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.

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.

AI/ML Overview

This document describes the premarket notification (510(k)) for the GRI-Alleset Veress Needle, a disposable, single-use, sterile device intended for establishing pneumoperitoneum in minimally invasive abdominal procedures. The submission aims to demonstrate substantial equivalence to a predicate device, the Ethicon Endopath Ultra Veress Needle (K983925).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table as "acceptance criteria." Instead, the document outlines performance tests that were conducted and states that the "results show acceptable results and demonstrate that the GRI-Alleset Veress Needle meets its specifications." The direct comparisons are made against the predicate device.

Test / Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Material Biocompatibility	ISO 10993 standards compliance	Biocompatible
Cytotoxicity	ISO 10993-5:2009 compliance	Acceptable
Irritation	ISO 10993-10:2010 compliance	Acceptable
Sensitization	ISO 10993-10:2010 compliance	Acceptable
Sterilization	ISO 11135-1:2014 compliance	Validated
ETO Residuals	ISO 10993-7:2008 compliance	Acceptable
Mechanical Bench Testing	Performance equivalent or superior to predicate	Acceptable, met specifications
Gas flow	Comparable to predicate	Acceptable
Leakage	Comparable to predicate	Acceptable
Max Puncture Force	Comparable to predicate	Acceptable
Rotational Valve Operation	Comparable to predicate	Acceptable
Stylet Alignment	Comparable to predicate	Acceptable
Stylet Strength	Comparable to predicate	Acceptable
Connector Fitting	Comparable to predicate	Acceptable
Audible Rate	Comparable to predicate	Acceptable
Shelf Life	Maintain functional performance and sterility	Maintains over proposed shelf life
Functional Performance	Maintained throughout shelf life	Acceptable
Packaging Sterility	Maintained throughout shelf life	Acceptable

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the test sets used in the biocompatibility, sterilization, mechanical bench testing, or shelf-life studies. It only mentions that these tests were "conducted in comparison with the predicate." The data provenance is not specified, but typically such testing would be performed in a controlled laboratory environment. The studies are prospective in the sense that the new device was evaluated against established standards and a predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For medical devices like a Veress needle, "ground truth" is typically established through adherence to engineering standards, validated test methods, and comparison data from a legally marketed predicate, rather than expert consensus on a test set in the way AI algorithms are evaluated (e.g., image interpretation). The "experts" would be the engineers, quality specialists, and toxicologists conducting and interpreting the tests according to relevant ISO standards.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and the tests performed. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic accuracy assessments where there might be disagreement among human readers or interpreters. For device performance testing against engineering standards, results are typically objective and measurable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic tools or AI algorithms where human interpretation is involved. The GRI-Alleset Veress Needle is a surgical instrument, and its effectiveness is assessed through physical and mechanical performance tests, not through reader interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The GRI-Alleset Veress Needle is a physical surgical instrument, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

Established ISO Standards: For biocompatibility (ISO 10993 series) and sterilization (ISO 11135-1).
Performance Specifications: The device must meet its own design specifications and perform comparably to the legally marketed predicate device (Ethicon Endopath Ultra Veress Needle).
Predicate Device Performance: The predicate device itself serves as a benchmark for acceptable performance.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are used for machine learning models. The GRI-Alleset Veress Needle is a hardware medical device, and its development does not involve machine learning training sets.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for a hardware medical device.

Summary

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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.

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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

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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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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

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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	Laparoscopicinsufflator
	Product Code	HIF	HIF, FHP
Intended Use	Intended User	Surgeons in operating room	Surgeons inoperating room
	Intended Use	The Veress Needle has application in minimally invasive abdominal procedures for the establishment of pneumoperitoneum.	The ENDOPATHUltra VeressInsufflation Needlehas application ingynecologiclaparoscopy andother minimallyinvasive abdominalprocedures forestablishment ofpneumoperitoneum.

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Element of Comparison		Subject Device	Predicate Device
TechnologicalCharacteristics	Device Description	14 gauge, 120mm and 150mm,two way valve with luer lockconnector, red safety indicator	14 gauge, 120mmand 150mm,optional stop cockwith luer lockconnector, redsafety indicator
	Materials/Composition	Stainless steel, ABS	Stainless Steel, ABS
	Sterility	Provided Sterile via EtO; Single-Use Disposable	Provided Sterile viaGamma Radiation;Single-UseDisposable
	Length	120mm, 150mm	120mm
	Diameter	2.1mm (14 gauge)	14 gauge
	Luer Lock Connector	Yes	Yes
	Spring Loaded	Yes	Yes
	Indicator for when inperitoneal cavity	Yes (red indicator)	Yes (red ball)
	Sterile Packaging	Tyvek to PET peel pouch	Tyvek to poly peelpouch
	Design Differences	Handle design (shape)	Handle Design(shape); indicator forUltra Veress Needleis red ball, hasoptional luerconnector

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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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.

Regulation Number and Section

§ 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.