(205 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard gravity-feed administration set. There is no mention of any computational or analytical functions that would suggest the use of AI/ML.
No
This device is an administration set used to deliver fluids, but it does not treat or cure a disease or condition itself. It is a tool for administering therapy, not a therapeutic device.
No
This device is an ResQ Administration set, which is used for administering fluids to a patient's venous system. It is a therapy delivery device, not a diagnostic device that detects or monitors a medical condition.
No
The device description clearly outlines numerous physical components (protective cap, air filtration membrane, drip chamber, tubing, etc.) and describes bench testing related to the performance and integrity of these physical components. There is no mention of software as a component or function of the device.
Based on the provided information, the ResQ Administration set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to administer fluids to a patient's venous system. This is a direct interaction with the patient's body for therapeutic or supportive purposes.
- Device Description: The description details a system for delivering fluids into the bloodstream, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Clinical Setting: The device is used in a hospital or clinical setting for direct patient care.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health. The ResQ Administration set is a medical device used for administering substances into the body.
N/A
Intended Use / Indications for Use
ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.
Product codes
FPA
Device Description
ResQ Administration set is a single use, gravity feed, sterile device sterilized with Ethylene Oxide Gas. ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.
ResQ Administration set is compatible with various cannula or catheters models and can be used for most low viscosity fluids or medications.
The proposed device consists of protective cap, air filtration membrane, closure-piercing device, drip chamber, medicine fluid filter, roller clamp, tubing, flow regulator, injection sites (needle access - needleless access), in-line filter &two-part luer lock connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's venous system
Indicated Patient Age Range
All age groups
Intended User / Care Setting
Qualified physicians or nurses in hospital or clinical settings.
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
Bench Testing of ResQ Administration set was conducted according to identified standards/guidelines. Tests included: Leakage test of Infusion set, Tensile strength, Leakage of the IV injection site, Efficiency of the IV set fluid filter, Particulate contamination test, Test for titration acidity or alkalinity, Test for Reducing (oxidizing matters), Test for non-volatile residue, UV Absorption of extract solution, Determination of Fluid Flow Rate for IV Administration Set with Integral Air Inlet Device, Flow rate for graduate flow regulator, Determination of Graduated Flow Regulator Leakage Test, Test for falling drop positive pressure liquid leakage for male luer connector, Test for Resistance to overriding for male luer connector, Test for Resistance from separation from axial load for male luer connector, Test for Resistance to overriding for needle free connector with LAV, Test for Resistance from separation from axial load for Luer Activated Valve (LAV) of Needle Free Connector, Resistance to separation from unscrewing for needle free, Positive Pressure Liquid Leakage (activated) for Needle Free, Sub atmospheric pressure air leakage (activated) for Needle Free, Test for IPA Exposure for Needle Free, Test for Priming Volume for Needle Free, Test for Residual Volume for Needle Free, Test Method of Flow rate for needle free, Test for Backpressure (unactivated) for Needle Free, Test for Displacement for Needle Free, Test for sub atmospheric pressure air leakage (Unactivated) for Needle Free, Test of Number of Activations for Needle free, Test for Infusate compatibility, microbial ingress of check valve, needle less port and Y-injection port, Needleless Access Port Activation Time Test, Needleless Access Port Leakage Test During Aspiration, Needleless Access Port Leakage Test, Test for air/water leakage for infusion set in line filter, Ethylene oxide sterilization validation and routine control, Shelf-life study by accelerated aging studies, Device packaging integrity testing (Dye Penetration Test), Device packaging integrity testing (Bubble emission), Device packaging integrity testing, Bio-burden Of Finished Product, Sterility Test for Sterile Product, and Test Method of Pyrogen Test. Test results demonstrated that the subject device's results were accepted as per acceptance criteria for the tests.
Biocompatibility testing was also performed as per ISO 10993-1 for external communication devices with indirect blood path contact for prolonged duration (24 h to 30 days). Tests included: Cytotoxicity, Sensitization guinea pig maximization test (GPMT), Irritation, Acute toxicity, Subacute toxicity, Hemocompatibility, Hemolysis. Testing results and risk assessment demonstrated that materials used were safe and elicited no reactions in test animals.
No clinical tests were conducted for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 3, 2024
Q for Plastic Industries % Abdel Halim President Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831
Re: K231707
Trade/Device Name: ResQ Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: December 3, 2023 Received: December 4, 2023
Dear Abdel Halim:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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.
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices,
2
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
3
Indications for Use
510(k) Number (if known) K231707
Device Name ResO Administration Set
Indications for Use (Describe)
ResO Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.
| 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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4
K231707 - 510(k) Summary
| Date: | Dec. 22, 2023 |
|---|---|
| Submitter (Owner): | Islam Nazeih Mohamed Ali |
| Chief Executive Officer | |
| Islam Nazeih Mohamed Ali and Partner | |
| Land plot #25,27 first industrial zone, Badr city ,11829Cairo, | |
| Egypt | |
| Phone: +20 1146626663 | |
| E-mail ID: i.aly@qmedicaldevices.com | |
| 510(k) Contact Person: | Yasmeen Fawzy |
| Quality manager of Q for plastic industries | |
| Land plot #25,27 first industrial zone, Badr city ,11829Cairo, | |
| Egypt | |
| Phone: +20 1019670495 | |
| E-mail ID: yasmeen.fawzy@qmedicaldevices.com | |
| Device Trade Name: | ResQ Administration Set |
| Common name: | Intravascular administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation classification | |
| Description: | Intravascular Administration Set |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Product Code: | FPA |
| Predicate Device: | 510(k) Number: K112204 |
| Product Name: KDL Disposable Infusion Set | |
| Manufacturer: Shanghai Kindly Enterprise Development | |
| Group Co., Ltd. |
Device Description
ResO Administration set is a single use, gravity feed, sterile device sterilized with Ethylene Oxide Gas. ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.
ResQ Administration set is compatible with various cannula or catheters models and can be used for most low viscosity fluids or medications.
The proposed device consists of protective cap, air filtration membrane, closure-piercing device, drip chamber, medicine fluid filter, roller clamp, tubing, flow regulator, injection sites (needle access - needleless access), in-line filter &two-part luer lock connector.
5
The protective cap is intended to maintain sterility and to protect the closure piercing device that used to pierce the container, the drip chamber is transparent so that the user can observe the dropping condition of the medical solution, it has an air filtration membrane which can filter the air into the container and an air-inlet set which can control the air into the container and a medicine fluid filter which can filter the medical solution, the roller clamp is used to control the flow of the medicine solution, the tubing is used to connect various components, the flow regulator is used to adjust the flow rate from zero to maximum, there are two injection sites one is needleless and the other is needle access, which are used to inject solution into the tubing, the in-line filter used for retention of particles, bacteria and fungi, also it used for elimination of the air, two-part luer lock connector is used to connect the infusion needle or catheter with the tubing.
- It is single use device, sterilized by EO sterilization. ●
- . Environment of Use: healthcare facility/hospital
Indications for Use
ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.
Contraindications
- Some patients have anatomy that poses a risk for fluid extravasation or inadequate flow and peripheral IVs should be avoided in these situations.
- . Include extremities that have massive edema, burns or injury.
- · For the patient with severe abdominal trauma, it is preferable to start the IV in an upper extremity because of the potential for injury to vessels between the lower extremities and the heart.
- For the patient with cellulitis of an extremity, the area of infection should be avoided when starting . an IV because of the risk of inoculating the circulation with bacteria. As well, extremities on the side of a mastectomy or that have an indwelling fistula should be avoided because of concerns about adequate flow.
- . Administration of highly viscous fluids like human albumin, Dextrans, Etherified Starch, Plasma Protein Fraction & Gelatin.
- Blood transfusion: the device isn't designed to be used for blood transfusion. -
Working Principle
Closure piercing device inserted into ResQ Administration set. Container and roller clamp is opened and permitted chamber to fill to required level, squeeze drip chamber to fill half full and open roller clamp again to refill to required level. Close roller clamp and make sure there is solution in the drip chamber that way it enables precise volume and slow Administration of infusion or injectable medicine.
A micro regulator is integrated into ResQ Administration set for precise flow control to regulate the flow of IV fluid from an infusion set into an IV catheter.
A filter serves as security barrier, its membrane has symmetrical diameter ensuring no medium to fall off or deform with the function of removing contaminations including bacteria, fungi and endotoxins from the tubing, it guarantees high-precision filtration.
6
Comparison to Predicate Device
One predicate device is selected in this submission for ResQ Administration set. Predicate device: KDL Disposable Infusion Set and the details of the substantial equivalence between the subject device and predicate device is explained below:
| Comparable
Properties | Subject Device (K231707) | Predicate Device (K112204) | Comparison
Results |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | ResQ Administration set | KDL Disposable Infusion Set | N/A |
| Regulation
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical |
| Product Code | FPA | FPA | Identical |
| Product Class | II | II | Identical |
| Intended Use /
Indications for Use | The device is intended to administer
fluids from a container to a patient's
venous system through a needle or
catheter inserted into the vein. The
set is a sterile, disposable for a single
use. The ResQ Administration Set
should be used no more frequently
than at 96-hour intervals. It can be
used on patients of all age groups
under the supervision of a qualified
physicians or nurses in hospital or
clinical settings. | Disposable Infusion Set is
intended to administer fluids
from a container to a patient's
vascular system through a needle
or catheter inserted into the vein.
It can be used on patients of all
age groups under the supervision
of a qualified physician or health
care professionals in hospital or
clinical settings. | Different
Only we
mentioned in
the
indication
for use of
our device
that it should
be used no
more
frequently
than at 96-
hour
intervals
And we state
that the
solution will
be
administered
in to the
patients
venous
system and
the predicate
states that it
is
administered
into the
patients
vascular
system |
| Mode of Fluid
Delivery | Gravity | Gravity | Identical |
Table 1: Comparison to Predicate Devices
7
| Comparable
Properties | Subject Device (K231707) | | Predicate Device (K112204) | | Comparison
Results |
|-------------------------------|-------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------------|----------|-----------------------|
| Single-Use | Yes | | Yes | | Identical |
| Prescription
only | Yes | | Yes | | Identical |
| Disposable | Yes | | Yes | | Identical |
| Configuration and
material | Configuration | material | Configuration | material | Different 1 |
| | Protective Cap of
Closure-piercing
Device (Spike) | HDPE | Protective Cap of
Closure-piercing
Device | | |
| | Closure-piercing
Device (Spike) | ABS | Closure-piercing
Device | Unknown | |
| | Air Vent | PVC | Air Vent | | |
| | Drip Chamber | PVC | Drip Chamber | | |
| | Fluid Filter | ABS | Fluid Filter | | |
| | Flexible Tube | PVC | Flexible Tube | | |
| | Roller Clamp | HDPE | Roller Clamp | | |
| | needleless port | Synthetic Silicone | needleless port | | |
| | Y-Injection site | Synthetic Silicone | Y-Injection site | | |
| | Luer Lock
Connector | PVC | Luer Lock
Connector | | |
| | Protector Cap of | HDPE | Protector Cap of | | |
| | Luer Lock
Connector | PVC | Luer Lock
Connector | | |
| | In-Line Filter | PVC | In-Line Filter | | |
| | Flow regulator | ABS | Flow regulator | | |
| | — | — | Infusion needle | | |
| Tubing Diameter | 4mm | | 3.9 mm | | Different 3 |
| Filter
Characteristics | 0.2 µm for in line filter and 15µm for
fluid filter | | 0.2 µm for in line filter and 15 µmfor
fluid filter | | Identical |
| Infusion Set
Performance | Conform with ISO 8536-4:2019 | | Conform with ISO 8536-4:2010 | | Identical |
| Flow rate of
regulator | 5 to 250 ml/hour | | 20 to 250 ml/hour | | Different 4 |
| Sterility | ETO sterilization | | ETO sterilization | | Identical |
| Biocompatibility | ISO 10993-1
ISO 10993-4
ISO 10993-5
ISO 10993-10
ISO 10993-11
ISO 10993-23 | | Conform with ISO 10993 series
standards | | Identical |
8
| Comparable
Properties | Subject Device (K231707) | Predicate Device (K112204) | Comparison
Results |
|--------------------------|---------------------------------------------|---------------------------------------------|-----------------------|
| Labeling | Meet the requirements of 21 CFR Part
801 | Meet the requirements of 21 CFR Part
801 | Identical |
| Note 1 | The subject device Configurations and materials are not contained needle where the KDL Disposable infusion set configuration with infusion needle. The performance and biocompatibility testing on the subject device demonstrate substantial equivalence. All the performance testing of the device as mentioned below in table 2 in this summary and they were done as per product standard and FDA guidance for this device indicate that the subject device testing results were all accepted as per acceptance criteria for the tests and the biocompatibility testing as mentioned below in table 3 in this summary also done as per ISO10993-1 and all the results was accepted for the subject device and their testing results was accepted as per testing ISO standard requirements. |
|---|---|
| Note 2 | The subject device configuration and material not contain needle but contain the male luer lock with its cover which comply with ISO 80369 where the KDL Disposable infusion set configuration with infusion needle so it complies with ISO 594-1, ISO 594-2. The performance testing on the subject device demonstrates substantial equivalence without raising any new questions of safety and effectiveness. |
| Note 3 | The Subject device tube diameter is 4mm. The performance testing on the subject device demonstrates substantial equivalence without raising any new questions of safety and effectiveness. We did for the subject device flow rate testing and tensile strength testing as per (ISO 8536-4 Sixth edition 2019-09 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.) and the results were accepted as per acceptance criteria for the test and the tube diameter was not raise any new question for safety or performance of the device |
| Note 4 | The subject device Flow rate limit from 5 to 250mm, the performance testing on the subject device demonstrates substantial equivalence without raising any new questions of safety and effectiveness. As the flow rate of the predicate device limit is from 20 to 250 and the subject device limit is from 5 to 250 so all the predicate device range is within the range of the subject device and we did the flow rate testing for the subject device and all results were accepted as per test acceptance criteria. |
9
Performance Data
The following tests according to the identified standards / guidance were conducted
on ResQ Administration set to verify the performance of the device:
Table 2: Bench Testing of ResQ Administration set
Inner Diameter of PVC Tube: 3.0 ± 0.1mm as per ISO 8536-4:2019 Outer Diameter of PVC Tube: 4.1 ± 0.1 mm as per ISO 8536-4:2019
| S.
| No. | Test Description | Standard/Guideline |
|---|---|---|
| 1. | Leakage test of Infusion set. | ISO 8536-4 Sixth edition 2019-09 Infusion |
| equipment for medical use - Part 4: Infusion sets | ||
| for single use, gravity feed. | ||
| 2. | Tensile strength. | |
| 3. | Leakage of the IV injection site. | |
| 4. | Efficiency of the IV set fluid filter. | |
| 5. | Particulate contamination test. | |
| 6. | Test for titration acidity or alkalinity | |
| 7. | Test for Reducing (oxidizing matters). | |
| 8. | Test for non- volatile residue. | |
| 9. | UV Absorption of extract solution. | |
| 10. | Determination of Fluid Flow Rate for IV | |
| Administration Set with Integral Air Inlet Device. | ||
| 11. | Flow rate for graduate flow regulator. | ISO 8536-13 First edition 2016-10 Infusion |
| equipment for medical use - Part 13: Graduated | ||
| flow regulators for single use with fluid contact. | ||
| 12. | Determination of Graduated Flow Regulator Leakage | |
| Test. | ||
| 13. | Test for falling drop positive pressure liquid leakage | |
| for male luer connector. | ISO 80369-7 Second | |
| edition 2021-05 Small- bore connectors for | ||
| liquids and gases in healthcare applications - | ||
| Part 7: Connectors for intravascular or | ||
| hypodermic applications. | ||
| 14. | Test for Resistance to overriding for male luer connector. | |
| 15. | Test for Resistance from separation from axial load for | |
| male luer connector. | ISO 80369-20 First | |
| edition 2015-05-15 Small-bore connectors for | ||
| liquids and gases in healthcare applications - | ||
| Part 20: Common test methods. | ||
| 16. | Test for Resistance to overriding for needle free connector | |
| with LAV. | ISO 80369-7 Second | |
| edition 2021-05 Small- bore connectors for | ||
| liquids and gases in healthcare applications - | ||
| Part 7: Connectors for intravascular or | ||
| hypodermic applications. | ||
| 17. | Test for Resistance from separation from axial load for | |
| Luer Activated Valve (LAV) of Needle Free Connector. | ||
| 18. | Resistance to separation from unscrewing for needle free. | ISO 80369-20 First |
| edition 2015-05-15 Small-bore connectors for | ||
| liquids and gases in healthcare applications - | ||
| Part 20: Common test methods. | ||
| 19. | Positive Pressure Liquid Leakage (activated) for Needle | |
| Free. | ||
| 20. | Sub atmospheric pressure air leakage (activated) for | |
| Needle Free. | ANSI AAMI | |
| CN27:2021 General requirements for Luer | ||
| activated valves (LAVs) incorporated into | ||
| medical devices for intravascular applications. | ||
| 21. | Test for IPA Exposure for Needle Free. | ISO 1135-4:2015 |
| Transfusion equipment for medical use – Part 4: | ||
| Transfusion sets for single use, gravity feed. | ||
| 22. | Test for Priming Volume for | |
| Needle Free. | ||
| 23. | Test for Residual | |
| Volume for Needle Free. | ||
| 24. | Test Method of | |
| Flow rate for needle free. | ||
| 25. | Test for Backpressure (unactivated) for Needle Free. | |
| 26. | Test for Displacement for Needle Free. | |
| 27. | Test for sub atmospheric pressure air leakage | |
| (Unactivated) for Needle Free. | ||
| 28. | Test of Number of Activations for Needle free. | |
| 29. | Test for Infusate compatibility. | |
| 30. | microbial ingress of check valve, needle less port and | |
| Y- injection port | ||
| 31. | Needleless Access Port Activation Time Test. | ISO 1135-4:2015 |
| Transfusion equipment for medical use – Part 4: | ||
| Transfusion sets for single use, gravity feed. | ||
| 32. | Needleless Access Port Leakage Test During | |
| Aspiration. | ||
| There are 6 models of our device 2 of which | ||
| containing 1 check valve only, one model containing | ||
| no any check valve and the other 3 models containing | ||
| 3 check valves The microbial ingress test is | ||
| concerned with only the check valves (injection ports | ||
| and needless ports) So, we should do the test on the | ||
| worst case model that contain 2 check valves We | ||
| performed the microbial ingress test for the test | ||
| article (IVQ49) as we consider this model as the | ||
| worst case model (in this test) which contains 2 check | ||
| valves (1 injection port, and one needless port) also it | ||
| contains the most number of device other | ||
| components. | ||
| 33. | Needleless Access Port Leakage Test. | |
| 34. | Test for air/water leakage for infusion set in line filter. | ISO 8536-11 Second |
| Edition 2015-06-15 Infusion Equipment for | ||
| Medical Use - Part 11: Infusion Filters for Single | ||
| Use with Pressure Infusion Equipment. | ||
| 35. | Ethylene oxide sterilization validation and routine | |
| control. | ISO 11135:2014 | |
| Sterilization of health- care products - Ethylene | ||
| oxide - Requirements for the development, | ||
| validation and routine control of a sterilization | ||
| process for medical devices [Including: | ||
| Amendment 1 (2018)]. | ||
| 36. | Shelf-life study by accelerated aging studies. | ASTM F1980-16 |
| Standard Guide for Accelerated Aging of Sterile | ||
| Barrier Systems for Medical Devices. | ||
| 37. | Device packaging integrity testing (Dye Penetration | |
| Test). | ASTM F1929-15 | |
| Standard Test Method for Detecting Seal Leaks | ||
| in Porous Medical Packaging by Dye Penetration. | ||
| 38. | Device packaging integrity testing (Bubble emission). | ASTM D3078-02 |
| (Reapproved 2013) Standard Test Method for | ||
| Determination of Leaks in Flexible Packaging by | ||
| Bubble Emission. | ||
| 39. | Device packaging integrity testing. | ASTM F1140/F1140M-13 |
| Standard Test Methods for Internal Pressurization | ||
| Failure Resistance of Unrestrained Packages. | ||
| 40. | Bio-burden Of Finished Product. | ISO 11737-1:2018. |
| 41. | Sterility Test for Sterile Product. | -USP 41 chapter 71. |
| 42. | Test Method of Pyrogen Test. | - ISO 11737-2: 2019. |
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Based on the tests performed and information provided on predicate devices, it can be concluded that the subject device is substantially equivalent to the predicate devices and raises of safety and performance.
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Biocompatibility Data
Product name: ResQ Administration set.
Category: external communication device.
Contact: blood path indirect.
Contact duration: prolonged (24 h to 30 days)
And are under category of external communication device blood path indirect to ensure safety of ResQ Administration set during use in patients, testing and risk assessment as per ISO 10993-1 were performed. Testing included the following assessments:
Table 3: Biological Evaluation of ResQ Administration set
| S. No. | Test Name | Reference guidance document /
standard |
|--------|--------------------------------------------|-------------------------------------------|
| 1. | Cytotoxicity | ISO 10993-5:2009 |
| 2. | Sensitization guinea pig maximization test | ISO 10993-10:2021 |
| 3. | (GPMT) | ISO 10993-23:2021 |
| 4. | Irritation | ISO 10993-11:2017 |
| 5. | Acute toxicity | ISO 10993-11:2017 |
| 6. | Subacute toxicity | ISO 10993-4:2017 |
| 7. | Hemocompatibility | ISO 10993-4:2017 |
| 8. | Hemolysis | ISO 10993-11:2017 |
Testing results and risk assessment demonstrated that materials used in the construction of ResQ Administration set were safe and elicited no reactions in test animals.
Clinical Performance Summary
Not applicable. No clinical tests were conducted for this submission.
Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The ResQ Administration set manufactured by Q for Plastic Industries is substantially equivalent to the KDL Disposable Infusion Set and is as safe and effective when used as intended.