(198 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a blood collection needle with a safety mechanism, with no mention of AI or ML.
No.
This device is designed for blood collection and short-term infusion of intravenous fluids, which are diagnostic and supportive procedures, not primarily therapeutic in nature. Its main function is to facilitate access to the bloodstream, not to treat a disease or condition itself.
No
The device is a blood collection needle and for short-term infusion, used for obtaining samples or administering fluids, not for interpreting medical conditions or diagnosing diseases.
No
The device description clearly outlines physical components such as needles, tubing, wings, and a safety shield, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "blood collection or short-term infusion (up to 2 hours) of intravenous fluids." This describes a device used to obtain a sample (blood) or deliver a substance (fluids) to the body.
- Device Description: The description details a needle, tubing, wings, and a safety mechanism. These are components of a device used for accessing the circulatory system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. This device is used to collect the specimen, not to perform the diagnostic test on it. There is no mention of reagents, assays, or analysis of the collected blood.
The device is a blood collection needle, which is a medical device used in the process of obtaining a sample for subsequent in vitro diagnostic testing, but it is not the IVD device itself.
N/A
Intended Use / Indications for Use
The Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder) is a single, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury
Product codes
JKA, FPA
Device Description
The Sol-Care Safety Blood Collection Needle Set (Butterfly Needle) is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term infusion of intravenous fluids. The Butterfly Needle Set is available with a 21, 23 or 25 gauge needle with Butterfly Wings and a Safety Shield with tubing leading to a covered needle assembly and Tube Holder. The product is available with and without the Tube Holder.
The Sol-Care Safety Blood Collection Needle consists of:
- Stainless steel cannula (Intravenous end and Non-patient end of Cannula) -
- Wings (Color coded according to needles gauge) -
- -Tubing
- -Female luer adaptor
- -Intravenous (IV) needle protector (covers the needle before use)
The optional SOL-M™ Blood Collection Tube Holder and SOL-M™M Blood Culture Holder include a male luer adapter for attachment to the Sol-Care Safety Blood Collection Needle.
The Sol-Care Safety Blood Collection Needle has a sharps injury prevention feature. The Butterfly Wing Assembly consists of a needle assembly and a Safety Shield. After use, the health care professional can pull back on the tubing while holding the butterfly wing and the needle will retract and lock into the Safety Shield. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
The devices are sterilized by Ethylene Oxide Gas. The Safety Blood Collection Needle is supplied in a hard Tray Pack while the Safety Blood Collection Needle with a preattached Tube Holder is supplied in a soft Tray Pack. Twenty-Five Safety Blood Collection Needles with a pre-attached Tube Holders are packaged in a chipboard box while fifty Safety Blood Collection Needles are packaged in a chipboard box. Each Tray Pack is labeled with the contents and the appropriate information per the Medical Device Directive and FDA's Quality System Regulation and Labeling requirements, 21CFR Part 801.
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
Nonclinical Tests: The device met requirements of:
- ISO 8536-4:2010, Infusion Equipment for Medical Use Part 4: Infusion Sets For Single Use, Gravity Feed and ISO 7864:1993, Sterile Hypodermic Needles for Single Use. Specific tests included: PRJ001_096, Butterfly Needle Chemistry Test Protocol and Report; PRJ001 062, Butterfly Needle Appearance and Size Test Protocol and Report; PRJ001 060, Butterfly Needle Systematic Flow Test Protocol and Report; PRJ001 056, Butterfly Needle Systematic Blocking Test Protocol and Report; PRJ001 057, Butterfly Needle Protector Drawing Force Test Protocol and Report; PRJ001 054, Butterfly Needle Puncture Force Test Protocol and Report; PRJ001 053, Butterfly Needle Unlocking Force Test Protocol and Report; PRJ001 052, Butterfly Needle Shield Pulling Force Test Protocol and Report; PRJ001 049, Butterfly Needle Rubber Sealing Test Protocol and Report.
- ISO 23908:2011, Sharps Injury Protection Requirements and Test Methods - Sharps Protection Features for Single-Use Hypodermic Needles, Introducers For Catheters And Needles Used for Blood Sampling. This included a Simulated Use Study with Nurse Evaluators.
- ISO 11607-1.-1:2009+A1:2014, Packaging for terminally sterilized medical Devices and ISO 11607-2:2006, Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes. Specific tests included: Seal Validation of the Soft Pack; Seal Validation of the Hard Pack; Simulated Transit Test for the Soft Pack; Simulated Transit Test for the Hard Pack; Accelerated Aging of the Soft Pack and Product Testing at time 0, years 1, 2 and 3; Accelerated Aging of the Hard Pack and Product Testing at time 0, years 1, 2 and 3; Low Temperature (-20°C) Product Qualification; High Temperature (60°C) Product Qualification.
- ISO 11135-1:2007, Medical Apparatus Epoxy Ethane Sterilization Confirmation and Routine Control. The device family was adopted into an existing validated sterilization cycle, complying with AAMI TIR 28 and ISO 11135-1: 2014.
- ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings. This included PRJ001_059, Butterfly Needle Systematic Leakage Test Protocol and Report.
- ISO 10993-1:2006, Biological evaluation of medical devices Part 1: Evaluation and testing. This included Cytotoxicity, Irritation Test/Intracutaneous Reactivity, Sensitization Study, USP and ISO Systemic Toxicity Studies, Haemolysis test, Thrombosis Testing, Complement Activation C3a and SC5b-9 Asay with Sponsor-Supplied Comparison Articie (GLP), ASTM Hemolysis Assay Direct Contact and Extract Method (GLP).
Clinical Tests: None submitted.
Key Metrics
Not Found
Predicate Device(s)
March 3, 1998 K980414
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol composed of three overlapping profiles facing to the right. The profiles are arranged in a way that creates a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Sol-Millennium Medical, Inc. Mr. James Barley Regulatory Affairs Director 1735 North Brown Road, Suite 120 Lawrenceville, Georgia 30043
Re: K163073
Trade/Device Name: Sol-Care Safety Blood Collection Needle (with and without Preattached Tube Holder) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FPA Dated: April 10, 2017 Received: April 18, 2017
Dear Mr. James Barley:
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. 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.
1
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang -
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Change Control Table, Change History
Change Control Table
| Version | Document Author | Document Approver | Date Approved |
|---|---|---|---|
| 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY |
Complete Change Control Table (all versions) retained in SWIFT Docs.
3
Indications for Use
510(k) Number (if known) K163073
Device Name
Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder)
Indications for Use (Describe)
The Sol-Care Safety Blood Collection Needle(with and without Pre-attached Tube Holder) is a single, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)
510(k) Summary
(As required by 21 CFR 807.92(a))
510(k) Number K163073
Date Prepared: April 10, 2017
- A. Submitter Information
Sol-Millennium Medical, Inc. 1735 North Brown Road Suite 120 Lawrenceville, GA 30043 Contact Person: Phone Number:
Common name of device:
Classification Name:
Product Code:
Regulatory Class:
Reason for 510(k):
Predicate Device:
Predicate 510(k) #:
C.
Classification Number:
- B. Device Information Trade/Proprietary Name:
404-973-2200 Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder)
Winged Collection Set, Small Vein Set
Blood Specimen Collection Device
JKA, FPA II 862.1675
James Barley
New device
BD Vacutainer Safety Lok Blood Collection Set
March 3, 1998
Predicate product code:
JKA
5
Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)
D. Device Description
The Sol-Care Safety Blood Collection Needle Set (Butterfly Needle) is a single-use, sterile, winged blood collection needle that can be used for blood collection and/or the short-term infusion of intravenous fluids. The Butterfly Needle Set is available with a 21, 23 or 25 gauge needle with Butterfly Wings and a Safety Shield with tubing leading to a covered needle assembly and Tube Holder. The product is available with and without the Tube Holder.
The Sol-Care Safety Blood Collection Needle consists of:
- Stainless steel cannula (Intravenous end and Non-patient end of Cannula) -
- Wings (Color coded according to needles gauge) -
- -Tubing
- -Female luer adaptor
- -Intravenous (IV) needle protector (covers the needle before use)
The optional SOL-M™ Blood Collection Tube Holder and SOL-M™M Blood Culture Holder include a male luer adapter for attachment to the Sol-Care Safety Blood Collection Needle.
The Sol-Care Safety Blood Collection Needle has a sharps injury prevention feature. The Butterfly Wing Assembly consists of a needle assembly and a Safety Shield. After use, the health care professional can pull back on the tubing while holding the butterfly wing and the needle will retract and lock into the Safety Shield. In the activated position the needle cover guards against accidental needlesticks during normal handling and disposal.
The devices are sterilized by Ethylene Oxide Gas. The Safety Blood Collection Needle is supplied in a hard Tray Pack while the Safety Blood Collection Needle with a preattached Tube Holder is supplied in a soft Tray Pack. Twenty-Five Safety Blood Collection Needles with a pre-attached Tube Holders are packaged in a chipboard box while fifty Safety Blood Collection Needles are packaged in a chipboard box. Each Tray Pack is labeled with the contents and the appropriate information per the Medical Device Directive and FDA's Quality System Regulation and Labeling requirements, 21CFR Part 801.
6
Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)
E. Statement of Indications for Use
Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder)
The Sol-Care Safety Blood Collection Needle (with and without Pre-attached Tube Holder) is a single use, sterile, winged blood collection needle to be used for blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needlestick injury.
- F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Sol-Care Safety Blood Collection Needle and BD Vacutainer Safety Lok Blood Collection Set. The following comparison chart shows that the subject device and the predicate device are substantially equivalent:
| Feature | Sol-Care Safety Blood
Collection Needle
(Subject Device) | BD Vacutainer Safety-Lok Blood
Collection Set (Predicate Device) | Same, similar
or different |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Indication for Use | The Sol-Care Safety
Blood Collection
Needle (with and
without a Pre-attached
Tube Holder) is a single
use, sterile, winged
blood collection needle
to be used for blood
collection or short-term
infusion (up to 2 hours)
of intravenous fluids.
The device is designed
with a safety
mechanism to help
reduce the risk of
needlestick injury. | The Vacutainer Brand Blood
Collection Set and Safety-Lok
Blood Collection Set is a winged
blood collection needle and
flexible tubing for venipuncture
to collect blood specimen from
patients or monitoring blood
pressure. The Safety-Lok Blood
Collection Set also contains a
needle safety shield which
minimizes the possibility of a
needlesticks if manually
activated following blood
collection. The Vacutainer
Brand Blood Collection Set and
Safety-Lok Blood Collection Set
is also recommended for use in
patients with small veins.
The Vacutainer Brand Blood
Collection Sets and Safety-Lok
Blood is also indicated for the | Similar |
SIDE BY SIDE COMPARISON TABLE
7
| Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k) | ||||
|---|---|---|---|---|
| | Blood Collection Needle (with and without pre-attached Tube Holder) 510(k) | intravenous administration of
fluids and may be used for any
patient population with
consideration given to patient
size, appropriateness for the
solution being infused and
duration of therapy. | | |
|-------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------|
| Intended use | Blood Collection and
Infusion of Intravenous
Solutions for up to 2
hours | Blood Collection and Infusion of
Intravenous Solutions for up to 2 hours | | Same |
| Product design/ component materials | | | | |
| Needle Cap | LDPE (Low Density
Polyethylene) | Plastic | | Similar |
| Needle, Butterfly
Wings | PVC | PVC | | Same |
| Safety Shield | Polypropylene | Polypropylene | | Same |
| Tubing | PVC | PVC | | Same |
| Female Fitting | ABS | ABS | | Same |
| Male Fitting | White Polypropylene | White Polypropylene | | Same |
| Blood Collection
Needle | Stainless Steel (SUS 304) | Stainless Steel (SUS 304) | | Same |
| Needle Cover | Clear LDPE (Low Density
Polyethylene) | Plastic | | Similar |
| Needle gauges | 21G, 23G and 25G | 21G, 23G and 25G | | Same |
| Needle Length | 3/4" | 3/4" | | Same |
| Needle Bevel | 60 degree | 60 degree | | Same |
| Tubing length | 7" and 12" | 12" | | Same |
| Packaging design w/o
Holder/ materials | Tray Pack | Tray Pack | | Same |
| Method to retract
needle | Pull back on tubing until
needle is locked within the
Safety Shield | Pull back on tubing until
needle is locked within the
Safety Shield | | Same |
| Method of
sterilization | EO | EO | | Same |
| Shelf life | 3 year | 3 year | | Same |
8
Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)
-
Summary and Conclusion of Nonclinical Tests: G.
The Sol-Care Safety Blood Collection Needle (with and without a pre-attached Tube Holder) met the appropriate requirements contained in the following standards: -
- ISO 8536-4:2010, Infusion Equipment for Medical Use Part 4: Infusion Sets For Single Use, Gravity Feed and ISO 7864:1993, Sterile Hypodermic Needles for Single Use;
- PRJ001_096, Butterfly Needle Chemistry Test Protocol and Report ●
- . PRJ001 062, Butterfly Needle Appearance and Size Test Protocol and Report
- PRJ001 060, Butterfly Needle Systematic Flow Test Protocol and Report .
- . PRJ001 056, Butterfly Needle Systematic Blocking Test Protocol and Report
- PRJ001_057, Butterfly Needle Protector Drawing Force Test Protocol and Report
- . PRJ001_054, Butterfly Needle Puncture Force Test Protocol and Report
- PRJ001 053, Butterfly Needle Unlocking Force Test Protocol and Report ●
- PRJ001 052, Butterfly Needle Shield Pulling Force Test Protocol and ● Report
- . PRJ001 049, Butterfly Needle Rubber Sealing Test Protocol and Report
-
- ISO 23908:2011, Sharps Injury Protection Requirements and Test Methods - Sharps Protection Features for Single-Use Hypodermic Needles, Introducers For Catheters And Needles Used for Blood Sampling.
- . Simulated Use Study with Nurse Evaluators
-
ISO 11607-1.-1:2009+A1:2014. Packaging for terminally sterilized medical 3. Devices and ISO 11607-2:2006, Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes.
- Seal Validation of the Soft Pack ●
- Seal Validation of the Hard Pack ●
- Simulated Transit Test for the Soft Pack ●
- . Simulated Transit Test for the Hard Pack
- . Accelerated Aging of the Soft Pack and Product Testing at time 0, years 1, 2 and 3
- Accelerated Aging of the Hard Pack and Product Testing at time 0, years ● 1.2 and 3
- Low Temperature (-20°C) Product Qualification
- High Temperature (60°C) Product Qualification ●
9
Safety Blood Collection Needle (with and without pre-attached Tube Holder) 510(k)
-
- ISO 11135-1:2007, Medical Apparatus Epoxy Ethane Sterilization Confirmation and Routine Control
- The Sol-Care Safety Blood Collection Device family was adopted into an existing validated sterilization. This adoption complies with AAMI TIR 28: . Product Adoption and Process Equivalency for Ethylene Oxide Sterilization. The cycle was validated according to the requirements of ISO 11135-1: 2014, Medical devices – Validation and Routine Control of Ethylene Oxide Sterilization.
-
- ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
- . PRJ001_059, Butterfly Needle Systematic Leakage Test Protocol and Report
- ISO 10993-1:2006, Biological evaluation of medical devices Part 1: 6. Evaluation and testing
- Cytotoxicity, ●
- Irritation Test/Intracutaneous Reactivity ●
- Sensitization Study, ●
- USP and ISO Systemic Toxicity Studies ●
- Haemolysis test
- Thrombosis Testing
- . Complement Activation C3a and SC5b-9 Asay with Sponsor-Supplied Comparison Articie (GLP)
- ASTM Hemolysis Assay Direct Contact and Extract Method (GLP) ●
- H. Discussion of Clinical Tests:
None submitted
- I. Conclusions Demonstrating Substantial Equivalence through Performance Testing:
The device has been tested and found to meet all product specifications and requirements. Product labeling clearly shows that the device is for single use only. After review of the Risk Analysis, all verification and validation test data and reports, the conclusion of the Design Review Committee was that the Sol-Care Safety Blood Collection Needle (with and without pre-attached Tube Holder) are substantially equivalent to the predicate device.