (ShenZhen) Co., Ltd.

### 4. Identification of the Predicative Device

| Device<br>Name | Common<br>Name | Manufacturer | Classification<br>and Product<br>Code | Classification<br>regulation | 510(k)<br>number |
|----------------------------|------------------|-----------------------------------|---------------------------------------|------------------------------|------------------|
| Unimax<br>Veress<br>Needle | Veress<br>Needle | Unimax<br>Medical<br>Systems Inc. | Class II,<br>HIF | 21CFR<br>884.1730 | K111441 |
| | | | Class II,<br>FHO | 21CFR<br>876.1500 | |

Table 1: Predicative Device Information

### 5. Indications for Use

The Unimicro 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.

### 6. Device Description

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

### 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 Unimicro Veress Needle. The tests listed below were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-12:2012 and ISO 11135-1:2007.

- Cytotoxicity Test .
- Skin irritation Test •
- Skin Sensitization Test ( the Guinea Pig maximization test) .

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# Co., Ltd.

- EO Sterilization Validation
- . Ethylene Oxide Sterilization Residuals Test

The tests listed below have demonstrated that the subject device performs as well as the predicate device.

- Tip Pull Test .
- Switch Operation •
- Spring Obturator Operation •
- Needle Puncture Force Test .

In each of the above tests, the Unimicro Veress Needle met the

requirements ofthe pre-defined acceptance criteria.

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

### 8. Substantial Equivalence Determination

The Unimicro 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 Unimax Veress Needle which is the subject of K111441. There are no differences between the two devices that raise any new issues of safety or effectiveness.

The comparison to predicate device as below Table 2.

| Item | Proposed Device | Predicate Device | | |
|-----------------------|----------------------------|-----------------------------|--|--|
| Trade Name | Unimicro Veress Needle | Unimax Veress Needle | | |
| 510(K) Submitter | Unimicro Medical Systems | Unimax Medical Systems Inc. | | |
| | (ShenZhen) Co.,Ltd. | | | |
| 510(K) Number | | K111441 | | |
| Classification | 21CFR 884.1730 | 21CFR 884.1730 | | |
| regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | | |
| Classification<br>and | Class II , | Class II , | | |
| Code | HIF,FHO | HIF,FHO | | |
| Common name | Veress Needle | Veress Needle | | |
| Intended Use | The Unimicro Veress Needle | The Unimax Veress Needle is | | |

Table 2 : Comparison to Predicate Device

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# ШПіШіСГ © Unimicro Medical Systems (ShenZhen) Co., Ltd.

| | is intended for percutaneous<br>insertion into the peritoneal<br>cavity for the purpose of<br>insufflation with carbon<br>dioxide to establish<br>pneumoperitoneum prior to<br>the placement of trocars<br>during laparoscopic<br>procedures. | intended for percutaneous<br>insertion into the peritoneal<br>cavity for the purpose of<br>insufflation with carbon<br>dioxide to establish<br>pneumoperitoneum prior to<br>the placement of trocars<br>during laparoscopic<br>procedures. |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Consisted | Veress Needle | Veress Needle |
| Instruments | Obturator | Obturator |
| Models | MND 11200,MND 11500 | xVN Series |
| Length | 120mm,150mm | 120mm,150mm |
| Sterilization | EO Sterilized | EO Sterilized |
| Disposable | Yes | Yes |
| Principles of operation | Connect the device to the<br>insufflators with insufflation<br>tubing, insufflating with<br>carbon dioxide to establish<br>pneumoperitoneum | Connect the device to the<br>insufflators with insufflation<br>tubing, insufflating with<br>carbon dioxide to establish<br>pneumoperitoneum |
| Safety standards | ISO 10993-1:2009<br>ISO 10993-5:2009<br>ISO 10993-7:2008<br>ISO 10993-10:2010<br>ISO 10993-12:2012<br>ISO 11135-1:2007 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-7<br>ISO 10993-10<br>ISO 10993-12<br>ISO 11135-1 |
| Performance standards | Not Applicable | Not Applicable |
| Compared performance testing | • Tip Pull Test<br>• Switch Operation<br>• Spring Obturator Operation | • Tip Pull Test<br>• Switch Operation<br>• Spring Obturator Operation |

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| Image: Unimicro Medical Systems (ShenZhen) Co., Ltd. | |
|------------------------------------------------------|-------------------------|
| • Needle Puncture Force | • Needle Puncture Force |

Test

Test

### 9. Conclusion

Based upon the non-clinical performance and safety tests, it can be concluded that the Unimicro Veress Needle is as safe and effective as the predicate device. Therefore, Unimicro Veress Needle is substantially equivalent to the Unimax Veress Needle.