(81 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "U-Blade Veress Needle." It outlines the device's intended use, description, non-clinical testing, and a comparison to a predicate device to establish substantial equivalence.
Based on the information provided in the document, here's a breakdown regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document states that "The performance test results demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the specific numerical acceptance criteria and the reported device performance values for each test are not quantitatively detailed in this summary. Instead, it lists the types of performance tests conducted:
| Test Name | Reported Device Performance (Specificity/Detail Not Provided) |
|---|---|
| Tip Pull Test | Met acceptance criteria |
| Switch Operation Test | Met acceptance criteria |
| Spring Obturator Operation Test | Met acceptance criteria |
| Needle Puncture Force Test | Met acceptance criteria |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical performance tests (Tip Pull, Switch Operation, Spring Obturator Operation, Needle Puncture Force Tests). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission from "Tianjin UWell Medical Device Manufacturing Co. Ltd." located in China, it's highly probable the testing was conducted in China, but this is not explicitly stated as the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This section is not applicable to the type of testing described in the document. The studies were non-clinical performance (mechanical/material) tests of a physical device, not studies involving human subjects, image interpretation, or diagnostic accuracy where expert consensus or ground truth would be established by medical professionals.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to the non-clinical performance tests conducted. Adjudication methods are typically used in clinical studies or studies involving subjective assessments (e.g., image interpretation) to resolve disagreements among reviewers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as part of this submission. This type of study is relevant for AI-powered diagnostic devices, which the U-Blade Veress Needle is not. It is a physical surgical instrument.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not conducted. This device is not an algorithm or software. It is a manually operated surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" (or reference standard) would be the specific engineering and material specifications of the device and relevant industry standards (e.g., ISO, ASTM). For example, the "Needle Puncture Force Test" would have an expected range of force for successful puncture, defined by engineering requirements, rather than expert consensus or pathology. The document lists compliance with several ISO standards (ISO 10993-1, -5, -10, -12; ISO 11137-1, -2) which serve as the "ground truth" for biocompatibility and sterilization.
8. The sample size for the training set
There is no mention of a training set because this is not an AI/ML device. The testing described is for a physical medical instrument.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
Summary of the Study Proving Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria was a series of non-clinical performance tests and biocompatibility tests.
- Non-Clinical Performance Tests: These included "Tip Pull Test," "Switch Operation Test," "Spring Obturator Operation Test," and "Needle Puncture Force Test." The document states that these tests were performed and their results "demonstrate that the U-Blade Veress Needle meet its acceptance criteria." However, the actual numerical acceptance criteria and the quantitative test results are not provided in this summary document.
- Biocompatibility Tests: These tests were conducted in accordance with ISO 10993 series standards, specifically ISO 10993-1 (general), -5 (cytotoxicity), -10 (irritation and sensitization), and -12 (sample preparation). The device was categorized as an external communicating device with limited contact duration (<24 h). The "Cytotoxicity Test", "Intracutaneous Irritation Test", and "Skin Sensitization Test (the Guinea Pig maximization test)" were completed and demonstrated biocompatibility.
- Sterilization Validation: Conducted according to ISO 11137-1 and -2.
- Package integrity and functional performance testing were also completed following aging to support the proposed shelf life.
The overall conclusion is that based on these performance tests, the UWell Veress Needle is "as safe and effective as the predicate device" and is therefore "substantially equivalent."
{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 ManagerPhone: (86)18616806984Email: 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 | HIFFHO | 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 (<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(U-Blade Veress Needle) | Predicate Device(Unimax Veress Needle, K111441) | |
|---|---|---|
| Trade Name | U-Blade Veress Needle | Unimax Veress Needle |
| 510(k) Submitter | Tianjin UWell Medical DeviceManufacturing 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,HIF, FHO | Class II,HIF, FHO |
| Device Classification Name | Laparoscopic insufflator | Laparoscopic insufflator |
| Models | UV120/150, BV 120/150 | xVN Series |
Comparison to Predicate Device
{6}------------------------------------------------
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 Blunderstylet, Handle, and Valveconnector | Needle tube, Inner Blunderstylet, Handle, and Valveconnector |
| Materials: | PC resin, SUS 304/316 | PC resin, SUS 304,Acrylonitrile styrene |
| Dimension | Length:120-150 mm | Length:120-150 mm |
| Indications for Use | Intended for percutaneousinsertion into the peritonealcavity for the purpose ofinsufflation with carbondioxide to establishpneumoperitoneum prior to theplacement of trocars duringlaparoscopic procedures. | Intended for percutaneousinsertion into the peritonealcavity for the purpose ofinsufflation with carbondioxide to establishpneumoperitoneum prior to theplacement of trocars duringlaparoscopic procedures. |
| Sterilization method | Gamma sterilization | EO sterilization |
| Disposable for SingleUse | 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.
§ 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.