(287 days)
No
The device description and performance studies focus on the physical characteristics, materials, and functional performance of the needles, with no mention of AI or ML.
No
The device is a needle used to deliver local anesthetics, which are the therapeutic agents. The device itself is not a therapeutic agent or device.
No
The device description clearly states its intended use is for "injection of local anesthetics into a patient to provide regional anesthesia," which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical needles made of stainless steel and polycarbonate with specific tip configurations and hubs. The performance studies focus on material properties and functional performance of these physical components. There is no mention of software as part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject local anesthetics into a patient to provide regional anesthesia." This is a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from the body.
- Device Description: The device is a needle designed for injection into the spinal or epidural space. This is a medical device used for a procedural intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
Therefore, this device falls under the category of a medical device used for a therapeutic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
Product codes
BSP
Device Description
RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use.
The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards.
RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration.
Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in sterile and non-sterile packaging.
Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging.
The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths.
Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging.
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
Adult and child
Intended User / Care Setting
Not Found
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)
Non-clinical performance testing was conducted including biocompatibility and functional performance testing.
Biocompatibility testing included: Cytotoxicity (Non-Cytotoxic), Sensitization (Non-Sensitizer), Intracutaneous Reactivity (Non-Irritant), Acute Systemic Toxicity (Non-Toxic), Material Mediated Pyrogenicity (Non-Pyrogenic), Hemocompatibility (Non-Hemolytic), and Chemical Characterization (acceptable extractables/leachables profile).
Functional performance testing included: Stability Test Bonding to Hub, Penetration Force and Drag Force for Needles, Breakage Test, Stability Test Bending Rigidity, Positive pressure leakage, Resistance to separation from axial load, Resistance to separation from unscrewing, and Resistance to overriding, Stress Cracking. Additional testing standards included: Particulate Matter and LAL Endotoxin.
Sterilization and Shelf Life testing confirmed an EtO sterilization method with a SAL of 10-6 and a 2-year shelf life.
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
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 shows 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 29, 2021
MYCO Medical Supplies, Inc. % E.J. Smith Consultant Smith Associates 1468 Harwell Ave. Crofton, Maryland 21114
Re: K203668
Trade/Device Name: RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: August 30, 2021 Received: August 31, 2021
Dear E.J. Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Courtnev Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
29
510(k) Number (if known)
Device Name
RELI® NRFit® Spinal Needles, RELI® NRFit®Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles
Indications for Use (Describe)
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
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.
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3
510k Summary K203668
SPONSOR | ||
---|---|---|
Company Name: | MYCO Medical | |
Company Address: | 2015 Production Drive | |
Apex, NC 27539 | ||
Telephone: | 919-460-2535 | |
Contact Person: | Sanjiv Kumar | |
Summary Preparation Date: | September 24, 2021 | |
DEVICE NAME | ||
Trade Name: | RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural | |
Needles, Phoenix NRFit® Spinal Needles, and Phoenix | ||
NRFit® Epidural Needles | ||
Common/Usual Name: | Needle, Hypodermic, Single Lumen | |
Classification Name: | Anesthesia Conduction Needle | |
Regulation Number: | 21 CFR 868.5150 | |
Product Code: | BSP | |
Device Class: | II |
PREDICATE DEVICE
Legally Marketed Equivalent Devices
K Number | Brand Name | Manufacturer | |
---|---|---|---|
Primary | K183316 | Dr J Spinal and Epidural Needles | Dr. Japan |
Reference | K990519 | Dr. Japan's Phoenix Brand Spinal and Epidural Needles | Myco Medical Supplies, Inc. |
Reference | K142553 | UNIEVER Disposable Epidural Anesthesia | |
Needle, UNIEVER Disposable Nerve Blocked | Unisis Corp. |
DEVICE DESCRIPTION
RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Spinal and Epidural needles are supplied in bulk nonsterile, or sterile by ethylene oxide gas in peel open packages and are intended for one-time use.
The RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles feature an ISO 80369-6 compliant connector that is about 20% smaller than the predicate device. The ISO 80369-6 hub design reduces the risk of cross connection when used with luer connectors developed under the same series of standards.
RELI® NRFit® Spinal Needles and Phoenix NRFit® Spinal Needles are composed of a stainless-steel cannula and stylet, a hub, and plunger. The spinal needle is supplied with either the Quincke Point (K-3 Point) or the Pencil Point tip configuration.
Quincke point spinal needles feature fitted, close tolerance stylet and cannula bevel to minimize coring and trauma; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size; some sizes are also available with short bevel. Available in
4
sterile and non-sterile packaging.
Pencil point spinal needles feature an atraumatic point with side-port dispensing to reduce loss of CSF; large clear hubs for enhanced tactile feel and visualization of CSF; color coded stylet hub to easily identify gauge size. Some sizes are available with tapered design to counter bending and minimize flexing during insertion. Available in sterile and non-sterile packaging.
The RELI® NRFit® Epidural Needles and Phoenix NRFit® Epidural Needles are composed of a stainlesssteel cannula, a polycarbonate hub and detachable wing, a stainless-steel stylet and plunger as Tuohy (Huber point) tip configuration in various needle gauge sizes and lengths.
Epidural needles feature large clear hub for enhanced tactile feel; wide metric marking for maximum visibility and accuracy in placement; color coded stylet/hub to identify needle gauge size. Epidural needles are available in sterile and non-sterile packaging.
DEVICE INDICATIONS FOR USE
Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.
| | Subject New
Device
Myco Medical
Supplies, Inc. | Primary
Predicate
Dr. Japan | Reference
Predicate
Myco Medical
Supplies, Inc. | Reference
Predicate Unisis
Corp. | Similarities
and
Differences |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------------|
| K Number | | K183316 | K990519 | K142553 | |
| Brand Name | RELI® NRFit® Spinal
Needles, RELI®
NRFit® Epidural
Needles, Phoenix
NRFit® Spinal
Needles, and
Phoenix NRFit®
Epidural Needles | Dr J Spinal and
Epidural Needles | Dr. Japan's Phoenix
Epidural and Spinal
Needles | UNIEVER Disposable
Epidural Anesthesia
Needle, UNIEVER
Disposable Nerve
Blocked Needle | |
| Regulation
Description | Anesthesia
conduction needle | Anesthesia
conduction | Anesthesia
conduction needle | Anesthesia
conduction needle | Same |
| Regulation No. | 21 CFR 868.5150 | 21 CFR 868.5150 | 21 CFR 868.5150 | 21 CFR 868.5150 | Same |
| Product Code | BSP | BSP | BSP | BSP | Same |
COMPARISON OF TECHNILOGICAL CHARACTERISTICS
5
| | Subject New
Device
Myco Medical
Supplies, Inc. | Primary
Predicate
Dr. Japan | Reference
Predicate
Myco Medical
Supplies, Inc. | Reference
Predicate Unisis
Corp. | Similarities
and
Differences |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Spinal and Epidural
needles are to be
used to inject local
anesthetics into a
patient to provide
regional anesthesia. | Dr. J Spinal and
Epidural needles
are intended to
be used for
injection of local
anesthetics into a
patient to
provide regional
anesthesia | Spinal and Epidural
needles are to be
used to inject local
anesthetics into a
patient to provide
regional anesthesia | The Uniever
Disposable Epidural
Anesthesia Needle is
intended to be used
for injection into the
epidural space / or
placing the epidural
catheter into the
epidural space.
Uniever Disposable
Nerve Blockade
Needle is intended to
be used for injection
of local anesthetic
agent near the nerve
for temporary pain
control. | Same |
| Device Design | | | | | |
| Needle Hub | NRFit® connector
conforming to ISO
80369-6 for
neuraxial device | Hub luer taper
connector
conforming to
ISO 80369-7 | Hub luer taper
connector
conforming to ISO
594 | Hub luer taper
connector
conforming to ISO
594 | Different
The subject
device differs
from the
predicates only
in hub
dimensions. ISO
80369-6
specifies a 6%
taper hub vs. 5%
taper hub in ISO
80369-7 (ISO
594). |
| | Subject New
Device
Myco Medical
Supplies, Inc. | Primary
Predicate
Dr. Japan | Reference
Predicate
Myco Medical
Supplies, Inc. | Reference
Predicate Unisis
Corp. | Similarities
and
Differences |
| Operating
Principle, Spinal
Needle | Spinal anesthesia is
a form of regional
anesthesia involving
the injection of a
local anesthetic into
the subarachnoid
space through a
spinal needle.
Regardless of the
anesthetic agent
used, the desired
effect is to block the
transmission of
afferent nerve
signals from
peripheral
nociceptors. Sensory
signals from the site
are blocked, thereby
eliminating pain.
Spinal anesthetics
are typically limited
to procedures
involving most
structures below the
upper abdomen. To
administer a spinal
anesthetic to higher
levels may affect
the ability to
breathe by
paralyzing the
intercostal
respiratory muscles,
or even the
diaphragm in
extreme cases, as
well as the body's
ability to control
the heart rate via
the cardiac
accelerator fibers. | Spinal anesthesia
is a form of
regional anesthesia
involving the
injection of a local
anesthetic into
the subarachnoid
space through a
spinal needle.
Regardless of the
anesthetic agent
used, the desired
effect is to block the
transmission of
afferent nerve
signals from
peripheral
nociceptors.
Sensory signals
from the site are
blocked, thereby
eliminating pain. | Spinal anesthesia is a
form of regional
anesthesia involving
the injection of a
local anesthetic into
the subarachnoid
space through a
spinal needle.
Regardless of the
anesthetic agent used,
the desired effect is
to block the
transmission of
afferent nerve signals
from peripheral
nociceptors. Sensory
signals from the site
are blocked, thereby
eliminating pain.
Spinal anesthetics
are typically limited
to procedures
involving most
structures below
the upper abdomen.
To administer a
spinal anesthetic to
higher levels may
affect the ability to
breathe by
paralyzing the
intercostal
respiratory muscles,
or even the
diaphragm in
extreme cases, as
well as the body's
ability to control the
heart rate via the
cardiac accelerator
fibers. | Spinal anesthesia is a
form of regional
anesthesia involving
the injection of a
local anesthetic into
the subarachnoid
space through a spinal
needle. Regardless of
the anesthetic agent
used, the desired
effect is to block the
transmission of
afferent nerve signals
from peripheral
nociceptors. Sensory
signals from the site
are blocked, thereby
eliminating pain.
Spinal anesthetics
are typically limited
to procedures
involving most
structures below the
upper abdomen. To
administer a spinal
anesthetic to higher
levels may affect the
ability to breathe by
paralyzing the
intercostal
respiratory muscles,
or even the
diaphragm in
extreme cases, as
well as the body's
ability to control the
heart rate via the
cardiac accelerator
fibers. | Same |
| | Subject New
Device
Myco Medical
Supplies, Inc. | Primary
Predicate
Dr. Japan | Reference
Predicate
Myco Medical
Supplies, Inc. | Reference
Predicate Unisis
Corp. | Similarities
and
Differences |
| Operating
Principle,
Epidural Needle | Epidural anesthesia
is a regional
anesthesia that
blocks pain in a
particular region of
the body. An
epidural needle is
used to inject local
anesthetic agent into
the epidural space of
the spinal cord to
block the pain. To
provide continuous
epidural anesthesia,
a small hollow
catheter is threaded
through the epidural
needle into the
epidural space and
left there while the
needle is removed. | Epidural
anesthesia is a
regional anesthesia
that blocks pain in
a
particular region of
the body. An
epidural needle is
used to inject local
anesthetic agent
into the epidural
space of the spinal
cord to block the
pain. To provide
continuous
epidural
anesthesia, a small
hollow catheter is
threaded through
the epidural needle
into the epidural
space and left
there while the
needle is removed. | Epidural anesthesia is
a regional anesthesia
that blocks pain in a
particular region of
the body. An epidural
needle is used to
inject local anesthetic
agent into the
epidural space of the
spinal cord to block
the pain. To provide
continuous epidural
anesthesia, a small
hollow catheter is
threaded through the
epidural needle into
the epidural space
and left there while
the needle is
removed. | Epidural anesthesia
is a regional
anesthesia that
blocks pain in a
particular region of
the body. An
epidural needle is
used to inject local
anesthetic agent
into the epidural
space of the spinal
cord to block the
pain. To provide
continuous epidural
anesthesia, a small
hollow catheter is
threaded through
the epidural needle
into the epidural
space and left there
while the needle is
removed. | Same |
| Intended
Patient
Population | Adult and child | Adult and child | Adult and child | Not Specified | Same, though
Unisis device
patient
population is
not specified. |
| Material Specifications | | | | | |
| Needle/
Cannula
material | Cold-rolled stainless
steel
(JIS G4305-SUS304) | Cold-rolled
stainless steel
(JIS G4305-
SUS304) | Cold-rolled stainless
steel
(JIS G4305-SUS304) | Stainless steel
SUS304 | Same |
| Cannula depth
markings | The system to
cause a chemical
change of the
metal ion on the
surface to a black
color by
electrolysis without
changing the
material of
cannula. | The system to
cause a chemical
change of the
metal ion on the
surface to a black
color by
electrolysis
without changing
the material of
cannula. | The system to cause
a chemical change
of the metal ion on
the surface to a
black color by
electrolysis without
changing the
material of cannula. | Cannula depth
markings are
present | Same |
| Stylet material | Stainless steel
wire for spring (JIS
G4314-SUS304) | Stainless steel
wire for spring
(JIS G4314-
SUS304) | Stainless steel wire
for spring (JIS
G4314-SUS304) | Plastic | Same
Different for
Unisis Epidural
Needle |
| Hub material | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate | Same |
| | Subject New
Device
Myco Medical
Supplies, Inc. | Primary
Predicate
Dr. Japan | Reference
Predicate
Myco Medical
Supplies, Inc. | Reference
Predicate Unisis
Corp. | Similarities
and
Differences |
| Gauge
length/color
depiction | Per ISO 6009 | Per ISO 6009 | Per ISO 6009 | Per ISO 6009 | Same |
| Plunger/
Stylet Hub | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate | Same |
| Final Needle
assembly
protection | Protector
(polyethylene) | Protector
(polyethylene) | Protector
(polyethylene) | Protective Sheath | Same |
| Sterilization
Method | Supplied Sterile via
EtO and Non-sterile
intended to be
sterilized via EtO
prior to end use.
•ISO 11135
•SAL 10-6
•Maximum EO
residual levels
comply with
ISO 10993-7 | Sterile EO (=ETO)
per ISO
11135:2014
SAL 10-6
Maximum EO
levels comply
with
ISO 10993-7:2008 | Sterile via EtO | Sterile via EtO | Same |
6
7
8
Discussion of Technological Differences
Similarities
The intended use statement, indications for use, technical specifications and descriptions of the needle, materials used, sterilization method and sterility assurance level, and biocompatibility are identical to predicate device previously cleared.
Differences
The only difference between the predicate devices and the subject device is the design of the needle´s hub. The predicate device was cleared with a hub luer taper connector conforming to ISO 594. The subject devices are equipped with a NRFit connector conforming to ISO 80369-6 for neuraxial devices. The subject device removes a brass bush/washer component that was part of the predicate device detachable wing Tuohy (Huber point) Epidural needle hub. The NRFit® Spinal and Epidural needle hubs for the subject device are composed of the same polycarbonate material as the predicate device. The difference of the needle's hub design raises no issues of safety and effectiveness.
9
| Subject Device | | | Primary Predicate Device
K183316 | | | Reference Predicate Device
K990519 | | |
|----------------|------------------|----------------------|-------------------------------------|------------------|----------------------|---------------------------------------|------------------|----------------------|
| Spinal Needles | | | Spinal Needles | | | Spinal Needles | | |
| Gauge | Length
Inches | Tip
Configuration | Gauge | Length
Inches | Tip
Configuration | Gauge | Length
Inches | Tip
Configuration |
| 20 – 27 | 2.5 - 5 | Pencil Point | 25 - 27 | 3.5 | Pencil Point | 22 - 27 | 1.5 – 5 | Pencil Point |
| 18 – 29 | 1.5 – 8 | Quincke (K-3 Point) | 18 – 27 | 3.5 | Quincke (K-3 Point) | 18 – 29 | 1 – 7 | Quincke (K-3 Point) |
Comparison Table of Spinal Needles
These range of gauge sizes offered fall within the ranges of identified predicates. The range of RELI® NRFit® and Phoenix NRFit® Spinal Needle length has been expanded based on engineering drawings and to meet clinical requirements for the patient population. These additional line items raise no new issues of safety and effectiveness.
Comparison Table of Epidural Needles
| | Subject Device | | | Primary Predicate Device
K183316 | | | Reference Predicate Device
K142553 | | |
|---------|------------------|------------------|------------------|-------------------------------------|------------------|------------------|---------------------------------------|---------------|--|
| | Epidural Needles | | Epidural Needles | | | Epidural Needles | | | |
| | Length | Tip | | Length | Tip | | Length | Tip | |
| Gauge | Inches | Configuration | Gauge | Inches | Configuration | Gauge | Inches | Configuration | |
| 16 – 22 | 2.5 - 6 | Tuohy
(Huber) | 16 – 20 | 3.5 | Tuohy
(Huber) | 14 - 25 | 1 - 6 | Tuohy (Huber) | |
All the gauge sizes and lengths offered for the RELI® NRFit® and Phoenix NRFit® Epidural Needles fall within the ranges for standard epidural needles offered by the identified predicates. These additional line items raise no new issues of safety and effectiveness.
PERFORMANCE TESTING - NON-CLINICAL
The following biocompatibility and functional performance testing were conducted on the RELI® NRFit® Spinal Needles, RELI® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles:
Biocompatibility
Spinal Needles are classified as External communicating device, Blood path, indirect Limited (, Non-Pyrogenic |
| Hemocompatibility | Per ISO 10993-4, Non-Hemolytic |
| Chemical Characterization | Per ISO 10993-18, acceptable extractables/leachables profile |
10
Performance Testing
Functional Test | Test Standard |
---|---|
Stability Test Bonding to Hub | Per ISO 7864:2016 |
Penetration Force and Drag Force for Needles | Per ISO 7864:2016 |
Breakage Test | Per ISO 9626:2016 |
Stability Test Bending Rigidity | Per ISO 9626:2016 |
Positive pressure leakage | Per ISO 80369-6:2016 |
Resistance to separation from axial load | Per ISO 80369-6:2016 |
Resistance to separation from unscrewing | Per ISO 80369-6:2016 |
Resistance to overriding | Per ISO 80369-6:2016 |
Stress Cracking | Per ISO 80369-6:2016 |
Additional Testing Standards
Test | Standard |
---|---|
Particulate Matter | USP |
LAL Endotoxin | AAMI 72, USP , ≤ 2.15 EU/device |
Sterilization and Shelf Life
Parameters | Responses |
---|---|
Method of Sterilization | EtO |
Method of Validation | ISO 11135-1 |
Sterility Assurance Level (SAL) | 10-6 |
Pyrogen Testing | ISO 10993-11 |
Maximum Levels of Residues of EO, Ethylene Glycol and Ethylene Chlorohydrin | |
EtO | below allowable limits per ISO 10993-7 |
ECH | below allowable limits per ISO 10993-7 |
Shelf Life | |
2-Years |
CONCLUSION
The subject device and the predicate have the same intended use and the technological differences do not raise different questions of safety and effectiveness. Based upon the intended use, principles of operation, materials, technology characteristics and safety performance testing it is the conclusion of MYCO Medical Supplies, Inc., that the RELI® NRFit® Spinal Needles, RELl® NRFit® Epidural Needles, Phoenix NRFit® Spinal Needles, and Phoenix NRFit® Epidural Needles are substantially equivalent to the predicate device.