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.

AI/ML Overview

This document is a 510(k) summary for the Ally Blood Collection Device, a blood specimen collection device. It outlines the device's technical characteristics, its comparison to a predicate device, and the performance testing conducted to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but it does not specify quantitative acceptance criteria or detailed numerical results for each test. Instead, it broadly states that "The subject Ally device met all predetermined acceptance criteria." The table below summarizes the listed performance tests:

Acceptance Criteria (Implied)	Reported Device Performance
Physical/Mechanical Performance
Flow Conduit Inner Diameter	Met predetermined criteria
Flow Conduit Outer Diameter	Met predetermined criteria
Flow Conduit Effective Length and Flow Conduit Exposure Length	Met predetermined criteria
Open-System Introducer Length	Met predetermined criteria
Extension Tubing Inner Diameter	Met predetermined criteria
Flow Conduit-to-Extension Tubing Assembly Tensile	Met predetermined criteria
Extension Leg-to-Stop Ring Assembly Tensile	Met predetermined criteria
Extension Tubing-to-Proximal Luer Assembly Tensile	Met predetermined criteria
Guide Cannula-to-Introducer Assembly Tensile	Met predetermined criteria
Introducer to Housing Retention	Met predetermined criteria
Sheathing Cannula Tensile Testing	Met predetermined criteria
Kink Diameter	Met predetermined criteria
Aspiration Flow Rate	Met predetermined criteria
Leak Decay	Met predetermined criteria
Housing Seal Leak Decay Testing	Met predetermined criteria
Particulate testing per USP <788>	Met predetermined criteria
Biocompatibility (per ISO 10993-1 for external communicating device, limited (<24 hour) blood contacting device)
Cytotoxicity MEM Elution ISO 10993-5	Met predetermined criteria
Sensitization ISO 10993-10	Met predetermined criteria
Irritation ISO 10993-10	Met predetermined criteria
Material Mediated Pyrogenicity ISO 10993-11	Met predetermined criteria
Acute Systemic Toxicity ISO 10993-11	Met predetermined criteria
Hemolysis (direct and indirect) ISO 10993-4	Met predetermined criteria
Mechanically Induced Hemolysis ASTM F-756-17	Met predetermined criteria
Complement Activation Assay C3a and SC5b9 Methods-ISO 10993-4	Met predetermined criteria
Partial Thromboplastin Time (PTT) ISO 10993-4	Met predetermined criteria
Platelet and Leucocyte Count (PLC) ISO 10993-4	Met predetermined criteria

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the performance or biocompatibility tests. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The tests are described as "Performance Testing included the following," suggesting they were conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts

This document does not describe a test set that required expert ground truth establishment in the traditional sense (e.g., image interpretation). The tests listed are primarily engineering performance and biocompatibility assessments, which are evaluated against defined scientific and regulatory standards rather than expert consensus on a diagnostic outcome. Therefore, information about the number or qualifications of experts for ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

As the performance and biocompatibility tests are against defined standards and criteria, a specific "adjudication method" like 2+1 or 3+1 (often used in clinical studies with human assessors) is not described or applicable. The determination of whether the device "met all predetermined acceptance criteria" would be based on the results of the specific laboratory tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human reader performance is a key metric. The Ally device is a blood collection device, and its evaluation focuses on physical performance and biocompatibility, not interpretive tasks.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Since the Ally device is a physical medical device for blood collection and not an algorithm or AI system, the concept of "standalone (i.e. algorithm only without human-in-the-loop performance)" is not applicable. The performance tests evaluate the device's physical and biological characteristics.

7. Type of Ground Truth Used

The "ground truth" for the performance tests would be the established scientific and engineering standards and specifications against which the device's performance was measured (e.g., tensile strength requirements, flow rate targets, ISO 10993 series for biocompatibility). For biocompatibility, this involves specific laboratory assays with established positive/negative controls and interpretation guidelines.

8. Sample Size for the Training Set

As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set" in the context of data-driven model development. All tests performed are considered verification and validation tests against established specifications and regulatory standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

{4}------------------------------------------------

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:

K190604

PRODUCT DESCRIPTION:

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 CollectionDevice(K220258)(Subject Device)	PIVO™(K190604)(Predicate Device)	Analysis ofDifferences
Indications forUse	The Ally device isattached to a PIVcatheter system forblood sampling into avacuum tube or syringe.	The PIVO™ deviceattaches to a peripheralIV catheter system foruse as a direct blood drawdevice into a vacuumtube or a syringe.	SubstantiallyEquivalentThe indication foruse is the same. Thedifference inphrasing does notalter the meaning ofthe indication for useor negatively impactthe clarity.
DeviceConfigurationsand Colors	• 20G – Pink• 22G – Blue	• 20G – Pink• 22G – Blue• 24G – Yellow	SubstantiallyEquivalentThe subject deviceutilizes the sameprimary color as thepredicate forequivalent gaugesizes.
Distal TubeMaterial	Polyimide	Polyimide	Same
Characteristic	Ally Blood CollectionDevice(K220258)(Subject Device)	PIVOTM(K190604)(Predicate Device)	Analysis ofDifferences
Proximal TubeMaterial	Polyurethane	Pebax	DifferentPerformance andbiocompatibilitytesting pertaining tothe proximal tubing(leak, tensile,hemolysis) show thecomponent to beequivalent to thepredicate withrespect to applicablerequirements. Thesubject devices weredetermined to bebiocompatible fortheir intended useper ISO 10993-1testing as noted inthe summary below.Material differencedoes not raise newquestions for safetyor effectiveness withrespect to theintended use.
Inner TubingLength	• 20G and 22G Open-System - 6.253"	• 20G – 5.85"• 22G – 5.85"• 24G – 141.2mm	DifferentDistal tube lengthsof the subject deviceare designed suchthat the tubing canbe extendedthroughout a PIVcatheter system inthe same manner asthe predicate.Appropriateness wasdemonstratedthrough testing(dimensional,hemolysis, flowtesting, usability).Differences in lengthdo not raise newquestions for safetyor effectiveness of the
Characteristic	Ally Blood CollectionDevice(K220258)(Subject Device)	PIVOTM(K190604)(Predicate Device)	Analysis ofDifferences
			or effectiveness withrespect to theintended use.
Outer Diameter(OD) of DistalInner 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	DifferentThe method ofsterilization for thesubject device wasfound to be valid fora sterility claim andappropriate throughpackaging,biocompatibility,and sterilizationevaluations. Bothsubject device andpredicate devices areclassified as sterile.

{5}------------------------------------------------

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.

{6}------------------------------------------------

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

{7}------------------------------------------------

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 <788>

Biocompatibility per ISO 10993-1 for an external communicating device, limited (<24 hour) blood contacting device.

· Cytotoxicity MEM Elution ISO 10993-5
· Sensitization ISO 10993-10
· Irritation ISO 10993-10
· Material Mediated Pyrogenicity ISO 10993-11
· Acute Systemic Toxicity ISO 10993-11
· Hemolysis (direct and indirect) ISO 10993-4
· Mechanically Induced Hemolysis ASTM F-756-17
· Complement Activation Assay C3a and SC5b9 Methods-ISO 10993-4
· Partial Thromboplastin Time (PTT) ISO 10993-4
· Platelet and Leucocyte Count (PLC) ISO 10993-4

The subject Ally device met all predetermined acceptance criteria and raised no new concerns regarding safety or effectiveness.

CONCLUSION:

The subject Ally has been demonstrated to be substantially equivalent in design, materials, sterilization, principles of operation, performance, and indications for use to the predicate PIVO™ device (K190604). Any differences do not raise new or different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.