GRAFTSITE is 28.25 cm in length with an inner diameter of 2.6 mm and an outer diameter of 4.0 mm, sized to fit down the hamstring harvest site. It is rounded and blocked at the patient end and has a 6% female luer at the user end. There are lateral eyes over a length at the patient end of the catheter. A buttoned stylet consisting of a rigid stainless steel rod of diameter slightly less than the bore of the catheter, functions to stiffen the device. GRAFTSITE can be used to directly administer a bolus of the users chosen local anesthetic, via injection down the lumen of the catheter, into the terminus of the gutter at the site of comorbidity.

AI/ML Overview

The provided text describes the GRAFTSITE Local Anesthetic Delivery Assistance Device. It details the device's characteristics and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

1. Table of acceptance criteria and the reported device performance

Since this is a non-clinical submission, the "acceptance criteria" are the ability to perform equally well as the predicate device in specific non-clinical tests. The "reported device performance" refers to the successful completion of these tests.

Acceptance Criteria (Test)	Reported Device Performance
Pressure testing of the catheter/hub for resistance to liquid leakage (EN 1618 and ISO 594-2)	GRAFTSITE performed equally well to the predicate.
Tensile bond performance of the catheter/hub and stylet/button (BS 6196 and EN 1618)	GRAFTSITE performed equally well to the predicate.
Corrosion resistance of the stylet (EN 1618)	GRAFTSITE performed equally well to the predicate.
Flow rate of the catheter (EN 1618)	GRAFTSITE performed equally well to the predicate.
Radio-opacity of the catheter (ASTM F640-12)	GRAFTSITE performed equally well to the predicate.
Human factors/usability validation	GRAFTSITE was proven to be usable in a cadaveric usability investigation and did not raise different questions of safety and effectiveness when compared to the predicate.
Biocompatibility (ISO 10993-1 and FDA guidance)	Biocompatibility testing on the fully finished device demonstrated that GRAFTSITE is biocompatible in relation to its intended use. This included cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, particulate analysis, hemolysis, and endotoxin testing.
Gamma irradiation validation (ISO 11137-1 and ISO 11137-2)	Validation using the VDmax25 method was successful in eliciting no growth for a routine processing dose of 25-40kGy and giving a SAL of 10-6 (in accordance with EN 556).

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

The document does not provide specific numerical sample sizes for each test set (e.g., number of devices tested for flow rate). However, it states that "GRAFTSITE was directly compared to the predicate in comparative performance tests" and that "comparative in vitro testing was performed, with the results for GRAFTSITE compared to the predicate."

The data provenance is not explicitly stated in terms of country of origin but is implicitly from the manufacturer, Summit Medical Ltd. in the United Kingdom. The tests performed are non-clinical (in vitro and cadaveric usability), not human clinical studies, so the terms "retrospective" or "prospective" are not applicable in the same way they would be for patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are physical and mechanical performance evaluations against established standards, and a cadaveric usability study. While the cadaveric study would involve experts (e.g., surgeons/clinicians), the document does not specify their number or qualifications as ground truth experts for a diagnostic algorithm.

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

This is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, and a cadaveric usability study. There's no "ground truth" to be adjudicated in the sense of medical image interpretation or diagnosis.

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

No MRMC comparative effectiveness study was done. This device is a local anesthetic delivery assistance device, not an AI-powered diagnostic or interpretive tool.

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

No standalone algorithm performance study was done. This device does not involve an algorithm.

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

The "ground truth" for the non-clinical tests were established engineering and medical device performance standards (e.g., EN 1618, ISO 594-2, BS 6196, ASTM F640-12, ISO 10993-1, ISO 11137-1, ISO 11137-2). For the usability study, the ground truth was the ability to perform the intended function in a cadaveric model.

8. The sample size for the training set

This is not applicable since the device does not employ machine learning or AI models, and therefore does not have a "training set."

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

This is not applicable as there is no training set for this device.

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.

May 18, 2018

Summit Medical Ltd. Robyn Cochrane RA Executive - Projects Industrial Park Bourton on the Water Gloucestershire GL54 2HO United Kingdom

Re: K173110

Trade/Device Name: Graftsite Local Anesthetic Delivery Assistance Device Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: April 2, 2018 Received: April 2, 2018

Dear Robyn Cochrane:

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

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental 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) K173110

Device Name

GRAFTSITE Local Anesthetic Delivery Assistance Device

Indications for Use (Describe) Assistance in the delivery of local anaesthetic after hamstring ligament reconstruction 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)

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510(k) Summary – K173110 Summit Medical Ltd GRAFTSITE

Summit Medical Ltd.

Part of the OrthoD Group

Head Office Industrial Park Bourton-on-the-Water GL54 2HQ United Kingdom

tel: +44 (0) 1451 821 311 email: info@orthod.com website: www.orthod.com

Date prepared	17/May/2018
Submitter	Summit Medical Ltd
Contact person	Robyn CochraneProject ManagerSummit MedicalIndustrial ParkBourton-on-the-WaterGloucestershireGL54 2HQPhone: + 44(0)1451 823357Fax: +44 (0)1451 821092Email: robyn.cochrane@orthod.com
Name of device	GRAFTSITE Local Anesthetic Delivery Assistance Device
Classification	Classification - IIProduct Code - BSPClassification name – Anesthesia conduction needleClassification Rule - 868.5150Device Panel – 73 - “Anesthesiology”
Predicate device(s)	Pajunk® “Unipolar Needles”, initially cleared under K000722 andsubsequently cleared under part of Special 510(k) K053283(under new trade name UniPlex NanoLine cannula).
Indications for use	GRAFTSITE Indications for Use Statement - "Assistance in thedelivery of local anaesthetic after hamstring harvest duringligament reconstruction procedures."The Indications for Use statement of GRAFTSITE is different tothat of the predicate device - "The PAJUNK needles are used topuncture the tissue in order to gain entry and locally injectanesthetics to induce regional anesthesia. An electrical stimulusmay be applied to the needle via a cable and connector to assistthe physician pinpoint the area of application." due toGRAFTSITE having a more limited depiction of use compared tothat of the predicate.GRAFTSITE has a catheter round and blocked at the patient endas is not required to puncture tissue to gain entry, due to the

	method of access being through the already present femoralgutter, compared to the predicate that requires a puncturing tipat the end of the cannula in order to pierce the skin for nerveaccess. Therefore, this difference does not raise differentquestions of safety and effectiveness.
	GRAFTSITE is used for inducing regional anesthesia byassisting in the injection of anesthetics like the predicate, it justhas a more limited depiction of use to only after hamstringharvest during ligament reconstruction procedures. Insubsequent clearance K053283 it states that PAJUNK Unipolarneedles (initially cleared under K000722) are marketed as singleshot needles under the trade name UniPlex and that theanesthesia conduction catheter allows for bolus injections orcontinuous infusion of local anesthetics. This shows thepredicate can be used for the same intended purpose asGRAFTSITE, assisting in delivery of a bolus of anesthetic,therefore this does not raise different questions of safety oreffectiveness.
	GRAFTSITE does not require the physician to pinpoint the areaof application via electrical stimulus, as it fulfils its intended usethrough localization of anesthetic directly to nerve endingswithin, and surrounding, the comorbidities at the already femoralgutter, compared to the predicate which utilizes nerve stimulationto localize the more proximal nerve sheath. Therefore, thisdifference does not raise different questions of safety andeffectiveness.
Device description	GRAFTSITE is 28.25 cm in length with an inner diameter of 2.6mm and an outer diameter of 4.0 mm, sized to fit down thehamstring harvest site. It is rounded and blocked at the patientend and has a 6% female luer at the user end. There are lateraleyes over a length at the patient end of the catheter. A buttonedstylet consisting of a rigid stainless steel rod of diameter slightlyless than the bore of the catheter, functions to stiffen the device.GRAFTSITE can be used to directly administer a bolus of theusers chosen local anesthetic, via injection down the lumen ofthe catheter, into the terminus of the gutter at the site ofcomorbidity.
Non-clinical testing	Based on the characteristics identified as relevant fromperformance standards, GRAFTSITE was directly compared tothe predicate in comparative performance tests.
	Testing performed in order to verify substantial equivalenceincluded:

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Pressure testing of the catheter/hub for resistance to ● liquid leakage (in accordance with EN 1618 and ISO 594-2) Tensile bond performance of the catheter/hub and . stylet/button (in accordance with BS 6196 and EN 1618) Corrosion resistance of the stylet (as per EN 1618) ● . Flow rate of the catheter (in accordance with EN 1618) Radio-opacity of the catheter (in accordance with ASTM ● F640-12) Human factors/usability validation of the device ● GRAFTSITE performed equally well in all performed tests necessary to demonstrate that it is substantially equivalent to the predicate. The catheter luer hub is manufactured in accordance with EN1707/ISO 594-2 and BS EN 20594-1/ISO 594-1. Further testing specific to ISO 594-1/ISO 594-2 was not required due to the following; Gauging testing - no axial force applied during intended ● use . Air leakage during aspiration - no aspiration during intended use . Separation force - no axial force applied during intended use . Stress cracking - limited stress applied during intended duration of use (≤1 minute) Unscrewing torque - no unscrewing torque applied during . intended use Ease of assembly - no axial or rotational force applied . during intended use . Resistance to overriding - no torque applied during intended use In addition, the requirement for a compliant 6% luer syringe, in accordance with ISO 594-2, to be used in conjunction with the device is indicated to users in the IFU. Biocompatibility testing on the fully finished device demonstrated that GRAFTSITE is biocompatible in relation to its intended use in accordance with ISO 10993-1 and the FDA guidance document on that standard, and is therefore determined to be

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	biocompatible within a risk management process. This testprocess included cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, material-mediated pyrogenicity, particulate analysis, hemolysis, andendotoxin testing.
	Gamma irradiation validation using the VDmax25 method, inaccordance with ISO 11137-1 and ISO 11137-2, was successfulin eliciting no growth for a routine processing dose of 25-40kGyand giving a SAL of 10-6 (in accordance with EN 556).
Clinical testing	Clinical data was not required to establish substantialequivalence between GRAFTSITE and the predicate device.
Physical differences	Both GRAFTSITE and the predicate are constructed ofestablished, clinically used materials, with confirmatorybiocompatibility testing verifying this.
	The catheter being rounded and blocked at the patient end isdue to the method of access being through the already presentfemoral gutter, compared to the predicate that requires apuncturing tip at the end of the cannula in order to pierce theskin to access the femoral nerve.
	The length of the catheter is significantly longer due to therequirement for placement at the terminus of the proximalfemoral gutter compared to the predicate, which typically onlyrequires access 2 – 3cm below the skin.
	The stainless steel stylet assembly of GRAFTSITE providesrigidity to the catheter upon insertion compared to the predicatewhich has a rigid stainless steel cannula for insertion
	The presence of a stimulator cable with the predicate is due tothe indications for use (i.e. for the localization of peripheral nervebundles through nerve stimulation). GRAFTSITE is not indicatedfor peripheral nerve stimulation.
	Comparative in vitro testing was performed, with the results forGRAFTSITE compared to the predicate, which showed thatthere were no different questions of safety and effectivenessraised.
Handlingdifferences	Whilst the predicate is of a clinically standard technique,GRAFTSITE was proven to be usable in a cadaveric usabilityinvestigation, and did not raise different questions of safety andeffectiveness when compared to the predicate
Chemicaldifferences	Both GRAFTSITE and the predicate are constructed ofestablished, clinically used materials, with confirmatorybiocompatibility testing verifying this. Comparative in vitro testingwas performed, with the results for GRAFTSITE compared to thepredicate.
Substantialequivalence	Based on the similarities in design, function, indications for useand fundamental scientific technology, the subject devices of thissubmission is similar to the predicate device and does not raisedifferent questions of safety and effectiveness. Therefore,Summit Medical concludes that the subject device, GRAFTSITE,is substantially equivalent to the predicate device.

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Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).