(879 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a blood collection system, with no mention of AI or ML technologies.
No.
The device's intended use is to improve blood collection for diagnostic purposes by reducing contamination, not to treat or prevent a disease or condition.
No
The device description indicates its purpose is to "manually divert the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination." It is a blood collection system, not a device that analyzes or interprets data for diagnostic purposes. Its function is to facilitate a cleaner blood sample, which is then used for diagnosis, but the device itself does not perform the diagnosis.
No
The device description clearly outlines physical components (transfer device, waste tube, skirt, adapter) and describes physical actions (removes initial portion of blood, attached to IV-line, collects 3mL). The performance studies also focus on physical and mechanical testing. There is no mention of software as a component or function of the device.
Based on the provided information, the Velano Vascular Blood Collection Adapter is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device is used as a "blood collection system" and is designed to "reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample." This directly relates to the collection and preparation of a biological specimen (blood) for subsequent in vitro diagnostic testing (blood cultures and other blood tests).
- Device Description: The description details how the device collects blood samples, including diverting an initial portion and collecting a subsequent sample for "culture bottle" or "evacuated tube for additional processing." This further confirms its role in preparing samples for laboratory analysis.
- Performance Studies: The performance studies include a "contamination study" where the device's ability to prevent contamination of test samples is evaluated. This type of study is relevant to the performance of a device used in the collection of samples for diagnostic testing.
- Predicate Device: The predicate device listed, K192247; Magnolia Steripath® Gen2 Blood Collection System, is also a blood collection system designed to reduce contamination for diagnostic testing. This suggests that devices with this function are typically classified as IVDs.
While the device itself doesn't perform the diagnostic test, its function is to collect and prepare a biological specimen specifically for in vitro diagnostic procedures. This falls under the scope of IVD devices as defined by regulatory bodies.
N/A
Intended Use / Indications for Use
The Velano Vascular Blood Collection Adapter is indicated for use as a blood collection system that manually diverts the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The Blood Collection Adapter is a sterile, single-use device that removes the initial portion of the blood specimen (potentially contaminated) into a waste or discard tube prior to collecting a subsequent blood sample. The Blood Collection Adapter is comprised of a transfer device, a waste tube, a skirt that holds the waste tube in place, and an adapter inside the transfer device that is used for narrow neck culture tubes and additional blood collection tubes.
The device is designed to be attached to a newly placed IV-line, vascular access device, or venipuncture needle set and is not intended for blood specimen collection from preexisting lines or IV site. Place a new peripheral IV catheter prior to drawing blood sample. The device collects approximately 3mL of the initial blood sample into the waste tube. The subsequent blood sample is collected directly into a culture bottle (not provided by Velano Vascular) or into an evacuated tube for additional processing.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and Safety Testing:
To verify that the device design meets its functional and performance requirements, devices underwent physical and mechanical testing. As a result of verification and validation activities and risk assessment, testing ensured the device design meets its functional and performance requirements. The following tests were performed:
- Visual inspection
- Simulated shipping
- Dimensional measurements
- Activation force
- Inlet compatibility
- Outlet compatibility
- Simulated use
- Discard volume
- Multiple engagements
A contamination study was performed to validate the device performs as intended. Under simulated use conditions, test samples were contaminated with various organisms (Staphylococcus aureus, Bacillus Cereus, Escherichia coli, Pseudomonas aeruginosa). Test samples using the Blood Collection Adapter demonstrated no growth and all positive control test samples demonstrated growth of each organisms evaluated.
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.
Not Found
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
§ 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.
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.
October 3, 2022
Velano Vascular Tiffini Wittwer Regulatory Affairs Consultant 221 Pine Street #200 San Francisco, California 94104
Re: K201237
Trade/Device Name: Velano Vascular Blood Collection Adapter Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: September 26, 2022 Received: October 3, 2022
Dear Tiffini Wittwer:
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,
Paval 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) K201237
Device Name Velano Vascular Blood Collection Adapter
Indications for Use (Describe)
The Velano Vascular Blood Collection Adapter is indicated for use as a blood collection system that manually diverts the initial specimen prior to collection of a subsequent test sample to reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K201237 – September 26, 2022
510(k) Summary
| Submitter: | Velano Vascular
221 Pine Street #200
San Francisco CA 94104 | | Subject Device:
Velano Vascular Blood
Collection Adapter | Predicate Device:
Magnolia Steripath®
Gen2 Blood Collection
System | Comment: |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Wittwer
Regulatory Affairs Consultant
Phone: (707) 799-6732
Email: twittwer@mededge.io | 510(k) | K201237 | K192247 | |
| Trade Name: | Velano Vascular Blood Collection Adapter | Manufacturer | Velano Vascular | Magnolia | |
| Common Name: | Blood Collection Serum Separators, Systems, Vials, Tubes | Classification | II | II | Same |
| Classification: | Class II | Product Code | JKA | JKA | Same |
| Product Code: | JKA | Subsequent
Product Code | None | FPA | Predicate design allows
for infusion, subject
device does not. No effect
on safety or efficacy for
blood collection indication |
| Regulation: | CFR 862.1675 – Blood specimen collection device | Regulation | 862.1675 | 862.1675 | Same |
| Predicate Device(s): | The subject device is equivalent to the following device:
• Magnolia Steripath Gen2 Blood Collection System - K192247 | Common
Name | Blood Specimen Collection
Set | Blood Specimen
Collection Set | Same |
| Device Description: | The Blood Collection Adapter is a sterile, single-use device that
removes the initial portion of the blood specimen (potentially
contaminated) into a waste or discard tube prior to collecting a
subsequent blood sample. The Blood Collection Adapter is
comprised of a transfer device, a waste tube, a skirt that holds the
waste tube in place, and an adapter inside the transfer device that is
used for narrow neck culture tubes and additional blood collection
tubes.
The device is designed to be attached to a newly placed IV-line,
vascular access device, or venipuncture needle set and is not intended
for blood specimen collection from preexisting lines or IV site. Place
a new peripheral IV catheter prior to drawing blood sample. The
device collects approximately 3mL of the initial blood sample into
the waste tube. The subsequent blood sample is collected directly
into a culture bottle (not provided by Velano Vascular) or into an
evacuated tube for additional processing. | Device
Classification | Tubes, Vials, Systems, Serum
Separators | Tubes, Vials, Systems,
Serum Separators | |
| Indication for Use: | The Velano Vascular Blood Collection Adapter is indicated for use
as a blood collection system that manually diverts the initial
specimen prior to collection of a subsequent test sample to reduce the
frequency of blood culture contamination when contaminants are
present in the initial blood sample compared to blood cultures drawn
with standard procedure without manual diversion. | Indications for
Use | The Velano Vascular Blood
Collection Adapter is
indicated for use as a blood
collection system that
manually diverts the initial
specimen prior to collection of
a subsequent test sample to
reduce the frequency of blood
culture contamination when
contaminants are present in
the initial blood sample
compared to blood cultures
drawn with standard
procedure without manual
diversion. | The Steripath® Gen2
Blood Collection System
is indicated for use as a
blood collection system
that diverts and sequesters
the initial specimen prior
to collection of a
subsequent test sample to
reduce the frequency of
blood culture
contamination when
contaminants are present
in the initial blood sample
compared to blood
cultures drawn with
standard procedure
without manual
diversion.
Additionally, components
of the system may be used
for infusion following
sample collection after
disconnection of the Initial
Specimen Diversion
Device® (ISDD®).
Venipuncture needles are
indicated for short term
infusion (less than 2
hours). | Same indication for use
for blood collection;
subject device does not
have an infusion
indication. |
| Intended Use | The Velano Vascular Blood
Collection Device is intended | The Steripath® Gen2
Blood Collection System
is a system to draw blood | Same | | |
4
5
| Subject Device: | Predicate Device: | Comment: | |
|---|---|---|---|
| Velano Vascular Blood | |||
| Collection Adapter | Magnolia Steripath® | ||
| Gen2 Blood Collection | |||
| System | |||
| to draw blood for in vitro | |||
| diagnostic testing. | for in vitro diagnostic | ||
| testing. | |||
| Method of | |||
| Operation | Used with newly placed IV | ||
| lines or blood collection | |||
| devices, diverts initial blood | |||
| volume into separate location | |||
| prior to attaching culture | |||
| bottle | Used with newly placed | ||
| IV lines or blood | |||
| collection devices, , | |||
| diverts initial blood | |||
| volume into separate | |||
| location prior to attaching | |||
| culture bottle | Same | ||
| Patient Contact | Yes | Yes | Same |
| Blood Volume | |||
| Discarded | 2 - 3mL | 1.5 - 2mL | Subject device diverts |
| more blood than predicate. | |||
| Simulated use and | |||
| contamination study | |||
| demonstrate this | |||
| difference does not alter | |||
| the safety or efficacy of | |||
| the device. | |||
| Blood | |||
| collection | |||
| device inlet | Male Luer | Male Luer | Same |
| Off the shelf | |||
| collection | |||
| device | Yes | Yes | Same |
| Infusion | |||
| Capabilities | No | Yes | Subject device has no |
| infusion indication where | |||
| predicate device does. No | |||
| change to the safety or | |||
| efficacy of the device for | |||
| blood collection | |||
| Can be used | |||
| for additional | |||
| blood tube | |||
| draws (after | |||
| blood culture | |||
| collection) | No | No | Same |
| Disposable or | |||
| Reusable | Single-use, disposable | Yes | Same |
| Sterilization | |||
| Method | Ethylene Oxide | Yes | Same |
| Minimum SAL | 1 x 10-6 | Yes | Same |
6
Functional and Safety Testing:
To verify that the device design meets its functional and performance requirements, devices underwent physical and mechanical testing. As a result of verification and validation activities and risk assessment, testing ensured the device design meets its functional and performance requirements. The following tests were performed:
- Visual inspection
- Simulated shipping ●
- Dimensional measurements
- Activation force
- Inlet compatibility ●
- Outlet compatibility ●
- Simulated use
- . Discard volume
- Multiple engagements ●
Testing was performed in accordance with the following:
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 11135, Sterilization of health-care products -Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI TIR28, Product Adoption and Process Equivalence for Ethylene Oxide Sterilization
ISO 10993-5, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for skin sensitization
ISO 10993-23, Biological evaluation of medical devices - Part 23: Tests for irritation
7
| | ASTM D4169, Standard practice for performance testing of shipping
containers and systems |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ASTM F1980, Standard guide for accelerated aging of sterile
medical device packages. |
| | In addition, a contamination study was performed to validate the
device performs as intended. Under simulated use conditions, test
samples were contaminated with various organisms ( Staphylococcus
aureus, Bacillus Cereus, Escherichia coli, Pseudomonas
aeruginosa ). Test samples using the Blood Collection Adapter
demonstrated no growth and all positive control test samples
demonstrated growth of each organisms evaluated. |
| Conclusion: | The Blood Collection Adapter device is substantially equivalent to
the predicate device listed above. This conclusion is based upon the
identical intended use, similar indication for use, principles of
operation, and sterilization processes and results of functional
performance testing and contamination study. |