(206 days)
Not Found
No
The description focuses on a mechanical safety mechanism for a syringe and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is a syringe used for injecting medication or withdrawing fluid, and its primary function is to prevent needle stick injuries and reuse, not to diagnose, treat, or prevent a disease or condition.
No
The provided text describes a safety syringe used for injecting medication or withdrawing fluid, and its primary function is to prevent needle stick injuries and reuse. There is no mention of it being used for diagnostic purposes like identifying diseases or conditions.
No
The device description clearly indicates it is a physical syringe with a safety mechanism, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "medication can be injected into or fluid withdrawn from the human body." This describes a device used for direct interaction with the human body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description focuses on the mechanical function of a syringe for injection and withdrawal, and its safety features related to needle stick prevention and reuse. This aligns with a medical device used for administering substances or collecting samples from the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
- Reagents, calibrators, or controls typically associated with IVD tests.
In summary, the Safe Plus Disposable Safety Syringe is a medical device used for administering or withdrawing substances from the human body, which falls under the category of a general medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Safe Plus Disposable Safety Syringe is a sterile, non-pyrogenic, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.
Product codes
MEG
Device Description
The Safe Plus Disposable Syringe is a single use hypodermic syringe similar to a traditional syringe in application and function except for its safety mechanism which when activated:
- completely retracts and encloses the needle in the barrel thereby preventing finger access
- renders the needle unusable again as it is crushed within the puncture resistant barrel.
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)
Based on tests performed in accordance with "Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features", "Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes" and internationally recognized standards for syringe performance, the Safe Plus Disposable Safety Syringe has been shown to be substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
5. 510(k) Summary
AUG - 6 2007
Submitted on behalf of:
Dolomite Biotech Sdn. Bhd 3 Jalan SBC 2, Taman Sri Batu Caves, 68100 Batu Caves, Selangor Darul Ehsan, Malaysia Tel: 603-6186-0000 Fax: 603-6187-2310 Email: taicp@pc.jaring.my
By official correspondent and contact:
Timothy Liew Tel: 510-686-2481 Tel: 510-686-2588 Email: epitome.ent@comcast.net
Date Prepared: 01/05/2007
Proprietary Name: Safe Plus Disposable Safety Syringe Common Name: Piston Syringe Classification Name: Piston Syringe Class: II Panel: 80 Product Code: MEG - Antistick Syringe
Predicate Device: SEZ Safety Syringe by SEZ Corporation (K031163)
Device Description:
The Safe Plus Disposable Syringe is a single use hypodermic syringe similar to a traditional syringe in application and function except for its safety mechanism which when activated:
-
completely retracts and encloses the needle in the barrel thereby preventing finger access
-
renders the needle unusable again as it is crushed within the puncture resistant barrel.
1
No special techniques are required to use the safety mechanism and the user is clearly able to visualize the results when the sharps prevention feature has been activated.
Indications for Use:
The Safe Plus Disposable Safety Syringe is a sterile, non-pyrogenic, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.
| Device Name | Predicate Device:
SEZ Safety Syringe (K031163) | Safe Plus Disposable Safety
Syringe |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is a safety hypodermic
syringe for intramuscular and
subcutaneous injection. This device
aids in prevention of needle stick
injuries. | Identical |
| Principal of
Operation | Activation of safety feature consists
of:
- disassemble needle assembly
from the plunger by turning the
plunger - retract needle into the barrel
and confine it by pushing
plunger forward before
disposal | Activation of safety feature consist
of: - pushing the plunger forward
until the gasket locks onto
adaptor, hub and needle. - Identical |
| Volume | 3 and 5 ml sizes | Identical |
| Nozzle Type | Female conical lock fitting with
rotatable internally threaded neck | Identical |
| Barrel Marking | Scale: conforms to ISO 7886-
1:1993(E). | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conforms to ISO 10993-1 | Identical |
| Materials | 1. Plastic parts: polypropylene (homo
type) - Gasket: thermoplastic rubber
- O-Ring: nitrile rubber
- Packing film: Medipeel film | 1. Identical
- thermoplastic elastomer
- thermoplastic elastomer
- Polyester/polyethylene |
| Sterility | Sterilized by ethylene oxide gas
SAL=10-6 | Identical |
Safety and Effectiveness, comparison to predicate device
2
K 070117
Conclusion:
Based on tests performed in accordance with "Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features", "Guidance on the Content of Premarket Notification 510(k) Submissions for Piston Syringes" and internationally recognized standards for syringe performance, the Safe Plus Disposable Safety Syringe has been shown to be substantially equivalent to the legally marketed predicate device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2007
Dolomite Biotech Sdn Bhd C/O Mr. Timothy Liew President Epitome Enterprises 417 Whitney Street San Leandro, California 94577
Re: K070117
Trade/Device Name: Safe Plus Disposable 2.5, 3cc syringes with needles 23 g x 1 inch, 25 g x 1 inch and 5 cc syringes with needles 21g x 1 1/2 inches, 20g x 1 inch, 20g x 1 1/2 inches and 21g x 1 inch Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: June 4, 2007 Received: June 11, 2007
Dear Mr. Liew:
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.
4
Page 2 -- Mr. Liew
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) 276-0120. 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
5
4. Indications for Use
510(k) Number (if known): K070117
Device Name: Safe Plus Disposable Safety Syringe
Indications for Use:
The Safe Plus Disposable Safety Syringe is an ETO sterile, non-toxic, non-pyrogenic, latex free, single-use, non-reusable, disposable manual retractable safety syringe in which medication can be injected into or fluid withdrawn from the human body. This device aids in prevention of needle stick injuries and reuse of the needle.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
and and (Division Sign-Off) (Division of Anesthesiology, General Hospital Page of of nfection Control, Dental Devices
10(k) Number: _kg7947