Gangi-SoftGuard Coaxial Needle together with Gangi-HydroGuard Coaxial Needle forms the Gangi Coaxial Needle family. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are manually operated, sterile, single use coaxial guiding needles with a spring loaded blunt-tip stylet, to be used as a guiding needle for biopsy instruments in procedures in soft tissue. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has the same intended use.

Coaxial Needle and Gangi-SoftGuard Gangi-HydroGuard Coaxial Needle are gastroenterological, manually operated, sterile, single use coaxial introducer needles. Both Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle consists of three parts: a needle (cannula) provided with a trocar stylet, and a spring-loaded blunt tip stylet. The difference from Gangi-SoftGuard Coaxial Needle is that Gangi-HydroGuard Coaxial Needle has a Luer hub located on the blunt stylet housing and the blunt stylet is hollow and has a distal tip hole. This enables injection of fluid without the need to remove the blunt stylet.

AI/ML Overview

The provided text describes a medical device submission (K181756) for the Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle. This submission is for a traditional medical device (biopsy needle) and does not involve an Artificial Intelligence/Machine Learning (AI/ML) powered device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable.

However, I can extract information regarding the acceptance criteria and the studies performed for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI/ML medical device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for clinical outcomes. Instead, they are related to compliance with recognized standards and design requirements for a biopsy needle. The "reported device performance" refers to the successful verification against these standards and requirements.

Acceptance Criteria (Study Type)	Reported Device Performance
Biocompatibility Testing:	Passed:
- Cytotoxicity (ISO 10993)	Verified criteria are fulfilled.
- Sensitization (ISO 10993)	Verified criteria are fulfilled.
- Intracutaneous irritation (ISO 10993)	Verified criteria are fulfilled.
- Acute Systemic Toxicity (ISO 10993)	Verified criteria are fulfilled.
- Pyrogenicity (ISO 10993)	Verified criteria are fulfilled.
Qualification of Metal Tubing:	Conformity Demonstrated:
- Compliance with ISO 9626:2016	Metal tubing is qualified and conforms.
Qualification of Needle Component:	Conformity Demonstrated:
- Compliance with ISO 7864:2016	Needle component is qualified and conforms.
Conical Fittings:	Conformity Demonstrated:
- Compliance with ISO 594	Luer lock fittings are qualified and conform.
Mechanical Performance:	Passed:
- All design requirements	Mechanical performance testing passed.
Verification of Penetration Force and Spring:	Passed:
- All design requirements	Penetration force and spring evaluation passed.
Sufficiency for Substantial Equivalence:	Substantial Equivalence Demonstrated, Safety Supported:
- Conformance to applicable technical requirements	Demonstrated.
- Conformance to user needs	Demonstrated.
- No new issues of safety and effectiveness (vs. predicate)	Not raised.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable (N/A) for an AI/ML device. For this traditional medical device, testing involved bench testing of components and the final device against engineering and biocompatibility standards. The document does not specify exact sample sizes for each test unless it's inherent in the standard (e.g., number of units tested for mechanical performance or biocompatibility). Data provenance is not described as country of origin, but rather as "bench testing." These were likely performed in a controlled laboratory setting by the manufacturer (AprioMed AB, Sweden). The nature of these tests is prospective for the device evaluation.

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):

Not Applicable (N/A): This is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. Ground truth for the tests performed (biocompatibility, mechanical strength, dimensional conformity) is established by adherence to recognized international standards and engineering specifications, verified by testing laboratories or internal qualified personnel.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable (N/A): This concept primarily applies to AI/ML or diagnostic studies where human experts disagree on findings. For bench testing, results are typically objective measurements against set specifications.

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:

Not Applicable (N/A): This is a traditional medical device (biopsy needle), not an AI/ML system. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not Applicable (N/A): This is a traditional medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For this traditional medical device, the "ground truth" for its performance is:
- Adherence to recognized international standards: e.g., ISO 10993 (biocompatibility), ISO 9626 (metal tubing), ISO 7864 (hypodermic needles), ISO 594 (conical fittings).
- Compliance with internal design requirements: for mechanical performance, penetration force, and spring force. These are objective engineering specifications.

8. The sample size for the training set:

Not Applicable (N/A): This is a traditional medical device, not an AI/ML system, so there is no "training set."

9. How the ground truth for the training set was established:

Not Applicable (N/A): As there is no training set for an AI/ML model, this question is irrelevant to the provided document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 18, 2018

AprioMed AB Katrin Svensson Director Quality & Regulatory Affairs Virdings Allé 28 Uppsala, 75450 Sweden

Re: K181756 Trade/Device Name: Gangi-SoftGuard Coaxial Needle Gangi-HydroGuard Coaxial Needle Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: November 12, 2018 Received: November 16, 2018

Dear Katrin Svensson:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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,

Daniel G. Walter Jr -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181756

Device Name Gangi-SoftGuard Coaxial Needle Gangi-HydroGuard Coaxial Needle

Indications for Use (Describe)

As a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

☑ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

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5 510(K) SUMMARY

As Required by 21 CFR 807.92(c) 510(k) Summary

Submitter/510(k) Holder 5.1

AprioMed AB Virdings Allé 28 Uppsala, SWEDEN 754 50

Contact Person: Katrin Svensson, Director Quality & Regulatory Affairs Telephone: +46 (0) 73- 345 14 40

Date Prepared: December 12, 2018

5.2 Device

Proprietary Name:	Gangi-SoftGuard Coaxial NeedleGangi-HydroGuard Coaxial Needle
Common/Usual Names:	Biopsy Needle
Regulation number:	21 CFR 876.1075
Classification Name:	Gastroenterology-Urology Biopsy Instrument
Class:	II
Product Code:	FCG
510(k) number:	K181756

Predicate Devices and Reference Device identification 5.3

Predicate device:

Proprietary Name:	Bard TruGuide Disposable Coaxial Biopsy Needle
Common/Usual Names:	Biopsy Needle
Regulation number:	21 CFR 876.1075
Classification Name:	Gastroenterology-Urology Biopsy Instrument
Class:	II
510(k) number:	K936194
Product Code:	FCG

Reference device:

Proprietary Name:	Surgineedle™ Pneumoperitoneum Needle
Common/Usual Names:	Pneumoperitoneum Needle
Regulation number:	21 CFR 876.1500
Classification Name:	Endoscope and accessories
Class:	II
510(k) number:	K863330
Product Code:	FHO

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5.4 Device Description

Technological Characteristics ર્સ્ટ

Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are delivered with the trocar stylet inserted in the needle (cannula). When the trocar is exchanged to the blunt stylet, the blunt tip protrudes out from the distal end of the needle (cannula) which makes the coaxial needle tip non-traumatic. shielding the surroundings from the sharp needle (cannula tip).

The position of the coaxial needle is monitored using imaging technique. If resistance or hard surface is met when using the device, the blunt tip retracts into the needle (cannula), exposing the sharp needle (cannula) tip and enabling cutting through tissue. The retraction of the blunt tip can be prevented by pressing the proximal part of the stylet (covered by a plastic cap) or the proximal Luer hub on the housing.

After cutting through the tissue with the sharp needle (cannula) and the resistance is reduced, the hollow blunt stylet tip springs back i.e., the non-traumatic tip will once again shield the surrounding tissue from the sharp needle (cannula tip).

When the targeted lesion has been reached, Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle enables biopsy to be performed per normal hospital routines.

The materials used for construction of the needles are typical for this type of medical device. The only material in direct patient contact is stainless steel AISI 304 and stainless steel AISI 302. The needles are designed in accordance with ISO 7864 - Sterile hypodermic needles for single use.

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5.6 Indications for Use

Gangi-SoftGuard Coaxial Needle is intended as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Gangi-HydroGuard Coaxial Needle is intended as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Substantial Equivalence 5.7

AprioMed AB has determined that Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are substantially equivalent to the predicate device based on the Indications for Use, compliance with internationally recognized design and performance standards, material specifications, use environments, and performance. The differences between subject devices and the predicate device used for the same Indications for Use do not raise new issues of safety and effectiveness.

A substantial equivalence comparison table of subject devices, Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle and the predicate device, Bard TruGuide Disposable Coaxial Biopsy Needle (K936194) is provided in Table 5-1.

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Table 5-1: Substantial equivalence table
Parameter	Subject Devices	Predicate Device
Proprietary Name	Gangi-SoftGuard Coaxial NeedleGangi-HydroGuard Coaxial Needle	Bard TruGuide Disposable Coaxial Biopsy Needle
510(k)	This 510(k) application	K936194
Device ClassificationName	Biopsy needle	Biopsy needle
Product Code	FCG	FCG
Regulationdescription	Gastroenterology-Urology BiopsyInstruments	Gastroenterology-Urology BiopsyInstruments
Regulation Number	21 CFR 876.1075	21 CFR 876.1075
Intended Use/Indications for Use	As a guiding needle in obtaining corebiopsy samples from soft tissue such asliver, kidney, spleen, lymph nodes andvarious soft tissue lesions.	The Coaxial biopsy needle guide isintended for use as a guiding needle inobtaining core biopsy samples from softtissue such as liver, kidney, spleen, lymphnodes and various soft tissue lesions.
Device type	Coaxial introducer needle with a springloaded blunt tip stylet/hollow blunt tip stylet	Coaxial introducer needle with a blunt tipstylet
Visualizationtechnique	Conventional imaging guidance equipmentexcluding MRI	Conventional imaging guidance equipmentexcluding MRI
Single Use	Yes	Yes
Sterile	Yes, Ethylene Oxide	Yes, Ethylene Oxide
Needle material	Stainless Steel	Stainless Steel
Needle Hub	Luer	Luer
Needle size	Gangi-SoftGuard Coaxial Needle:12G-17G7,1-17,1 cmGangi-HydroGuard Coaxial Needle:15G-17G12,1-17,1 cm	11G-19G7.0-17.8 cm
Needle penetrationdepth	17.1 cm free length	17.8 cm free length
Anatomical sites	Liver, kidney, spleen, lymph nodes andvarious soft tissue lesions	Liver, kidney, spleen lymph nodes andvarious soft tissue lesions

Table 5-1: Substantial equivalence table

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5.7.1 Intended Use/Indication for Use

AprioMed has determined that the intended use of Gangi-HydroGuard and Gangi-SoftGuard coaxial biopsy needle are substantially equivalent to the predicate device.

5.7.2 Materials

AprioMed has determined that the Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are substantially equivalent to the predicate device based on materials. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle and the predicate is constructed with medical grade stainless steel. Gangi Coaxial Needle material also fulfill the, by FDA, recognized consensus standard, ISO 9626 Stainless Steel Needle Tubing for the Manufacture of Medical Devices.

5.7.3 Use Environment

Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle is intended to be used in a standard clinical setting for percutaneous imaging-guided biopsy sampling excluding in Magnetic Resonance Imaging (MRI) equipment. The users are physicians trained in percutaneous image-guided biopsy sampling of soft tissue. AprioMed has determined that Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are substantially equivalent to the predicate device based on the use environment.

5.7.4 Size, stylet size and penetration depth

AprioMed has determined that the sizes, stylet size and penetration depth of Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle is substantially equivalent to the predicate device.

5.7.5 Tip design

AprioMed has determined that the tip design of Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle is substantially equivalent to the predicate device.

5.7.6 Penetration force

AprioMed has determined that Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are substantially equivalent to the predicate device with respect to needle penetration.

5.7.7 Safety Features

AprioMed believes that Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle is substantially equivalent to the predicate device in respect to safety features. Neither Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle nor the predicate has any specific safety features.

Summary of non-clinical and performance testing 5.8

Testing in the form of bench testing was performed to evaluate the performance and functionality to evaluate the device against requirements specification. The devices have been subjected to compliance testing to voluntary standards e.g. ISO 7864, ISO 9626, ISO 10993-7, ISO 10993-1, ISO 11607-1.

Results from verification and validation testing demonstrates that conformance to applicable technical requirements specification and user needs have been met and substantial equivalence has been demonstrated.

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5.8.1 Biocompatibility testing

The material used in Gangi-SoftGuard Coaxial Needle and Gang-HydroGuard Coaxial Needle has been tested for biocompatibility in accordance with ISO 10993 for externally communicating devices in contact with tissue for 24 hours or less. The material in direct patient contact is the cannula needle and stylets made of stainless steel AISI 304 and stainless steel AISI 302. Gangi-SoftGuard Coaxial Needle and Gang-HydroGuard Coaxial Needle have successfully been tested for:

Cytotoxicity ।
Sensitization ।
Intracutaneously irritation -
Acute Systemic Toxicity -
-Pyrogenicity

The test results verify that the biocompatibility criteria given in ISO 10993 are fulfilled. AprioMed concludes that Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle is non-toxic and biocompatible.

5.8.2 Performance testing - Bench

5.8.2.1 Qualification metal tubing

The stainless-steel tubing is qualified in compliance with ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods, and conformity demonstrated.

Qualification of Needle component 5.8.2.2

The needle used for Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are qualified in compliance with ISO7864:2016 Sterile hypodermic needles for single use -Requirements and test methods.

5.8.2.3 Conical Fittings

The Luer lock fittings used for Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are qualified in compliance with ISO 594 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment, and conformity demonstrated.

5.8.2.4 Mechanical performance

The mechanical performance testing of Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has passed all design requirements.

5.8.2.5 Verification of penetration force and spring

The penetration force and the spring force have been evaluated and passed all design requirements.

Summary and Conclusion 5.9

Based on the above discussion, the non-clinical testing supports the safety of the device and demonstrates that the Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle should perform as intended in the specified use conditions. The data supports the substantial equivalence determination between the Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle and the predicate device.

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. 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 § 876.9.