(182 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of needles and a kit for use with infusion pumps, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device, consisting of needles and an OR prep kit, is used to administer infusate solutions via an implanted pump and prepare the pump for implantation. It facilitates the delivery of therapeutic solutions but is not itself a therapeutic agent or device that directly treats a condition.
No
This device is designed for administering infusate solutions and preparing implanted infusion pumps, not for diagnosing medical conditions.
No
The device description clearly details physical components such as needles, hubs, tubing, and a syringe barrel, indicating it is a hardware-based medical 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 administer infusate solutions to a patient via an implanted infusion pump. This is a therapeutic or drug delivery function, not a diagnostic function performed in vitro (outside the body) on biological specimens.
- Device Description: The devices are needles and an OR prep kit used for accessing and preparing an implanted pump. They are tools for delivering substances or preparing a device for implantation, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
The device is clearly intended for direct patient care and drug delivery, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Intera Non-coring (Huber) Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.
Specifically,
-
the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
-
the Special Bolus Needles are indicated for delivering bolus injections through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
-
the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.
Product codes (comma separated list FDA assigned to the subject device)
PTI
Device Description
The Intera Refill Needle is a straight 22 gauge stainless steel non-coring needle with hub and needle cap. The Refill Needle is available in 1", 1 ½", and 2" lengths and is used to empty and fill the reservoir of a subcutaneously implanted infusion pump through the pump septum. The Refill Needle is provided sterile and is intended for single patient use.
The Intera Special Bolus Needle is a straight 20 gauge stainless steel non-coring needle with hub and needle cap. A tubing extension set is integrated with the needle hub. The Special Bolus Needle is available in 1 3/8" and 2" lengths and is used to deliver infusate through the pump septum to the pump catheter. The Special Bolus Needle is provided sterile and is intended for single patient use.
The Intera OR Prep Kit contains the accessories used to prep and fill the pump prior to implantation and is assembled as a convenience to the end-user with the following sterile, single-use items:
- One (1) 22g non-coring (Huber) Refill Needle
- One (1) 20g non-coring (Huber) Special Bolus Huber Needle with attached tubing, ● clamp, and female luer
- One (1) 33cm (13") tubing set with clamp and female luer assembled to an empty ● syringe barrel
The empty syringe barrel acts as a liquid waste receptacle to hold the fluid that is passively drained from the infusion pump during pump preparation prior to implantation. The empty syringe barrel and drained fluid are discarded after use and have no direct patient contact. The empty syringe barrel does not include a piston and does not function as a piston syringe.
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
Not Found
Intended User / Care Setting
Healthcare providers licensed to use Huber needles and infusion sets. Hospital or clinic setting.
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)
Performance Testing: Bench performance tests were conducted. No animal or clinical testing was conducted.
Key results: All tests met or exceeded the acceptance criteria of the applicable standards.
Tests conducted include:
- Visual inspections
- Needle length tolerance verification
- Tensile Testing of needle/hub connections
- Patency of Flow Testing
- Drag/Penetration force testing
- Acidity / Alkalinity testing
- Extractables testing
- Stiffness testing
- Resistance to breakage testing
- Corrosion testing
- Non-Coring Testing
- Leak Testing (Cannula/Hub connection)
- Tensile testing of tubing luer connections
- Leak testing of tubing luer connections
- Luer performance testing
- Particulate testing
- Clamp Flow Stoppage and Release Testing
- Leak Testing (Syringe Barrel Lid)
Sterilization Validation:
- Ethylene oxide sterilization was validated to a Sterility Assurance Level (SAL) of 10^-6 using the half-cycle, overkill method per ISO 11135:2014.
- Bacterial endotoxin testing per USP 40-NF35:2017 confirmed endotoxin levels well below the limit (
- Hemocompatibility per ISO 10993-4:2017, including hemolysis per ASTM F756-17.
Shelf-Life Validation Testing:
- Completed on final, finished EtO sterilized samples real-time aged for at least 25 months.
- Transportation testing according to ISTA 3A.
- Package integrity testing, including dye penetration test per ASTM F1929-15 and seal strength test per ASTM F88M/F88-15.
- Device integrity testing, including tensile strength and leak testing.
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.
Not Found
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(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.
October 14, 2021
Intera Oncology, Inc. % Sheila Hemeon-Heyer President Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, Massachusetts 01002
Re: K211121
Trade/Device Name: Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: September 14, 2021 Received: September 15, 2021
Dear Sheila Hemeon-Heyer:
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.
For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal. ObGyn. General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211121
Device Name
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit
Indications for Use (Describe)
The Intera Non-coring (Huber) Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.
Specifically,
-
the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
-
the Special Bolus Needles are indicated for delivering bolus injections through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump;
-
the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.
| 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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3
K211121 - 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted per the requirements of 21 CFR 807.92.
| A. Submitter: | Intera Oncology, Inc. | |
|---|---|---|
| 65 Williams St, Suite 200 | ||
| Wellesley, MA 02481 | ||
| Contact: Michael Gaisford | ||
| Title: | Chief Executive Officer | |
| Tel #: | 781-489-5724 | |
| Email: | mgaisford@interaoncology.com |
- B. Date Prepared: October 14, 2021
D. Device Name and Classification Information:
| Trade Name: | Intera Non-coring (Huber) Refill Needles |
|---|---|
| Intera Non-coring (Huber) Special Bolus Needles | |
| OR Prep Kit | |
| Common Name: | Non-Coring (Huber) Needle |
| Classification Name: | Hypodermic Single Lumen Needle |
| Classification: | 21 CFR 880.5570 |
| Product Code: | PTI |
| Review Panel: | General Hospital |
| Class: | II |
E. Predicate Devices: K200463 Huber Needle Infusion Set
F. Summary Device Description:
The Intera Refill Needle is a straight 22 gauge stainless steel non-coring needle with hub and needle cap. The Refill Needle is available in 1", 1 ½", and 2" lengths and is used to empty and fill the reservoir of a subcutaneously implanted infusion pump through the pump septum. The Refill Needle is provided sterile and is intended for single patient use.
The Intera Special Bolus Needle is a straight 20 gauge stainless steel non-coring needle with hub and needle cap. A tubing extension set is integrated with the needle hub. The Special Bolus Needle is available in 1 3/8" and 2" lengths and is used to deliver infusate through the pump septum to the pump catheter. The Special Bolus Needle is provided sterile and is intended for single patient use.
4
The Intera OR Prep Kit contains the accessories used to prep and fill the pump prior to implantation and is assembled as a convenience to the end-user with the following sterile, single-use items:
- One (1) 22g non-coring (Huber) Refill Needle
- One (1) 20g non-coring (Huber) Special Bolus Huber Needle with attached tubing, ● clamp, and female luer
- One (1) 33cm (13") tubing set with clamp and female luer assembled to an empty ● syringe barrel
The empty syringe barrel acts as a liquid waste receptacle to hold the fluid that is passively drained from the infusion pump during pump preparation prior to implantation. The empty syringe barrel and drained fluid are discarded after use and have no direct patient contact. The empty syringe barrel does not include a piston and does not function as a piston syringe.
G. Indications for Use Statement:
The Intera Non-coring (Huber) Needles (Refill Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions.
Specifically,
- the Refill Needles are indicated for emptying and refilling the reservoir of an Intera ● 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump
- . the Special Bolus Needles are indicated for delivering bolus injections or infusions through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump
- the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or . CODMAN® 3000 Series Pump prior to implantation.
H. Technical Comparison with Predicate Devices
The table below provides technological comparisons between the proposed and predicate devices. A discussion of the differences is provided following the table.
5
| Comparison Item | Proposed Device
K211121 | Predicate Device
K200463 | Assessment of
Substantial
Equivalence |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Devices | Intera Non-coring (Huber) Refill
Needle
Intera Non-coring (Huber)
Special Bolus Needle
Intera OR Prep Kit | Huber Needle Infusion Set | N/A |
| Manufacturer | Intera Oncology, Inc. | Jiangsu Caina Medical Co.,
Ltd | N/A |
| FDA Product
Code | PTI | PTI | Same |
| Class | II | II | Same |
| Indication for Use | The Intera Non-coring (Huber)
Needles (Refill Needles and
Special Bolus Needles) and OR
Prep Kit are indicated for use
with the Intera implanted
infusion pumps to administer
infusate solutions. Specifically,
• the Refill Needles are
indicated for emptying and
refilling the reservoir of an
Intera 3000 Hepatic Artery
Infusion Pump or
CODMAN® 3000 Series
Pump
• the Special Bolus Needles
are indicated for delivering
bolus injections or infusions
through an Intera 3000
Hepatic Artery Infusion
Pump or CODMAN® 3000
Series Pump
• the OR Prep Kit is used to
prepare the Intera 3000
Hepatic Artery Infusion
Pump or CODMAN® 3000
Series Pump prior to
implantation | The Huber Needle Infusion Set
is a device with a non-coring
right angle needle intended for
insertion into the septum of a
subcutaneously implanted port
and for the infusion of fluids
and drugs, as well as blood
sampling into the port.
The 19G-22G needles of
device are also suitable for
power injection of contrast
media to a maximum pressure
of 325psi. When used with
ports indicated for power
injection, the maximum
recommended infusion rate is
approximately 5ml/s for 19G
and 20G, 2ml/s for 22G | See SE discussion |
| Comparison Item | Proposed Device
K211121 | Predicate Device
K200463 | Assessment of
Substantial
Equivalence |
| Use environment | Hospital or clinic setting | Hospital or clinic setting | Same |
| Intended users | Healthcare providers licensed
to use Huber needles and
infusion sets | Healthcare providers licensed
to use Huber needles and
infusion sets | Same |
| Components and
materials of
construction | Huber needles - 304 stainless
steel
PVC tube
Clamps
Male and female Luers
Empty syringe barrel (no piston) | Huber needles - stainless
steel
PVC tube
Clamps
Male and female Luers
Needle-less connector
Y-needleless adapter
Y-needle adapter | Different, see SE
discussion in Section I
and discussion of testing
in Section J. |
| Hub/needle bond
strength | ≥ 15 lbf (66 N) | Unknown | Different. Intera
needle/hub bond
strength exceeds
requirement of ISO
7864:2016. See Section
J. |
| Needle tip
configuration | Non-coring (Huber) tip, straight | Non-coring (Huber) tip, bent,
90° angle | Different, see SE
discussion |
| Dimensions | Needle gauges: 20G, 22G
Needle lengths: 1", 1 3/8", 1.5",
2"
Tubing set length: 33 cm | Needle gauges: 19G, 20G,
22G, 24G, 25G
Needle lengths: 0.5", 0.75",
1", 1.25", 1.5"
Tubing set: Unknown | Different, See SE
discussion |
| Safety and
Performance tests | Coring test
Penetration force
Occlusion testing
Joint integrity/tensile testing
Leak testing
Needle performance
Luer connector performance
Particulates
Biocompatibility
Sterilization validation
Transportation testing
Shelf life testing | Coring test
Penetration force
Occlusion testing
Joint integrity/tensile testing
Leak testing
Needle performance
Luer connector performance
Wing flexibility
Particulates
Biocompatibility
Sterilization validation
Transportation testing
Shelf life testing | Same except wing
flexibility is not required
for proposed device as it
does not contain any
wings.
See Section J for
discussion of Intera
safety and performance
tests. |
| Material safety | Complies with ISO 10993 | Complies with ISO 10993 | Same |
| Sterile | Yes, EtO, SAL 10-6 | Yes, EtO, SAL 10-6 | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Shelf life | 24 months | Unknown | Different |
Table 1. Comparison of the Intera Huber Needle Set to the Predicate Huber Needle Set
6
7
-Discussion of Differences
Indications for Use
Both the proposed and predicate devices are intended for insertion through the septum of subcutaneously implanted receptacles for infusion of fluids and drugs. The proposed device is used for infusion of an implanted infusion pump, while the predicate device is used for infusion of an implanted port. The predicate device is also used for blood sampling from the implanted port and for power injection, neither of which can be done with the proposed device. These differences do not raise new questions of safety or effectiveness because the indications for use of the proposed device are within those of the predicate device.
Infusion Set Components
Both the proposed and predicate devices include non-coring (Huber) needles, tubing, luers, and clamps. Some of the accessories in the two infusion sets differ, i.e., the predicate infusion set also includes connectors, wings, and Y-adapters, that are needed for its intended uses related to an implanted port, while the proposed infusion set includes an empty syringe barrel, which is needed for its intended uses related to an implanted infusion pump. The empty syringe barrel is provided as a convenience to the user and serves as a passive waste receptacle for bacteriostatic water that is removed from the pump prior to implantation. The empty syringe barrel is not a piston syringe and contains no piston is not needed to draw out the fluid. There is no patient contact with the empty syringe barrel, and both the barrel and removed fluid are discarded after use. The end of the empty syringe barrel is covered by a Tyvek seal, and leak testing conducted to an internal protocol (see Section J) confirmed the integrity of this seal. Even if the Tyvek seal were to leak, there would be no risk to the patient or user as: 1) this process occurs during pump preparation before pump implantation: 2) the operator will be wearing sterile gloves; and 3) the removed fluid is bacteriostatic water. Therefore, this additional infusion set accessory does not raise any new questions of safety or effectiveness.
Hub/Needle Bond Strength
The hub/needle bond strength for the predicate device is unknown. However, the hub/needle bond strength for the Intera needles was tested to and demonstrated to comply with the requirements of ISO 7864:2016 (See Section J). Therefore, any differences between the proposed and predicate devices do not raise any new questions of safety or effectiveness.
Huber Needle Tip Configuration
The Huber needles in the proposed device have a straight tip, while the Huber needles in the predicate device have a bent (90 degrees) tip. The straight tip of the Intera Huber needles is appropriate for accessing the Intera 3000 and Codman 3000 infusion pumps, which are implanted subcutaneously in the lower abdomen. A bent needle is not necessary for pump access. The Intera needles were tested to and shown to comply with the applicable requirements of ISO 7864:2016, ISO 9626:2016, and ASTM F3212-16 for stainless steel needles (see Section J). Therefore, this difference does not raise any new questions of safety or effectiveness for the Intera Huber needles.
8
Needle Gauge and Length
The needle gauges of the Intera Huber needles are within the range offered by the predicate device. The Intera Huber needle lengths are also within the range offered by the predicate device except that the largest Intera Huber needle is 2" as compared to 1.5" for the predicate. This longer length is only needed in the case of a larger patient where there may be a greater distance to reach the pump receptacle. All needle lengths function the same. The Intera needles were tested to and shown to comply with the applicable requirements of ISO 7864:2016, ISO 9626:2016, and ASTM F3212-16 for stainless steel needles (see Section J). Therefore, this difference does not raise new questions of safety or effectiveness.
Shelf Life
The shelf life for the predicate device is unknown. However, the 24-month shelf life for the Intera Non-coring (Huber) Needles and OR Prep Kit was established by testing samples that had been real-time aged under warehouse conditions in conformance with ASTM F1929-15 and ASTM F88M/F88-15 for package integrity and applicable requirements of ISO 7864:2016 and ISO 8536-9:2015 for device integrity (see Section J). Therefore, any differences between the proposed and predicate devices do not raise any new questions of safety or effectiveness.
J. Testing to Support Substantial Equivalence
Performance Testing
The table below presents all of the bench performance tests conducted to support this 510(k). All tests met or exceeded the acceptance criteria of the applicable standards. No animal or clinical testing was conducted.
| Test Standard | Tests Conducted | Test Acceptance Criteria |
|---|---|---|
| ISO 7864:2016 Sterile | ||
| Hypodermic Needles for | ||
| Single Use - | ||
| Requirements and Test | ||
| Methods | Visual inspections | Outside surface of the tubing shall |
| be smooth and free from defects. | ||
| Needle tube shall appear straight | ||
| and of regular roundness. | ||
| Surfaces of the tubing shall be free | ||
| from metal soil and processing | ||
| agents. | ||
| Needle length tolerance | ||
| verification | Needle length shall be within +1.5 | |
| mm/-2.5 mm of the nominal length. | ||
| Tensile Testing of | ||
| needle/hub connections | Cannula/Hub connection shall | |
| withstand a 15 lbf tensile load | ||
| Patency of Flow Testing | Stainless steel stylet of 0.30 mm | |
| shall pass through the needle to | ||
| the non-coring feature. | ||
| Drag/Penetration force | ||
| testing | Maximum Drag/Penetration force of | |
| 5 lbf. | ||
| Test Standard | Tests Conducted | Test Acceptance Criteria |
| Acidity / Alkalinity testing | Extract PH shall be within one unit | |
| of pH of that of the control fluid. | ||
| Extractables testing | Limit of 5 mg/L of lead, tin, zinc, | |
| and iron. Limit of 0.1 mg/L of | ||
| cadmium. | ||
| ISO 9626:2016 Stainless | ||
| Steel Needle Tubing for | ||
| The Manufacture of | ||
| Medical Devices - | ||
| Requirements and Test | ||
| Methods | Stiffness testing | Maximum deflection of 0.42 mm. |
| Resistance to breakage | ||
| testing | No visible breakage. | |
| Corrosion testing | No visible sign of corrosion. | |
| ASTM F3212-16 | ||
| Standard Test Method for | ||
| Coring Testing of Huber | ||
| Needles | Non-Coring Testing | Absence of core in the needle |
| cannula | ||
| ISO 8536-9:2015 | ||
| Infusion Equipment for | ||
| Medical Use - Part 9: | ||
| Fluid Lines for Single | ||
| Use with Pressure | ||
| Infusion Equipment | Leak Testing | Cannula/Hub connection shall |
| maintain leak integrity when a | ||
| pressure of 45 psi | ||
| Tensile testing of tubing | ||
| luer connections | Each joint in the device shall | |
| withstand a tensile for of 5 lbs | ||
| Leak testing of tubing luer | ||
| connections | Flow path shall withstand a | |
| minimum of 50 psig of air | ||
| ISO 594-1:1986 and ISO | ||
| 594-2:1998 | ||
| Conical Fittings With 6 % | ||
| (Luer) Taper for | ||
| Syringes, Needles and | ||
| Certain Other Medical | ||
| Equipment - Part 1: | ||
| General Requirements | ||
| and Part 2: Lock Fittings | Luer performance testing | The connectors fit within the limits |
| of the gauge. | ||
| No observed leakage sufficient to | ||
| form a falling drop of water. | ||
| Connectors remained attached | ||
| under 35 N load. | ||
| Connectors remained attached | ||
| under 0.020 N·m unscrewing | ||
| torque. | ||
| Connectors successful connected | ||
| to the reference fitting/male luer. | ||
| Connector did not override threads | ||
| under load. | ||
| No signs of stress cracking | ||
| observed | ||
| Test Standard | Tests Conducted | Test Acceptance Criteria |
| USP Particulate | ||
| Matter in Injections | Particulate testing | Average number of particles |
| present does not exceed 6000 per | ||
| device equal to or greater than 10 | ||
| µm and does not exceed 600 per | ||
| device equal to or greater than 25 | ||
| µm. | ||
| Internal Intera Protocols | Clamp Flow Stoppage and | |
| Release Testing | Clamp shall prevent water at 45 | |
| psig from flowing once clamped for | ||
| 2 minutes. | ||
| Upon release of the clamp, water at | ||
| 5 psig must flow through the | ||
| clamped section. | ||
| Internal Intera Protocols | Leak Testing (Syringe | |
| Barrel Lid) | No leakage when inverted with 18 | |
| mL of water present |
9
10
Sterilization Validation
Ethylene oxide sterilization was validated to a Sterility Assurance Level (SAL) of 10° using the half-cycle, overkill method per ISO 11135:2014, 2m edition, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices. Bacterial endotoxin testing conducted using the LAL Test per USP 40-NF35:2017 Bacterial Endotoxins Test confirmed endotoxin levels well below the limit of the standard ( Pyrogen Test (USP Rabbit Test)
- Hemocompatibility per ISO 10993-4:2017 Biological evaluation of medical devices-● Part 4: Selection of tests for interactions with blood, including hemolysis per ASTM
11
F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials (indirect), and hemocompatibility
Shelf-Life Validation Testing
The following package validation and shelf life testing was completed on final, finished EtO sterilized samples that had been real-time aged for at least 25 months.
- Transportation testing according to ISTA 3A for Packaged-Products for Parcel Delivery System Shipments 70kg (150 lb) or Less (standard, small, flat or elongated)
- Package integrity testing, including the dye penetration test per ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration and the seal strength test per ASTM F88M/F88-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- Device integrity testing, including tensile strength and leak testing .
K. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The information and testing presented in this 510(k) demonstrate that the Intera Non-coring (Huber) Refill and Special Bolus Needles and OR Prep Kit with Tubing Set are substantially equivalent to the Huber Needle Infusion Set cleared under K200463 with respect to the indications for use and technological characteristics.