(170 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard syringe, with no mention of AI or ML capabilities.
No
The device is described as a syringe intended for injecting or withdrawing fluids, which is an instrumental function rather than a therapeutic one. It does not provide any treatment or therapy to the patient.
No
The device description indicates it is a syringe used for injecting or withdrawing fluids, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly outlines physical components like a barrel, piston, plunger tip, and lubricant, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for injecting fluids into or withdrawing fluids from the body." This describes a device used directly on or in a patient for therapeutic or diagnostic procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe, which is a tool for administering or collecting substances from a living organism. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This syringe's function is to physically move fluids into or out of the body.
N/A
Intended Use / Indications for Use
DMC Medical piston type syringes are single use syringes, intended for injecting fluids into or withdrawing fluids from the body.
Product codes
FMF
Device Description
DMC Medical Single-Use Polycarbonate Syringe is offered in the same configurations as the predicate. It is made from a calibrated hollow barrel, and a moveable piston with a plunger tip at the end of the piston. The piston shaft does not contact any part of the fluid path, rather the tip which attaches to the shaft and the barrel are fluid path components. Individual components are made from properly tested materials included in this submission. Additionally, there is a small amount of lubricant for moving the piston shaft smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals.
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
general medicine in clinical, hospital, or other settings of healthcare professionals.
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)
DMC Medical syringes are tested to ISO 7886-1, as well as pressure testing to failure. All syringes conform to ISO 10993-1, including minimizing residual gases. This testing ensures that the devices meet the needs of the healthcare professional using them. Additionally, the testing demonstrates that the device is as safe, as effective, and performs as well as or better than the 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
K103736 Jun 10 2011
DMC MEDICAL Ltd.
Unit 2, Abbey House Shannon Town Centre Shannon, County Clare Ireland 353-61-7148900, Phone 353-61-7148944, Fax TSB / Bryan Wixted Preparation Date: April 6th 2011
Domestic Contact: Charmaine Henderson Phone: 925-299-8702 Fax: 925-299-8702
510(K) Summary for the:
| Trade Name: | DMC Medical Single-Use Polycarbonate Syringe |
|---|---|
| Common Name: | Syringe, Hypodermic |
| Classification Name: | Piston Syringe, 21 CFR 880.5860, Class II Device, Product Code: FMF |
Legally Marketed Predicate Devices for Substantial Equivalence:
*K070856 - ICU Medical Single-Use Syringe
Rationale for SE:
The ICU Medical Single-Use Syringe is a Class II device that is offered pre-sterilized or in bulk for offer to other kit manufacturers. The ICU Medical Single-Use Polycarbonate Syringe is made from identical materials and by the same processes.
Description of Submitted Device:
DMC Medical Single-Use Polycarbonate Syringe is offered in the same configurations as the predicate. It is made from a calibrated hollow barrel, and a moveable piston with a plunger tip at the end of the piston. The piston shaft does not contact any part of the fluid path, rather the tip which attaches to the shaft and the barrel are fluid path components. Individual components are made from properly tested materials included in this submission. Additionally, there is a small amount of lubricant for moving the piston shaft smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals.
Intended Uses of the DMC Medical Syringe:
DMC Medical piston type syringes are single use syringes, intended for injecting fluids into or withdrawing fluids from the body.
1
Technological Characteristics and Substantial Equivalence Table:
| Component: | ICU Medical, Inc. | DMC Medical, Ltd |
|---|---|---|
| Syringe Barrel: | Polycarbonate | Polycarbonate |
| Plunger Tip: | Polyisoprene | Elastomer |
| Silicone Oil | Medical Grade Oil | Medical Grade Oil |
| Calibrated Barrel Volume: | YES | YES |
| Sterilization method: | EtO | EtO |
| 51 O(k) Approval | K070856 | This submission |
The operational characteristics, when compared to the predicate device, are identical. The user connects the syringe via the threaded luer, then manually advancing or withdrawing the plunger internal to the barrel, is able to express or withdraw fluids are measured via the printed external housing of the barrel; measurements are indicated in ml (milliliters). Operation is similar for most all piston syringes whether fitted with a threaded luer end or a slip-fit only end.
Safety and Performance:
DMC Medical syringes conform to the requirements offSO 7886-1, an FDA recognized standard. Additionally, the Sterility Assurance Level, (SAL) has been established to meet the 10- level. The single use syringes are packaged in a way as to ensure conformity with ISO 10993-1, including minimizing residual gases as well as discourage re-use.
Non-clinical Testing:
DMC Medical syringes are tested to ISO 7886-1, as well as pressure testing to failure. All syringes conform to ISO 10993-1, including minimizing residual gases. This testing ensures that the devices meet the needs of the healthcare professional using them. Additionally, the testing demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device.
Conclusion:
The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent and are safe and effective for their intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DMC Medical, Limited C/O Ms. Tracy Best Tracy Best Consulting 944 North Main Street Bountiful, Utah 84010
JUN 1 0 2511
Re: K103736
Trade/Device Name: DMC Medical Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 26, 2011 Received: June 2, 2011
Dear Ms. Best:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Best
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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): K103736
. .. ..
Device Name: DMC Medical Syringe
Indications For Use: DMC Medical piston type syringes are single use syringes intended for injecting fluids into or withdrawing fluids from the body.
2 Prescription Use (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. C. A 6/8/4
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: