(202 days)
No
The document describes a standard IV administration set with no mention of AI or ML components or functionality.
No.
Therapeutic devices are generally defined as those that treat or cure a disease or condition. This device is for "delivery of fluids," which is a supportive function, not a direct treatment.
No
The device is described as an IV administration set for delivering fluids, not for diagnosing medical conditions.
No
The device description explicitly lists physical components such as insertion spike, drip chamber, clamp, tubing, etc., indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for delivery of fluids from a container into a patient's vascular system." This describes a device used in vivo (within the body) for administering substances, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details components like spikes, drip chambers, tubing, and connectors, which are typical for devices used for intravenous fluid delivery. It does not mention components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Therefore, the device described is an IV administration set, which is a medical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
IV Administration Sets are intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Product codes
FPA
Device Description
Quest Medical's Q2 IV Administration Sets are single use, disposable intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components including insertion spike, drip chamber, clamp, check valye, stopcock, tubing, luer connections and needleless connector,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench and nonclinical tests conducted on the Q2 IV Administration Sets in this submission included:
- Maximum Simulated Use Test
- Flow Rate Test
- High Pressure Leak Test
- Vacuum Pressure Leak Test
- Closure Piercing Device Test
- Air Inlet Device Test
- Drip Chamber Test
- Flow Regulator Test
- Tubing Bonding Strength Test
- Priming Volume Test
- Spike Cap Retention Test
- ISO 8536-4 Chemical Test
- USP Particulate Test
- Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Acute Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity)
- EO Residual Test
- Bacterial Endotoxin Test
- ISO 80369-7:2016 Luer compliance
Microbial ingress data for the needleless connector component used on the Q2 IV Admin Sets was referenced to the previously cleared K002689.
The collective results of the performance testing demonstrate that the Q2 IV Administration Sets meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Q2 IV Administration Sets does not raise different questions of safety or effectiveness when compared to the predicate device. The results from the performance testing support the conclusion that the Q2 IV Administration Sets is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 2, 2022
Quest Medical, Inc. Tosan Eweka Regulatory Affairs Manager One Allentown Parkway Allen, Texas 75002
Re: K213588
Trade/Device Name: O2 IV Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: May 2, 2022 Received: May 3, 2022
Dear Tosan Eweka:
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
1
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 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,
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) K213588
Device Name Q2 IV Administration Sets
Indications for Use (Describe)
IV Administration Sets are intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
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) Notification K213588
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 Fax: 972-390-2881
Contact Person:
Tosan Eweka Regulatory Affairs Manager Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 972-390-2881 Fax: Email: teweka@questmedical.com
Date Prepared: November 9, 2021
DEVICE INFORMATION [807.92(a)(2)]
Trade Name: Q2 IV Administration Sets
Generic/Common Name:
Intravascular Administration Set
Classification:
Class II per 21CFR§880.5440
Product Code:
FPA
4
PREDICATE DEVICE(S) [807.92(a)(3)]
B.Braun Medical IV Administration Sets (K170595)
DEVICE DESCRIPTION [807.92(a)(4)]
Quest Medical's Q2 IV Administration Sets are single use, disposable intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components including insertion spike, drip chamber, clamp, check valye, stopcock, tubing, luer connections and needleless connector,
INDICATIONS FOR USE [807.92(a)(5)]
The IV Administration Sets are intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE [807.92(a)(6)]
The O2 IV Administration Sets has the same intended use, indications for use, and principles of operation as the predicate device, and has similar design features and technological characteristics as the predicate device. The table below outlines the similarities and differences between the subject device and the predicate device.
5
| Element of
Comparison | Predicate Device – Extension
Sets with B.Braun Medical IV
Administration
Sets(K170595) | Subject Device | Analysis of Differences |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FPA | FPA | Same |
| Regulation
Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Regulation Name | Intravascular Administration Set | Intravascular Administration Set | Same |
| Class | II | II | Same |
| Indications for
Use | The IV Administration Sets are
intravenous administration sets
intended for delivery of fluids
from a container into a patient's
vascular system. These devices
may be used for any patient
population with consideration
given to adequacy of vascular
anatomy and appropriateness for
the solution being infused and
duration of therapy. | The IV Administration Sets
are intended for delivery of
fluids from a container into
a patient's vascular system.
These devices may be used
for any patient population
with consideration given to
adequacy of vascular
anatomy and
appropriateness for the
solution being infused and
duration of therapy. | Removed "intravenous
administration sets" from the
subject device indications to avoid
repetition. There is no difference
in the actual indications for use.
The indications for use for the
subject device and predicate
device are therefore substantially
equivalent. |
| Components | Insertion spike
drip chamber
tubing
luer
connections
manifold
needleless connector
stopcocks
clamps
check
valve | Insertion spike
drip chamber
tubing
luer connections
needleless connector
stopcocks
clamps
check
valve | The predicate device and
subject device are comprised of
the same components with the
exception of a manifold in some
configurations of the predicate
device, which is not included in
the subject device.
Configurations of the predicate
device without the manifold are
therefore substantially
equivalent to the subject device.
The results from performance
testing conducted on the subject
device demonstrates that the
difference in components
between the subject device and
predicate device do not raise
different questions of safety and
effectiveness. The subject
device met all performance
specifications necessary to fulfil
its intended use. |
| Mode of Fluid
Delivery | Gravity | Gravity | Same |
| Control
Mechanism | Clamps and Stopcock | Clamps and Stopcock | Same |
| Compatibility
with Blood and
Blood Products | Not intended for use with blood or
blood products per IFU | The subject device is not
intended to be used with blood
or blood products | Same |
| Sterilization | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL 10-6 | Same |
| Element of
Comparison | Predicate Device –
Extension Sets with B.Braun
Medical IV Administration
Sets(K170595) | Subject Device | Analysis of Differences |
| Device Materials | Unknown | Tubing - Alpha Gary 2235L-78
PVC not made with DEHP
Vented drip chamber
• Alpha Gary 2235L-78
PVC not made withDEHP
• ABS
• HDPE
• LDPE
• Lexan polycarbonate and
304 stainless steel.
Check valve - Plexiglas DR100,
DR6602, Silicone
Needless Connector y-site-
Makrolon RX 1805-451118
Polycarbonate, LR3003/40
Silicone
Pinch clamp –
Polypropylene Roller clamp
– ABS
Male luer - Eastman Tritan
MX-
731 Copolyester
Female luer - Eastman DN003
Copolyester
Male Luer - ABS
Terlux PP Purell
HP317P
Stopcock - Makrolon RX
1805- 451118 Polycarbonate,
LR3003/40 Silicone, HDPE
Solvent 20/80 Code R –
Cyclohexanone, Methyl Ethyl
Ketone | The materials used on components of
the predicate device is unknown.
Materials used in the subject device
are identical to those used in currently
marketed Quest IV Administration
Sets. Results from biocompatibility
testing conducted on the subject
device demonstrate that differences (if
any) in the materials used in the
subject device and predicate device do
not raise different questions of safety
and effectiveness. |
| Patient Contact
Category/Duration | Externally Communicating,
Blood
Path Indirect, Prolonged contact | Externally Communicating,
Blood
Path Indirect, Prolonged contact | Same |
| Shelf-Life | Unknown | 1 year | The shelf life of the predicate device is
unknown. The subject device was
qualified with 1 year shelf life and all
acceptance criteria were met. Results
from shelf life testing conducted on the
subject device demonstrate that
differences (if any) between the shelf
life of the predicate device and the
subject device shelf life do not raise
different questions of safety and
effectiveness. |
| Tubing length | Unknown | 102"- 118" | The tubing length of the predicate device
is unknown. Results from product
performance qualification testing
conducted on the subject device
demonstrate that differences (if any)
between the tubing length of the
predicate device and the subject device
do not raise different questions of
safety and effectiveness. |
6
7
Discussions of differences in Components
The component used in the various configurations of the predicate device and subject device are similar. The main difference between the components used on the predicate device and those used on the subject device is the inclusion of manifold in some configurations of the predicate device, which is not included in the subject device. Configurations of the predicate device without the manifold are therefore substantially equivalent to the subject device. The results from performance qualification testing conducted on the subject device demonstrates that the difference in components between the subject device and predicate device do not raise different questions of safety and effectiveness. The subject device met all performance specifications necessary to fulfil its intended use.
Discussions of differences in Materials
The materials used on the predicate device is unknown. Materials used in the subject device are identical to those used in currently marketed Quest IV Administration Sets. Additionally, results from biocompatibility testing conducted on the subject device demonstrate that differences (if any) between the materials used in the subject device and those used in the predicate device do not raise different questions of safety and effectiveness.
Discussions of differences in Shelf Life
The shelf life of the predicate device is unknown. The subject device was qualified with 1 year shelf life and all acceptance criteria were met. Results from shelf life testing conducted on the subject device demonstrate that differences (if any) between the shelf life of the predicate device and the subject device shelf life do not raise different questions of safety and effectiveness.
Discussions of differences in Tubing Length
The tubing length of the predicate device is unknown. The tubing length of the subject device ranges from 102"- 118". Results from performance qualification testing conducted on the subject device demonstrate that differences (if any) between the tubing length of the predicate device and the subject device do not raise different questions of safety and effectiveness as all acceptance criteria were met.
PERFORMANCE DATA [807.92(b)]
All necessary bench, nonclinical, and human factors testing was conducted on the Q2 IV Administration Sets to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary [807.92(b)(1)]
The bench and nonclinical tests conducted on the Q2 IV Administration Sets in this submission included:
- Maximum Simulated Use Test ●
8
- Flow Rate Test ●
- High Pressure Leak Test 0
- Vacuum Pressure Leak Test ●
- Closure Piercing Device Test
- Air Inlet Device Test 0
- 0 Drip Chamber Test
- Flow Regulator Test
- Tubing Bonding Strength Test ●
- Priming Volume Test ●
- Spike Cap Retention Test ●
- ISO 8536-4 Chemical Test .
- USP Particulate Test
- Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation, 0 Hemocompatibility, Acute Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity)
- EO Residual Test ●
- Bacterial Endotoxin Test ●
- ISO 80369-7:2016 Luer compliance ●
Microbial ingress data for the needleless connector component used on the Q2 IV Admin Sets was referenced to the previously cleared K002689.
Clinical Testing Summary [807.92(b)(2)|
Not applicable. Clinical testing was not performed to support this 510(k) submission.
CONCLUSIONS [807.92(b)(3)]
The collective results of the performance testing demonstrate that the Q2 IV Administration Sets meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Q2 IV Administration Sets does not raise different questions of safety or effectiveness when compared to the predicate device. The results from the performance testing support the conclusion that the Q2 IV Administration Sets is substantially equivalent to the predicate device.
SUMMARY
The Q2 IV Administration Sets is substantially equivalent to the predicate device.