(407 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a needle infusion set, with no mention of AI or ML.
No
This device is for infusing fluids and drugs as well as sampling blood, and not for treating a disease or condition. These are supportive functions in a medical process.
No
This device is designed for the infusion of fluids and drugs, as well as blood sampling, and power injection of contrast media. While blood sampling and contrast media injection can be part of diagnostic procedures, the device itself is an infusion set used for delivery and collection, not for analyzing or interpreting medical information to diagnose a condition.
No
The device description clearly details physical components such as needles, tubing, and a safety mechanism, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is 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." This describes a device used for administering substances into the body and collecting samples from the body, not for performing tests on those samples to diagnose conditions.
- Device Description: The description focuses on the physical characteristics of the needle and set, its function in accessing an implanted port, and its suitability for infusion and blood sampling. There is no mention of reagents, assays, or any process for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases.
The device is a medical device used for accessing a port for therapeutic and sample collection purposes, not for performing diagnostic tests on the collected samples.
N/A
Intended Use / Indications for Use
Huber Needle Infusion Set
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.
Safety Huber Needle Infusion Set
The Safety 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 safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks.
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.
Product codes (comma separated list FDA assigned to the subject device)
PTI
Device Description
The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s).
The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Performance Testing:
- Wing Flexibility: Verify whether wings are able to withstand bending without cracking
- Penetration Force: ISO 10555-6:2015 Intravascular catheters – Sterile and single-use catheters Part 6: Subcutaneous implanted ports
- Coring Testing: ASTM F3212-16: Standard test method for coring testing of Huber needles
- Occlusion Testing: Verify that the device can understand 45 psi pressure, and the liquid path is freedom from leakage
- Leakage, Joint integrity, tubing testing, tensile strength: ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed
- Safety Mechanism Activation and Function: ISO 23908:2011 Sharps injury protection - Requirements and test methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling; FDA Guidance Medical Devices with Sharps Injury Prevention Features, Issued August 9, 2005
- Ability to withstand power injection pressures: Watertight and resistant up to a high pressure of 330 psi
- Power Injection Flow rate: Confirm Maximum flow rates with a power injector
- Needle performance: ISO 7864:2016 Sterile Hypodemic Needles for Single Use- Requirements And Test Methods; ISO 9626:2016 Stainless Steel Needle Tubing For The Manufacture of Medical Devices- Requirements and Test Methods
- Luer Connector performance: ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications; ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods
- MRI Compatibility: ASTM F2182-09 Standard test method for measurement of radio frequency induced heating on or near passive implants during magnetic resonance imaging; ASTM F2052-06 Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment; ASTM 2119-07 Standard test method for evaluation of MR image artifacts from passive implants; ASTM 2213-06 R11 Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment
- Simulated Use Study: FDA Guidance Medical Devices with Sharps Injury Prevention Features, Issued August 9, 2005
- Particulates: USP
- Sterilization: ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals; ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection; ASTM F88/F88M-15, Standard Test Method For Seal Strength Of Flexible Barrier Materials. (Sterility); ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
Biocompatibility testing:
The materials of construction of a fully assembled Huber Needle Infusion Set and Safety Huber Needle Infusion Set were tested according to ISO 10993-1:2018. The following biocompatibility testing was performed with the reference standard: Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Pyrogen (ISO 10993-11, USP 42 NF 37 ), Hemolytic Property (ASTM F756), Partial Thromboplastin (ASTM F2382), Complement Activation (ISO 10993-4), Bacterial Endotoxin Limit (USP ).
No clinical study is included in this 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services USA seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the agency name in a rectangular shape.
Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 CN
Re: K200463
Trade/Device Name: Huber Needle Infusion Set. Safety Huber Needle Infusion Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: February 1, 2021 Received: March 8, 2021
Dear Diana Hong:
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.
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
1
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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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.
James M. Simpson Jr -S7
for Paval Patel Acting 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) K200463
Device Name
Huber Needle Infusion Set Safety Huber Needle Infusion Set
Indications for Use (Describe)
Huber Needle Infusion Set
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.
Safety Huber Needle Infusion Set
The Safety 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 safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks.
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.
| 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
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K200463
-
- Date of Preparation: 3/31/2021
-
- Sponsor Identification Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town, Jiangyin city, Jiangsu, 214415, China. Establishment Registration Number: 3005670221 Contact Person: Jianwei Pan Position: Management Representative Tel: +86-510-8686 6666-8027 Fax: +86-510-8686 6666-8009 Email: jianwei.pan@cainamed.com
-
- Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (Alternative Contact Person) Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-228-15850, Fax: +1-360-925-3199 Email: info@mid-link.net
-
- Identification of Proposed Device
Trade Name: Huber Needle Infusion Set, Safety Huber Needle Infusion Set Common Name: Intravascular Administration Set Regulatory Information Classification Name: Hypodermic Single Lumen Needle Classification: II Product Code: PTI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;
4
-
- Identification of Predicate Device 510(k) Number: K170897 Product Name: Surecan Safety II
Indication for Use:
- Identification of Predicate Device 510(k) Number: K170897 Product Name: Surecan Safety II
Huber Needle Infusion Set
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.
Safety Huber Needle Infusion Set
The Safety 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 safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle sticks.
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.
Device Description:
The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle
5
Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s).
The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.
-
- Summary of Technological Characteristics
| Item | Proposed Device
Huber Needle
Infusion Set | Proposed Device
Safety Huber Needle
Infusion Set | Predicate Device
K170897 | Remake |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Product Code | PTI | PTI | PTI | Same |
| Regulation No. | 880.557 | 880.557 | 880.557 | Same |
| Class | II | II | II | Same |
| Indication for
Use | 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 Safety 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 safety feature is
manually activated during
needle removal, and is
designed to aid in the
prevention of accidental
needle sticks. | The Surecan Safety II
power-injectable safety
non-coring needle is a
device intended for
insertion into the
septum of a
subcutaneously
implanted port for the
infusion of fluids and
drugs, as well as blood
sampling through the
port.
The Surecan Safety II
safety feature is
manually activated
during needle removal,
and is designed to aid in
the prevention of
accidental
needle-sticks. When
used with ports that are | Similar 1 |
| | 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 | The 19G-22G needles of
device are also suitable
for power injection of
contrast media to a
maximum pressure of | | |
| Item | Proposed Device
Huber Needle
Infusion Set | Proposed Device
Safety Huber Needle
Infusion Set | Predicate Device
K170897 | Remake |
| | indicated for power
injection, the
maximum
recommended
infusion rate is
approximately 5ml/s
for 19G and 20G,
2ml/s for 22G. | 325psi. For power
injection of contrast
media, the maximum
recommended infusion
rate is approximately
5ml/s for 19G and 20G,
2ml/s for 22G. | indicated for power
injection of contrast
media into the central
venous system, the
Surecan Safety II
needle is also indicated
for power injection of
contrast media.
For power injection of
contrast media, the
maximum flow rates at
325 psi are 5mL/s for
19 gauge and 20 gauge
needles and 2mL/s for
the 22 gauge needles. | |
| | Non-coring needle | Non-coring needle | Non-coring needle | |
| | NA | Safety mechanism-hub | Safety mechanism-hub | |
| | PVC tube | PVC tube | PVC tube | |
| | Clamps | Clamps | Clamps | |
| Configuration | Female luer fitting | Female luer fitting | Female luer fitting | Similar 2 |
| | Male luer cap | Male luer cap | Male luer cap | |
| | Needleless connector | Needleless connector | Needleless connector | |
| | Y needleless adapters | Y needleless adapters | Y needleless adapters | |
| | Y needle adapters | Y needle adapters | Y needle adapters | |
| | NA | Safety Mechanism | Safety Mechanism | |
| Label/Labeling | Complied with 21
CFR part 801 | Complied with 21 CFR
part 801 | Complied with 21
CFR part 801 | |
| Needle gauge | 19G, 20G, 22G, 24G,
25G | 19G, 20G, 22G, 24G,
25G | 19G, 20G, 22G | Different 3 |
| Needle length | 0.5 ", 0.75 ", 1 ",
1.25 ", 1.5 " | 0.5 ", 0.75 ", 1 ",
1.25 ", 1.5 " | 0.5 ", 0.6 ", 0.8 "
1 ", 1.3 ", 1.5 " | Different 4 |
| Item | Proposed Device
Huber Needle
Infusion Set | Proposed Device
Safety Huber Needle
Infusion Set | Predicate Device
K170897 | Remake |
| Available for use
with contrast
media | 19G, 20G, 22G | 19G, 20G, 22G | 19G, 20G, 22G | Same |
| Infusion rate
with contrast
media | 5ml/s for 19G and
20G
2ml/s for 22G | 5ml/s for 19G and 20G
2ml/s for 22G | 5ml/s for 19G and 20G
2ml/s for 22G | Same |
| Needle bevel
design | Non-coring needle | Non-coring needle | Non-coring needle | Same |
| Priming volume | S-1: 0.4mL
S-2: 0.5mL
Y-1: 0.7mL
Y-2: 0.7mL
D-2: not applicable | S-1s: 0.4mL
S-2s: 0.5mL
Y-1s: 0.7mL
Y-2s: 0.7mL | 19ga (without
Caresite)- 0.32mL
20ga (without
Caresite)- 0.24mL
22ga (without
Caresite)- 0.18mL
19ga (with Caresite)-
0.62mL
20ga (with Caresite)-
0.53mL
22ga (with Caresite)-
0.46mL | Different 5 |
| Safety
Mechanism
Design | NA | The activation of the
safety device is manual.
After the infusion is
completed, hold the base
of the safety
mechanism-plate with one
hand, hold the double
wing with the other hand
and pull the needle out.
When the needle is
completely pulled out
until the click sound is
heard, the tip of the
needle is locked in the
safety mechanism-plate. | Manually activated
safety mechanism upon
removal of the needle
from the implanted
vascular port. Safety
mechanism locks
needle into place when
a firm stop is felt.
A green dot appears on
the clear bottom plate
when safety mechanism
is fully engaged. | Different 6 |
| Item | Proposed Device
Huber Needle
Infusion Set | Proposed Device
Safety Huber Needle
Infusion Set | Predicate Device
K170897 | Remake |
| Does the device
have wings? | NA | Yes | Yes | Same |
| Is the
engagement of
the safety
mechanism
visible to the
user? | NA | Yes | Yes | Same |
| Hub | Methyl methacrylate
acrylonitrile
butadiene styrene
plastics (MABS) | NA | | |
| Joint pipe | Polyvinyl chloride
(PVC) | NA | | |
| PVC tube | Polyvinyl chloride
(PVC) | Polyvinyl chloride (PVC) | | Non-clinical
testing
performed.
Does not
raise new
question of
safety and
effectiveness. |
| Female Luer
fitting | Methyl methacrylate
acrylonitrile
butadiene styrene
plastics (MABS);
Polypropylene (PP)
White Color | Methyl methacrylate
acrylonitrile butadiene
styrene plastics (MABS);
White Color | Unknown | |
| Needleless
connector | Polycarbonate
(PC)+Silicone rubber | Polycarbonate (PC)
+Silicone rubber | | |
| Y needleless
adapters | Polycarbonate (PC) +
Silicone rubber | Polycarbonate (PC) +
Silicone rubber | | |
| PVC extend tube | Polyvinyl chloride
(PVC) | Polyvinyl chloride (PVC) | | |
| Y needle
adapters-connect
or | Methyl methacrylate
acrylonitrile
butadiene styrene
plastics (MABS) | Methyl methacrylate
acrylonitrile butadiene
styrene plastics (MABS) | | |
| Y needle
adapters-injectio
n site | Silicone rubber | Silicone rubber | | |
| Lubricant | Polydimethylsiloxane | Polydimethylsiloxane | | |
| Item | Proposed Device
Huber Needle
Infusion Set | Proposed Device
Safety Huber Needle
Infusion Set | Predicate Device
K170897 | Remake |
| Safety
mechanism-hub | NA | Polycarbonate (PC) | | |
| Protective pad | NA | Polyethylene (PE) | | |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | same |
| Sterilization | EO sterilization | EO sterilization | EO sterilization | Same |
| SAL | 10-6 | 10-6 | 10-6 | Same |
| Single use | Single use | Single use | Single use | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | 20 EU per device | Same |
Table 1 Comparison of Technological Characteristics with the Predicate Device
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7
8
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Similar 1- Indications for Use
Both the predicate and Huber Needle Infusion Set and Safety Huber Needle Infusion Set are intended for use 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 into the port. Although the Huber Needle Infusion Set has no safety mechanism, the predicate and proposed device have similar Indications for Use, and the same intended use.
Similar 2- Configuration
The Safety Huber Needle Infusion Set and Huber Needle Infusion Set have the similar configuration with the predicate device. Although the Huber Needle infusion Set does not have the safety mechanism, the difference will not affect the safety and effectiveness of the proposed device. Therefore, the difference does not raise new questions on safety and effectiveness of the proposed device.
Different 3- Needle gauge
The needle gauge of proposed device is different from the predicate device. However, the performance of needle has been evaluated and test results demonstrated compliance with related needle performance standards requirements. Therefore, the difference does not raise new questions on safety and effectiveness of the proposed device.
Different 4- Needle length
The needle length of proposed device is different form the predicate device. However, the needle length of the Safety Huber Needle Infusion Set and Huber Needle Infusion Set is within the needle length of the predicate device. Additionally, the performance of the needle has evaluated per ISO 7864 and test results meet related standards requirements. Therefore, the difference does not raise new questions on safety and effectiveness of the
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proposed device.
Different 5 - Priming volume
The priming volume of the proposed device is different from the predicate device. The priming volume for each configuration of proposed device is included in the user manual. Therefore, the slight difference on priming volume does not raise new questions on safety and effectiveness of the proposed device.
Different 6 - Safety Mechanism Design
The proposed Huber Needle Infusion Set does not have a safety mechanism. The safety mechanism design of proposed Safety Huber Needle Infusion Set is different from predicate device. However, both the proposed device and predicate device were tested in simulated clinical use study. The test results showed the safety mechanism can protect the needle tip from exposure. And there's a click sound for the user to know when the needle is locked. Therefore, the difference does not raise new questions on safety and effectiveness of the proposed device.
7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Performance Testing
Functional performance testing was completed to demonstrate that the proposed device performs as intended after ethylene oxide (EO) sterilization. The following performance tests were evaluated in support of the substantial equivalence determination:
| Wing Flexibility | Verify whether wings are able to withstand bending without cracking |
|---|---|
| Penetration Force | ISO 10555-6:2015 Intravascular catheters – Sterile and single-use |
| catheters Part 6: Subcutaneous implanted ports | |
| Coring Testing | ASTM F3212-16: Standard test method for coring testing of Huber |
| needles | |
| Occlusion Testing | Verify that the device can understand 45 psi pressure, and the liquid path |
| is freedom from leakage | |
| Leakage, Joint integrity, | |
| tubing testing, tensile | |
| strength | ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusion |
| sets for single use, gravity feed | |
| Safety Mechanism | ISO 23908:2011 Sharps injury protection - Requirements and test |
| Activation and Function | methods – Sharps protection features for single-use hypodermic |
| needles, introducers for catheters and needles used for blood | |
| Sampling; | |
| FDA Guidance Medical Devices with Sharps Injury | |
| Prevention Features, Issued August 9, 2005 | |
| Ability to withstand power | |
| injection pressures | Watertight and resistant up to a high pressure of 330 psi |
| Power Injection Flow rate | Confirm Maximum flow rates with a power injector |
| Needle performance | ISO 7864:2016 Sterile Hypodemic Needles for Single Use- Requirements |
| And Test Methods; | |
| ISO 9626:2016 Stainless Steel Needle Tubing For The Manufacture of | |
| Medical Devices- Requirements and Test Methods | |
| Luer Connector performance | ISO 80369-7:2016 Small-bore connectors for liquids and gases in |
| healthcare applications-Part 7: Connectors for intravascular or | |
| hypodermic applications; | |
| ISO 80369-20:2015 Small-bore connectors for liquids and gases in | |
| healthcare applications-Part 20: Common test methods | |
| MRI Compatibility | ASTM F2182-09 Standard test method for measurement of radio |
| frequency induced heating on or near passive implants during | |
| magnetic resonance imaging; | |
| ASTM F2052-06 Standard test method for measurement of | |
| magnetically induced displacement force on medical devices in the | |
| magnetic resonance environment; | |
| ASTM 2119-07 Standard test method for evaluation of MR image | |
| artifacts from passive implants; | |
| ASTM 2213-06 R11 Standard test method for measurement of | |
| magnetically induced torque on medical devices in the magnetic | |
| resonance environment | |
| Simulated Use Study | FDA Guidance Medical Devices with Sharps Injury Prevention |
| Features, Issued August 9, 2005 | |
| Particulates | USP |
| Sterilization | ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: |
| Ethylene Oxide Sterilization Residuals | |
| ASTM F1886 / F1886M-16, Standard Test Method for Determining | |
| Integrity of Seals for Flexible Packaging by Visual Inspection | |
| ASTM F88/F88M-15, Standard Test Method For Seal Strength Of | |
| Flexible Barrier Materials. (Sterility) | |
| ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in | |
| Porous Medical Package by Dye Penetration |
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Biocompatibilty testing
The materials of construction of a fully assembled Huber Needle Infusion Set and Safety Huber Needle Infusion Set were tested according to ISO 10993-1:2018. The following biocompatibility testing was performed with the reference standard:
| Biocompatibility Testing | Standard |
|---|---|
| Cytotoxicity | ISO 10993-5 |
| Skin Sensitization | ISO 10993-10 |
| Intracutaneous Reactivity | ISO 10993-10 |
| Acute Systemic Toxicity | ISO 10993-11 |
| Pyrogen | ISO 10993-11, USP 42 NF 37 |
| Hemolytic Property | ASTM F756 |
| Partial Thromboplastin | ASTM F2382 |
| Complement Activation | ISO 10993-4 |
| Bacterial Endotoxin Limit | USP |
8. Clinical Test Conclusion
No clinical study is included in this testing.
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device, K200463, the Huber Needle Infusion Set and the Safety Huber Needle Infusion Set are as safe and effective for its intended use and substantially equivalent to the predicate device, K170897.