(177 days)
No
The summary describes a standard blood administration set with mechanical components and does not mention any AI/ML capabilities or related performance metrics.
Yes
The device is used to deliver blood, blood components, and IV fluids to a patient's vascular system, which implies a direct therapeutic intervention to sustain or improve a patient's health.
No
Explanation: The device described is a blood administration set, used for delivering fluids to a patient's vascular system. It does not perform any diagnostic functions like analyzing samples or providing diagnostic information.
No
The device description explicitly lists physical components such as tubing, bag spike, filter, connectors, clamps, hand pump, stopcock, and needleless connector, 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 "deliver blood, blood components, and IV fluids from a container to a patient's vascular system." This describes a device used for administering substances into the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description details components like tubing, filters, connectors, and a hand pump, all consistent with an administration set for infusion. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic or monitoring information
- Using reagents or assays
The device is clearly intended for therapeutic administration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Blood Administration Sets are used to deliver blood, blood components, and IV fluids from a container to 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 the duration of therapy.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
Quest Medical's Q2 Blood Administration Sets are single use, disposable intravenous administration sets used to deliver blood, blood components and IV fluids from a container to a patient's vascular system through the use of a hand pump or through gravity flow. The sets include tubing, bag spike, 200 micron blood filter drip chamber, luer connectors, clamps, hand pump, stopcock 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)
All necessary bench and nonclinical testing was conducted on the Q2 Blood Administration Sets to support a determination of substantial equivalence to the predicate device.
A. Performance Test- Bench: The subject device met the applicable test specifications/acceptance criteria as described in the submission for tests including ISO 1135-4:2015, ISO 80369-7:2016, Particulate matter testing (USP ), and Mechanical Hemolysis Test.
B. Biocompatibility: Tested per ISO 10993-1 as Externally Communicating Device with Direct Blood contact for Prolonged Contact Duration (>24hrs -30days.). Testing included Cytotoxicity, Sensitization, Irritation, Hemocompatibility, Acute Systemic Toxicity, Sub-Chronic Toxicity, and Genotoxicity.
C. Sterility, Shipping, and Shelf-Life: Sterilized with Ethylene Oxide procedures validated per ISO 11135:2014. Met acceptance criteria for EO residuals per ISO 10993-7:2008 and pyrogenicity (LAL method) per USP . Additional tests: Sterile Barrier Packaging Testing (ASTM F1140 Burst Test, Peel Test and ASTM F1929 Dye Penetration Test), 3 year shelf-life test per ASTM F1980-16, Simulated Shipping per ASTM D4169-16. Microbial ingress data for the needleless connector was referenced to K002689.
Clinical testing was not performed.
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
Quest Medical, Inc. Tosan Eweka Regulatory Affairs Manager One Allentown Parkway Allen, Texas 75002
Re: K213846
Trade/Device Name: 02 Blood Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 5, 2022 Received: May 6, 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) K213846
Device Name Q2 Blood Administration Sets
Indications for Use (Describe)
The Blood Administration Sets are used to deliver blood, blood components, and IV fluids from a container to 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 the 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
K213846-510K Summary
GENERAL INFORMATION
Date Prepared: June 6, 2022
Applicant:
Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 972-390-2881 Fax:
Contact Person:
Tosan Eweka Regulatory Affairs Manager Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 Fax: 972-390-2881 Email: teweka@questmedical.com
DEVICE INFORMATION
Trade Name: Q2 Blood Administration Set
Generic/Common Name: Intravascular Administration Set
Classification: Class II Regulation Number: 21CFR§880.5440
FPA Product Code:
4
PREDICATE DEVICE(S)
K143082, B. Braun Medical IV Administration Sets with 200um Blood Filter.
DEVICE DESCRIPTION
Quest Medical's Q2 Blood Administration Sets are single use, disposable intravenous administration sets used to deliver blood, blood components and IV fluids from a container to a patient's vascular system through the use of a hand pump or through gravity flow. The sets include tubing, bag spike, 200 micron blood filter drip chamber, luer connectors, clamps, hand pump, stopcock and needleless connector.
INDICATIONS FOR USE
| Characteristics | Predicate Device | Subject Device |
|---|---|---|
| IV Administration Sets with 200µm | ||
| Blood Filter | ||
| K143082 | Q2 Blood Administration Sets | |
| K213846 | ||
| Indication for Use | The IV Administration Sets with 200µm Blood Filter are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. When the hand pump component is activated, the device is intended to deliver blood, blood products and crystalloid and colloid resuscitative fluids. 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 the duration of therapy. | The Blood Administration Sets are used to deliver, blood components, and IV fluids from container to a patient's vascular system. The devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy. |
| Prescription Only | ||
| or over the Counter | Prescription Only | Prescription Only |
Discussions of differences in Indications for Use statement
The subject device indications does not include the sentence "When the hand pump component is activated, the device is intended to deliver blood, blood products and crystalloid and colloid resuscitative fluids" which is included in the indications for the predicate device. The sentence describes the fluids delivered when using the hand pump component. It specifies crystalloid and colloid resuscitative fluids. Quest does not intend to make any compatibility claims on these fluids, hence it has been deleted from the indications statement of the subject device. Deleting this sentence does not change the overall intended use of both devices, which is administration of blood, blood components, and IV fluids to a patient. The difference in indications statements does not create a new intended use.
5
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Q2 Blood 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 and differences between the subject device and the predicate device.
| Element of Comparison | Predicate Device | Subject Device | Analysis of |
|---|---|---|---|
| IV Administration Sets with 200um Blood | |||
| Filter | Q2 Blood administration Set | Differences | |
| K143082 | K213846 | ||
| Product Code | FPA | Same | Same |
| Regulation Number | 21 CFR 880.5440 | Same | Same |
| Regulation Name | Intravascular Administration Set | Same | Same |
| Class | II | Same | Same |
| Mode of Fluid | |||
| Delivery | Gravity or Hand Pump Activation | Same | Same |
| Hand Pump Design | Cylindrical shape with ball check valves | Same | Same |
| Components | Tubing, drip chamber with 200 micron filter, bag | ||
| spike, luer connector, roller clamp, slide clamp, | |||
| hand pump, stopcocks, manifolds and/or luer | |||
| access devices. | Tubing, drip chamber with 200 micron filter, | ||
| bag spike, luer connector, roller clamp, slide | |||
| clamp, pinch clamp, hand pump, stopcocks and | |||
| luer access device | Different | ||
| See Comment #1 | |||
| Element of | |||
| Comparison | Predicate Device - IV Administration | ||
| Sets with 200um Blood | |||
| Filter(K143082) | Subject Device | Analysis of Differences | |
| Device Materials | Unknown | Vented Spike - LDPE Riblene FH20, | |
| Polyethylene and ABS | |||
| Roller Clamp - ABS | |||
| Tubing – Alpha Gary 2235L-78 not made | |||
| with DEHP PVC | |||
| 200 Micron Blood Filter Drip Chamber - | |||
| DEHP Free PVC, Purell HP Polypropylene | |||
| and PA | |||
| Hand Pump - not made with DEHP PVC | |||
| and Polypropylene | |||
| Slide Clamp - Purell HP Polypropylene | |||
| Pinch Clamp – Polypropylene, Flint Hills | |||
| P5M6K-080 | |||
| Spin Lock Male Luer - Terlux 2802 HD | |||
| ABS | |||
| Stopcock - HDPE, RX1805451118 | |||
| Polycarbonate, LR 3003/40 Wacker | |||
| Silicone, Blue Colorant K-75238 | |||
| Female Luer - PVC AM22W17 Female | |||
| Luer Cap - HDPE Chevron HD 9012 | |||
| Y-Site with needleless connector- | |||
| Polycarbonate and Silicone | |||
| Solvent Code L – Dichloromethane and | |||
| Cyclohexanone | |||
| Solvent Code R – Methyl-Ethyl Ketone | |||
| and Cyclohexanone | Different | ||
| See Comment #2 | |||
| Patient Contact | |||
| Category/Duration | Externally Communicating, Blood Path | ||
| Indirect, Prolonged contact | Same | Same | |
| Sterilization | Ethylene Oxide | Same | Same |
| Tubing Length | Unknown | 114" — 129" | See comment# 3 |
| Priming Volume | Unknown | 74mL - 76mL | See comment# 3 |
| Needleless | |||
| Connector Residual | |||
| Volume | Unknown | 0.09mL | See comment# 3 |
6
7
510(k) Summary
Discussions of differences in Technological Characteristics
Comment # 1: Components
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 and use of pinch clamp in the subject device. Configurations of the predicate device without the manifold are therefore equivalent to the subject device. The additional pinch clamp used in the subject device performs the same functions as the slide clamp. 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.
Comment # 2: Materials
The materials used on the predicate device is unknown. Materials used in the subject device are broadly used in medical devices and have been used on IV Admin and Extension Sets currently marketed by Quest Medical. 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.
Comment # 2: Tubing Length, Priming Volume and Residual Volume
The tubing length, priming volume and residual volume of the predicate device is unknown. Results from performance qualification testing conducted on the subject device demonstrate that these differences (if any) between the predicate device and the subject device do not raise different questions of safety and effectiveness as all acceptance criteria were met.
PERFORMANCE DATA
All necessary bench and nonclinical testing was conducted on the Q2 Blood Administration Sets to support a determination of substantial equivalence to the predicate device.
Nonclinical Testing Summary
A. Performance Test- Bench
The bench and nonclinical tests conducted on the Q2 Blood Administration Sets in this submission are summarized below. The subject device met the applicable test specifications/acceptance criteria as described in the submission.
- ISO 1135-4:2015 Transfusion equipment for medical use-Part 4: Transfusion . sets for single use, gravity feed
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for Intravascular or hypodermic applications
- Particulate matter testing was conducted in accordance with USP Particulate Matter in Injections and met the USP acceptance criteria.
- Mechanical Hemolysis Test
8
510(k) Summary
B. Biocompatibility
In accordance with ISO 10993-1, the Q2 Blood Administration Set, the proposed device were classified as: Externally Communicating Device with Direct Blood contact for Prolonged Contact Duration (>24hrs -30days.). The following Testing was conducted:
- Cytotoxicity
- Sensitization ●
- Irritation
- Hemocompatibility
- Acute Systemic Toxicity
- Sub-Chronic Toxicity
- . Genotoxicity
C. Sterility, Shipping, and Shelf-Life
The subject device is intended to be sterilized with Ethylene Oxide procedures validated per ISO 11135:2014. The subject device met applicable acceptance criteria for EO residuals per ISO 10993-7:2008 and pyrogenicity (LAL method) per USP . The following additional tests were conducted:
- . Sterile Barrier Packaging Testing (ASTM F1140 Burst Test, Peel Test and ASTM F1929 Dye Penetration Test).
- 3 year shelf-life test per ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- Simulated Shipping per ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and System.
Microbial ingress data for the needleless connector component used on the Q2 Blood Administration Sets was referenced to the previously cleared K002689.
Clinical Testing Summary
Not applicable. Clinical testing was not performed to support these 510(k) submissions.
CONCLUSIONS
The collective results of the performance testing demonstrate that the Q2 Blood Administration Sets meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Q2 Blood Administration Sets do 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 Blood Administration Sets is substantially equivalent to the predicate device.