U-Blade Veress Needle

K162648 · Tianjin Uwell Medical Device Manufacturing Co., Ltd. · HIF · Dec 12, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K162648
• Device Name: U-Blade Veress Needle
• Applicant: Tianjin Uwell Medical Device Manufacturing Co., Ltd.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Dec 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The U-Blade 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 U-Blade Veress Needle is a sterile, single-use surgical instrument used to establish pneumoperitoneum. It consists of an external stainless steel needle tube with a sharp point for tissue puncture and an internal spring-loaded, round-tipped obturator. The obturator extends automatically when the needle tip enters the peritoneal cavity, protecting internal organs from the sharp point. The handle includes a red indicator to verify obturator retraction and a valve connector for attachment to an insufflation pump. Used by surgeons in clinical settings during laparoscopic procedures, the device facilitates the introduction of carbon dioxide into the peritoneal cavity. The device is available in 120mm and 150mm lengths with either U-shaped or bugle-shaped handles.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1, -5, and -10 (cytotoxicity, irritation, sensitization). Performance testing included tip pull, switch operation, spring obturator operation, and needle puncture force tests. Sterilization validated per ISO 11137-1 and -2. Package integrity and shelf-life testing were also conducted.

Technological Characteristics

Materials: PC resin, SUS 304/316 stainless steel. Dimensions: 120-150 mm length. Principle: Mechanical spring-loaded obturator for organ protection. Connectivity: Valve connector for insufflation pump. Sterilization: Gamma radiation. Standards: ISO 10993 (biocompatibility), ISO 11137 (sterilization).

Indications for Use

Indicated for patients undergoing laparoscopic procedures 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 12, 2016

Tianjin UWell Medical Device Manufacturing Co. Ltd. Tao Fan General Manager A02, Plant B. No. 278, Hangkong Rd Tianjin Free Trade Zone Tianjin, CN 300308

Re: K162648 Trade/Device Name: U-Blade Veress Needle Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: Class II Product Code: HIF, FHO Dated: September 2, 2016 Received: September 22, 2016

Dear Tao Fan,

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 device

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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/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,

For Division

Douglas Silverstein -S 2016.12.12 12:31:16 -05'00'

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) K162648

Device Name U-Blade Veress Needle

Indications for Use (Describe)

The U-Blade 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) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for U-Well. The logo consists of a blue and green circular design with a plus sign in the center, followed by the text "U-Well" in blue and green. To the right of "U-Well" is Chinese text in green.

TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO., LTD

# 510(k) Summary K162648

| Submitter: | Tianjin UWell Medical Device Manufacturing Co., Ltd.<br>A02, Plant B, No. 278, Hangkong Road, Tianjin Free Trade Zone<br>(Airport Industrial Park), Tianjin, 300308 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Fan, Tao General Manager<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | December 9, 2016 |
| Device Trade Name: | U-Blade Veress Needle |
| Device Common Name: | Veress Needle |
| Classification Name: | Laparoscopic insufflator |
| Class: | II |
| Regulation Number: | 884.1730 |
| Panel: | Obstetrical and Gynecological Devices |
| Product Code: | HIF (Insufflator. Laparoscopic). FHQ (Pneumoperitoneum needle |

# 1. Predicate Device:

| Device | Company | Product Code | 510(k) Number |
|-----------------------------------------------------------------------|----------------------------|--------------|---------------|
| Unimax Veress Needle | Unimax Medical Systems Inc | HIF<br>FHO | K111441 |
| The Predicate Device has not been subject to a design-related recall. | | | |

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Image /page/4/Picture/0 description: The image shows the logo for U-Well. The logo consists of a blue and green circular design with a plus sign in the center, followed by the text "U-Well" in blue and green. To the right of the text is Chinese characters in green.

## 2. Indications for Use:

The U-Blade 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.

# 3. Device Description:

The U-Blade Veress Needle is a slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a surgical/radiological procedural method. It is used for percutaneous insertion into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The device consists of an external stainless steel needle tube with a sharp point to puncture tissue. It is also equipped with an internal spring-loaded round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage to internal organs from the sharp point. The subject device also has a handle with a red indicator mark to verify when the spring-loaded obturator is retracted and a valve connector which connects to an insufflation pump.

As described in the following table, the U-Blade Veress Needle is available in 120mm and 150mm needle lengths and two types of handles with different shapes (U shape and Bugle).

| Model Number | Length (mm) | Comments |
|--------------|-------------|--------------------|
| UV120 | 120 mm | U shape handle |
| UV150 | 150 mm | U shape handle |
| BV120 | 120 mm | Bugle shape handle |
| BV150 | 150 mm | Bugle shape handle |

This is a sterile and single-use device.

## 4. Non-Clinical Testing

A series of tests were performed to assess the safety and effectiveness of the U-Blade Veress Needle. These tests were conducted in accordance with ISO 10993-1:2009. ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-12:2012, ISO 11137-1:2006, and ISO 11137-2:2012.

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Image /page/5/Picture/0 description: The image shows the logo for U-Well. The logo consists of a green and blue symbol that looks like three people holding hands in a circle with a plus sign in the middle. To the right of the symbol is the text "U-Well" in blue, followed by some Chinese characters in green.

Per ISO 10993-1:2009, the subject device is an external communicating device (tissue/bone/dentin) with limited contact duration (<24 h); and therefore, the following biocompatibility tests were completed and demonstrated biocompatibility:

- Cytotoxicity Test (ISO 10993-5:2009)
- Intracutaneous Irritation Test (ISO 10993-10:2010) ●
- . Skin Sensitization Test (the Guinea Pig maximization test) (ISO 10993-10:2010)

The performance testing conducted on subject device and predicate device are listed below:

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

The performance test results demonstrate that the U-Blade Veress Needle meet its acceptance criteria.

Sterilization validation was conducted in accordance with ISO 11137-1:2006 and ISO 11137-2:2012.

Package integrity and functional performance testing were completed on the subject device following aging to support the proposed shelf life.

## 5. Substantial Equivalence Determination

The U-Blade Veress Needle and the predicate device have the same intended use but different technological characteristics. The differences in technological characteristics between the devices do not raise different questions of safety or effectiveness.

The comparison to predicate device is described in the table below.

| | Proposed Device<br>(U-Blade Veress Needle) | Predicate Device<br>(Unimax Veress Needle, K111441) |
|---------------------------------|--------------------------------------------------------|-----------------------------------------------------|
| Trade Name | U-Blade Veress Needle | Unimax Veress Needle |
| 510(k) Submitter | Tianjin UWell Medical Device<br>Manufacturing Co., Ltd | Unimax Medical Systems Inc. |
| 510(k) Number | K162648 | K111441 |
| Common Name | Veress Needle | Veress Needle |
| Classification | CFR 884.1730 | 21 CFR 884.1730 |
| Classification and Product Code | Class II,<br>HIF, FHO | Class II,<br>HIF, FHO |
| Device Classification Name | Laparoscopic insufflator | Laparoscopic insufflator |
| Models | UV120/150, BV 120/150 | xVN Series |

## Comparison to Predicate Device

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Image /page/6/Picture/0 description: The image shows the logo for U-Well. The logo consists of a blue and green graphic to the left, followed by the text "U-Well" in blue and the text "优外" in green. The graphic appears to be a stylized representation of a medical symbol.

| | TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO., LTD | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comprised Elements | Needle tube, Inner Blunder<br>stylet, Handle, and Valve<br>connector | Needle tube, Inner Blunder<br>stylet, Handle, and Valve<br>connector |
| Materials: | PC resin, SUS 304/316 | PC resin, SUS 304,<br>Acrylonitrile styrene |
| Dimension | Length:<br>120-150 mm | Length:<br>120-150 mm |
| Indications for Use | 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 the<br>placement of trocars during<br>laparoscopic 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 the<br>placement of trocars during<br>laparoscopic procedures. |
| Sterilization method | Gamma sterilization | EO sterilization |
| Disposable for Single<br>Use | Yes | Yes |

# 6. Conclusion

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