(81 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing.
No.
The device facilitates a surgical procedure by creating insufflation, but it does not directly treat a disease or condition.
No
This device is used for percutaneous insertion and insufflation to establish pneumoperitoneum prior to laparoscopic procedures. Its purpose is to facilitate a surgical procedure, not to diagnose a condition.
No
The device description clearly outlines a physical, mechanical medical device (a needle with a spring-loaded obturator and handle) and the performance studies focus on physical and biological testing, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous insertion into the peritoneal cavity for insufflation with carbon dioxide to establish pneumoperitoneum during laparoscopic procedures. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical instrument designed for puncturing tissue and introducing gas into a body cavity. It does not involve the examination of specimens derived from the human body for the purpose of providing information about a physiological state, health, disease, or congenital abnormality.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the device (tip pull, switch operation, spring obturator operation, puncture force) and its biocompatibility and sterilization. These are typical tests for surgical instruments, not IVDs.
IVD devices are used to perform tests on samples taken from the body (like blood, urine, tissue) to diagnose or monitor conditions. This device is used directly in a surgical procedure on the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HIF, FHQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Per ISO 10993-1:2009, the subject device is an external communicating device (tissue/bone/dentin) with limited contact duration (
§ 884.1730 Laparoscopic insufflator.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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.
A02, Plant B, No. 278, Hangkong Road, Tianjin Free Trade Zone
(Airport Industrial Park), Tianjin, 300308 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Fan, Tao General Manager
Phone: (86)18616806984
Email: fant01@uwellmed.com |
| 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 | |
| FHO | K111441 | ||
| The Predicate Device has not been subject to a design-related recall. |
4
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.
5
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 (