(265 days)
Not Found
No
The device description and performance studies focus on mechanical function and comparison to a predicate device, with no mention of AI/ML capabilities or data processing.
No
A therapeutic device is used to treat or cure a disease or condition. This device is used to establish pneumoperitoneum for minimally invasive abdominal procedures, which is a preparatory step for surgery, not a treatment itself.
No
The device is a surgical instrument used to establish pneumoperitoneum for minimally invasive abdominal procedures, not to diagnose a condition.
No
The device description clearly outlines a physical, sterile surgical instrument made of stainless steel and plastic, with mechanical components like a needle, handle, stopcock, and spring-loaded stylet. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to establish pneumoperitoneum in minimally-invasive abdominal procedures. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical instrument (a needle) used to access the abdominal cavity. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no reagents, test strips, or other components typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for a procedural step.
N/A
Intended Use / Indications for Use
The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.
Product codes
HIF
Device Description
The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons in operating room
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)
Cytotoxicity, irritation and sensitization testing were conducted according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-12:2012. The results demonstrate that the subject device is biocompatible.
Sterilization validation was performed according to ISO 11135-1:2014. Ethylene Oxide residuals were evaluated according to ISO 10993-7:2008 and are acceptable.
Mechanical bench testing, including assessments of gas flow, leakage, max puncture force, rotational valve operation, stylet alignment, stylet strength, connector fitting, and audible rate, were conducted in comparison with the predicate, Ethicon Endopath Ultra Veress Needle. All performance tests show acceptable results and demonstrate that the GRI-Alleset Veress Needle meets its specifications.
Shelf life testing demonstrates that the subject device maintains its functional performance and its packaging maintains device sterility over the duration of the proposed shelf life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around a symbol. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
June 11, 2018
GRI Medical and Electronic Technology Co., Ltd. % Sharon Marrow Consultant Sharon Marrow 2907 Cherry Branch Drive Knoxville, TN 37948
Re: K172835
Trade/Device Name: GRI-Alleset Veress Needle Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: April 13, 2018 Received: May 10, 2018
Dear Sharon Marrow:
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.
1
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 of medical device-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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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) K172835
Device Name GRI-Alleset Veress Needle
Indications for Use (Describe)
The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.
| 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) |
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Image /page/3/Picture/1 description: The image shows the logo for Global Resources International (GRI). The logo features the letters "gri" in a stylized, lowercase font, with a blue curved line above the "i". Below the letters, the words "Global Resources International" are written in a smaller, sans-serif font.
510(K) SUMMARY
1. 510(k) Summary
Date Prepared: June 8, 2018
1.1 Applicant: Owner and Official Correspondent
GRI Medical & Electronic Technology Co., Ltd. 1805 Honggao Rd. Xiuzhou Industry Zone Jiaxing, CN-33 CHINA 314031 Phone: 86-135-11359722
Contact: Martin D. Paugh GLOBAL RESOURCES INTERNATIONAL, INC. 4142 Industry Way Flowery Branch, GA 30549 Phone: 770 9253251 Fax: 770 9259469 Email: mpaugh@gri-usa.com
1.1. Device Trade Name: Trade/Proprietary Name
GRI-Alleset Veress Needle
| Common or Usual Name: | Veress Needle |
|---|---|
| Regulation Name: | Laparoscopic insufflator |
| Regulation Number: | 21 CFR 884.1730 |
| Class: | II |
| Product Code: | HIF (insufflator, laparoscopic) |
1.2. Predicate Device:
| Device Name: | Endopath Ultra Veress Needle |
|---|---|
| 510(k) Number: | K983925 |
| Manufacturer: | Ethicon Endosurgery, Inc. |
The predicate device has not been subject to a design related recall.
1.3. Description of the Device
The GRI-Alleset Veress Needle is a disposable, single-use, sterile surgical instrument used during minimally invasive surgery for the establishment of peritoneum of the abdominal cavity prior to abdominal surgery. The device is comprised of a 14 gauge stainless steel needle (120mm and 150mm in length) which is attached to a plastic handle that contains a stopcock with a luer lock
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Image /page/4/Picture/1 description: The image shows the logo for GRI, which likely stands for Global Resources International. The logo features the letters 'gri' in a bold, sans-serif font, with the 'i' having a curved line above it, resembling a check mark or a stylized accent. Below the letters, there is some text that is not legible.
connector. The spring-loaded, blunt stylet extends beyond the needle tip and retracts as the needle is pushed through the abdominal tissue; it automatically advances forward once the peritoneum is penetrated. A red safety indicator, attached to the proximal end of the stylet, is exposed above the handle as an indication of an exposed needle tip. The device is provided sterile via ethylene oxide.
1.4. Indications for Use
The GRI-Alleset Veress Needle is a disposable, single-use, sterile device intended to be used in minimally-invasive abdominal procedures for the establishment of pneumoperitoneum.
1.5. Comparison to the Predicate Device
The table below provides an overview of the comparison of the new device to the predicate device. As noted in the table below, the subject and predicate device have the same intended use. There are also differences in technological characteristics between the subject and predicate device; however, these differences do not raise different questions of safety or effectiveness.
| Element of Comparison | Subject Device | Predicate Device | |
|---|---|---|---|
| General | Manufacturer | GRI | Ethicon |
| (K983925) | |||
| Trade Name | Veress Needle | Ultra Veress Needle | |
| Class | II | II | |
| Regulation Name | Laparoscopic insufflator | Laparoscopic | |
| insufflator | |||
| Product Code | HIF | HIF, FHP | |
| Intended Use | Intended User | Surgeons in operating room | Surgeons in |
| operating room | |||
| Intended Use | The Veress Needle has application in minimally invasive abdominal procedures for the establishment of pneumoperitoneum. | The ENDOPATH | |
| Ultra Veress | |||
| Insufflation Needle | |||
| has application in | |||
| gynecologic | |||
| laparoscopy and | |||
| other minimally | |||
| invasive abdominal | |||
| procedures for | |||
| establishment of | |||
| pneumoperitoneum. |
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Image /page/5/Picture/1 description: The image shows the logo for GRI, which stands for Global Reporting Initiative. The logo is in black and features the letters 'gri' in a stylized, italicized font. Above the 'i' is a blue curved line, adding a modern touch to the design. The logo is simple, clean, and easily recognizable.
| Element of Comparison | Subject Device | Predicate Device | |
|---|---|---|---|
| Technological | |||
| Characteristics | Device Description | 14 gauge, 120mm and 150mm, | |
| two way valve with luer lock | |||
| connector, red safety indicator | 14 gauge, 120mm | ||
| and 150mm, | |||
| optional stop cock | |||
| with luer lock | |||
| connector, red | |||
| safety indicator | |||
| Materials/Composition | Stainless steel, ABS | Stainless Steel, ABS | |
| Sterility | Provided Sterile via EtO; Single- | ||
| Use Disposable | Provided Sterile via | ||
| Gamma Radiation; | |||
| Single-Use | |||
| Disposable | |||
| Length | 120mm, 150mm | 120mm | |
| Diameter | 2.1mm (14 gauge) | 14 gauge | |
| Luer Lock Connector | Yes | Yes | |
| Spring Loaded | Yes | Yes | |
| Indicator for when in | |||
| peritoneal cavity | Yes (red indicator) | Yes (red ball) | |
| Sterile Packaging | Tyvek to PET peel pouch | Tyvek to poly peel | |
| pouch | |||
| Design Differences | Handle design (shape) | Handle Design | |
| (shape); indicator for | |||
| Ultra Veress Needle | |||
| is red ball, has | |||
| optional luer | |||
| connector |
1.6. Summary of non-clinical tests submitted
Cytotoxicity, irritation and sensitization testing were conducted according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-12:2012. The results demonstrate that the subject device is biocompatible.
Sterilization validation was performed according to ISO 11135-1:2014. Ethylene Oxide residuals were evaluated according to ISO 10993-7:2008 and are acceptable.
Mechanical bench testing, including assessments of gas flow, leakage, max puncture force, rotational valve operation, stylet alignment, stylet strength, connector fitting, and audible rate, were conducted in comparison with the predicate, Ethicon Endopath Ultra Veress Needle. All
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Image /page/6/Picture/1 description: The image shows the logo for GRI, which is a company that provides sustainability reporting standards. The logo is black text with a blue arc over the "i". The text is in a sans-serif font and is slightly italicized.
performance tests show acceptable results and demonstrate that the GRI-Alleset Veress Needle meets its specifications.
Shelf life testing demonstrates that the subject device maintains its functional performance and its packaging maintains device sterility over the duration of the proposed shelf life.
1.7. Conclusion of the tests
The results of performance testing demonstrate that the GRI-Alleset Veress Needle is substantially equivalent to the Ethicon Endopath Ultra Veress Needle.