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

Q: Who is the manufacturer of Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors?

Smiths Medical Asd, Inc. filed the 510(k) submission for Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors (K172800).

Q: What is the FDA product code for Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors?

MIA. It is classified under 21 CFR 868.5150 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K172800 · Smiths Medical Asd, Inc. · MIA · Jun 14, 2018 · Anesthesiology

Device Facts

Record ID	K172800
Device Name	Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors
Applicant	Smiths Medical Asd, Inc.
Product Code	MIA · Anesthesiology
Decision Date	Jun 14, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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 Story

Sterile, single-use spinal needles (Lancet or Pencil point) featuring ISO 80369-6 compliant NRFit™ connectors; designed to replace standard luer connectors to prevent neuraxial misconnections. Used in clinical settings (ICU/OR) by healthcare professionals for intrathecal delivery of anesthetics/narcotics or CSF withdrawal. Device consists of stainless steel cannula, polycarbonate hub, and polyethylene sheath. NRFit™ connector ensures compatibility only with neuraxial-specific components, reducing risk of medication errors. Output is physical access to intrathecal space; clinical decision-making relies on provider assessment of patient need for regional anesthesia or diagnostic CSF sampling.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 80369-6 (connector integrity, leakage, stress cracking, non-interconnectability), ISO 11607 (packaging), ISO 11135 (sterilization), and ISO 10993 series (biocompatibility, cytotoxicity, sensitization, systemic toxicity, genotoxicity, leachable substances).

Technological Characteristics

Stainless steel cannula; polycarbonate hub; polyethylene sheath. ISO 80369-6 compliant NRFit™ connector. Sterile, ethylene oxide (EO) sterilized, single-use. Needle gauges 22-27G; lengths 38-152mm. No software or electronic components.

Indications for Use

Indicated for injection of local anesthetics/narcotics for regional anesthesia or withdrawal of cerebrospinal fluid in pediatric and adult patients.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

PORTEX® Spinal Anesthesia Needles and Introducer Needles (K983858)

Reference Devices

Pencan Spinal Needles, Spinocan Spinal Needles, Spinal Introducer Needles (K112515)
Unisis Corporation Spinal Needles (K141126)

Related Devices

K193131 — BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle · Becton, Dickinson and Company · Sep 29, 2020
K160294 — SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles · PAJUNK GmbH Medizintechnologie · Oct 21, 2016
K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles · Myco Medical Supplies, Inc. · Sep 29, 2021
K172823 — Portex NRFit Epidural Needles · Smiths Medical Asd, Inc. · Jun 12, 2018
K160295 — SPROTTE NRFit, Quincke NRFit · PAJUNK GmbH Medizintechnologie · Oct 27, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) 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. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 1. ADMINISTRATIVE INFORMATION | 510(k) | K172800 | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant's Name And Address | Smiths Medical ASD, Inc. 6000 Nathan Lane North Minneapolis, MN 55442 USA | | Contact Person | Sunita Teekasingh Senior Principal Regulatory Specialist Vascular Access and Infusion Regulatory Affairs Interim Manager Phone: 763-383-3336 Fax: 763-383-3679 Email: sunny.teekasingh@smiths-medical.com | | Date | June 8, 2018 | | Regulation No. | 21 CFR 868.5150 | | Regulation Name | Anesthesia conduction needle | | Primary Product Codes | MIA | | Classification | Class II | | Trade Name | PORTEX® Lancet Point Spinal Needles with NRFit™ connectors PORTEX® 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 Needles and Introducer Needles | PORTEX® NRFit™ Spinal Lancet Point Needles PORTEX® NRFit™ Spinal Pencil Point Needles | | 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® 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 {4}------------------------------------------------ #### 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® Lancet Point Spinal Needles with NRFit 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® Pencil Point Needles with NRFit™ 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® Lancet Point Spinal Needles with NRFit 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® Pencil Point Needles with NRFitTM connectors | 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. {5}------------------------------------------------ A comparative analysis is provided in Table 1. | Characteri stic | Predicate Device K983858 | Subject Device | Discussion | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Sims Portex® (Smiths Medical) | Smiths Medical | N/A | | FDA Product Code & CFR | MIA 21 CFR 868.5150 | MIA 21 CFR 868.5150 | Same | | Regulation Name | Anesthesia conduction needle | Anesthesia conduction needle | Same | | Regulatory | II | II | Same | | Trade Name(s) | PORTEX® Spinal Anesthesia Needles and Introducer Needles | PORTEX® NRFit™ Spinal Lancet Point Needles PORTEX® NRFit™ Spinal Pencil Point Needles | N/A | | Common Name | Spinal Anesthesia Needles | Spinal Anesthesia Needles | Same | | Indications for Use | Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia. | The Portex® Lancet Point and 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. | Similar. Both the subject and predicate device are indicated for the injection of local anesthetics, and to provide regional anesthesia. The introduction of the spinal needles with the NRFit connectors into the intrathecal space does not alter the safety profile of the subject devices. Both the subject and predicate devices can be used for collection of cerebral spinal fluids. The addition of the NRFit connector does not impact the safety profile when compared to the predicate device. The addition of the narcotics is an extension of regional anesthesia administration procedures, therefore the safety profile remains the same. The NRFit connection is a safety feature that aids in prevention of inadvertent misconnections. | | | | | | | Indications for Use | Spinal needles are indicated for the injection of local anesthetics into a patient to provide regional anesthesia. | The Portex® Lancet Point and 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. | bringing technology to life Similar. Both are indicated for the injection of local anesthetics, and to provide regional anesthesia. | | Hospital Location Use | ICU/OR | ICU/OR | Same | | Characteristic | Predicate Device K983858 | Subject Device | Discussion | | Connector | ISO 594 Luer | ISO 80369-6 NRFit™ | ISO 80369-6 NRFit™ connector intended to reduce risk of misconnections. Both met the requirements of the respective standards recognized 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: 22-25 Lancet: 18-25 | Pencil: 22-27 Lancet: 22-27 | Similar. Needle gauge of subject device includes a 27 gauge needle in addition to the range of the predicate. The use of a 27 gauge needle is physician preference. The use of a 27 gauge needle is physician preference. The use of a 27 gauge needle is physician preference. 18-27G Spinal Needles are also being offered by other manufacturers such as Unisis Corporation (K141126). | | Needle Length (mm) | Pencil: 50.8-152.4 Lancet: 50.8-152.4 | Pencil: 90-152 Lancet: 38-152 | Similar. Subject device length is similar to predicate's length. The shorter spinal needle is to satisfy physician preference when using accepted clinical methods. | | Cannula Material | Stainless steel | Stainless steel | Same | | Needle Hub Material | Polycarbonate | Polycarbonate | Same | | Sheath Material | Polyethylene | Polyethylene | Same | ## Table 1: PORTEX® NRFit™ Spinal Needles {6}------------------------------------------------ #### 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. {7}------------------------------------------------ #### 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. {8}------------------------------------------------ ## 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 | |---------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Functional Performance | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | | | 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 | | | Resistance to separation from unscrewing | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | | | Resistance to overriding | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | | | Leakage by Pressure Decay | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | | | Subatmospheric Pressure | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | | | Stress Cracking | ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications - part 6: connectors for neuraxial applications | | | 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 | | Packaging | Package integrity, sterile barrier | ISO 11607, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | | 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. | | | Residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | | Biocompatibility | Intracutaneous Reactivity | 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 and reproductive toxicity | ISO 10993-3, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | | | Leachable substances | ISO 10993-17, Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances | | 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 {9}------------------------------------------------ ## 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.