(200 days)
Not Found
No
The device description focuses on mechanical features for needle retraction and safety, with no mention of AI or ML.
No
The device is a syringe designed for administering subcutaneous and intramuscular injections, with an added safety feature to prevent needlestick injuries. It is not described as treating, preventing, or diagnosing a disease or condition for therapeutic purposes itself.
No
This device is a safety syringe intended for the administration of insulin and medication, and for the prevention of needlestick injuries. It is not used to diagnose a medical condition.
No
The device description clearly outlines a physical syringe with a retractable needle mechanism, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous and intramuscular injection of insulin and other medications into patients. This is an in-vivo (within a living organism) application, not an in-vitro (in glass or outside the body) diagnostic test.
- Device Description: The description details a syringe designed for administering substances into the body and preventing needlestick injuries. It does not mention any components or functions related to analyzing samples of bodily fluids or tissues for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's condition
- Using reagents or test strips
The device is clearly a medical device for administering medication and enhancing safety during injections.
N/A
Intended Use / Indications for Use
The OMI Retractable Safety Syringe: This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free. The function of the OMI Retractable Safety Syringe is to provide a safe, accurate and reliable method of injecting medication into a patient.
The OMI Insulin Safety Syringe: The OMI Safety Insulin Syringes are intended for the subcutaneous injection of insulin. In addition, the syringe is designed to aid in prevention of needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
MEG
Device Description
The OMI Retractable Safety Syringe is a Sterile, Non Toxic, Non Pyrogenic, Latex Free, Single Use, automatically activated anti-stick piston syringe with integral needle. Available in 1ml, 3ml and 10ml sizes with various needle sizes. The OMI Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the plunger immediately after patient injection. Needle retraction is activated by the syringe user. The primary intended use is to administer safe and accurate subcutaneous and intramuscular injections. The secondary intended use is to retract and contain the contaminated needle after injection for the purpose of aiding in the prevention of accidental needle stick injuries.
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)
Not Found
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.
Not Found
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
001 2 4 2006
EXHIBIT 2 510(k) Summary
-
- Submitter Name: OMI Manufacturing Pty Ltd
-
- Address: 1/12 Booran Dr.
Slacks Creek, Queensland,
- Australia 4127
-
- Phone:
-
- Fax: 61 7 32094765
-
- Email: projects(@omiltd.com
-
- Contact: Graham McNicol Project Manager
61 7 34517000
-
- Establishment Registration Number: 3003462738
-
- Date summary prepared: March 1, 2006
-
- Device Trade or Proprietary Name: OMI Retractable Safety Syringe
-
- Device Common or usual name: Safety Syringe
-
- Device Classification Name: Piston Syringe/Syringe Anti-stick
-
- Device Classification Code: MEG
-
- Device Class: class 11 as per regulation 21 CFR 880.5860
-
- Compliance (performance Standard): None established under section 513-514 Complies with voluntary standards and FDA guidance documents: ISO6009: Hypodermic needles for single use color coding for identification. ISO7864 Sterile hypodermic needles for single use
- ISO7886-1 Sterile Hypodermic syringes for single use
- ISO7886-4 Syringes with reuse Prevention Features
- ISO10993: Biological evaluation of medical devices
- EN550/ISO11135 Sterilization of Medical Devices- Validation and routine control Of Ethylene Oxide Sterilization
- 15: Predicate Device: Vanishpoint Syringe (K946219) from Retractable Technologies Inc.
- 16: Device Description: The OMI Retractable Safety Syringe is a Sterile, Non Toxic, Non Pyrogenic, Latex Free, Single Use, automatically activated anti-stick piston syringe with integral needle. Available in 1ml, 3ml and 10ml sizes with various needle sizes.
The OMI Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside the plunger immediately after patient injection. Needle retraction is activated by the syringe user.
The primary intended use is to administer safe and accurate subcutaneous and intramuscular injections. The secondary intended use is to retract and contain the contaminated needle after injection for the purpose of aiding in the prevention of accidental needle stick injuries.
1
KCC9.71
-
- Indications for Use: This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free. The function of the OMI Retractable Safety Syringe is to provide a safe, accurate and reliable method of injecting medication into a patient.
18. Summary Comparing Technological Characteristics With Predicate Devices:
The OMI Manufacturing Pty Ltd makes a Substantial Equivalence claim of the OMI Retractable Safety Syringe to Retractable Technologies, Inc., Pop-n-Lock Syringe (currently marketed as the Vanishpoint syringe), 510(k) # K946219. Both syringes are similar and in some cases the same, with regards to parts, design, material, operating procedure and intended use. Both the OMI and Vanishpoint syringes consist of a syringe barrel, syringe plunger, single lumen hypodermic needle, needle hub and stem. Both have a spring retracting mechanism which is user activated once medication has been injected. Both are plunger syringes which are supplied with permanently attached needles. Both are supplied sterile, single-use and disposable.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2006
OMI Manufacturing Pty., Limited C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K060971
Trade/Device Name: OMI Retractable Safety Syringe and OMI Insulin Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: October 16, 2006 Received: October 19, 2006
Dear Mr. Kamm:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 -- Mr. Kamm
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susi Runne
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K060971
Device Name: OMI Insulin Safety Syringe
Indications For Use:
The OMI Safety Insulin Syringes are intended for the subcutaneous injection of insulin. In addition, the syringe is designed to aid in prevention of needlestick injuries.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antar Ume
n of Anesthesiology, General Hospital, on Control, Dental Devices
K46971
Page 1 of 2
5
Indications for Use
510(k) Number (if known): צו 609 7/
Device Name: OMI Retractable Safety Syringe
Indications For Use:
This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, and latex free.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ell for ADK 10/25/2022
in of Anesthesiology, General Hospital, con Control, Dental Devices
Page 1 of 1
1124
Page 7 of 323