RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use.

The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards.

RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration.

Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in sterile and non-sterile packaging.

Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging.

The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths.

Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging.

AI/ML Overview

The provided text is a 510(k) summary for medical devices (spinal and epidural needles) and does not describe the acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical performance testing (biocompatibility, functional, sterilization).

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from this document as it pertains to a different type of medical device assessment.

Summary

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September 29, 2021

MYCO Medical Supplies, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Ave. Crofton, Maryland 21114

Re: K203668

Trade/Device Name: RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: August 30, 2021 Received: August 31, 2021

Dear E.J. Smith:

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. Although this letter refers to your product as a device, please be aware 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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Todd Courtnev Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known)

Device Name

RELI® NRFit® Spinal Needles, RELI® NRFit®Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles

Indications for Use (Describe)

Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

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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510k Summary K203668

SPONSOR
Company Name:	MYCO Medical
Company Address:	2015 Production Drive
	Apex, NC 27539
Telephone:	919-460-2535
Contact Person:	Sanjiv Kumar
Summary Preparation Date:	September 24, 2021
DEVICE NAME
Trade Name:	RELI® NRFit® Spinal Needles, RELI® NRFit® EpiduralNeedles, Phoenix NRFit® Spinal Needles, and PhoenixNRFit® Epidural Needles
Common/Usual Name:	Needle, Hypodermic, Single Lumen
Classification Name:	Anesthesia Conduction Needle
Regulation Number:	21 CFR 868.5150
Product Code:	BSP
Device Class:	II

PREDICATE DEVICE

Legally Marketed Equivalent Devices

	K Number	Brand Name	Manufacturer
Primary	K183316	Dr J Spinal and Epidural Needles	Dr. Japan
Reference	K990519	Dr. Japan's Phoenix Brand Spinal and Epidural Needles	Myco Medical Supplies, Inc.
Reference	K142553	UNIEVER Disposable Epidural AnesthesiaNeedle, UNIEVER Disposable Nerve Blocked	Unisis Corp.

DEVICE DESCRIPTION

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sterile and non-sterile packaging.

DEVICE INDICATIONS FOR USE

Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

	Subject NewDeviceMyco MedicalSupplies, Inc.	PrimaryPredicateDr. Japan	ReferencePredicateMyco MedicalSupplies, Inc.	ReferencePredicate UnisisCorp.	SimilaritiesandDifferences
K Number		K183316	K990519	K142553
Brand Name	RELI® NRFit® SpinalNeedles, RELI®NRFit® EpiduralNeedles, PhoenixNRFit® SpinalNeedles, andPhoenix NRFit®Epidural Needles	Dr J Spinal andEpidural Needles	Dr. Japan's PhoenixEpidural and SpinalNeedles	UNIEVER DisposableEpidural AnesthesiaNeedle, UNIEVERDisposable NerveBlocked Needle
RegulationDescription	Anesthesiaconduction needle	Anesthesiaconduction	Anesthesiaconduction needle	Anesthesiaconduction needle	Same
Regulation No.	21 CFR 868.5150	21 CFR 868.5150	21 CFR 868.5150	21 CFR 868.5150	Same
Product Code	BSP	BSP	BSP	BSP	Same

COMPARISON OF TECHNILOGICAL CHARACTERISTICS

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	Subject NewDeviceMyco MedicalSupplies, Inc.	PrimaryPredicateDr. Japan	ReferencePredicateMyco MedicalSupplies, Inc.	ReferencePredicate UnisisCorp.	SimilaritiesandDifferences
Indications forUse	Spinal and Epiduralneedles are to beused to inject localanesthetics into apatient to provideregional anesthesia.	Dr. J Spinal andEpidural needlesare intended tobe used forinjection of localanesthetics into apatient toprovide regionalanesthesia	Spinal and Epiduralneedles are to beused to inject localanesthetics into apatient to provideregional anesthesia	The UnieverDisposable EpiduralAnesthesia Needle isintended to be usedfor injection into theepidural space / orplacing the epiduralcatheter into theepidural space.Uniever DisposableNerve BlockadeNeedle is intended tobe used for injectionof local anestheticagent near the nervefor temporary paincontrol.	Same
Device Design
Needle Hub	NRFit® connectorconforming to ISO80369-6 forneuraxial device	Hub luer taperconnectorconforming toISO 80369-7	Hub luer taperconnectorconforming to ISO594	Hub luer taperconnectorconforming to ISO594	DifferentThe subjectdevice differsfrom thepredicates onlyin hubdimensions. ISO80369-6specifies a 6%taper hub vs. 5%taper hub in ISO80369-7 (ISO594).
	Subject NewDeviceMyco MedicalSupplies, Inc.	PrimaryPredicateDr. Japan	ReferencePredicateMyco MedicalSupplies, Inc.	ReferencePredicate UnisisCorp.	SimilaritiesandDifferences
OperatingPrinciple, SpinalNeedle	Spinal anesthesia isa form of regionalanesthesia involvingthe injection of alocal anesthetic intothe subarachnoidspace through aspinal needle.Regardless of theanesthetic agentused, the desiredeffect is to block thetransmission ofafferent nervesignals fromperipheralnociceptors. Sensorysignals from the siteare blocked, therebyeliminating pain.Spinal anestheticsare typically limitedto proceduresinvolving moststructures below theupper abdomen. Toadminister a spinalanesthetic to higherlevels may affectthe ability tobreathe byparalyzing theintercostalrespiratory muscles,or even thediaphragm inextreme cases, aswell as the body'sability to controlthe heart rate viathe cardiacaccelerator fibers.	Spinal anesthesiais a form ofregional anesthesiainvolving theinjection of a localanesthetic intothe subarachnoidspace through aspinal needle.Regardless of theanesthetic agentused, the desiredeffect is to block thetransmission ofafferent nervesignals fromperipheralnociceptors.Sensory signalsfrom the site areblocked, therebyeliminating pain.	Spinal anesthesia is aform of regionalanesthesia involvingthe injection of alocal anesthetic intothe subarachnoidspace through aspinal needle.Regardless of theanesthetic agent used,the desired effect isto block thetransmission ofafferent nerve signalsfrom peripheralnociceptors. Sensorysignals from the siteare blocked, therebyeliminating pain.Spinal anestheticsare typically limitedto proceduresinvolving moststructures belowthe upper abdomen.To administer aspinal anesthetic tohigher levels mayaffect the ability tobreathe byparalyzing theintercostalrespiratory muscles,or even thediaphragm inextreme cases, aswell as the body'sability to control theheart rate via thecardiac acceleratorfibers.	Spinal anesthesia is aform of regionalanesthesia involvingthe injection of alocal anesthetic intothe subarachnoidspace through a spinalneedle. Regardless ofthe anesthetic agentused, the desiredeffect is to block thetransmission ofafferent nerve signalsfrom peripheralnociceptors. Sensorysignals from the siteare blocked, therebyeliminating pain.Spinal anestheticsare typically limitedto proceduresinvolving moststructures below theupper abdomen. Toadminister a spinalanesthetic to higherlevels may affect theability to breathe byparalyzing theintercostalrespiratory muscles,or even thediaphragm inextreme cases, aswell as the body'sability to control theheart rate via thecardiac acceleratorfibers.	Same
	Subject NewDeviceMyco MedicalSupplies, Inc.	PrimaryPredicateDr. Japan	ReferencePredicateMyco MedicalSupplies, Inc.	ReferencePredicate UnisisCorp.	SimilaritiesandDifferences
OperatingPrinciple,Epidural Needle	Epidural anesthesiais a regionalanesthesia thatblocks pain in aparticular region ofthe body. Anepidural needle isused to inject localanesthetic agent intothe epidural space ofthe spinal cord toblock the pain. Toprovide continuousepidural anesthesia,a small hollowcatheter is threadedthrough the epiduralneedle into theepidural space andleft there while theneedle is removed.	Epiduralanesthesia is aregional anesthesiathat blocks pain inaparticular region ofthe body. Anepidural needle isused to inject localanesthetic agentinto the epiduralspace of the spinalcord to block thepain. To providecontinuousepiduralanesthesia, a smallhollow catheter isthreaded throughthe epidural needleinto the epiduralspace and leftthere while theneedle is removed.	Epidural anesthesia isa regional anesthesiathat blocks pain in aparticular region ofthe body. An epiduralneedle is used toinject local anestheticagent into theepidural space of thespinal cord to blockthe pain. To providecontinuous epiduralanesthesia, a smallhollow catheter isthreaded through theepidural needle intothe epidural spaceand left there whilethe needle isremoved.	Epidural anesthesiais a regionalanesthesia thatblocks pain in aparticular region ofthe body. Anepidural needle isused to inject localanesthetic agentinto the epiduralspace of the spinalcord to block thepain. To providecontinuous epiduralanesthesia, a smallhollow catheter isthreaded throughthe epidural needleinto the epiduralspace and left therewhile the needle isremoved.	Same
IntendedPatientPopulation	Adult and child	Adult and child	Adult and child	Not Specified	Same, thoughUnisis devicepatientpopulation isnot specified.
Material Specifications
Needle/Cannulamaterial	Cold-rolled stainlesssteel(JIS G4305-SUS304)	Cold-rolledstainless steel(JIS G4305-SUS304)	Cold-rolled stainlesssteel(JIS G4305-SUS304)	Stainless steelSUS304	Same
Cannula depthmarkings	The system tocause a chemicalchange of themetal ion on thesurface to a blackcolor byelectrolysis withoutchanging thematerial ofcannula.	The system tocause a chemicalchange of themetal ion on thesurface to a blackcolor byelectrolysiswithout changingthe material ofcannula.	The system to causea chemical changeof the metal ion onthe surface to ablack color byelectrolysis withoutchanging thematerial of cannula.	Cannula depthmarkings arepresent	Same
Stylet material	Stainless steelwire for spring (JISG4314-SUS304)	Stainless steelwire for spring(JIS G4314-SUS304)	Stainless steel wirefor spring (JISG4314-SUS304)	Plastic	SameDifferent forUnisis EpiduralNeedle
Hub material	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate	Same
	Subject NewDeviceMyco MedicalSupplies, Inc.	PrimaryPredicateDr. Japan	ReferencePredicateMyco MedicalSupplies, Inc.	ReferencePredicate UnisisCorp.	SimilaritiesandDifferences
Gaugelength/colordepiction	Per ISO 6009	Per ISO 6009	Per ISO 6009	Per ISO 6009	Same
Plunger/Stylet Hub	Polycarbonate	Polycarbonate	Polycarbonate	Polycarbonate	Same
Final Needleassemblyprotection	Protector(polyethylene)	Protector(polyethylene)	Protector(polyethylene)	Protective Sheath	Same
SterilizationMethod	Supplied Sterile viaEtO and Non-sterileintended to besterilized via EtOprior to end use.•ISO 11135•SAL 10-6•Maximum EOresidual levelscomply withISO 10993-7	Sterile EO (=ETO)per ISO11135:2014SAL 10-6Maximum EOlevels complywithISO 10993-7:2008	Sterile via EtO	Sterile via EtO	Same

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Discussion of Technological Differences

Similarities

The intended use statement, indications for use, technical specifications and descriptions of the needle, materials used, sterilization method and sterility assurance level, and biocompatibility are identical to predicate device previously cleared.

Differences

The only difference between the predicate devices and the subject device is the design of the needle´s hub. The predicate device was cleared with a hub luer taper connector conforming to ISO 594. The subject devices are equipped with a NRFit connector conforming to ISO 80369-6 for neuraxial devices. The subject device removes a brass bush/washer component that was part of the predicate device detachable wing Tuohy (Huber point) Epidural needle hub. The NRFit® Spinal and Epidural needle hubs for the subject device are composed of the same polycarbonate material as the predicate device. The difference of the needle's hub design raises no issues of safety and effectiveness.

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Subject Device			Primary Predicate DeviceK183316			Reference Predicate DeviceK990519
Spinal Needles			Spinal Needles			Spinal Needles
Gauge	LengthInches	TipConfiguration	Gauge	LengthInches	TipConfiguration	Gauge	LengthInches	TipConfiguration
20 – 27	2.5 - 5	Pencil Point	25 - 27	3.5	Pencil Point	22 - 27	1.5 – 5	Pencil Point
18 – 29	1.5 – 8	Quincke (K-3 Point)	18 – 27	3.5	Quincke (K-3 Point)	18 – 29	1 – 7	Quincke (K-3 Point)

Comparison Table of Spinal Needles

These range of gauge sizes offered fall within the ranges of identified predicates. The range of RELI® NRFit® and Phoenix NRFit® Spinal Needle length has been expanded based on engineering drawings and to meet clinical requirements for the patient population. These additional line items raise no new issues of safety and effectiveness.

Comparison Table of Epidural Needles

	Subject Device			Primary Predicate DeviceK183316			Reference Predicate DeviceK142553
	Epidural Needles		Epidural Needles			Epidural Needles
	Length	Tip		Length	Tip		Length	Tip
Gauge	Inches	Configuration	Gauge	Inches	Configuration	Gauge	Inches	Configuration
16 – 22	2.5 - 6	Tuohy(Huber)	16 – 20	3.5	Tuohy(Huber)	14 - 25	1 - 6	Tuohy (Huber)

All the gauge sizes and lengths offered for the RELI® NRFit® and Phoenix NRFit® Epidural Needles fall within the ranges for standard epidural needles offered by the identified predicates. These additional line items raise no new issues of safety and effectiveness.

PERFORMANCE TESTING - NON-CLINICAL

The following biocompatibility and functional performance testing were conducted on the RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles:

Biocompatibility

Spinal Needles are classified as External communicating device, Blood path, indirect Limited (<24h).

Epidural Needles are classified as External communicating device, Tissue contact, Limited (<24h).

Testing per ISO 10993-1:2018
Cytotoxicity	Per ISO 10993-5, Non-Cytotoxic
Sensitization	Per ISO 10993-10, Non-Sensitizer
Intracutaneous Reactivity	Per ISO 10993-10, Non-Irritant
Acute Systemic Toxicity	Per ISO 10993-11, Non-Toxic
Material MediatedPyrogenicity	Per ISO 10993-11 and USP <151>, Non-Pyrogenic
Hemocompatibility	Per ISO 10993-4, Non-Hemolytic
Chemical Characterization	Per ISO 10993-18, acceptable extractables/leachables profile

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Performance Testing

Functional Test	Test Standard
Stability Test Bonding to Hub	Per ISO 7864:2016
Penetration Force and Drag Force for Needles	Per ISO 7864:2016
Breakage Test	Per ISO 9626:2016
Stability Test Bending Rigidity	Per ISO 9626:2016
Positive pressure leakage	Per ISO 80369-6:2016
Resistance to separation from axial load	Per ISO 80369-6:2016
Resistance to separation from unscrewing	Per ISO 80369-6:2016
Resistance to overriding	Per ISO 80369-6:2016
Stress Cracking	Per ISO 80369-6:2016

Additional Testing Standards

Test	Standard
Particulate Matter	USP <788>
LAL Endotoxin	AAMI 72, USP <85>, ≤ 2.15 EU/device

Sterilization and Shelf Life

Parameters	Responses
Method of Sterilization	EtO
Method of Validation	ISO 11135-1
Sterility Assurance Level (SAL)	10-6
Pyrogen Testing	ISO 10993-11
Maximum Levels of Residues of EO, Ethylene Glycol and Ethylene Chlorohydrin
EtO	below allowable limits per ISO 10993-7
ECH	below allowable limits per ISO 10993-7
Shelf Life
2-Years

CONCLUSION

The subject device and the predicate have the same intended use and the technological differences do not raise different questions of safety and effectiveness. Based upon the intended use, principles of operation, materials, technology characteristics and safety performance testing it is the conclusion of MYCO Medical Supplies, Inc., that the RELI® NRFit® Spinal Needles, RELl® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are substantially equivalent to the predicate device.

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).