(267 days)
No
The device description and intended use describe a mechanical needle for epidural procedures, with no mention of software, algorithms, or any technology that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
The device is used to facilitate the placement of epidural catheters and for the injection/infusion of regional anesthetics or narcotics, which are methods of pain management or anesthesia, but the needle itself is not a therapeutic device. It is an access device.
No
The device is described as facilitating the placement of an epidural catheter and for injection/infusion of regional anesthetics/narcotics, and for insertion into the epidural space. These are therapeutic or interventional functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly describes physical needles and connectors, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placement of an epidural catheter and for the injection or infusion of regional anesthetics or narcotics. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a needle for insertion into the epidural space for delivering substances or introducing other devices. This aligns with a procedural tool.
- No mention of diagnostic testing: There is no indication that this device is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to provide information about a person's health status. This device is used directly on the patient for a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BSP
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
pediatrics and adults.
Intended User / Care Setting
ICU/OR
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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);
1
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
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)
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1. ADMINISTRATIVE INFORMATION
| 510(k) | K172823 |
|---|---|
| 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 needles |
| Primary Product | |
| Codes | 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.
4
| Device Type | Description |
|---|---|
| PORTEX® | |
| NRFit™ Epidural | |
| Needles: | 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. |
5. INDICATIONS FOR USE
| Device Category | Indications for Use |
|---|---|
| PORTEX® NRFit™™ | |
| Epidural Needles: | 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. |
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 Device
K090261 | Subject Device | Discussion |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Company | Smiths Medical | Smiths Medical | N/A |
| FDA Product
Code & CFR | BSP
21 CFR 868.5150 | BSP
21 CFR 868.5150 | Same |
| Regulation
Name | Anesthesia conduction needle | Anesthesia conduction needle | Same |
| Regulatory Class | II | II | Same |
| Trade Name | PORTEX® Tuohy Epidural
Needles | PORTEX® NRFit™ Epidural
Needles | N/A |
| Common Name | Epidural Anesthesia Needles | Epidural Anesthesia Needles | Same |
| Indications for
Use | An Epidural Needle is
indicated for the injection of
anesthetic agents into the
epidural space or to facilitate
the placement of an epidural
catheter. | 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. | Similar. Both are used for
the injection of anesthetics
and facilitate the placement
of an epidural catheter. |
| Hospital
Location Use | ICU/OR | Same | N/A |
Table 1: PORTEX® NRFit™ Epidural Needles
5
510(k) Summary K172823; PORTEX® NRFit™ Epidural
al
| bringing technology to life | |||
|---|---|---|---|
| Connector | ISO 594 Luer | ISO 80369-6 NRFitTM | ISO 80369-6 NRFitTM |
| connector intended to | |||
| reduce risk of | |||
| misconnections. Both met | |||
| the requirements of the | |||
| respective standards and | |||
| these standards are | |||
| recognized by FDA. | |||
| Tip Design | Tuohy | Tuohy, Hustead | Same, with addition of |
| Hustead | |||
| Packaging | Tyvek pouch | Same | N/A |
| Sterility | Sterile, EO | Same | N/A |
| Use | Single Use Disposable | Same | N/A |
| Needle (Gauge) | 17, 18 | Tuohy: 16-20 | |
| Hustead: 18 | Similar. These ranges have | ||
| been expanded to meet | |||
| clinical requirements for the | |||
| patient population. The 16-20 | |||
| Guage needles are also being | |||
| offered by other | |||
| manufacturers such as Unisis | |||
| Corporation (K141126). | |||
| Needle Length (mm) | Tuohy: 90 | Tuohy: 50-110 | |
| Hustead: 90 | Similar. These ranges have | ||
| been expanded to meet | |||
| clinical requirements for the | |||
| patient 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 |
6
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 |
|---|---|---|
| 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 | ISO 80369-6, Small bore connectors for liquids and gases | |
| in healthcare applications - part 6: connectors for neuraxial | ||
| applications | ||
| Stiffness | ||
| Characteristics | 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 Force | |
| for 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 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 - | |
| 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 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. | |
| 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
7
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.