(269 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and compatibility of blunt needles and cannulas, with no mention of AI or ML.
No
The device is used to penetrate stoppers or access pre-slit septums for the injection or aspiration of fluid, not to treat a medical condition.
No
The device description indicates that the blunts are used for injection or aspiration of fluid, and for connecting with syringes. There is no information suggesting that the device performs any diagnostic function (e.g., measuring, analyzing, or detecting conditions or diseases).
No
The device description clearly outlines physical components (stainless steel needle tube, molded plastic cannula, luer slip hubs) and bench testing related to these physical characteristics and connections, 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 clearly states the devices are for "injection or aspiration of fluid" in conjunction with a syringe, either by penetrating vial/ampoule stoppers or accessing pre-slit septums on IV systems. This is a direct interaction with the patient's body or a system connected to the patient, not for examining specimens in vitro (outside the body).
- Device Description: The description details the physical characteristics and function of the blunt fill needle and blunt plastic cannula, which are designed for fluid transfer and access to containers or IV systems. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The device is a medical device used for administering or withdrawing fluids, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The blunts include two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.
The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.
Product codes
FMI
Device Description
The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is an 18G stainless needle tube with a luer slip hub. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. The hub is a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe. It is not intended to access the injection site on I.V. System. The blunt plastic cannula is a molded plastic blunt tipped cannula to penetrate pre-slit septum injection site on I.V. Safety Systems, which is designed for penetration with needleless I.V. access device, intended for injection and/or aspiration of fluid. It also has a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe to be filled. The blunt plastic cannula is used to replace hypodermic needles to prevent from the unintended injury by metal needle. These two products can be sold together in one immediate package or respectively in separate immediate packages.
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)
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Female Luer Slip Connector of both blunt fill need and blunt plastic cannula were tested per ISO 594-1:1986 to evaluate whether it could be compatible with standard male luer slip connector of the syringe.
Blunt Fill Needle was tested per ISO 7864:1993 and ISO9626:1991 to evaluate its physical and chemical specifications.
There is no international performance standard established for blunt plastic cannula. The sponsor has performed the testing on surface condition of the blunt plastic cannula, and comparison test between the proposed and 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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Exhibit #1 510(k) Summary
1 3 2011 MAY
Exhibit #1 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) Number: K102328
- Date of Submission: 03 MAY 2011 1.
-
- Sponsor
ShanDong WeiGao Group Medical Polymer Co., Ltd No. 348, Shichang Road, Weihai Shandong, 264209, China Establishment Registration Number: 3007084575 Contact Person: · ( Ms. Suxia Zhao, Quality Manager T: +86-631-5621632 F: +86-631-2620522 E: zsx9001@sina.com
-
- Submission Correspondent Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd P.O. BOX 237-023 Shanghai, 200237, China T: +86-21-22815850 F: 240-238-7587 E: info@mid-link.net
-
- Proposed Device Identification
Proposed Device Name: Blunts Proposed Device Model: Blunt Fill Needle and Blunt Plastic Cannula Regulation Name: needle, hypodermic, single lumen Classification: Class II Product Code: FMI Regulation Number: 21 CFR 880.5570
1
5. Intended Use
The blunts include two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.
The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.
-
- Predicate Device Identification
510(k) Number: K974006 Product Name: BD TwinPak Manufacturer: Becton and Dickinson Company
- Predicate Device Identification
-
Device Description 7.
The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is an 18G stainless needle tube with a luer slip hub. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. The hub is a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe. It is not intended to access the injection site on I.V. System. The blunt plastic cannula is a molded plastic blunt tipped cannula to penetrate pre-slit septum injection site on I.V. Safety Systems, which is designed for penetration with needleless I.V. access device, intended for injection and/or aspiration of fluid. It also has a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe to be filled. The blunt plastic cannula is used to replace hypodermic needles to prevent from the unintended injury by metal needle. These two products can be sold together in one immediate package or respectively in separate immediate packages. -
- Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
- Non-Clinical Test Conclusion
-
Female Luer Slip Connector of both blunt fill need and blunt plastic cannula were tested per a) ISO 594-1:1986 to evaluate whether it could be compatible with standard male luer slip connector of the syringe.
-
b) Blunt Fill Needle was tested per ISO 7864:1993 and ISO9626:1991 to evaluate its physical and chemical specifications.
-
c) There is no international performance standard established for blunt plastic cannula. The sponsor has performed the testing on surface condition of the blunt plastic cannula, and comparison test between the proposed and predicate device.
.2
2
Substantially Equivalent Analysis and Conclusion 9.
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Blunts | BD TwinPak, K974006 | |
| Indications for Use | The blunts include two models, which are | |
| blunt fill needle and blunt plastic cannula. | ||
| The blunt fill needle is used in conjunction | ||
| with a syringe to penetrate the vial/ampoules | ||
| stopper intended for injection or aspiration of | ||
| fluid. The blunt plastic cannula is used in | ||
| conjunction with a syringe to access the | ||
| pre-slit septum covering injection sites on | ||
| I.V. System intended for injection or | ||
| aspiration of fluid. | Substantially Equivalent | |
| Components | Blunt Fill Needle | |
| Blunt Plastic Cannula | Substantially Equivalent | |
| Blunt Fill Needle Gauge | 18 G | 20 G |
| Material | ||
| Blunt Fill Needle | Stainless Steel | Substantially Equivalent |
| Blunt Plastic Cannula | Polycarbonate | Polypropylene |
| Sterilization | ||
| SAL | 10-6 | Substantially Equivalent |
| Method | Radiation | Substantially Equivalent |
| Biocompatibility | Comply with ISO 10993 Standards | Substantially Equivalent |
| Safety and Effectiveness | Various performance tests conducted to | |
| demonstrate the safety and effectiveness of | ||
| the proposed device. | Some comparison tests conducted that the | |
| proposed device has similar performance | ||
| with the predicate device. |
Table 1 Comparison of Technological Characteristic
Compared with the identified predicate device, the proposed device has same indications, component and design features as well as the sterilization requirements. They are different in Needle Gauge of Blunt Fill Needle and Material of Blunt Plastic, but these differences are approved not to affect the safety and effectiveness equivalence between the predicate and proposed device.
The proposed device, Blunts including Blunt Fill Needle and Blunt Plastic Cannula, is determined to be Substantially Equivalent (SE) to the predicate device, BD TwinPak as cleared in K974006, in respect of safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Shandong Weigao Group Medical Polymer Company, Limited C/O Ms. Diana Hong Shanghai Mid-Link Business Consultants Company, Limited P.O Box 237-023 Shanghai, China 200237
MAY 1 3 2011
Re: K102328
Trade/Device Name: Blunts Model: Blunt Fill Needle and Plastic Cannula Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 3, 2011 Received: May 6, 2011
Dear Ms. Hong:
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.
4
Page 2- Ms. Hong
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/ ucm 1 15809.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.
Zh 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
5
Exhibit #2 Indications for Use
510(k) Number: K102328 Device Name: Blunts Model: Blunt Fill Needle and Blunt Plastic Cannula
Indications for Use:
The blunts include two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.
The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.
ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhi C. 5/10/11
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102328