(113 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of a safety syringe and do not mention any AI or ML components.
Yes
The device is intended to inject insulin into the body, which is a therapeutic action for managing blood sugar levels in individuals with diabetes.
No
Explanation: The device is an insulin syringe, intended for injecting insulin, not for diagnosing medical conditions.
No
The device description clearly outlines a physical syringe with a needle and safety mechanism, which are hardware components. There is no mention of any software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "inject U-100 insulin into the body." This is a direct administration of a substance into a living organism, not a test performed in vitro (outside the body) on a sample from the body.
- Device Description: The description details a standard syringe for injection, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely for delivering medication.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not perform any such analysis.
N/A
Intended Use / Indications for Use
The UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries.
Product codes
MEG, FMF, FMI
Device Description
The UltiCare Safety Insulin Syringe is a standard piston type syringe with permanently attached (uni-body) needle and protective shield. These syringes are sterile, single-use, disposable piston syringes consisting of a syringe barrel calibrated in units of insulin (U-100), plunger rod with gasket, permanently attached single lumen needle, needle cap, and protective shield. The UltiCare Safety Insulin Syringes are non-toxic and non-pyrogenic, and will be available in numerous sizes and combinations between the smallest (0.3 ml x 31G x 5 / 16 ") and the largest (1 ml x 29G x 1 / 2 ").
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
The UltiCare Safety Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO 7864, ISO 8537, and ISO 9626.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
UltiCare™ Safety Insulin Syringe
Traditional 510(k) Premarket Notification
FEB - 2 201
K10301
Page 5-1 of 3
.
TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | UltiMed Inc.
287 East Sixth Street, Ste 380
St. Paul, MN 55101 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Henderson, Ph.D.
Principal Advisor
Regulatory & Clinical Research Institute, Inc.
5353 Wayzata Boulevard, Suite 505
Minneapolis, Minnesota 55416
952-227-3380
mbhenderson@rcri-inc.com |
| Date of Summary: | December 9, 2010 |
| Device Trade Name: | UltiCare ™ Safety Insulin Syringe
[Numerous sizes and combinations varying between the smallest
(0.3 ml x 31G x 5 / 16 ") and the largest (1 ml x 29G x 1 / 2 ")] |
| Common or Usual Name: | Syringe with Sharps Injury Prevention Feature |
| Classification: | Anti-stick Syringe § 880.5860 MEG Class II
Piston Syringe § 880.5860 FMF Class II
Hypodermic Single Lumen Needle § 880.5570 FMI Class II |
| Predicate Device(s): | K080600: UltiMed UltiCare ™ Safety Syringe
K922522: Sherwood (Tyco) Monoject ® Safety Syringe (Model
Monoject Insulin Safety Syringe) |
| Device Description: | The UltiCare Safety Insulin Syringe is a standard piston type syringe
with permanently attached (uni-body) needle and protective shield.
These syringes are sterile, single-use, disposable piston syringes
consisting of a syringe barrel calibrated in units of insulin (U-100),
plunger rod with gasket, permanently attached single lumen needle,
needle cap, and protective shield. The UltiCare Safety Insulin
Syringes are non-toxic and non-pyrogenic, and will be available in
numerous sizes and combinations between the smallest (0.3 ml x
31G x 5 / 16 ") and the largest (1 ml x 29G x 1 / 2 "). |
| Intended Use: | The UltiCare Safety Insulin Syringe is intended to inject U-100
insulin into the body. The safety mechanism aids in the prevention
of needle stick injuries. |
.
·
·
·
1
Technological Characteristics:
The UltiCare Safety Insulin Syringe is substantially equivalent in device description, function, principle of operation, and basic composition to the predicate devices. The subject device and the predicate devices consist of a syringe barrel, plunger rod with gasket, permanently attached single lumen needle, needle cap, and protective shield.
The protective shield is identical to the currently marketed UltiCare Safety Syringe (K080600). It is made of clear plastic and is furnished in a retracted position with the needle cap over the needle. When the needle cap is removed, insulin can be drawn and injected in the conventional manner. After the injection, the protective shield is engaged by sliding it away from the finger grip to an extended position over the needle and then applying a turning or rotating motion to lock the shield in place.
The UltiCare Safety Insulin Syringes will be available in a range of needle gauges and lengths encompassed by the predicate devices.
The UltiCare Safety Insulin Syringes have been designed and tested to meet the requirements of voluntary standards and FDA guidance documents applicable to the subject and predicate devices. Results of the non-clinical testing support the conclusion of substantial equivalence to the UltiCare Safety Insulin Syringes to the predicate devices.
Performance Testing:
The UltiCare Safety Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO 7864, ISO 8537, and ISO 9626.
Biocompatibility Testing:
The new UltiCare Safety Insulin Syringe devices use the exact same materials, dyes/inks, manufacturing process, adhesives, and sterilization process/cycle as the previously cleared UltiCare Safety Syringes (K080600), with the exception of the orange colorant of the needle cap, and therefore additional biocompatibility testing to ISO 10993 standards is not required.
Sterilization and Shelf-life Testing:
Sterilization of the UltiCare Safety Insulin Syringes is validated using the Half Cycle method as outlined in ISO 11135. The maximum levels of residues of ethylene oxide and ethylene chlorohydrin will not exceed the limits presented in ISO 10993-7.
Clinical Data:
No prospective clinical trials were conducted in support of this Traditional 510(k).
Testing:
2
Substantial Equivalence:
The vast similarities of the UltiCare Safety Insulin Syringes to the predicate devices support the substantial equivalence in intended use, function and basic composition. The non-clinical testing to voluntary standards and applicable FDA guidances provide additional evidence the UltiCare Insulin Syringes are substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.
The minor differences between the UltiCare Safety Insulin Syringes and the predicate devices do not raise new issues of safety or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ulti- Med International, Incorporated C/O Ms. Mary Beth Henderson Regulatory & Clinical Research Institute. Incorporated 5353 Wayzata Boulevard, Suite 505 Minneapolis. Minnesota 55416
FEB - 2 2011
Re: K103011
Trade/Device Name: UltiMed UltiCare™ Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF, FMI Dated: January 20, 2011 Received: January 21, 2011
Dear Ms. Henderson:
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.
4
Page 2- Ms. Henderson
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 go to
http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Jum T. Rosado
Fos
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
UltiCare™ Safety Insulin Syringe Traditional 510(k) Premarket Notification
INDICATIONS FOR USE STATEMENT 4.0
| 510(k) Number: | To be determined. | (K103011) |
|---|---|---|
| Device Name: | UltiMed UltiCare™ Safety Insulin Syringe | |
| Intended Use: | The UltiCare Safety Insulin Syringe is intended to inject U-100 insulin into the body. The safety mechanism aids in the prevention of needle stick injuries. |
Prescription Use: NO
AND/OR
Over-the-Counter Use: YES
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ril C. Chaym 2/2/11
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology. General Hospital
Division of Anesthesiology. General Devices Division of Antool, Dental Devices
510(k) Number: K103011