(460 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, materials, and standard bench testing for blood collection needles, with no mention of AI or ML.
No
The device is strictly for venous blood collection, which is a diagnostic procedure, not a therapeutic one. It does not provide any treatment or cure.
No
This device is a blood collection needle, which is used to collect blood samples. It does not perform any analysis or interpretation of the collected blood, which are functions of a diagnostic device. Its purpose is solely for sample acquisition.
No
The device description clearly outlines physical components made of stainless steel and polypropylene, and the performance studies focus on bench testing of these physical attributes, biocompatibility, and sterilization. There is no mention of software as a component or function of the device.
Based on the provided information, the CHIRAVAC™ Blood Collection Needles are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for venous blood collection in connection with blood collection tubes." This describes a device used to obtain a sample, not to test or analyze a sample.
- Device Description: The description focuses on the physical components and function of the needle for drawing blood. It does not mention any components or processes related to analyzing the blood itself.
- Performance Studies: The performance studies listed are related to the physical properties, safety, and sterility of the needle (e.g., ISO standards for needles, biocompatibility, sterilization). There are no studies related to the analytical performance of the device on a biological sample.
- Lack of IVD-specific information: The document does not contain information typically found in IVD submissions, such as details about reagents, calibrators, controls, analytical performance characteristics (sensitivity, specificity, etc.), or clinical performance studies related to a diagnostic test.
In summary, the CHIRAVAC™ Blood Collection Needles are a medical device used for the collection of a biological sample (blood), which is a necessary step before an IVD test can be performed, but the needle itself does not perform the diagnostic test.
N/A
Intended Use / Indications for Use
The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.
Product codes
JKA, FMI
Device Description
The CHIRAVAC™ Blood Collection Needles consists of a double-ended hollow stainless steel thin-walled cannula, a threaded polypropylene hub, a sleeve that interrupts blood flow between filling multiple tubes, and polypropylene caps. The device is single use and supplied sterile (ethylene oxide sterilized). The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have no contact with patient blood, tissue, or skin. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to be used to collect blood from the vein puncture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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 CHIRAVAC™ Blood Collection Needles have been tested in the following test modes:
A. Performance Testing - Bench:
- ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test methods.
- Color Coding
- Size Designation
- Cleanliness
- pH Limits
- Limits of Extractable Metals
- Inspection of Needle Length
- Inspection of Defects
- Inspection of Lubrication
- Needle/Hub Bond Strength
- Lumen Patency
- Fragmentation
- Inspection of Needle Sharpness/Cleanness
- Penetration Force Test
- ISO 6009:2016 Hypodermic needles for single use.
- Color coding
- ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- pH Limits
- Inspection of Surface Appearance
- Inspection of Tubing Dimensions
- Stiffness Test
- Breakage Resistance Test
- Corrosion Resistance Test
- Internal Procedure SOP 4113
- Visual Inspection of Labeling
- Internal Procedure SOP 4401
- Inspection of Blister/Label Perforation
- Vacuum Function Evaluation
- Test for Rubber Sleeve Returning to Original Position without Damage from Repeated Use
- Internal Procedure SOP 4405
- Inspection of Cannula Transparency
- Cleanliness
B. Biocompatibility:
- Cytotoxicity per ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- Sensitization per ISO 10993-10 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization.
- Irritation per ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- Acute Systemic Toxicity per ISO 10993-11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- Hemocompatibility per ASTM F756 Standard Practice for Assessment of Hemolytic Properties of Materials.
- Material Mediated pyrogenicity per European Pharmacopoeia 10.0 Article 2.6.8 Pyrogens.
C. Sterilization, Shipping and Shelf-life:
- Packaging integrity test per internal procedures.
- Sterile Barrier Packaging test done per ISO 7886-1 Sterile hypodermic syringes for single use – Part 1: Syringes for manual use.
- Shelf life of 5 years - validated by accelerated aging per ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
July 21, 2021
CHIRANA T. Injecta % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201009
Trade/Device Name: CHIRAVAC™ Blood Collection Needles Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FMI Dated: June 16, 2021 Received: June 21, 2021
Dear Nathan Wright:
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,
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) K201009
Device Name CHIRAVAC™ Blood Collection Needles
Indications for Use (Describe)
The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X 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
K201009 - 510K SUMMARY
| Submitter's Name: | CHIRANA T. Injecta |
|---|---|
| Submitter's Address: | Nám. Dr. Schweitzera 194 |
| Stará Turá 916 01 | |
| Slovak Republic | |
| Submitter's Telephone: | 421-32-770-9972 |
| Contact Person: | Nathan Wright, MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | July 14, 2021 |
| Trade or Proprietary Name: | CHIRAVACTM Blood Collection Needles |
| Common or Usual Name: | Blood specimen collection device |
| Classification: | Class II per 21 CFR §862.1675 |
| Product Code: | JKA, FMI |
| Classification Panel: | Office of In Vitro Diagnostics and Radiological Health |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The CHIRAVAC™ Blood Collection Needles consists of a double-ended hollow stainless steel thin-walled cannula, a threaded polypropylene hub, a sleeve that interrupts blood flow between filling multiple tubes, and polypropylene caps. The device is single use and supplied sterile (ethylene oxide sterilized). The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (≤24 hours) duration contact; all other device components have no contact with patient blood, tissue, or skin. Once the vein has been accessed by puncturing with the intravenous end of the cannula, the healthcare professional will begin the blood collection process by placing evacuated blood collection tubes on the cannula's non-patient end, where the sleeve acts as a non-return valve and allows for more than one tube to be used to collect blood from the vein puncture.
| Size Metric
(mm) | Size (G x ") | Color Code | Pieces per Box
(pcs) | Pieces per Case
(pcs) | Item Code |
|---------------------|--------------|------------|-------------------------|--------------------------|------------|
| 0.6x25 | 23G x 1" | Blue | 100 | 1 000 | CHBCN23100 |
| 0.6x38 | 23G x 1.5" | Blue | 100 | 1 000 | CHBCN23112 |
| 0.7x25 | 22G x 1" | Black | 100 | 1 000 | CHBCN22100 |
| 0.7x38 | 22G x 1.5" | Black | 100 | 1 000 | CHBCN22112 |
| 0.8x25 | 21G x 1" | Green | 100 | 1 000 | CHBCN21100 |
| 0.8x38 | 21G x 1.5" | Green | 100 | 1 000 | CHBCN21112 |
| 0.9x25 | 20G x 1" | Yellow | 100 | 1 000 | CHBCN20100 |
| 0.9x38 | 20G x 1.5" | Yellow | 100 | 1 000 | CHBCN20112 |
| 1.2x25 | 18G x 1" | Pink | 100 | 1 000 | CHBCN18100 |
| 1.2x38 | 18G x 1.5" | Pink | 100 | 1 000 | CHBCN18112 |
Table 5-1 CHIRAVACTM Blood Collection Needles
INDICATIONS FOR USE
The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.
4
The indications for use for the CHIRAVAC™ Blood Collection Needles are similar to the indications of the listed predicate devices.
| Subject | Predicate | |
|---|---|---|
| CHIRAVACTM Blood Collection | ||
| Needles | ||
| (Subject - K201009) | Sol-M Blood Collection Needles, Sol-Care Safety | |
| Blood Collection Needles, Sol-Care Safety Blood | ||
| Collection Needle with Holder, Sol-M Blood | ||
| Collection Set | ||
| (K182146) | ||
| Indications | ||
| for Use | The CHIRAVACTM Blood | |
| Collection Needles are single use | ||
| and are intended for venous blood | ||
| collection in connection with blood | ||
| collection tubes. | The Blood Collecting Needle is intended to be used | |
| with vacuum blood collection tube for the collection of | ||
| venous blood. | ||
| The Safety Blood Collecting Needle is intended to be | ||
| used with vacuum blood collection tube for the | ||
| collection of venous blood. The safety shield is | ||
| intended to aid in the protection against accidental | ||
| needle stick injury. The Blood Collecting Set with | ||
| Holder is intended to be used with vacuum blood | ||
| collection tube for the collection of venous blood. |
Discussion of differences in Indications for Use Statements
The subject and predicate device have indication for use in collection of blood from the veins. In addition to their blood collection needles, the predicate offers safety blood collecting needles and a blood collecting set with holder with particular indications for those devices that do not apply to the subject.
TECHNICAL CHARACTERISTICS COMPARISON
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are similar between the subject and predicates:
- Indications for Use .
- Sizes .
- Materials of manufacture
- Principles of Operations .
| Table 5-2: Predicate Devices | |||
|---|---|---|---|
| ------------------------------ | -- | -- | -- |
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holder, Sol-M Blood Collection Set | Sol-Millennium Medical, Inc. | Primary |
5
| | CHIRAVACTM Blood Collection
Needles
(Subject - K201009) | Sol-M Blood Collection Needles,
Sol-Care Safety Blood Collection
Needles, Sol-Care Safety Blood
Collection Needle with Holder,
Sol-M Blood Collection Set
(K182146) | Discussion/
Comment |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation
Number | 21 CFR § 880.5570 | 21 CFR § 880.5570 | Same |
| Classification
Name | Needle, Hypodermic, Single-Lumen | Needle, Hypodermic, Single-Lumen | Same |
| Regulatory
Class | Class II | Class II | Same |
| Product Code | JKA, FMI | FMI | Same. JKA is current
product code for blood
collection needles. |
| Intended
Use/Indications
for Use | The CHIRAVACTM Blood
Collection Needles are single use
and are intended for venous blood
collection in connection with blood
collection tubes. | The Blood Collecting Needle is
intended to be used with vacuum
blood collection tube for the
collection of venous blood.
The Safety Blood Collecting Needle
is intended to be used with vacuum
blood collection tube for the
collection of venous blood. The
safety shield is intended to aid in the
protection against accidental needle
stick injury. The Blood Collecting
Set with Holder is intended to be
used with vacuum blood collection
tube for the collection of venous
blood. | Similar |
| Principles of
Operation | Needles accesses the vein by
puncturing with the intravenous end
of the cannula. With the non-patient
end of the cannula attached to the
blood collection tube, the blood is
drawn via the piston vacuum into
the syringe. The sleeve acts as a
non-return valve. | The blood collection devices form a
channel between patient's vein and
the vacuum blood collection tube
which draw the blood to the blood
collection tube. | Same |
| Color Coding | Pink - 18G
Yellow - 20G
Green - 21G
Black - 22G
Blue - 23G | Pink - 18G
Yellow - 20G
Green - 21G
Black - 22G
Blue - 23G | Same |
| Single Use? | Yes | Yes | Same |
| Cannula
Material | 304 Stainless Steel | 304 Stainless Steel | Same |
| Other Needle
Materials | Polypropylene (needle hub and
protective caps), rubber (sleeve),
glue. | Polypropylene; Dialyzing Paper;
Glue; Rubber | Same. Predicates include
safety shields with dialyzing
paper. The subject does not
have dialyzing paper and
does not require a safety
shield because it comes with
a protective cap which is
removed prior to use. |
| Cannula
Lubricant | Silicone Oil | Silicone Oil | Same |
| Cannula Length | 1", 1.5" | 5/8", ¾", 1", 1.25", 1.5", 1.75", 2" | Same; additional lengths
offered by predicate not
offered by subject. |
| | CHIRAVACTM Blood Collection
Needles
(Subject - K201009) | Sol-M Blood Collection Needles,
Sol-Care Safety Blood Collection
Needles, Sol-Care Safety Blood
Collection Needle with Holder.
Sol-M Blood Collection Set
(K182146) | Discussion/
Comment |
| Cannula Gauge | 18G, 20G, 21G, 22G, 23G | 18G, 19G, 20G, 21G, 22G, 23G,
25G | Same; additional gauges
offered by predicate not
offered by subject. |
| Biocompatibility | Per ISO 10993 | Per ISO 10993 | Same |
| Sterility | Ethylene Oxide to SAL of 10-6 | Ethylene Oxide to SAL of 10-6 | Same |
Table 5-3: Predicate Comparison (CHIRAVAC™ Blood Collection Needles)
6
Discussion of differences in Technological characteristics.
- The predicate device includes safety shields with dialyzing paper. The subject does ● not require a safety shield because it comes with a protective cap which is removed prior to use and therefore does not have dialyzing paper like the predicates.
- All subject sizes (cannula lengths and gauge options) are sizes available by the ● predicates; however, not all sizes offered by the predicates are available in the subject needles.
PERFORMANCE TESTING SUMMARY
The CHIRAVAC™ Blood Collection Needles have been tested in the following test modes:
A. Performance Testing - Bench
- ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test . methods.
- Color Coding o
- Size Designation O
- Cleanliness O
- pH Limits о
- Limits of Extractable Metals O
- Inspection of Needle Length O
- Inspection of Defects O
- Inspection of Lubrication O
- Needle/Hub Bond Strength O
- Lumen Patency O
- Fragmentation O
- Inspection of Needle Sharpness/Cleanness о
- o Penetration Force Test
- ISO 6009:2016 Hypodermic needles for single use. ●
- o Color coding
- ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices -. Requirements and test methods
- o pH Limits
7
- Inspection of Surface Appearance o
- O Inspection of Tubing Dimensions
- Stiffness Test O
- Breakage Resistance Test о
- Corrosion Resistance Test O
- Internal Procedure SOP 4113 ●
- Visual Inspection of Labeling о
- Internal Procedure SOP 4401 ●
- Inspection of Blister/Label Perforation, O
- Vacuum Function Evaluation o
- Test for Rubber Sleeve Returning to Original Position without Damage from o Repeated Use
- Internal Procedure SOP 4405
- Inspection of Cannula Transparency о
- o Cleanliness
B. Biocompatibility
The stainless steel cannula and silicone cannula lubricants are classified as externally communicating with limited (