(16 days)
No
The summary describes a manual, retractable safety syringe and does not mention any computational or analytical capabilities that would involve AI or ML.
No
The device is a safety syringe intended for fluid injection and reducing sharps injuries, not for treating a specific medical condition.
No
The device description clearly states its intended use is "for injection of fluids into the body," which is a therapeutic or delivery function, not a diagnostic one. There is no mention of recording, analyzing, or interpreting physiological data for diagnostic purposes.
No
The device description clearly indicates it is a physical syringe with a needle, not a software-only product.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for injection of fluids into the body". This describes a device used on the body for therapeutic or diagnostic purposes, not a device used with samples taken from the body to diagnose conditions.
- Device Description: The description focuses on the physical characteristics of a syringe designed for injection and safety features. It doesn't mention any components or processes related to analyzing biological samples.
- 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 substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents or test kits
This device is clearly intended for direct use on a patient for administering substances, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Product codes
MEG
Device Description
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe provided with permanently attached needle. The Safety Tray Safety Allergy Syringe Tray consists of 25 Bak'Snap syringes within a single sterile barrier.
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)
Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards, testing according to FDA guidance, biocompatibility per ISO 10993, and sterilization re-validation.
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
510(k) Summary for the 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) (per 21CFR807.92)
1. SPONSOR
M.K. Meditech Co., Ltd. Suite 702, 7th Floor No. 5, Chingdau E. Rd. Taipei, Taiwan 100.
Contact Person: I-Ming Shih 886-2-23930855 Telephone:
Date Prepared: June 5, 2003
2. DEVICE NAME
| Proprietary Name: | Bak'Snap and Safety'Tray Models of the DuoPro™
Safety Syringe (DuoProSS™) |
|----------------------|------------------------------------------------------------------------------|
| Common/Usual Name: | Hypodermic Syringe (with needle) (tuberculin-type) |
| Classification Name: | Piston syringe
Hypodermic single lumen needle |
3. PREDICATE DEVICES
- DuoPro™ Safety Syringe (DuoProSS™) (K020623 & K022806) ●
- SECUREGARD® Retractable Safety Syringe (K012121) .
4. DEVICE DESCRIPTION
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe provided with permanently attached needle. The Safety Tray Safety Allergy Syringe Tray consists of 25 Bak'Snap syringes within a single sterile barrier.
1
5. INTENDED USE
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
M.K. Meditech Co., Ltd., makes a claim of substantial equivalence of the 1 mL Bak'Snap DuoProSS™ to the cited predicates based on similarities in intended use, design, and technological and operational characteristics. They are indicated for injecting fluids into the body, while helping to reduce the risk of sharps Both the 1 mL Bak'Snap DuoProSS™ and the SECUREGARD® injuries. syringe have permanently attached, single-lumen hypodermic needles.
All syringes are provided sterile, single-use, and disposable. All syringes have two-part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break off the plunger rod, and discard the pieces. M.K. Meditech Co., Ltd., believes that the differences between the 1 mL Bak'Snap DuoPro™ Safety Syringe and cited predicate devices are minor and they raise no new issues of safety or effectiveness.
7. TESTING
Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards, testing according to FDA guidance, biocompatibility per ISO 10993, and sterilization re-validation.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUN - 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
M.K. Meditech Company Limited C/O Ms. Rosina Robinson Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K031594
Trade/Device Name: Bak' Snap DuoProTM Safety Syringe (DuoProSSTM) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: May 20, 2003 Received: May 21, 2003
Dear Ms. Robinson:
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 vour 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 - Ms. Robinson
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
Susan Russer
Susan Runner, DDS, MA Interim 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K031594
M.K. Meditech Co., Ltd., Device Name: 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSSTM)
Indications For Use:
The 1 mL Bak'Snap DuoPro™ Safety Syringe (DuoProSS™) is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricio Cucente
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
infection control
510(k) Number: K031594
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)