(190 days)
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML capabilities.
No.
The device is a syringe intended for injecting or withdrawing fluids, primarily for diagnostic or drug delivery purposes, not for providing a therapeutic effect itself.
No
The device is described as being used to inject or withdraw fluids, specifically mentioning insulin injection. This indicates a therapeutic or procedural function, not a diagnostic one. No mention is made of analyzing samples or providing diagnostic information.
No
The device description clearly outlines physical components (barrel, plunger, stopper, cap, needle) and refers to bench tests verifying compliance with hardware standards (ISO 7886-1, ISO 9626, ISO 8537).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to inject fluids into or withdraw fluids from the body" and "for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin." This describes a device used for direct interaction with the body for therapeutic or diagnostic procedures involving fluid transfer, not for testing samples in vitro (outside the body).
- Device Description: The description details a standard syringe with components like a barrel, plunger, stopper, and cap. These are typical components of a device used for injecting or withdrawing substances from a living organism.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue), detect specific substances within those samples, or provide diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
- Sol-M TB Syringe: The Sol-M TB Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
- Sol-M Insulin Syringe: The Sol-M Insulin Syringe with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Sol-M Syringe is a sterile, single use, standard 3 piece piston syringe with a fixed needle. The Sol-M 0.3, 0.5 and 1 ml Insulin Syringe will be labeled with a Units Scale calibrated for U-100 Insulin. The 0.5 and 1 ml TB Syringe will be labeled with a mL Scale.
The piston type syringe is a plastic disposable syringe made of the following components:
-
- Barrel – The barrel has a scale showing the capacity of the syringe as well as the company brand name with the Do Not Reuse symbol.
-
- Plunger - The plunger is used to aspirate fluid into the barrel or push fluid out of the barrel.
-
- Stopper - The Stopper maintains the fluid in the barrel between the base of the barrel and Plunger.
- Cap The Cap is used to cover and protect the tip of the barrel from being 4. damaged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were conducted to verify that the proposed devices met all design specifications and were Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed devices comply with the following standards:
Sol-M TB Syringes
- ISO 7886-1:1993 Sterile Hypodermic syringes for single use Part 1: Syringes for ● manual use;
- ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical ● devices/Amendment:2001
Sol-M Insulin Syringes
- ISO 8537:2007 Sterile single use syringes, with and without needles, for insulin; ●
- ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical ● devices/Amendment:2001
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or abstract human figures in profile, with three distinct head shapes layered on top of each other. The image is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2016
Sol-Millennium Medical, Inc. Mr. Jim Barley Director of Regulatory Affairs 1735 North Brown Road, Suite 100 Lawrenceville, Georgia 30043
Re: K153537
Trade/Device Name: Sol-M Insulin Syringe and Sol-M TB Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: May 2, 2016 Received: May 10, 2016
Dear Mr. 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
Page 2 - Mr. Jim Barley
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 yours,
Tina Kiang -
for Erin I. Keith, M.S Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K153537 |
|---|---|
| Device Name | Sol-M TB Syringe |
| Indications for Use (Describe) | The Sol-M TB Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. |
| 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.
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
"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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 EF |
3
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number ( if known ) | K153537 |
| Device Name | Sol-M Insulin Syringe |
| Indications for Use ( Describe ) | The Sol-M Insulin Syringe with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. |
| 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.
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."
FORM FDA 3881 (8/14) Page 1 of 1
4
510(k) Summary for 510(k) # K153537
(As required by 21 CFR 807.92(a))
510(k) Summary for the Sol-M Insulin and TB Syringes
Date Prepared: June 16, 2016 A. Submitter Information
Sol-Millennium Medical, Inc. 1735 North Brown Road Suite 120 Lawrenceville, GA 30043 Contact: Phone Number:
Trade Names:
- B. Device Information Trade/Proprietary Name: Common name of device: Classification Name: Product Code: Regulatory Class: Classification Number: Reason for 510(k):
C. Predicate Device:
Predicate 510(k) #:
Predicate product code:
Reference Devices:
Jim Barley 404-973-2200
Sol-M Insulin Syringe Sol-M TB Syringe
Sol-M Insulin and TB Syringe Piston syringe Piston syringe 80 FMF II 880.5860 New device
KDL Syringes and Needles
FMF
Sol-Guard Insulin and Tuberculin Safety Syringe 510(k) # K132681
1 ml Fixed Needle, 3 ml Luer Lock, 5 ml Luer Lock, 10 ml Luer Lock, 20 ml LuerLock Safety Syringe 510(k) # K092430
Invirostripe Luer Lock Syringes (1, 3, 10, 20, 30 And 60 ml 510(k) #K101359
5
D. Device Description
The Sol-M Syringe is a sterile, single use, standard 3 piece piston syringe with a fixed needle. The Sol-M 0.3, 0.5 and 1 ml Insulin Syringe will be labeled with a Units Scale calibrated for U-100 Insulin. The 0.5 and 1 ml TB Syringe will be labeled with a mL Scale.
The piston type syringe is a plastic disposable syringe made of the following components:
-
- Barrel – The barrel has a scale showing the capacity of the syringe as well as the company brand name with the Do Not Reuse symbol.
-
- Plunger - The plunger is used to aspirate fluid into the barrel or push fluid out of the barrel.
-
- Stopper - The Stopper maintains the fluid in the barrel between the base of the barrel and Plunger.
- Cap The Cap is used to cover and protect the tip of the barrel from being 4. damaged.
Following is a listing of model numbers and product descriptions included in this submission:
Sol-M Insulin Syringes with Fixed Needle
| Sol-M 0.3 ml Insulin Syringe with Fixed Needle | |
|---|---|
| REF/Catalog # | Description |
| 16331518 | 0.3ml, 31G x 5/16"/10 Pack PE Bag |
| 16330518 | 0.3ml, 30G x 5/16"/10 Pack PE Bag |
| 16330128 | 0.3ml, 30G x 1/2"/10 Pack PE Bag |
| 16329128 | 0.3ml, 29G x 1/2"/10 Pack PE Bag |
| Sol-M 0.3 ml Insulin Syringe with Fixed Needle | |
| REF/Catalog # | Description |
| 16330516 | 0.3ml, 30G x 5/16"/1 ea. Blister Pack |
| 1633012 | 0.3ml, 30G x 1/2"/ 1 ea. Blister Pack |
| 1632912 | 0.3ml, 29G x 1/2"/ 1 ea. Blister Pack |
| Sol-M 0.5 ml Insulin Syringes with Fixed Needle | |
| REF/Catalog # | Description |
| 16531518 | 0.5ml, 31G x 5/16"/10 Pack PE Bag |
| 16530518 | 0.5ml, 30G x 5/16"/10 Pack PE Bag |
| 16530128 | 0.5ml, 30G x 1/2"/10 Pack PE Bag |
| 16529128 | 0.5ml, 29G x 1/2"/10 Pack PE Bag |
| 16130516 | 0.5ml, 30G x 5/16"/1 ea. Blister Pack |
| 1613012 | 0.5ml, 30G x 1/2"/ 1 ea. Blister Pack |
| 1612912 | 0.5ml, 29G x 1/2"/ 1 ea. Blister Pack |
6
| Sol-M 1 ml Insulin Syringes with Fixed Needle | |
|---|---|
| REF/Catalog # | Description |
| 16131518 | 1ml, 31G x 5/16"/10 Pack PE Bag |
| 16130518 | 1ml, 30G x 5/16"/10 Pack PE Bag |
| 16130128 | 1ml, 30G x 1/2"/10 Pack PE Bag |
| 16129128 | 1ml, 29G x 1/2"/10 Pack PE Bag |
| 16530516 | 1.0ml, 30G x 5/16"/1 ea. Blister Pack |
| 1653012 | 1.0ml, 30G x 1/2"/ 1 ea. Blister Pack |
| 1652912 | 1.0ml, 29G x 1/2"/ 1 ea. Blister Pack |
Sol-M TB Syringes with Fixed Needle
| Sol-M 0.5 ml TB Syringes with Fixed Needle | |
|---|---|
| REF/Catalog # | Description |
| 180527 | 0.5ml, 27G x 1/2"/1 each Blister Pack |
| 180526IDB | 0.5ml, 26G x 3/8" IDB/1 each Blister Pack |
| 180527T | 0.5ml, 27G x 1/2"/25 each Tray Pack |
| 180527IDB | 0.5ml, 27G x 3/8"/25 Tray Pack |
| Sol-M 1 ml TB Syringes with Fixed Needle | |
| REF/Catalog # | Description |
| 181027 | 1ml, 27G x 1/2"/1 ea. Blister Pack |
| 181026IDB | 1ml, 26G x 3/8"IDB /1 ea. Blister Pack |
| 181026T | 1ml, 26G x 1/2"/25 each Tray Pack |
| 181126IDB | 1ml, 26G x 1/2"IDB/25 each Tray Pack |
| 181026IDB | 1ml, 26G x 3/8”IDB/25 each Tray Pack |
| 181027T | 1ml, 27G x 1/2"/25 each Tray Pack |
| 181127IDB | 1ml, 27G x 1/2"IDB/25 each Tray Pack |
| 181027IDB | 1ml, 27G x 3/8”IDB/25 each Tray Pack |
| 181023T | 1ml. 23G x 1/2"/25 ea. Blister Pack |
The Sol-M Syringes are sterilized by Ethylene Oxide Gas and supplied sterile in blister pack, tray pack or 10 pack.
7
- E. Statement of Indications for Use
Sol-M Insulin Syringes
The Sol-M Insulin Syringe with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
Sol-M TB Syringe
The Sol-M TB Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
- F. Comparison of Required Technological Characteristics:
Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Sol-M Insulin and KDL Insulin Syringes and the Sol-M TB and KDL Hypodermic Syringes. The following comparison chart shows that the subject device and the predicate device are substantially equivalent:
Sol-M Insulin and TB Syringe versus the KDL Syringes and Needle
| ELEMENT OF
COMPARISON | Sol-M Insulin and
TB Syringe | KDL Syringes and Needle |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Syringe type | Piston | Piston |
| | Insulin | Insulin |
| Indications for
Use | The Sol-M Insulin Syringe
with needle, with the
calibration unit of insulin for
U-100, is a device intended
for medical purposes for the
manual aspiration of insulin,
and for the injection of insulin
into parts of the body below
the surface skin. | The sterile Insulin Syringe
for single use with needle is a
device intended for medical
purposes for the
manual aspiration of insulin,
and for the injection into parts
of the body below the surface
skin |
| | General Use | General Use |
| Indications for
Use | The Sol-M TB Syringe is
intended to be used for
medical purposes to inject
fluids into or withdraw fluids
from the body. | The Hypodermic Syringes
are intended to be used for
medical purposes to inject
fluids into or withdraw
fluids from the body. |
| Principle of
Operation | Three piece piston syringe.
Plunger is used to fill syringe
as well as discharge the fluid. | Three piece piston syringe.
Plunger is used to fill syringe
as well as discharge the
fluid. |
| Specific Drug
Use | Sol-M Insulin syringes -
Insulin
Sol-M TB syringes - General
Use | KDL Insulin syringes -
Insulin
KDL Hypodermic syringes -
General Use |
| Tip Type | Fixed Needle | Fixed Needle |
| Volume | Insulin Syringes - 0.3, 0.5
and 1ml
TB Syringes - 0.5 and 1 ml | Insulin Syringes - 0.3, 0.5
and 1ml
Hypodermic Syringes – 0.5
and 1 ml |
| Gradations
Legibility | Bold markings | Bold markings |
| Lubricant
Composition | Dow Corning Medical
Silicone 360 | Dow Corning Medical
Silicone 360 |
| Lubricant
amount/cm2 | 1ml-0.078mg/cm2 | 1 ml – 0.078 Mg/cm2 |
| Barrel
Transparency | Clear | Clear |
| Delivery
Accuracy | Insulin Syringes- Per ISO
8537:2007 | Insulin Syringes- Per ISO
8537:2007 |
| | Hypodermic Syringes - Per ISO 7886-1:1993 | Hypodermic Syringes - Per ISO 7886-1:1993 |
| Hub/Needle
Bond Strength | Per ISO 7886 | Per ISO 7886 |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 |
| Materials | Barrel, Plunger and Cap –
Polypropylene
Gasket - Santoprene | Barrel, Plunger and Cap –
Polypropylene
Gasket - Santoprene |
| Labeling | Per 21 CFR 801 | Per 21 CFR 801 |
SIDE BY SIDE COMPARISON TABLE
8
9
- G. Summary and Conclusion of Nonclinical and Clinical Tests:
Bench tests were conducted to verify that the proposed devices met all design specifications and were Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed devices comply with the following standards:
Sol-M TB Syringes
- ISO 7886-1:1993 Sterile Hypodermic syringes for single use Part 1: Syringes for ● manual use;
- ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical ● devices/Amendment:2001
Sol-M Insulin Syringes
- ISO 8537:2007 Sterile single use syringes, with and without needles, for insulin; ●
- ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical ● devices/Amendment:2001
- H. Discussion of Clinical Tests:
None submitted
10
- Substantially Equivalent Conclusion: I.
The proposed device, Sol-M TB Syringes (various sizes), has been determined to be substantially equivalent to the predicate device, Sterile Hypodermic Syringe for single use, with needle, (various sizes), 510(k) # K112057.
The proposed device, Sol-M Insulin Syringes (various sizes), is determined to be substantially equivalent (SE) to the predicate device, Sterile Insulin Syringe for single use with needle, 510(k) # K112057.