Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set
Device Facts
| Record ID | K182146 |
|---|---|
| Device Name | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set |
| Applicant | Sol-Millennium Medical, Inc. |
| Product Code | FMI · General Hospital |
| Decision Date | Dec 3, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
Indications for Use
The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood. The Sol-Care Safety Blood Collection 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 Sol-Care Safety Blood Collection Needle with Holder 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 Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.
Device Story
Manual blood collection devices consisting of stainless steel needles, hubs, and optional flexible tubing or holders; some models include safety shields to prevent accidental needle sticks. Devices create a channel between patient vein and vacuum collection tube. Used in clinical settings by healthcare professionals. Safety features activated manually to cover needle after use. Benefits include standardized venous blood collection and reduced risk of sharps injury to clinicians.
Clinical Evidence
Bench testing only. No clinical data submitted. Testing included ISO 9626 (tubing), ISO 7864 (sterile needles), ISO 10993 (biocompatibility: cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis), ASTM F88/F1140 (packaging), and USP <85> (endotoxins). Simulated use study conducted per FDA guidance for sharps injury prevention features.
Technological Characteristics
Stainless steel needle tubing (ISO 9626); silicone oil lubricant; epoxy resin adhesive. Manual operation. Available in 18G-25G gauges and various lengths. EO sterilization (SAL 10^-6). Conical fittings. Safety models include integrated shield mechanism.
Indications for Use
Indicated for the collection of venous blood using vacuum blood collection tubes. Intended for use by healthcare professionals in clinical settings.
Regulatory Classification
Identification
A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.
Predicate Devices
- Blood Collecting Devices (K172763)
Submission Summary (Full Text)
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December 3, 2018
Sol-Millennium Medical, Inc. James Barley Director of RA 1735 North Brown Road, Suite 120 Lawrenceville, Georgia 30043
Re: K182146
Trade/Device Name: Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holder, Sol-M Blood Collection Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 18, 2018 Received: August 8, 2018
Dear 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. 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
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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Sarah B. Mollo -S
for 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
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### Indications for Use
#### 510(k) Number (if known) K182146
#### Device Name
Sol-M Blood Collection Needle Sol-Care Safety Blood Collection Needle Sol-Care Safety Blood Collection Needle with Holder and Sol-M Blood Collecting Set
#### Indications for Use (Describe)
The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Sol-Care Safety Blood Collection 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 Sol-Care Safety Blood Collection Needle with Holder 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 Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous blood.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### 510(k) Summary (As required by 21 CFR 807.92(a)) K182146
#### Summary of for the Sol-M Blood Collection Needle, Sol-Care Safety Blood Collection Needle and Sol-M Blood Collection Set
Date Prepared: November 30, 2018
#### A. Applicant and Correspondent
| Name: | Sol-Millennium Medical, Inc. |
|-----------------|-------------------------------------------------------------|
| Address: | 1735 North Brown Road, Suite 120<br>Lawrenceville, GA 30043 |
| Contact Person: | James Barley<br>Director of RA |
| Phone: | (404) 433-3058 |
#### Manufacturer
#### Zhejiang kindly medical devices Co., Ltd.
No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District, 325025 Wenzhou, Zhejiang Province, PRC.
#### B. Name of Device
| ● | Trade/Proprietary/Model Name: | Sol-M Blood Collection Needle | |
|---|-------------------------------|----------------------------------|-----------------------------------------|
| | | O | Sol-Care Safety Blood Collection Needle |
| | | O | Sol-M Blood Collection Set |
| ● | Common Name of Devices: | | Blood Collection Needle |
| | | O | Safety Blood Collection Needle |
| | | O | Blood Collection Set |
| ● | Panel: | | General Hospital |
| ● | Classification Number: | | 21 CFR 880.5570 |
| ● | Classification Name: | Needle, Hypodermic, Single Lumen | |
| ● | Regulatory Class: | II | |
| ● | Product Code: | FMI | |
#### Device to Which New Device is Substantially Equivalent
| Device Name: | Blood Collecting Devices |
|------------------------|-------------------------------------------|
| Manufacturer: | Zhejiang Kindly Medical Devices Co., Ltd. |
| Classification Number: | 21 CFR 880.5570 |
| Classification Name: | Needle, Hypodermic, Single Lumen |
| Regulatory Class: | II |
| Product Code: | FMI |
| Reference: | K172763 |
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#### C. Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the vacuum blood collection tube intended for collection of blood. The proposed devices are divided into several types, the configuration for each type of proposed device are provided as follows
| Product name | Ref No. | Patient-End<br>Needle | Non-Patient<br>End Needle | Integrated<br>Needle | Flexible<br>Tube | Needle<br>Holder | Safety<br>Feature | Visible<br>Flashback |
|--------------------------------------------------------------|---------|-----------------------|---------------------------|----------------------|------------------|------------------|-------------------|----------------------|
| Blood Collection<br>Needle – one<br>piece | 04-11 | X | X | X | N.A. | N.A. | N.A. | N.A. |
| Blood Collection<br>Needle – Direct | 04-13 | X | X | X | N.A. | N.A. | N.A. | X |
| Blood Collection<br>Needle – Multi<br>piece | 04-31 | X | X | N.A. | N.A. | N.A. | N.A. | X |
| Safety Blood<br>Collection<br>Needle – Direct | 04-12 | X | X | X | N.A. | N.A. | X | N.A. |
| Safety Blood<br>Collection<br>Needle – Multi<br>piece | 04-32 | X | X | N.A. | N.A. | N.A. | X | X |
| Safety Blood<br>Collection Needle<br>w/Holder – One<br>piece | 04-15 | X | X | X | N.A. | X | X | N.A. |
| Safety Blood<br>Collection Needle<br>w/Holder - Direct | 04-34 | X | X | N.A. | N.A. | X | X | X |
In addition, the proposed devices are divided into several types and available in different specifications as follows:
| Device Name | Ref No. | Needle Gauge | Needle Length |
|--------------------------------------------|---------|--------------|--------------------------------------------|
| Blood Collection Needle | 04-11 | 18G-23G | 1", 1-1/4", 1-1/2" |
| Blood Collection Needle | 04-13 | 18G-23G | 1", 1-1/4", 1-1/2" |
| Blood Collection Needle | 04-31 | 19G, 25G | 5/8", 3/4", 1", 1-1/4", 1-1/2", 1-3/4", 2" |
| Safety Blood Collection Needle | 04-12 | 18G-23G | 1", 1-1/4", 1-1/2" |
| Safety Blood Collection Needle | 04-32 | 19G, 25G | 5/8", 3/4", 1", 1-1/4", 1-1/2", 1-3/4", 2" |
| Safety Blood Collection Needle with | 04-15 | 18G-23G | 1", 1-1/4", 1-1/2" |
| Holder | 04-34 | 19G, 25G | 5/8", 3/4", 1", 1-1/4", 1-1/2", 1-3/4", 2" |
| Blood Collection Set | 04-21 | 19G, 25G | 5/8", 3/4", 1" |
| Safety Blood Collection Set | 04-22 | 19G, 25G | 5/8", 3/4",1" |
| Blood Collection Set with Holder | 04-23 | 19G, 25G | 5/8", 3/4", 1" |
| Safety Blood Collecting Set with<br>Holder | 04-24 | 19G, 25G | 5/8", 3/4", 1" |
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#### D. Statement of Indications for Use
- The Sol-M Blood Collection Needle is intended to be used with vacuum blood collection tube for the collection of venous blood.
- The Sol-Care Safety Blood Collection 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 Sol-Care Safety Blood Collection Needle with Holder 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 Sol-M Blood Collecting Set is intended to be used with vacuum blood collection tube for the collection of venous
#### E. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the applicable sections of the following standards:
- A ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices; > Sample needles from Safety blood collection Sets with a Holder were tested as follows per the requirements of ISO 9626: Material verification, surface finish and visual appearance, cleanliness, limits for acidity and alkalinity, size designation, dimensional inspection, stiffness, resistance to breakage and resistance to corrosion.
- > ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
> Sample needles from Safety blood collection Sets with a Holder were tested as follows per the requirements of ISO7864: Cleanliness, limits for acidity and alkalinity, limits for extractable metals, tubular needle designation, color coding, conical fitting, color of hub, needle cap, tolerance on length, freedom from defects, lubricant, needle point, bond between hub and needle tube and patency of lumen.
- A ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
> EO and ECH Residuals Resting of sterilized product
- > ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials; > Seal Peel Testing of package seals
- A ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
> Burst and Creep Testing of package
- > USP38-NF33 <85> Bacterial Endotoxins Test. > Bacterial Endotoxin Testing of device
- ♪ ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
> Risk management report
- ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for In Vitro Cytotoxicity >
- Biocompatibility In Vitro Cytotoxicity Test A
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- > ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
> Intracutaneous reactivity test and Skin Sensitization test
- ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity A > Acute systemic toxicity test > Pyrogen test
- ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials A
> Testing for Hemolytic properties of devices
- A Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features Document Issued on: August 9, 2005
> A Simulated Use Study was conducted per the requirements of the FDA's Guidance for Industry and FDA Staff Medical Devices with Sharps Injury Prevention Features, Document Issued on: August 9, 2005
- F. Brief discussion of clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. Not applicable.
| ITEM | Predicate Device<br>K172763 | Proposed Devices | Remark |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Class | II | II | Same |
| Intended use | The Blood Collecting Needle<br>is intended to be used with<br>vacuum blood collection tube<br>for the collection of venous<br>blood. The Safety Blood Collecting<br>Needle is intended to be used<br>with vacuum blood collection<br>tube for the collection of<br>venous blood. The safety<br>shield is intended to aid in the<br>protection against accidental<br>needle stick injury. The Blood Collecting Set with<br>Holder is intended to be used<br>with vacuum blood collection<br>tube for the collection of<br>venous blood | The Sol-M Blood Collection Needle is<br>intended to be used with vacuum blood<br>collection tube for the collection of venous<br>blood. The Sol-Care Safety Blood Collection<br>Needle is intended to be used with vacuum<br>blood collection tube for the collection of<br>venous blood. The safety shield is intended<br>to aid in the protection against accidental<br>needle stick injury. The Sol-Care Safety Blood Collection<br>Needle with Holder is intended to be used<br>with vacuum blood collection tube for the<br>collection of venous blood. The safety<br>shield is intended to aid in the protection<br>against accidental needle stick injury. The Sol-M Blood Collecting Set is<br>intended to be used with vacuum blood<br>collection tube for the collection of venous | Same |
| ITEM | Predicate Device<br>K172763 | Proposed Devices | Remark |
| Configuration | Patient-end Needle<br>Protective Cover of<br>Patient-end Needle<br>Patient-end Needle<br>Hub<br>Non-patient<br>end Needle<br>Hub<br>Non-patient end Needle<br>Rubber Sleeve<br>Protective Cover of Non-patient<br>end Needle<br>Double Wing<br>Flexible Tube<br>Conical<br>Fitting<br>Connector<br>Conical<br>Fitting<br>Needle Holder | Patient-end Needle<br>Protective Cover of Patient-end<br>Needle<br>Patient-end Needle Hub<br>Non-patient end Needle<br>Hub<br>Non-patient end Needle Rubber Sleeve<br>Protective Cover of Non-patient end Needle<br>Double Wing<br>Flexible Tube<br>Conical Fitting Connector Conical<br>fitting<br>Needle Holder<br>Safety Shield | Same |
| ITEM | Predicate Device<br>K172763 | Proposed Devices | Remark |
| Operational<br>mode | Manual | Manual | Same |
| Specifications | 18G, 19G, 20G, 21G, 22G, 23G,<br>25G<br>5/8", ¾",1", 1-1/4", 1-1/2", 1-<br>3/4", 2" | 18G, 19G, 20G, 21G, 22G, 23G, 25G<br>5/8", ¾", 1", 1-1/4", 1-1/2", 1-3/4", 2" | Same |
| Safety<br>mechanism | The safety shield is intended to<br>prevent needle sticks. | The safety shield is intended to prevent needle<br>sticks. | Same |
| Labeling | Conforms to Part 801 | Conforms to Part 801 | Same |
| Single use | Yes | Yes | Same |
| ITEM | Predicate Device<br>K172763 | Proposed Devices | Remark |
| Patient-contact material | | | |
| Needle Tube | Stainless Steel | Stainless Steel | |
| Lubricant | Silicone Oil | Silicone Oil | Same |
| Adhesive | Epoxy Resin | Epoxy Resin | |
| Biocompatibility | | | |
| In Vitro Cytotoxicity | Conform with ISO 10993 | Conform with ISO 10993 | Same |
| Skin Sensitization | | | |
| Intracutaneous Reactivity | | | |
| Acute Systemic Toxicity | | | |
| Hemolytic Properties | | | |
| Sterilization | | | |
| Method | EO sterilized | EO sterilized | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | |
#### G. Substantially Equivalent (SE) Comparison
### Comparison of Technology for Substantial Equivalence
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The proposed devices, Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder are the same to the predicate device K172763 in device design, Indications for use, manufacturing materials and processes, sterilization, method of operation and technological characteristics. Therefore, the proposed devices can be determined substantially equivalence to predicatedevices.
#### H. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
