(128 days)
No
The summary describes a simple infusion set with tubing, filter, clamp, and connectors, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The devices are described as infusion sets used to administer or aspirate fluids, which are supportive functions, not therapeutic in themselves.
No
Explanation: The device is described as an infusion set intended to administer or aspirate fluids, and its description confirms it is used to deliver fluids to a patient. This functionality is therapeutic or supportive, not diagnostic.
No
The device description explicitly states it consists of physical components like tubing, filters, clamps, needleless connectors, and luers, 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 to "administer or aspirate fluids." This describes a device used for delivering substances into or removing substances from the body, which is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description details components like tubing, filters, clamps, connectors, and luers. These are typical components of infusion or aspiration sets used for fluid management, not for analyzing samples outside 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.
IVD devices are specifically designed to perform tests on biological samples in vitro (outside the body) to provide diagnostic information. This device is used in vivo (within the body) for fluid management.
N/A
Intended Use / Indications for Use
The Precision Delivery Infusion Sets are intended to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
Quest Medical's Precision Delivery Infusion Sets are single use, disposable, extension sets used to deliver fluids to a patient. The Precision Delivery Sets consist of various configurations, which includes tubing, filter, clamp, needleless connector and luers.
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
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)
All necessary testing was conducted on the Precision Delivery Infusion Sets to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary:
The bench and nonclinical tests conducted on the Precision Delivery Infusion Sets in this submission included:
- Priming Volume
- Backpressure Leak
- Flow Rate
- Simulated Maximum Use
- o Tubing Bond Strength
- Multiple Clamping
- Prolonged Clamping
- o Tubing Kink Resistance
- Aspiration Test
- ISO 8536-4 Chemical and Particulate Tests
- ISO 8536-4 Filter Efficiency Test
- ISO 80369-7:2016 Luer compliance
- USP Particulate Test
- Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, o Hemocompatibility, Acute Systemic Toxicity, Sub-Chronic Toxicity)
- Sterilization validation per ISO 11135:2014
- Bacterial Endotoxin Tests
Microbial ingress data for the needleless connector component was referenced to the previously cleared K002689.
Clinical Testing Summary:
Not applicable. Clinical testing was not performed to support this 510(k) submission.
Conclusions:
The collective results of the performance testing demonstrate that the Precision Delivery Infusion Sets meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Precision Delivery Infusion 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 Precision Delivery Infusion Sets is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 21, 2021
Quest Medical, Inc. Tosan Eweka Regulatory Affairs Supervisor One Allentown Parkway Allen, Texas 75002
Re: K202672
Trade/Device Name: Precision Delivery Infusion Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: December 17, 2020 Received: December 18, 2020
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,
CAPT Alan M. Stevens Director (acting) 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) K202672
Device Name Precision Delivery Infusion Sets
Indications for Use (Describe)
The Precision Delivery Infusion Sets are intended to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.
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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116
3
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 Supervisor 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: September 17, 2020
DEVICE INFORMATION [807.92(a)(2)]
Trade Name:
Precision Delivery Infusion 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)]
Extension Sets with BD Q-Syte Luer Access Split Septum (K142527)
DEVICE DESCRIPTION [807.92(a)(4)]
Ouest Medical's Precision Delivery Infusion Sets are single use, disposable, extension sets used to deliver fluids to a patient. The Precision Delivery Sets consist of various configurations, which includes tubing, filter, clamp, needleless connector and luers.
INDICATIONS FOR USE [807.92(a)(5)]
The Precision Delivery Infusion Sets are intended to be used to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE [807.92(a)(6)]
The Precision Delivery Infusion Set has the same intended use, indications for use, and principles of operation and similar design features and technological characteristics as the predicate device. The differences in the technological characteristics between the Precision Delivery Infusion Set and the predicate device do not raise different questions of safety or effectiveness. Thus, the Precision Delivery Infusion Set is substantially equivalent to the predicate device. An analysis of the differences in technological characteristics is provided in the table below.
| Element of
Comparison | Predicate Device –
Extension Sets with BD
Q-Syte Luer Access
Split Septum
(K142527) | Subject Device | Analysis of
Differences |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Extension Sets with an
attached BD Q-Syte
Luer Access Split
Septum are intended to
be used with
intravascular catheters to
aspirate blood or
administer fluids,
including medications
and blood or blood
products. These devices
may be used with any
patient population with
consideration given to
the procedure being
performed and fluids
being infused. | The Precision Delivery
Infusion Sets are
intended to be used to
administer or aspirate
fluids. These devices
may be used with any
patient population with
consideration given to
the procedure being
performed and fluids
being infused. | The main difference
is the indications for
use of the predicate is
broader than the
indications for use of
the subject device.
The predicate is
indicated for
aspiration and
administration of
blood, blood products
and fluids while the
subject device is
indicated for
administration or
aspiration of fluids.
The indications for
the subject device
falls within the
indications for the
predicate device. The
difference in the |
| Element of
Comparison | Predicate Device -
Extension Sets with BD
Q-Syte Luer Access
Split Septum
(K142527) | Subject Device | Analysis of
Differences |
| | | | indications for use
therefore does not
alter the intended use
of the predicate
device and the subject
device, which is to
provide a conduit for
the administration of
fluids. |
| Design
Features/Components | Tubing with Slide
clamp, Needleless
connector, Luers and
Caps. Extension Sets are
provided in single
tubing, bifurcated tubing
or trifurcated tubing
configurations with
lengths ranging from 5"-
21". | Tubing with Slide
clamp, Needleless
connector, Luers, Caps
and Filter. Extension
Sets are provided in
single tubing and
trifurcated tubing
configurations with
lengths ranging from 7"-
62". | The predicate device
and subject device are
both offered in single
and trifurcated tubing
configurations. The
predicate device
additionally has a
bifurcated tubing
configuration. The
subject device is not
offered in bifurcated
models. The predicate
device and subject
device are comprised
of the same
component types with
the exception of a
filter component
included in the
subject device. The
fluid filter in the
subject device is
intended to filter
particulates. Fluid
filter efficiency test
was conducted on the
subject device and all
acceptance criteria
was met. The
minimum/maximum
length configuration
of the subject device
is shorter/longer than
the predicate device.
The results from
performance testing
conducted on the
subject device
demonstrates that the |
| Element of
Comparison | Predicate Device -
Extension Sets with BD
Q-Syte Luer Access
Split Septum
(K142527) | Subject Device | Analysis of
Differences |
| | | | difference in design
features and
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 | Same | No difference |
| Device Materials | Tubing
• Non-DEHP
PVC
Slide clamp
• Unknown
Luer Cap
• Unknown
Needleless Connector
• Unknown
Luers
• Unknown | Tubing
• Non-DEHP
PVC
Slide clamp
• HDPE
Luer Cap
• HDPE
Filter
• Acrylic/PTFE/PES
Needleless Connector
• Polycarbonate/Silicone
Luers
• ABS/Co-Polyester | The subject device
tubing and predicate
device tubing are
made from Non-DEHP PVC. The
materials used on
other components of
the predicate device is
unknown. 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 | Same | No difference |
| Sterilization | SAL 10-6 | Same | No difference |
5
6
7
PERFORMANCE DATA [807.92(b)]
All necessary testing was conducted on the Precision Delivery Infusion 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 Precision Delivery Infusion Sets in this submission included:
- Priming Volume
- Backpressure Leak ●
- Flow Rate ●
- Simulated Maximum Use ●
- o Tubing Bond Strength
- Multiple Clamping
- Prolonged Clamping ●
- o Tubing Kink Resistance
- Aspiration Test ●
- ISO 8536-4 Chemical and Particulate Tests ●
- ISO 8536-4 Filter Efficiency Test
- ISO 80369-7:2016 Luer compliance
- USP Particulate Test
- Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, o Hemocompatibility, Acute Systemic Toxicity, Sub-Chronic Toxicity)
- Sterilization validation per ISO 11135:2014 ●
- Bacterial Endotoxin Tests ●
Microbial ingress data for the needleless connector component 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 Precision Delivery Infusion Sets meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Precision Delivery Infusion 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 Precision Delivery Infusion Sets is substantially equivalent to the predicate device.
SUMMARY
The Precision Delivery Infusion Sets is substantially equivalent to the predicate device.