(164 days)
Not Found
No
The description focuses on the mechanical function of the device for blood sampling and does not mention any AI/ML components or capabilities.
No
The device is used for blood sampling, not for treating a condition or disease.
No
The device is described as a "needleless blood draw device" used for "blood sampling into a vacuum tube or syringe." Its function is to facilitate blood collection, not to perform analysis or diagnosis.
No
The device description clearly states it is a physical device ("attached to a PIV catheter system," "extends a conduit tube," "sterile, single use device") and the performance studies detail testing of physical properties and biocompatibility, indicating it is not software-only.
Based on the provided information, the Ally device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for blood sampling into a vacuum tube or syringe. This describes a device used to collect a sample, not a device that performs a test on a sample.
- Device Description: The description focuses on the mechanical function of extending a conduit tube to facilitate blood collection. It does not mention any components or processes for analyzing or testing the blood sample itself.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical methods typically associated with IVD devices.
- Performance Studies: The performance studies listed focus on the physical and biological compatibility of the device for blood collection, not on the accuracy or performance of a diagnostic test.
An IVD device is used to examine specimens derived from the human body (like blood) to provide information for diagnostic, monitoring, or screening purposes. The Ally device's function is solely to facilitate the collection of the specimen.
N/A
Intended Use / Indications for Use
The Ally device is attached to a PIV catheter system for blood sampling into a vacuum tube or syringe.
Product codes
JKA
Device Description
The Ally device by Avia Vascular is intended to be attached to a peripheral intravenous (PIV) catheter system for use as a needleless blood draw device into a vacuum tube or syringe. Once attached to a PIV catheter system, the Ally device functions by extending a conduit tube through the internal lumen of the PIV catheter so that the distal tip of the Ally conduit extends beyond the tip of the PIV catheter, allowing for sampling of blood. The Ally device is a sterile, single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
The Ally Blood Collection Device was thoroughly tested and verifies that it performs as designed and is suitable for its intended use. Performance Testing included the following: Flow Conduit Inner Diameter, Flow Conduit Outer Diameter, Flow Conduit Effective Length and Flow Conduit Exposure Length, Open-System Introducer Length, Extension Tubing Inner Diameter, Flow Conduit-to-Extension Tubing Assembly Tensile, Extension Leg-to-Stop Ring Assembly Tensile, Extension Tubing-to-Proximal Luer Assembly Tensile, Guide Cannula-to-Introducer Assembly Tensile, Introducer to Housing Retention, Sheathing Cannula Tensile Testing, Kink Diameter, Aspiration Flow Rate, Leak Decay, Housing Seal Leak Decay Testing, Particulate testing per USP .
Biocompatibility per ISO 10993-1 for an external communicating device, limited (
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
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July 14, 2022
AVIA Vascular % Jonathan Holmes Senior Manager, Regulatory Affairs MedVenture Health 299 S Main Street, Suite 2300 Salt Lake City, Utah 84111
Re: K220258
Trade/Device Name: 20G Open-System Ally Device Kit (AV10000), 22G Open-System Ally Device Kit (AV110000) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: June 14, 2022 Received: June 15, 2022
Dear Jonathan Holmes:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (OS) 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,
David Wolloscheck, Ph.D. For 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220258
Device Name
20G Open-System Ally Device Kit (AV100000); 22G Open-System Ally Device Kit (AV110000)
Indications for Use (Describe)
The Ally device is attached to a PIV catheter system for blood sampling into a vacuum tube or syringe.
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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Image /page/3/Picture/0 description: The image shows the logo and address of Avia Vascular. The logo is a stylized, intertwined shape in shades of purple and pink. Below the logo is the text "AVIA VASCULAR", followed by the address "6030 W. Harold Gatty Dr., Salt Lake City, UT 84116".
K220258 510(k) SUMMARY
Submitter:
Kevin Cook President & CEO Avia Vascular 6030 W. Harold Gatty Dr. Salt Lake City, UT 84116 Phone: (801) 824-5375 Email: kcook(@avia-vascular.com
Correspondent:
Jonathan Holmes Senior Manager, Regulatory Affairs 299 S. Main St. Suite 2300 Salt Lake City, UT 84111 Phone: (801) 503-9065 Email: jholmes@medventurehealth.com
DATE PREPARED: July 14, 2022
SUBJECT DEVICE:
| Trade Name: | 20G Open-System Ally Device Kit (AV100000); |
|---|---|
| 22G Open-System Ally Device Kit (AV110000) | |
| Common Name: | Blood Collection Tubes, Vials, Systems, Serum Separators |
| Regulation Name: | Blood Specimen Collection Device |
| Classification Panel: | Clinical Chemistry |
| Regulatory Class: | Class II |
| Product Code: | JKA |
| Regulation Number: | 21 CFR 862.1675 |
PREDICATE DEVICE:
| Proprietary Name: | PIVOTTM |
|---|---|
| Common Name: | Blood Collection Tubes, Vials, Systems, Serum Separators |
| Regulation Name: | Blood Specimen Collection Device |
Avia Vascular
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Image /page/4/Picture/0 description: The image shows the Avia Vascular logo. The logo consists of a stylized letter "A" in a gradient of purple and pink. Below the logo, the words "AVIA VASCULAR" are written in a simple sans-serif font.
510(k) Number:
PRODUCT DESCRIPTION:
The Ally device by Avia Vascular is intended to be attached to a peripheral intravenous (PIV) catheter system for use as a needleless blood draw device into a vacuum tube or syringe. Once attached to a PIV catheter system, the Ally device functions by extending a conduit tube through the internal lumen of the PIV catheter so that the distal tip of the Ally conduit extends beyond the tip of the PIV catheter, allowing for sampling of blood. The Ally device is a sterile, single use device.
INTENDED USE/INDICATION FOR USE:
Intended Use: Venous blood drawing.
Indications for Use: The Ally device is attached to a PIV catheter system for blood sampling into a vacuum tube or syringe.
TECHNOLOGICAL COMPARISION TO PREDICATE DEVICE:
| Characteristic | Ally Blood Collection
Device
(K220258)
(Subject Device) | PIVO™
(K190604)
(Predicate Device) | Analysis of
Differences |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Ally device is
attached to a PIV
catheter system for
blood sampling into a
vacuum tube or syringe. | The PIVO™ device
attaches to a peripheral
IV catheter system for
use as a direct blood draw
device into a vacuum
tube or a syringe. | Substantially
Equivalent
The indication for
use is the same. The
difference in
phrasing does not
alter the meaning of
the indication for use
or negatively impact
the clarity. |
| Device
Configurations
and Colors | • 20G – Pink
• 22G – Blue | • 20G – Pink
• 22G – Blue
• 24G – Yellow | Substantially
Equivalent
The subject device
utilizes the same
primary color as the
predicate for
equivalent gauge
sizes. |
| Distal Tube
Material | Polyimide | Polyimide | Same |
| Characteristic | Ally Blood Collection
Device
(K220258)
(Subject Device) | PIVOTM
(K190604)
(Predicate Device) | Analysis of
Differences |
| Proximal Tube
Material | Polyurethane | Pebax | Different
Performance and
biocompatibility
testing pertaining to
the proximal tubing
(leak, tensile,
hemolysis) show the
component to be
equivalent to the
predicate with
respect to applicable
requirements. The
subject devices were
determined to be
biocompatible for
their intended use
per ISO 10993-1
testing as noted in
the summary below.
Material difference
does not raise new
questions for safety
or effectiveness with
respect to the
intended use. |
| Inner Tubing
Length | • 20G and 22G Open-
System - 6.253" | • 20G – 5.85"
• 22G – 5.85"
• 24G – 141.2mm | Different
Distal tube lengths
of the subject device
are designed such
that the tubing can
be extended
throughout a PIV
catheter system in
the same manner as
the predicate.
Appropriateness was
demonstrated
through testing
(dimensional,
hemolysis, flow
testing, usability).
Differences in length
do not raise new
questions for safety
or effectiveness of the |
| Characteristic | Ally Blood Collection
Device
(K220258)
(Subject Device) | PIVOTM
(K190604)
(Predicate Device) | Analysis of
Differences |
| | | | or effectiveness with
respect to the
intended use. |
| Outer Diameter
(OD) of Distal
Inner Tubing | • 20G Open-System –
0.0270”
• 22G Open-System –
0.0210” | • 20G = 0.709mm max
• 22G = 0.543mm max
• 24G = 0.400mm max | Same |
| Packaging | Tyvek Pouch | Tyvek Pouch | Same |
| Sterilization | Ethylene Oxide | Gamma | Different
The method of
sterilization for the
subject device was
found to be valid for
a sterility claim and
appropriate through
packaging,
biocompatibility,
and sterilization
evaluations. Both
subject device and
predicate devices are
classified as sterile. |
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Image /page/5/Picture/0 description: The image contains the logo for Avia Vascular. The logo consists of a stylized, intertwined ribbon-like shape in shades of purple and pink. Below the logo, the words "AVIA VASCULAR" are written in a simple, sans-serif font.
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Image /page/6/Picture/0 description: The image shows a logo with a stylized, abstract design. The logo features a shape that resembles two intertwined or overlapping curves, creating a sense of connection or flow. The color gradient transitions from a deep purple at the top to a lighter pink at the bottom, adding depth and visual interest to the design. The logo is simple, modern, and potentially represents a company or organization with a focus on innovation or collaboration.
AVIA VASCULAR
PERFORMANCE TESTING
The Ally Blood Collection Device was thoroughly tested and verifies that it performs as designed and is suitable for its intended use.
Performance Testing included the following:
- Flow Conduit Inner Diameter
- Flow Conduit Outer Diameter
- · Flow Conduit Effective Length and Flow Conduit Exposure Length
- Open-System Introducer Length
- Extension Tubing Inner Diameter
- · Flow Conduit-to-Extension Tubing Assembly Tensile
- Extension Leg-to-Stop Ring Assembly Tensile
- · Extension Tubing-to-Proximal Luer Assembly Tensile
- Guide Cannula-to-Introducer Assembly Tensile
- Introducer to Housing Retention
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Image /page/7/Picture/0 description: The image contains the logo for Avia Vascular. The logo consists of a stylized, intertwined ribbon-like shape in shades of purple and pink. Below the logo, the words "AVIA VASCULAR" are written in a simple, sans-serif font.
- · Sheathing Cannula Tensile Testing
- · Kink Diameter
- · Aspiration Flow Rate
- · Leak Decay
- · Housing Seal Leak Decay Testing
- · Particulate testing per USP
Biocompatibility per ISO 10993-1 for an external communicating device, limited (