(200 days)
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.
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 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.
The provided text is a 510(k) summary for the OMI Retractable Safety Syringe, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with defined performance metrics. Therefore, it does not contain the detailed information typically found in a clinical study report.
Based on the provided text, here's what can and cannot be answered regarding acceptance criteria and a study proving device performance:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in terms of numerical performance metrics for the OMI Retractable Safety Syringe (e.g., maximum force for activation, retraction success rate, etc.). Instead, it focuses on compliance with voluntary standards and the functional description of the device's safety feature.
The reported "performance" described is the device's ability to "retract the contaminated needle inside the plunger immediately after patient injection" and its intended use to "administer safe and accurate subcutaneous and intramuscular injections" and "aid in the prevention of accidental needle stick injuries."
While the document lists compliance with several ISO and EN standards (ISO6009, ISO7864, ISO7886-1, ISO7886-4, ISO10993, EN550/ISO11135), these are general standards for hypodermic needles, syringes, biological evaluation, and sterilization, rather than specific performance acceptance criteria for the safety mechanism itself. To understand the specific performance requirements, one would need to consult these standards directly.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the 510(k) summary. A 510(k) submission generally relies on demonstrating equivalence through comparison to a predicate device and adherence to recognized standards, which might involve internal testing, but the details of such testing (sample sizes, provenance, study design) are not typically included in the summary provided to the public.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable/provided. The 510(k) summary does not describe a study involving expert assessment of a "test set" or the establishment of "ground truth" in the way one would for diagnostic imaging or AI devices. The focus is on the physical and functional characteristics of a medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/provided. This type of study (MRMC, AI assistance) relates to diagnostic or AI-powered devices, which the OMI Ret retractable Safety Syringe is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/provided. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable/provided for the reasons stated above. The "ground truth" for a safety syringe would primarily relate to its mechanical function, sterility, and biocompatibility, which are verified through engineering tests and compliance with standards rather than expert consensus on a "case set."
8. The sample size for the training set:
This information is not applicable/provided. This device is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
This information is not applicable/provided for the reasons stated above.
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001 2 4 2006
EXHIBIT 2 510(k) Summary
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- Submitter Name: OMI Manufacturing Pty Ltd
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- Address: 1/12 Booran Dr.
Slacks Creek, Queensland,
- Australia 4127
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- Phone:
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- Fax: 61 7 32094765
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- Email: projects(@omiltd.com
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- Contact: Graham McNicol Project Manager
61 7 34517000
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- Establishment Registration Number: 3003462738
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- Date summary prepared: March 1, 2006
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- Device Trade or Proprietary Name: OMI Retractable Safety Syringe
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- Device Common or usual name: Safety Syringe
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- Device Classification Name: Piston Syringe/Syringe Anti-stick
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- Device Classification Code: MEG
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- Device Class: class 11 as per regulation 21 CFR 880.5860
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- 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.
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KCC9.71
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- 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.
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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.
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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
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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
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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
§ 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).