The Portex® Lancet Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The Portex® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

Device Description

The PORTEX® Lancet Point Spinal Needle with NRFit™ connectors and PORTEX® Pencil Point Spinal Needles with NRFit™ connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

The NRFit ™ connectors conform to ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications. The connectors are not compatible with standard luer connectors which is intended to reduce the risk of misconnection that may result in the infusion of medications not intended for neuraxial or regional anesthetic use.

The PORTEX® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended for neuraxial or regional anesthetic delivery.

This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors.

AI/ML Overview

The provided text details the non-clinical testing performed to demonstrate substantial equivalence for the Portex® Lancet Point Spinal Needles and Portex® Pencil Point Spinal Needles with NRFit™ connectors to their predicate devices. This is a premarket notification (510(k)) to the FDA, which focuses on demonstrating substantial equivalence rather than proving device efficacy from scratch.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for functional performance tests are primarily based on ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. While specific numerical acceptance criteria are not explicitly detailed in the summary, the document states that "All testing met pre-established specifications," implying adherence to the pass/fail criteria outlined in the referenced ISO standards.

Category	Evaluation	Test Criteria (Acceptance Criteria)	Reported Device Performance
Functional Performance	Resistance to overriding	ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted overriding according to the ISO standard.
	Resistance to separation from axial load	ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted separation from axial load according to the ISO standard.
	Resistance to separation from unscrewing	ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted separation from unscrewing according to the ISO standard.
	Leakage by Pressure Decay	ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the leakage by pressure decay requirements of the ISO standard.
	Subatmospheric Pressure	ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the subatmospheric pressure requirements of the ISO standard.
	Stress Cracking	ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully resisted stress cracking according to the ISO standard.
	Verifying Non-interconnectable characteristics (physical force)	ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device successfully demonstrated non-interconnectable characteristics according to the ISO standard.
Packaging	Package integrity, sterile barrier	ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the sterile barrier and packaging integrity requirements of ISO 11607.
Sterilization	Sterility	ISO 11135, Sterilization of health care products - Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the sterility requirements of ISO 11135.
	Residuals	ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device met the ethylene oxide sterilization residuals requirements of ISO 10993-7.
Biocompatibility	Intracutaneous Reactivity	ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable intracutaneous reactivity as per ISO 10993-10.
	Systemic Toxicity	ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable systemic toxicity as per ISO 10993-11.
	Sensitization	ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable sensitization as per ISO 10993-10.
	Cytotoxicity	ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable cytotoxicity as per ISO 10993-5.
	Genotoxicity, carcinogenicity and reproductive toxicity	ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable genotoxicity, carcinogenicity, and reproductive toxicity as per ISO 10993-3.
	Leachable substances	ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable leachable substances as per ISO 10993-17.
	Chemical characterization of materials	ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable chemical characterization as per ISO 10993-18.
	Bacterial endotoxins	ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable bacterial endotoxins levels as per ANSI/AAMI ST72.
	Particulate matter	USP 788, Particulate Matter in Injections	"All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended." This implies the device demonstrated acceptable particulate matter levels as per USP 788.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests as summarized in "Table 2: Summary of Non-Clinical Testing" and described in Section 7 of the document. These tests evaluated the functional performance of the NRFit™ connectors, packaging integrity, sterilization effectiveness, and biocompatibility of the materials.

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

The document does not specify the exact sample sizes used for each of the non-clinical tests. It states that "various configurations" of the spinal needles were included. The data provenance is also not explicitly stated in terms of country of origin, nor whether it was retrospective or prospective. Given it's non-clinical testing (bench testing, lab tests), these details are typically less relevant than for clinical trials. The tests were performed in a controlled laboratory environment.

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

This information is not applicable to this type of submission. The ground truth for non-clinical performance and biocompatibility tests is established by adherence to recognized international and national standards (e.g., ISO, ANSI/AAMI, USP). There are no "experts" in the sense of clinicians establishing a "ground truth" on patient data for this kind of engineering and laboratory testing.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on objective measurements against pre-defined engineering and biological standards, not subjective assessments requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tools where human readers interpret results, and the AI's impact on their performance is being evaluated. This submission concerns spinal needles, which are physical medical devices, not an AI or diagnostic algorithm, so an MRMC study is not relevant here.

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

This question is not applicable as the device is a physical medical instrument (spinal needle), not a software algorithm or an AI.

7. The Type of Ground Truth Used

For this submission, the "ground truth" is defined by established international and national standards (e.g., ISO 80369-6, ISO 11607, ISO 11135, ISO 10993 series, ANSI/AAMI ST72, USP 788). The device's performance is compared against the requirements and specifications outlined in these standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device and its non-clinical testing. Training sets are used in machine learning and AI development, which is not relevant here.

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

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Smiths Medical ASD, Inc. Sunita Teekasingh Senior Principal Regulatory Affairs Specialist Vascular Access and Infusion Regulatory Affairs Interim Manager 6000 Nathan Lane North Minneapolis, Minnesota 55442

Re: K172800

Trade/Device Name: Portex® Lancet Point Spinal Needles with NRFit™ connectors Portex® Pencil Point Spinal Needles with NRFit™ connectors Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: MIA Dated: May 11, 2018 Received: May 15, 2018

Dear Sunita Teekasingh:

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 comprehensive regulatory information about medical devices and radiation-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,

Todd D. Courtney -S

Tina Kiang, Ph.D. for 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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Indications for Use

510(k) Number (if known) K172800

Device Name

Portex® Lancet Point Spinal Needles with NRFit™ connectors Portex® Pencil Point Spinal Needles with NRFit™ connectors

Indications for Use (Describe)

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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1. ADMINISTRATIVE INFORMATION

510(k)	K172800
Applicant's NameAnd Address	Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442 USA
Contact Person	Sunita TeekasinghSenior Principal Regulatory SpecialistVascular Access and Infusion Regulatory Affairs Interim ManagerPhone: 763-383-3336Fax: 763-383-3679Email: sunny.teekasingh@smiths-medical.com
Date	June 8, 2018
Regulation No.	21 CFR 868.5150
Regulation Name	Anesthesia conduction needle
Primary ProductCodes	MIA
Classification	Class II
Trade Name	PORTEX® Lancet Point Spinal Needles with NRFit™ connectorsPORTEX® Pencil Point Spinal Needles with NRFit™ connectors

2. REASON FOR SUBMISSION

The purpose of this submission is to make a modification to the currently marketed Smiths Medical PORTEX® Spinal Anesthesia Needles and Introducer Needles, which are being updated to include an ISO 80369-6 compliant connector for neuraxial applications.

	Predicate Device	Subject Devices
Trade Name(s)	PORTEX® Spinal Anesthesia Needlesand Introducer Needles	PORTEX® NRFit™ Spinal Lancet PointNeedlesPORTEX® NRFit™ Spinal Pencil PointNeedles
Regulation No.	21CFR868.5150	21CFR868.5150
Regulation Name	Anesthesia conduction needle	Anesthesia conduction needle
Regulatory Class	II	II
Product Code	MIA	MIA
510(k)	K983858	K172800

3. DEVICE INFORMATION

Reference device - K112515 - Pencan Spinal Needles, Spinocan Spinal Needles, Spinal Introducer Needles. This is used to support the expansion of the indication of withdrawal of cerebrospinal fluid.

4. DEVICE DESCRIPTION

The PORTEX® NRFit™ Spinal Needles are color-coded yellow to indicate medication intended

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510(k) Summary K172800; PORTEX® NRFit™ Spinal

for neuraxial or regional anesthetic delivery.

This Premarket Notification Traditional 510(k) includes various configurations of PORTEX® Lancet Point with NRFit TM connectors and PORTEX® Pencil Point Spinal with NRFit TM connectors. Descriptions of the configurations are provided in the table below.

Device Type	Description
PORTEX® LancetPoint SpinalNeedles withNRFit connectors	The PORTEX® Spinal Lancet Point Needle with NRFit™ connectors are a range of sterile, single use needles, and are for the injection of local anesthetics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
PORTEX® PencilPoint Needles withNRFit™connectors	The PORTEX® Spinal Pencil Point Needle with NRFit™ connectors are a range of sterile, single use needles, and are for the injection of local anesthetics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

5. INDICATIONS FOR USE

Device Type	Description
PORTEX® LancetPoint SpinalNeedles withNRFit connectors	The Portex® Lancet Point Spinal Needles with NRFitTM connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.
PORTEX® PencilPoint Needles withNRFitTMconnectors	The Portex® Pencil Point Spinal Needles with NRFitTM connectors are indicated for the injection of local anesthetics or narcotics to provide regional anesthesia or withdrawal of cerebrospinal fluid when used with compatible components. The intended target population is pediatrics and adults.

6. SUBSTANTIAL EQUIVALENCE DISCUSSION

The Smiths Medical PORTEX® Lancet Point with NRFit ™ connectors and PORTEX® Pencil Point Spinal with NRFit ™ connectors have the same technological characteristics as the predicate devices with the exception of the NRFit TM Connectors.

The Smiths Medical PORTEX® Lancet Point with NRFit ™ connectors and PORTEX® Pencil Point Spinal with NRFit ™ connectors and predicate devices are both designed for the injection of local anesthetics and provide regional anesthesia. They are both made of the same materials, have the same chemical composition, and have the same design features excluding the NRFit TM connector design.

Differences in connector are addressed by ISO 80369-6, intending to reduce risk of misconnections by updating from luer to NRFit™ connectors. Needle gauge of subject device includes a 27 gauge needle in addition to the range of the predicate. Needle length range of the subject device is 38-152 mm and is within a similar range of the predicate device of 50.8-152.4 mm, being 12.8 mm shorter than the predicate. Potential risks associated with the length and gauge differences are addressed through biocompatibility and bench testing and validation and verification data. The differences are not critical to the intended therapeutic use of the device and do not raise different questions of safety and effectiveness of the device when used as labeled.

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A comparative analysis is provided in Table 1.

Characteristic	Predicate DeviceK983858	Subject Device	Discussion
Company	Sims Portex® (SmithsMedical)	Smiths Medical	N/A
FDA ProductCode & CFR	MIA21 CFR 868.5150	MIA21 CFR 868.5150	Same
RegulationName	Anesthesia conduction needle	Anesthesia conduction needle	Same
Regulatory	II	II	Same
TradeName(s)	PORTEX® Spinal AnesthesiaNeedles and IntroducerNeedles	PORTEX® NRFit™ SpinalLancet Point NeedlesPORTEX® NRFit™ SpinalPencil Point Needles	N/A
CommonName	Spinal Anesthesia Needles	Spinal Anesthesia Needles	Same
IndicationsforUse	Spinal needles are indicated forthe injection of localanesthetics into a patient toprovide regional anesthesia.	The Portex® Lancet Pointand Pencil Point SpinalNeedles with NRFit™connectors are indicated forthe injection of localanesthetics or narcotics toprovide regional anesthesiaor withdrawal ofcerebrospinal fluid whenused with compatiblecomponents.The intended targetpopulation is pediatrics andadults.	Similar. Both the subject andpredicate device are indicatedfor the injection of localanesthetics, and to provideregional anesthesia. Theintroduction of the spinalneedles with the NRFitconnectors into the intrathecalspace does not alter the safetyprofile of the subject devices.Both the subject and predicatedevices can be used forcollection of cerebral spinalfluids. The addition of theNRFit connector does notimpact the safety profile whencompared to the predicatedevice. The addition of thenarcotics is an extension ofregional anesthesiaadministration procedures,therefore the safety profileremains the same. The NRFitconnection is a safety featurethat aids in prevention ofinadvertent misconnections.

IndicationsforUse	Spinal needles are indicated forthe injection of localanesthetics into a patient toprovide regional anesthesia.	The Portex® Lancet Pointand Pencil Point SpinalNeedles with NRFitTMconnectors are indicated forthe injection of localanesthetics or narcotics toprovide regional anesthesiaor withdrawal ofcerebrospinal fluid whenused with compatiblecomponents.The intended targetpopulation is pediatrics andadults.	bringing technology to lifeSimilar. Both are indicated forthe injection of localanesthetics, and to provideregional anesthesia.
HospitalLocation Use	ICU/OR	ICU/OR	Same
Characteristic	Predicate DeviceK983858	Subject Device	Discussion
Connector	ISO 594 Luer	ISO 80369-6 NRFit™	ISO 80369-6 NRFit™connector intended to reducerisk of misconnections. Bothmet the requirements of therespective standardsrecognized by FDA.
Tip Design	Pencil, Lancet	Pencil, Lancet	Same
Packaging	Tyvek pouch	Tyvek pouch	Same
Sterility	Sterile, EO	Sterile, EO	Same
Use	Single Use Disposable	Single Use Disposable	Same
Needle Gauge	Pencil: 22-25Lancet: 18-25	Pencil: 22-27Lancet: 22-27	Similar. Needle gauge ofsubject device includes a 27gauge needle in addition tothe range of the predicate.The use of a 27 gaugeneedle is physicianpreference. The use of a 27gauge needle is physicianpreference. The use of a 27gauge needle is physicianpreference. 18-27G SpinalNeedles are also beingoffered by othermanufacturers such as UnisisCorporation (K141126).
Needle Length(mm)	Pencil: 50.8-152.4Lancet: 50.8-152.4	Pencil: 90-152Lancet: 38-152	Similar. Subject devicelength is similar topredicate's length. Theshorter spinal needle is tosatisfy physician preferencewhen using accepted clinicalmethods.
Cannula Material	Stainless steel	Stainless steel	Same
Needle HubMaterial	Polycarbonate	Polycarbonate	Same
Sheath Material	Polyethylene	Polyethylene	Same

Table 1: PORTEX® NRFit™ Spinal Needles

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510(k) Summary K172800; PORTEX® NRFit™ Spinal

Withdrawal of cerebrospinal fluid (CSF) using spinal needles is also indicated for similar devices. Please refer ● to K112515.

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510(k) Summary K172800; PORTEX® NRFit™ Spinal

bringing technology to life

● The differences of the NRFit and Luer connector is a matter of connection. The introduction of the spinal needles to the intrathecal space is not altered and therefore does not raise different questions of safety and effectiveness. Collection of cerebral spinal fluid through the needle with either connector does not change and therefore does not raise different questions of safety and effectiveness. The injection of local anesthetics and narcotics into the intrathecal space require a specific NRFit syringe for use in the neuroaxial procedure. This difference reduces the risk of misconnection. NRFit needles and syringes are designed for neuroaxial procedures and using this system inhibits mis-injection of medications not designed for neuroaxial procedures.

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7. SUMMARY OF NON-CLINICAL TESTING

The PORTEX® Spinal Needles with NRFit™ connectors were evaluated via non-clinical performance testing to demonstrate the devices are substantially equivalent to the predicate devices. All testing met pre-established specifications, and successfully demonstrated that the PORTEX® Spinal Needles with NRFit™ connectors performed as intended. A summary of the evaluation is provided in Table 2.

Category	Evaluation	Test Criteria
FunctionalPerformance	Resistance tooverriding	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
	Resistance toseparation fromaxial load	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
	Resistance toseparation fromunscrewing	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
	Resistance tooverriding	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
	Leakage by PressureDecay	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
	SubatmosphericPressure	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
	Stress Cracking	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
	Verifying Non-interconnectablecharacteristicsphysical force	ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications
Packaging	Package integrity,sterile barrier	ISO 11607, Packaging for terminally sterilized medicaldevices - Part 1: Requirements for materials, sterile barriersystems and packaging systems
Sterilization	Sterility	ISO 11135, Sterilization of health care products - EthyleneOxide - Requirements for development, validationand routine control of a sterilization process formedical devices.
	Residuals	ISO 10993-7, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
Biocompatibility	IntracutaneousReactivity	ISO 10993-10, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
	Systemic Toxicity	ISO 10993-11, Biological evaluation of medical devices -Part 11: Tests for systemic toxicity
	Sensitization	ISO 10993-10, Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
	Cytotoxicity	ISO 10993-5, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
	Genotoxicity,carcinogenicity andreproductive toxicity	ISO 10993-3, Biological evaluation of medical devices -Part 3: Tests for genotoxicity, carcinogenicity, andreproductive toxicity
	Leachablesubstances	ISO 10993-17, Biological evaluation of medical devices -Part 17: Establishment of allowable limits for leachablesubstances
Category	Evaluation	Test Criteria
	Chemical characterization of materials	ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials
	Bacterial endotoxins	ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
	Particulate matter	USP 788, Particulate Matter in Injections

Table 2: Summary of Non-Clinical Testing

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Smiths me

bringing technology to life

8. SUBSTANTIAL EQUIVALENCE CONCLUSION

The evaluation of the Smiths Medical PORTEX® Spinal Lancet Point Needles with NRFit™ connector and the PORTEX® Spinal Pencil Point Needles with NRFit™ connector device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate devices. Device testing met pre-defined acceptance criteria and demonstrated substantial equivalence 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).