(269 days)
No
The device description and intended use focus on the physical characteristics and function of spinal needles and connectors, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is a spinal needle for injecting substances or withdrawing fluid, not a device that directly provides therapy.
No
The device, a spinal needle, is used for injection or withdrawal of fluid, which are interventional procedures, not diagnostic ones.
No
The device description clearly describes physical spinal needles with NRFit™ connectors, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the injection of substances or withdrawal of cerebrospinal fluid directly from the patient's body. This is a procedure performed in vivo (within a living organism).
- Device Description: The description focuses on the physical characteristics of the needles and their connectors for delivering or withdrawing substances from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside of the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body for therapeutic or diagnostic procedures performed in vivo.
N/A
Intended Use / Indications for 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.
Product codes
MIA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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® 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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)
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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.