(267 days)
The PORTEX® Tuohy and Hustead Needles with NRFif™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.
The sterile, single use Tuohy and Hustead needles with NRFit™ connector are for insertion into the epidural space for either single shot doses of anesthetic or narcotics or as an introducer for epidural catheters or spinal needles. The Tuohy needles are marked at 10 mm graduations to enable the depth of needle insertion to be determined. The Tuohy needles are supplied with a removable wing which allow the needle to be used as a winged or non-winged needle. The stylet hub is color-coded for ease of identification. The intended target population is pediatrics and adults.
The provided text describes the non-clinical testing performed on the PORTEX® NRFit™ Epidural Needles to demonstrate their substantial equivalence to predicate devices. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Evaluation | 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 (Specific criteria within standard not provided) | All testing met pre-established specifications. |
| Resistance to separation from axial load | ISO 80369-6 | All testing met pre-established specifications. | |
| Resistance to separation from unscrewing | ISO 80369-6 | All testing met pre-established specifications. | |
| Leakage by Pressure Decay | ISO 80369-6 | All testing met pre-established specifications. | |
| Subatmospheric Pressure | ISO 80369-6 | All testing met pre-established specifications. | |
| Stress Cracking | ISO 80369-6 | All testing met pre-established specifications. | |
| Verifying Non-interconnectable characteristics | ISO 80369-6 | All testing met pre-established specifications. | |
| Stiffness Characteristics | ISO 9626-2016, 5.8- Stiffness (Annex B) | All testing met pre-established specifications. | |
| Bending Force | ISO 9626:2016, 5.8- Stiffness (Annex B) | All testing met pre-established specifications. | |
| Penetration Force | PWI-10005073-Test Method for Needle Penetration Force for Epidural, Spinal and Peripheral Nerve Block (Specific criteria within method not provided) | All testing met pre-established specifications. | |
| Deflection Force | ISO 9626:2016, 5.8-Stiffness (Annex B) | All testing met pre-established specifications. | |
| 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. |
| 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. |
| Residuals | ISO 10993-7, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | All testing met pre-established specifications. | |
| 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. |
| Systemic Toxicity | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | All testing met pre-established specifications. | |
| Sensitization | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | All testing met pre-established specifications. | |
| Hemocompatibility | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | All testing met pre-established specifications. | |
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | All testing met pre-established specifications. | |
| 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. | |
| 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. | |
| Chemical characterization of materials | ISO 10993-18, Biological evaluation of medical devices - Part 18: Chemical characterization of materials | All testing met pre-established specifications. | |
| Other | Bacterial endotoxins | ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing | All testing met pre-established specifications. |
| Particulate matter | USP 788, Particulate Matter in Injections | All testing met pre-established specifications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for each test. It broadly states that "All testing met pre-established specifications."
The data provenance is from non-clinical performance testing, meaning these are laboratory tests on the device itself, not clinical data from patients. There's no information about country of origin for the data or whether it's retrospective or prospective, as it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable. The "ground truth" in this context refers to established standards (e.g., ISO, ANSI/AAMI, USP) and the physical properties and performance of the device. There were no human experts establishing ground truth for a diagnostic outcome, as this is a device for fluid delivery and catheter placement, not a diagnostic imaging device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed for ambiguous cases. These were non-clinical, objective tests against established standards.
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
This section is not applicable. This document describes the testing for an epidural needle, not an AI-powered diagnostic device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This document describes the testing for a physical medical device (epidural needle), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing was established by recognized international and national standards and test methods. These include:
- ISO 80369-6 (for connectors for neuraxial applications)
- ISO 9626-2016 (for stiffness and bending force of needles)
- PWI-10005073-Test Method for Needle Penetration Force
- ISO 11607 (for packaging)
- ISO 11135 (for sterilization)
- ISO 10993 series (for biocompatibility)
- ANSI/AAMI ST72 (for bacterial endotoxins)
- USP 788 (for particulate matter)
These standards define the acceptable performance parameters and methodologies for testing.
8. The sample size for the training set
This section is not applicable. This document describes the testing of a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set for a machine learning model, the concept of establishing ground truth for it does not apply here.
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Image /page/0/Picture/0 description: The image contains 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.
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: K172823
Trade/Device Name: Portex® NRFit™ Epidural Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: May 11, 2018 Received: May 14, 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 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);
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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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Food and Drug Administration
Indications for Use
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172823
Device Name
PORTEX® NRFit™ Epidural Needles
Indications for Use (Describe)
The PORTEX® Tuohy and Hustead Needles with NRFif™ connectors are intended to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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1. ADMINISTRATIVE INFORMATION
| 510(k) | K172823 |
|---|---|
| Applicant's Nameand Address | Smiths Medical ASD, Inc.6000 Nathan Lane NorthMinneapolis, MN 55442USA |
| 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 needles |
| Primary ProductCodes | BSP |
| Classification | Class II |
| Trade Name | PORTEX® NRFit™ Epidural Needles |
2. REASONFOR SUBMISSION
The purpose of this submission is to make a modification to the currently marketed Smiths Medical PORTEX® Epidural Needles, which are being updated to include an ISO 80369-6 compliant connector for neuraxial applications.
3. DEVICE INFORMATION
| Predicate Device | Subject Device | |
|---|---|---|
| Trade Name | PORTEX® Tuohy Epidural Needles | PORTEX® NRFit™ Epidural Needles |
| Regulation No. | 21CFR868.5150 | 21CFR868.5150 |
| Regulation Name | Anesthesia conduction needle | Anesthesia conduction needle |
| Regulatory Class | II | II |
| Product Code | BSP | BSP |
| 510(k) | K090261 | K172823 |
4. DEVICE DESCRIPTION
The PORTEX® Tuohy and Hustead Needles with NRFit™ connectors are intended to facilitate the placement of an epidural catheter for the injection or infusion of regional anesthetics or narcotics.
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™ Epidural 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® NRFit™ Epidural Needles. A description of the configuration is provided in the table below.
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| Device Type | Description |
|---|---|
| PORTEX®NRFit™ EpiduralNeedles: | The sterile, single use Tuohy and Hustead needles with NRFit™ connector are forinsertion into the epidural space for either single shot doses of anesthetic or narcoticsor as an introducer for epidural catheters or spinal needles. The Tuohy needles aremarked at 10 mm graduations to enable the depth of needle insertion to be determined.The Tuohy needles are supplied with a removable wing which allow the needle to beused as a winged or non-winged needle. The stylet hub is color-coded for ease ofidentification. The intended target population is pediatrics and adults. |
5. INDICATIONS FOR USE
| Device Category | Indications for Use |
|---|---|
| PORTEX® NRFit™™Epidural Needles: | The PORTEX ® Tuohy and Hustead Needles with NRFit™ connectors are intendedto facilitate the placement of an epidural catheter for the injection or infusion ofregional anesthetics or narcotics. |
6. SUBSTANTIAL EQUIVALENCE DISCUSSION
The Smiths Medical PORTEX® NRFit™ Epidural Needles have the same technological characteristics as the predicate devices with the exception of the NRFit™ Connectors. The Smiths Medical PORTEX® NRFit™ Epidural Needles and predicate devices are both designed for the injection or infusion of regional anesthetics or narcotics. They are both made of the same materials, have the same chemical composition, and have the same design features excluding the NRFit ™ connector design. A comparative analysis is in Table 1.
| Characteristic | Predicate DeviceK090261 | Subject Device | Discussion |
|---|---|---|---|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA ProductCode & CFR | BSP21 CFR 868.5150 | BSP21 CFR 868.5150 | Same |
| RegulationName | Anesthesia conduction needle | Anesthesia conduction needle | Same |
| Regulatory Class | II | II | Same |
| Trade Name | PORTEX® Tuohy EpiduralNeedles | PORTEX® NRFit™ EpiduralNeedles | N/A |
| Common Name | Epidural Anesthesia Needles | Epidural Anesthesia Needles | Same |
| Indications forUse | An Epidural Needle isindicated for the injection ofanesthetic agents into theepidural space or to facilitatethe placement of an epiduralcatheter. | The PORTEX® Tuohy andHustead Needles withNRFit™ connectors areintended to facilitate theplacement of an epiduralcatheter for the injection orinfusion of regionalanesthetics or narcotics. | Similar. Both are used forthe injection of anestheticsand facilitate the placementof an epidural catheter. |
| HospitalLocation Use | ICU/OR | Same | N/A |
Table 1: PORTEX® NRFit™ Epidural Needles
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510(k) Summary K172823; PORTEX® NRFit™ Epidural
al
| bringing technology to life | |||
|---|---|---|---|
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTMconnector intended toreduce risk ofmisconnections. Both metthe requirements of therespective standards andthese standards arerecognized by FDA. |
| Tip Design | Tuohy | Tuohy, Hustead | Same, with addition ofHustead |
| Packaging | Tyvek pouch | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
| Needle (Gauge) | 17, 18 | Tuohy: 16-20Hustead: 18 | Similar. These ranges havebeen expanded to meetclinical requirements for thepatient population. The 16-20Guage needles are also beingoffered by othermanufacturers such as UnisisCorporation (K141126). |
| Needle Length (mm) | Tuohy: 90 | Tuohy: 50-110Hustead: 90 | Similar. These ranges havebeen expanded to meetclinical requirements for thepatient population. |
| Cannula Material | Stainless steel | Same | N/A |
| Needle Hub Material | Polycarbonate | Same | N/A |
| Sheath Material | Polyethylene | Same | N/A |
| Removable Wing | Polyethylene | Same | N/A |
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7. SUMMARY OF NON-CLINICAL TESTING
The PORTEX® NRFit™ Epidural Needles were evaluated via non-clinical performance testing to demonstrate the devices are as safe, as effective, and the subject device is substantially equivalent to the predicate device. All testing met pre-established specifications, and successfully demonstrated that the PORTEX® NRFit™ Epidural Needles 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-interconnectablecharacteristics | ISO 80369-6, Small bore connectors for liquids and gasesin healthcare applications - part 6: connectors for neuraxialapplications | |
| StiffnessCharacteristics | ISO 9626-2016, 5.8- Stiffness (Annex B) | |
| Bending Force | ISO 9626:2016, 5.8- Stiffness (Annex B) | |
| Penetration Force | PWI-10005073-Test Method for Needle Penetration Forcefor Epidural, Spinal and Peripheral Nerve Block | |
| Deflection Force | ISO 9626:2016, 5.8-Stiffness (Annex B) | |
| 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 - | |
| Hemocompatibility | ISO 10993-4, Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood | |
| 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. | |
| Chemicalcharacterization ofmaterials | 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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510(k) Summary K172823; PORTEX® NRFit™ Epidural
smiths medical
bringing technology to life
8. SUBSTANTIAL EQUIVALENCE CONCLUSION
The evaluation of the Smiths Medical PORTEX® NRFit™ Epidural Needles device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate devices. Device testing met pre-defined acceptance criteria and did not raise different question of safety or effectiveness.
§ 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).