(460 days)
The CHIRAVAC™ Blood Collection Needles are single use and are intended for venous blood collection in connection with blood collection tubes.
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.
This document describes a 510(k) premarket notification for the CHIRAVAC™ Blood Collection Needles. It does not present a clinical study involving human readers or AI algorithms. Instead, it focuses on demonstrating substantial equivalence to a legally marketed predicate device through performance testing (bench testing, biocompatibility, sterilization, shipping, and shelf-life).
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning human reader performance, AI assistance, standalone algorithm performance, and sample sizes for training/test sets, cannot be fully provided as it is not present in the document.
However, I can extract information related to the acceptance criteria for the device's physical and functional characteristics and the bench testing conducted to meet these criteria.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance (Summary of Bench Testing)
The document lists several international standards (ISO) and internal procedures to which the CHIRAVAC™ Blood Collection Needles were tested. The "reported device performance" is generally implied as "passed" or "met requirements" for each test, as the overall conclusion is that the device is substantially equivalent to the predicate. The document does not provide specific quantitative results for each test (e.g., "Fragmented less than X%").
| Acceptance Criteria (Test Mode) | Standard/Procedure | Reported Device Performance (Implied) |
|---|---|---|
| Performance Testing - Bench | ||
| Color Coding | ISO 7864:2016, ISO 6009:2016 | Met standard requirements |
| Size Designation | ISO 7864:2016 | Met standard requirements |
| Cleanliness | ISO 7864:2016, Internal Procedure SOP 4405 | Met standard requirements |
| pH Limits | ISO 7864:2016, ISO 9626:2016 | Met standard requirements |
| Limits of Extractable Metals | ISO 7864:2016 | Met standard requirements |
| Inspection of Needle Length | ISO 7864:2016 | Met specified lengths |
| Inspection of Defects | ISO 7864:2016 | No defects found |
| Inspection of Lubrication | ISO 7864:2016 | Met standard requirements |
| Needle/Hub Bond Strength | ISO 7864:2016 | Met standard requirements |
| Lumen Patency | ISO 7864:2016 | Patent |
| Fragmentation | ISO 7864:2016 | No fragmentation observed |
| Inspection of Needle Sharpness/Cleanness | ISO 7864:2016 | Met standard requirements |
| Penetration Force Test | ISO 7864:2016 | Met standard requirements |
| Inspection of Surface Appearance | ISO 9626:2016 | Met standard requirements |
| Inspection of Tubing Dimensions | ISO 9626:2016 | Met specified dimensions |
| Stiffness Test | ISO 9626:2016 | Met standard requirements |
| Breakage Resistance Test | ISO 9626:2016 | Met standard requirements |
| Corrosion Resistance Test | ISO 9626:2016 | No corrosion observed |
| Visual Inspection of Labeling | Internal Procedure SOP 4113 | Conformed to labeling requirements |
| Inspection of Blister/Label Perforation | Internal Procedure SOP 4401 | No perforations/damage observed |
| Vacuum Function Evaluation | Internal Procedure SOP 4401 | Functional |
| Test for Rubber Sleeve Returning to Original Position | Internal Procedure SOP 4401 | Returned to original position, no damage |
| Inspection of Cannula Transparency | Internal Procedure SOP 4405 | Transparent |
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizing |
| Irritation | ISO 10993-10 | Non-irritating |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Hemocompatibility | ASTM F756 | Hemocompatible |
| Material Mediated Pyrogenicity | European Pharmacopoeia 10.0 Article 2.6.8 | Non-pyrogenic |
| Sterilization, Shipping & Shelf-life | ||
| Packaging Integrity | Internal procedures | Integrity maintained |
| Sterile Barrier Packaging | ISO 7886-1 | Integrity maintained |
| Shelf Life (5 years) | ASTM F1980 (validated by accelerated aging) | Established 5-year shelf life |
2. Sample Size Used for the Test Set and Data Provenance
This document describes bench testing of a physical medical device (blood collection needles), not a diagnostic algorithm that relies on a "test set" of data in the common sense (e.g., medical images).
- Sample Size: The document does not explicitly state the number of samples (e.g., individual needles or batches) used for each specific test. This level of detail is typically found in the full test reports, not the 510(k) summary.
- Data Provenance: The tests are conducted according to international standards (ISO, ASTM, European Pharmacopoeia) and internal Standard Operating Procedures (SOPs). The testing was performed by CHIRANA T. Injecta or third-party labs on their behalf, based in the Slovak Republic (Submitter's address). This is a prospective evaluation of manufactured devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not a study requiring expert interpretation of data to establish a "ground truth" for a diagnostic task. The ground truth for device performance is established by objective measurements against predefined acceptance criteria from the relevant standards (e.g., physical dimensions, strength, sterility).
4. Adjudication Method for the Test Set
Not applicable. No "adjudication" is described as this is not a diagnostic performance study involving multiple human readers or AI.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not an MRMC comparative effectiveness study, nor does it involve AI. It's a submission for a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This device does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- International Standards: e.g., ISO 7864, ISO 6009, ISO 9626, ISO 10993 series, ASTM F756, ASTM F1980, European Pharmacopoeia. These standards define the acceptable physical, chemical, and biological properties.
- Predicate Device Characteristics: The device is compared to a legally marketed predicate (Sol-M Blood Collection Needles, K182146) to demonstrate substantial equivalence, implying the predicate's performance against relevant standards serves as a benchmark for safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set or associated ground truth as this is not an AI/ML device.
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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
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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)
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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.
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The indications for use for the CHIRAVAC™ Blood Collection Needles are similar to the indications of the listed predicate devices.
| Subject | Predicate | |
|---|---|---|
| CHIRAVACTM Blood CollectionNeedles(Subject - K201009) | Sol-M Blood Collection Needles, Sol-Care SafetyBlood Collection Needles, Sol-Care Safety BloodCollection Needle with Holder, Sol-M BloodCollection Set(K182146) | |
| Indicationsfor Use | The CHIRAVACTM BloodCollection Needles are single useand are intended for venous bloodcollection in connection with bloodcollection tubes. | The Blood Collecting Needle is intended to be usedwith vacuum blood collection tube for the collection ofvenous blood.The Safety Blood Collecting Needle is intended to beused with vacuum blood collection tube for thecollection of venous blood. The safety shield isintended to aid in the protection against accidentalneedle stick injury. The Blood Collecting Set withHolder is intended to be used with vacuum bloodcollection 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 | |||
|---|---|---|---|
| ------------------------------ | -- | -- | -- |
| 510kNumber | 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 |
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| CHIRAVACTM Blood CollectionNeedles(Subject - K201009) | Sol-M Blood Collection Needles,Sol-Care Safety Blood CollectionNeedles, Sol-Care Safety BloodCollection Needle with Holder,Sol-M Blood Collection Set(K182146) | Discussion/Comment | |
|---|---|---|---|
| RegulationNumber | 21 CFR § 880.5570 | 21 CFR § 880.5570 | Same |
| ClassificationName | Needle, Hypodermic, Single-Lumen | Needle, Hypodermic, Single-Lumen | Same |
| RegulatoryClass | Class II | Class II | Same |
| Product Code | JKA, FMI | FMI | Same. JKA is currentproduct code for bloodcollection needles. |
| IntendedUse/Indicationsfor Use | The CHIRAVACTM BloodCollection Needles are single useand are intended for venous bloodcollection in connection with bloodcollection tubes. | The Blood Collecting Needle isintended to be used with vacuumblood collection tube for thecollection of venous blood.The Safety Blood Collecting Needleis intended to be used with vacuumblood collection tube for thecollection of venous blood. Thesafety shield is intended to aid in theprotection against accidental needlestick injury. The Blood CollectingSet with Holder is intended to beused with vacuum blood collectiontube for the collection of venousblood. | Similar |
| Principles ofOperation | Needles accesses the vein bypuncturing with the intravenous endof the cannula. With the non-patientend of the cannula attached to theblood collection tube, the blood isdrawn via the piston vacuum intothe syringe. The sleeve acts as anon-return valve. | The blood collection devices form achannel between patient's vein andthe vacuum blood collection tubewhich draw the blood to the bloodcollection tube. | Same |
| Color Coding | Pink - 18GYellow - 20GGreen - 21GBlack - 22GBlue - 23G | Pink - 18GYellow - 20GGreen - 21GBlack - 22GBlue - 23G | Same |
| Single Use? | Yes | Yes | Same |
| CannulaMaterial | 304 Stainless Steel | 304 Stainless Steel | Same |
| Other NeedleMaterials | Polypropylene (needle hub andprotective caps), rubber (sleeve),glue. | Polypropylene; Dialyzing Paper;Glue; Rubber | Same. Predicates includesafety shields with dialyzingpaper. The subject does nothave dialyzing paper anddoes not require a safetyshield because it comes witha protective cap which isremoved prior to use. |
| CannulaLubricant | Silicone Oil | Silicone Oil | Same |
| Cannula Length | 1", 1.5" | 5/8", ¾", 1", 1.25", 1.5", 1.75", 2" | Same; additional lengthsoffered by predicate notoffered by subject. |
| CHIRAVACTM Blood CollectionNeedles(Subject - K201009) | Sol-M Blood Collection Needles,Sol-Care Safety Blood CollectionNeedles, Sol-Care Safety BloodCollection 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 gaugesoffered by predicate notoffered 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)
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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
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- 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 (<24 hours) duration contact; all other device components have limited (<24 hours) duration surface contact with intact skin of the health care professional user and the patient.
- 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
CONCLUSION
The overall technology characteristics and testing performance data lead to the conclusion that the CHIRAVAC™ Blood Collection Needles are substantially equivalent to the legally marketed predicate device.
§ 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.