(112 days)
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 works like this: STEP 1 After cap removal, fluid draw-up and aspiration is unchanged from conventional syringes. STEP 2 As the plunger rod is depressed and the plunger stopper makes contact with the needle hub, the elastic membrane conforms to the conical shape of the needle hub. The plunger stopper membrane stretches until the plunger rod is fully depressed and maximum fluid is expelled from the svringe. STEP 3 At the point of full plunger rod depression, the application of the injection force overcomes the strength of the web joining the inner and outer portions of the needle hub. As this web fractures and the outer portion of the needle hub moves forward, the plunger stopper membrane is simultaneously pierced by the conical end of the hub, releasing the inner portion of the hub carrying the needle to be retracted into the hollow stem of the plunger rod by the coiled spring. The activation force is controlled. The extra pressure required at the end of the injection stroke to retract the needle is minimal. The entire procedure designed for singlehanded use, with no change to common habits. STEP 4 The fracturing of the needle hub and the piercing of the plunger stopper allow the needle to be forced into the plunger rod by the coiled spring. The speed of this retraction and the minimal dead space avoids blood or fluid spatter. Retraction is accompanied by an audible "click" and the highly visible separation of the needle hub. The syringe is EO sterilized, non-pyrogenic, and latex free.
The provided text describes a 510(k) premarket notification for the OMI Ret retractable Safety Syringe. It focuses on demonstrating substantial equivalence to a predicate device, the SEZ Safety Syringe (K031163), rather than presenting a detailed study with specific acceptance criteria and performance metrics in the format of AI device evaluation.
However, I can extract the relevant information and present it in a manner that aligns with your request where possible, while noting limitations due to the nature of the legal filing.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion (Type of Test/Characteristic) | Acceptance Criteria (Predicate Device K031163) | Reported Device Performance (OMI Retractable Safety Syringe) |
|---|---|---|
| Intended Use | Safety hypodermic syringe for intramuscular and subcutaneous injection, aids in prevention of needlestick injuries. EO sterilized, non-pyrogenic, latex free. | Identical: "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." |
| Principle of Operation (Safety Feature) | Activation in two steps: Disassemble needle assembly, then retract into barrel and confine by pushing plunger. | Activation in a single step: "After injecting the medicine, the plunger is pushed in just a bit harder causing the retraction mechanism to pull the needle permanently inside the barrel." (This is presented as an improvement/difference but still meeting the safety intent.) |
| Volume (ml/cc) | 3 and 5 ml | 1, 3, 5 and 10 ml sizes (Broader range, but implies individual sizes meet performance) |
| Nozzle Type | Female conical lock fitting with rotatable internally threaded neck. | Needle and hub are integral to the syringe, not separable. (Structural difference, but functionally equivalent for intended use). |
| Barrel Marking | Conforms to ISO7886-1:1993(E) | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conforms to ISO 10993-1 | Identical |
| Materials | Plastic parts: polypropylene; Gasket: thermoplastic rubber; Packing film: Medipeel film; Packing paper: Ethypel paper. | Identical |
| Sterility | Sterilized by ethylene oxide gas (SAL = 10⁻⁶) | Identical |
| Clinical Acceptability | (Implicitly acceptable as a legally marketed device) | "The results of the investigation showed that the OMI Ret retractable Safety Syringe is clinically acceptable." |
Study Proving Device Meets Acceptance Criteria:
The document refers to a "clinical investigation" and "test for the comparison between OMI Ret retractable Safety Syringe and the legally marketed predicate device." This study was performed "in accordance with 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA'."
2. Sample Size for the Test Set and Data Provenance
- The document does not explicitly state the sample size used for the clinical investigation or comparison test.
- The data provenance (country of origin, retrospective/prospective) is not specified. However, the study was conducted to meet FDA regulations for a US-marketed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- The document does not provide details on the number of experts, their qualifications, or how ground truth was established for the clinical investigation. For a physical device like a syringe, "ground truth" would likely refer to objective measurements of performance (e.g., retraction force, completeness of retraction, prevention of needlesticks in simulated or actual use).
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (like AI in radiology) where human readers make a judgment. The OMI Ret retractable Safety Syringe is a physical medical device.
6. Standalone Performance Study
- Yes, a standalone study (referred to as a "clinical investigation" and "test for the comparison") was performed to demonstrate that the OMI Ret retractable Safety Syringe itself ("algorithm only" in AI terms) met the necessary safety and performance criteria, including comparison to the predicate device. The goal was to show "clinical acceptability."
7. Type of Ground Truth Used
- Based on the context of a safety syringe, the "ground truth" would likely involve objective measurements related to:
- Mechanical performance: Retraction force, completeness of needle retraction, prevention of re-exposure.
- Usability/Human factors: Ease of use, activation force, audible/visible confirmation of retraction, potential for needlestick incidents in simulated use.
- Biocompatibility: In vitro and in vivo testing demonstrating material safety.
- Sterility assurance.
- The document states that the findings were based on "biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the previous device."
8. Sample Size for the Training Set
- This is not applicable as the OMI Ret retractable Safety Syringe is a physical device, not an AI/software device that would require machine learning training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable (no training set for a physical device).
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Kobolog
MAY - 5 2006
EXHIBIT 2
510(k) Summary VitalCare Group, Inc. 8935 N.W. 27th Street Miami, Florida 33172 USA Telephone 305-620-4007 Fax 305-620-5220 Contact: Ramzi Abulhaj, President November 3, 2005
-
- Identification of the Device: Proprietary-Trade Name: OMI Retractable Safety Syringe Classification Name: Piston Syringe Common/Usual Name: Safety Syringe
-
- Equivalent legally marketed device: SEZ Safety Syringe, K031163
-
- Indications for Use (intended 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.
-
- Description of the Device: The OMI Retractable Safety Syringe works like this: STEP 1 After cap removal, fluid draw-up and aspiration is unchanged from conventional syringes.
STEP 2 As the plunger rod is depressed and the plunger stopper makes contact with the needle hub, the elastic membrane conforms to the conical shape of the needle hub. The plunger stopper membrane stretches until the plunger rod is fully depressed and maximum fluid is expelled from the svringe.
STEP 3 At the point of full plunger rod depression, the application of the injection force overcomes the strength of the web joining the inner and outer portions of the needle hub. As this web fractures and the outer portion of the needle hub moves forward, the plunger stopper membrane is simultaneously pierced by the conical end of the hub, releasing the inner portion of the hub carrying the needle to be retracted into the hollow stem of the plunger rod by the coiled spring. The activation force is controlled. The extra pressure required at the end of the injection stroke to retract the needle is minimal. The entire procedure designed for singlehanded use, with no change to common habits.
STEP 4 The fracturing of the needle hub and the piercing of the plunger stopper allow the needle to be forced into the plunger rod by the coiled spring. The speed of this retraction and the minimal dead space avoids blood or fluid spatter. Retraction is accompanied by an audible "click" and the highly visible separation of the needle hub.
The syringe is EO sterilized, non-pyrogenic, and latex free.
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| Device Name | SEZ safety syringe[K031163] | OMI Retractable Safety Syringe |
|---|---|---|
| Intended Use | This device is a Safety hypodermicsyringe for Intramuscular andSubcutaneous injection.This device aids in prevention ofneedlestick injuries. EO sterilized.non-pyrogenic, and latex free. | Identical |
| Principle operation | Activation of safety feature consistsof two steps :1) Disassemble needle assemblyfrom the barrel by turning theplunger2) Retract needle into barrel andconfine it in the barrel bypushing the plunger forwardbefore disposal | Activation of safety feature consistsof the following single step:After injecting the medicine, theplunger is pushed in just a bit hardercausing the retraction mechanism topull the needle permanently insidethe barrel. |
| Volume (ml/cc) | 3 and 5 | 1, 3, 5 and 10 ml sizes |
| Nozzle type | Female conical lock fitting withrotatable internally threaded neck | Needle and hub are integral to thesyringe, not separable. |
| Barrel Marking | Scale: confirms to ISO7886-1:1993(E) | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conform to ISO 10993-1 | Identical |
| Materials | 1 ) Plastic parts : polypropylene(homo type) | Identical |
| 2) Gasket : thermoplastic rubber | Identical | |
| 3) Packing film : Medipeel film | Identical | |
| 4) Packing paper : Ethypelpaper | Identical | |
| Sterility | Sterilized by ethylene oxide gasSAL = 10⁶ | Identical |
-
- Safety and Effectiveness, comparison to predicate device:
-
- Conclusion: In all material respects, the OMI Retractable Safety Syringe is substantially equivalent to the predicate device. The conclusion is based on biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the previous device. A clinical investigation was performed, and test for the comparison between OMI Retractable Safety Syringe and the legally marketed predicate device was performed in accordance with "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA". The results of the investigation showed that the OMI Retractable Safety Syringe is clinically acceptable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird-like figure, possibly representing an eagle, with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 5 2006
VitalCare Group, Incorporated C/O Mr. Daniel Kamm, P.E. Principal Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K060109
Trade/Device Name: OMI Retractable Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 11, 2006 Received: February 8, 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 8010 tartoon. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
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): | 060 i 09
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. EQ sterliized 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)
Quro Ls
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Page 1 of 1
§ 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).