Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is used to create pneumoperitoneum for laparoscopic procedures, which is a preparatory step for surgery, not a direct therapeutic intervention.
No
The Veress Needle is used to insufflate the peritoneal cavity with carbon dioxide to establish pneumoperitoneum, aiding in trocar placement during laparoscopic procedures. It is a surgical tool, not a diagnostic one.
No
The device description clearly describes a physical, sterile, single-use needle with a spring-loaded mechanism, indicating it is a hardware device, not software.
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. This is a surgical procedure performed directly on a patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The Veress Needle does not perform any such testing.
- Device Description: The description details a surgical instrument used for accessing a body cavity, not for analyzing biological samples.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic results, or any of the typical elements associated with IVD devices (like reagents, calibrators, controls, etc.).
The Veress Needle is a surgical instrument used in laparoscopic procedures.
N/A
Intended Use / Indications for Use
The 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
HIF, FHO
Device Description
The 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 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
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 Veress Needle. Biocompatibility tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. The biocompatibility tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity and Material-Mediated Pyrogenicity. Sterilization validation was performed per ISO 11135:2014.
The tests listed below evaluated the performance of the subject device.
- Tip Pull Test
- Switch Operation
- Spring Obturator Operation
- Needle Puncture Force Test
All the test results demonstrate the performance of Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Veress Needle is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/2 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 a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2017
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Haobin Li General Manager Tang Jiao Wang Street, Lilin Town, Zhongkai Hi-Tech Zone Huizhou, Guangdong 516000 China
Re: K172120 Trade/Device Name: Veress Needle, models: WVN0112T, WVN0115T Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, FHO Dated: July 7, 2017 Received: July 13, 2017
Dear Haobin Li:
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.
1
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 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 (DICE) 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 (DICE) 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,
Benjamin R. Fisher -S
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)
Device Name
Veress Needle, models :WVN0112T,WVN0115T
Indications for Use (Describe)
The 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) |
|---|---|
| ☑ | ☐ |
|× | Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Type of submission :Traditional
The assigned 510(K) number is: K172120
The date the summary was prepared: September 11, 2017
1. Submitter information:
Manufacturer Name: WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd.
Address: TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone, HuiZhou,GuangDong, China.
Tel : 0086-0752-3860807
Fax : 0086-0752-3863017
Establishment Registration Number:3010601992
2. Contact person:
Haobin Li (General Manager)
WickiMed(Huizhou)Medical Equipment Manufacturing Co.,Ltd
TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone, HuiZhou,GuangDong, China.
Tel : 0086-0752-3860807
Fax : 0086-0752-3863017
E-mail: mac lai@wickimed.com
3. Identification of the Device :
Trade Name: Veress Needle Model: WVN0112T,WVN0115T Common Name: Veress Needle
4
| Classification Name | Product
Code | Regulation
Number | Regulatory
Class | Review Panel |
|------------------------------|-----------------|----------------------|---------------------|---------------------------|
| Insufflator,
Laparoscopic | HIF
FHO | 21CFR
884.1730 | II | Obstetrics/Gynec
ology |
4. Identification of the Predicative Device
| Device
Name | Common
Name | Manufacturer | Classification
and Code | Classification
regulation | 510(k)
number |
|------------------------------|------------------|--------------------------------------------------------|----------------------------|------------------------------|------------------|
| Unimicro
Veress
Needle | Veress
Needle | Unimicro Medical
Systems
(ShenZhen) Co.,
Ltd. | Class II,
HIF | 21CFR
884.1730 | K150068 |
| | | | Class II,
FHO | 21CFR
876.1500 | |
There are no design-related recall records with Predicative Device K150068.
5. Intended Use and Indications for Use of the subject device
The 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 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 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
7. Substantial Equivalence Determination
The Veress Needle submitted in this 510(k) file is substantially equivalent to the cleared Unimicro Veress Needle which is the subject of K150068.
5
The comparison to the predicate device is provided below in Table 2.
| Item | Predicate Device | Proposed Device |
|---|---|---|
| Trade Name | Unimicro Veress Needle | Veress Needle |
| 510(K) Submitter | Unimicro Medical Systems | |
| (ShenZhen) Co.,Ltd. | WickiMed(Huizhou)Medical | |
| Equipment Manufacturing | ||
| Co.,Ltd | ||
| 510(K) Number | K150068 | - |
| Classification | ||
| regulation | 21CFR 884.1730 | 21CFR 884.1730 |
| Classification and | ||
| Product Code | Class II, | |
| HIF,FHO | ClassII, | |
| HIF,FHO | ||
| Common name | Veress Needle | Veress Needle |
| 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. | The 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. | ||
| Components | Veress Needle | |
| Obturator | Veress Needle | |
| Obturator | ||
| Models | MND 11200,MND 11500 | WVN0112T,WVN0115T |
| Length | 120mm,150mm | 120mm,150mm |
| Sterilization | EO Sterilized | EO Sterilized |
| Disposable | Yes | Yes |
| Materials | Patient-Contacting Material | |
| SUS 420 | Patient-Contacting Material | |
| SUS 304 |
Table 2 : Comparison to Predicate Device
6
| | ( Outer tube
inner tube ) | | ( Outer tube
inner tube ) | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----|---------------------------------------------------------------------------------------------------------------------------------------------|----|
| | Handle
Material | ABS | Handle
Material | PC |
| Principles of
operation | Connect the device to the
insufflators with insufflation
tubing, insufflating with
carbon dioxide to establish
pneumoperitoneum | | Connect the device to the
insufflators with insufflation
tubing, insufflating with
carbon dioxide to establish
pneumoperitoneum | |
The subject and predicate device have the same intended use. The subject and predicate device designs are nearly identical. Both are single-use devices and the lengths of the devices are identical. The differences in technological characteristics between the subject and predicate devices (i.e., different materials, and different needle inner diameter) do not raise different questions of safety and effectiveness.
8. Non-clinical Testing
A series of tests were performed to assess the safety and effectiveness of the Veress Needle. Biocompatibility tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006, and ISO 10993-12:2012. The biocompatibility tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity and Material-Mediated Pyrogenicity. Sterilization validation was performed per ISO 11135:2014.
The tests listed below evaluated the performance of the subject device.
- Tip Pull Test
- Switch Operation
- Spring Obturator Operation
- Needle Puncture Force Test
7
All the test results demonstrate the performance of Veress Needle meets the requirements of its pre-defined acceptance criteria and intended uses.
The results of the non-clinical testing demonstrate that the Veress Needle is as safe and effective as the predicate device.
9. Conclusion
Based on the results of the above described performance testing data, it can be concluded that Veress Needle is as safe and effective as the predicate device.