(251 days)
Sterile Blunt for Single Use includes 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.
The proposed device, Sterile Blunt for Single Use, includes two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle consists of a stainless steel needle tube, a hub and a sheath. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. It is not intended to access the injection site on I.V. System.
The blunt plastic cannula consists of molded plastic blunt tipped cannula, a hub and a sheath. It is used to replace hypodermic needles to prevent from the unintended injury by metal needle.
Both two models are available in either EO sterilized to achieve a Sterilized to achieve a Sterility Assurance Level (SAL) of 106. The proposed device is sealed in a sterility maintenance package to maintain its sterility during its shelf life of three (3) years.
This is a 510(k) premarket notification for a medical device, not a study evaluating a device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific effect sizes for human readers with and without AI) are not applicable to this type of document.
The document focuses on demonstrating Substantial Equivalence (SE) to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria from a clinical study. The "acceptance criteria" here refer to compliance with recognized consensus standards and general safety/performance attributes.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k), the "acceptance criteria" are compliance with various ISO and ASTM standards, as well as general performance attributes related to safety and effectiveness compared to the predicate device. The device "performance" is reported as meeting these standards and being substantially equivalent.
| Acceptance Criteria (Standards and Attributes) | Reported Device Performance (Compliance/Demonstration) |
|---|---|
| Mechanical/Physical Performance: | |
| ISO 9626:1991/Amendment 1:2001 (Stainless steel needle tubing) | Complies (mentioned under "Bench tests... met all design specifications" and "complied with the referenced standards") |
| ISO 7864:1993 (Sterile hypodermic needles for single use) | Complies |
| ISO 594-1:1986 (Conical Luer fittings) | Complies |
| ASTM F1140-07 (Internal Pressurization Failure Resistance of Unrestrained Packages) | Complies |
| ASTM F88-09 (Seal Strength of Flexible Barrier Materials) | Complies |
| Bevel of the device | Identical to the predicate device |
| Gauge of the device | Different from the predicate device, but physical performance tests demonstrated compliance with referenced standards. |
| Biocompatibility: | |
| ISO 10993-1: 2009 (Biological evaluation - Part 1) | Complies (biocompatibility test demonstrated materials are safe and acceptable) |
| ISO 10993-4:2002/Amd 1:2006 (Biological Evaluation - Part 4: Interactions with Blood) | Complies |
| ISO 10993-5: 2009 (Biological evaluation - Part 5: Cytotoxicity) | Complies |
| ISO 10993-10: 2002/Amd. 1:2006(E) (Biological evaluation - Part 10: Irritation and Hypersensitivity) | Complies |
| ISO 10993-11: 2006 (Biological evaluation - Part 11: Systemic toxicity) | Complies |
| Sterilization: | |
| ISO 11135-1: 2007 (Ethylene oxide sterilization) | Complies (for EO sterilized models); Achieves SAL of 10-6 |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complies |
| ISO 11137-2: 2006 (Radiation sterilization) | Complies (for Radiation sterilized models); Achieves SAL of 10-6 |
| USP 34:2011, <85> (Bacterial Endotoxins Test) | Complies |
| Shelf life | Maintains sterility for three (3) years. |
| Leachable substance analysis | Demonstrated materials are safe and acceptable |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The text refers to "bench tests" and "test results" but does not provide specific sample quantities for these tests.
- Data Provenance: The tests were conducted by the manufacturer, Shanghai Double-Dove Industry Co, Ltd., in China. The data would be considered prospective for the purpose of this 510(k) submission, as it was generated to support the review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a medical device 510(k) submission focused on mechanical, physical, and biological bench testing, there isn't a "ground truth" derived from expert consensus in the way it's used for diagnostic algorithms. Ground truth here refers to the validated methods and results of the specified international standards.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between readers. This submission relies on standardized test methods where the outcome (pass/fail against a standard's criteria) is objectively measured.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a sterile blunt needle/cannula, a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm, so "standalone performance" in that context is not relevant. The performance evaluated here is the device's compliance with established safety and performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and biological tests: The "ground truth" is defined by the acceptance criteria specified within the referenced ISO and ASTM standards (e.g., specific force limits, chemical concentrations, sterility levels, etc.). Compliance with these standards indicates the device meets established safety and performance benchmarks.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8).
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OCT 1 8 2012
Attachment III 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.
KIZOYNO The assigned 510(k) Number:
- Date of Submission: 17 OCT 2012 1 .
-
- Sponsor
Shanghai Double-Dove Industry Co, Ltd. No.1888 Huhang Road, Fengxian Economic Zone Shanghai, 201400, China
Establishment Registration No .: 3004416208
Contact Person Mr. Sanba Yang Vice General Manager Tel: +86-21-67104888 Fax: +86-21-67104666 Email: Yangsbmaster@hotmail.com
-
- Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net
4. Proposed Device Identification
Proposed Device Name: Sterile Blunt for Single Use Proposed Device Model: Blunt Fill Needle and Blunt Plastic Cannula
Classification: II Product Code: FMI Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital
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Intended Use Statement:
The Sterile Blunt for Single Use includes 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:K 102328 Product Name: Blunts Manufacturer: Shan Dong Wei Gao Group Medical Polymer Co., LTD
6. Device Description
The proposed device, Sterile Blunt for Single Use, includes two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle consists of a stainless steel needle tube, a hub and a sheath. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. It is not intended to access the injection site on I.V. System.
The blunt plastic cannula consists of molded plastic blunt tipped cannula, a hub and a sheath. It is used to replace hypodermic needles to prevent from the unintended injury by metal needle.
Both two models are available in either EO sterilized to achieve a Sterilized to achieve a Sterility Assurance Level (SAL) of 106. The proposed device is sealed in a sterility maintenance package to maintain its sterility during its shelf life of three (3) years.
7. 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. The test results demonstrated that the proposed device complies with the following standards:
ISO 9626:1991/Amendment 1:2001, Stainless steel needle tubing for the manufacture of medical devices.
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ISO 7864:1993, Sterile hypodermic needles for single use.
ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements.
ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 10993- 4:2002/And 1:2006, Biological Evaluation of Medical Device. Part 4: Selection of rest for Interactions with Blood.
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Viro cytotoxicity. 2-153
ISO 10993-7:2008, Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2002/Amd. 1:2006(E), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT I
ISO 10993-11: 2006. Biological evaluation of medical devices -- Part H : Tests for systemic toxicity. ISO 11135-1: 2007 Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements Tor development, validation and routine control of a sterifization process for medical devices.
USP 34:2011, -: 85> Bacterial Endotoxins Test
ASTM F1140-07, Standard Test Methods for Internal Pressurization Failure Resisunce of Unrestrained Packages.
ASTM F88-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
ISO 11137-2: 2006. Sterifization of healtheare products-Radistion-Part2: Establishing ប្រើ sterifization dose.
Substantially Equivalent Conclusion 8.
The proposed device, Sterile Blunt for Single Use, has same intended use, configuration, operation mode with those of the predicate device, Blunts (K 102328). The materials are different, the biocompatibility test and leachable substance analysis demonstrated that the materails used for manufacturing of proposed dveice are safe and accpetable. The bevel of the proposed device is identical to that of the predicate device, while the gauges of proposed and predicate device is different. The physical performance test results submitted demonstrated the proposed device complied with the referenced standards with different gauge of the predicate device. The proposed device is available in EO sterilization or Radiation sterilization, the predicate device is only avaiable in radiation sterilization. Various tests, including biocompatibility, perfromance, package, endotoxin tests demonstrated that the both EO sterilization sterilization sterilization proposed device complied with acceptance criteria. In addition, both of the proposed and predicate device could achieve same Sterility Assurance Level (SAL)
Therefore, the proposed device, Sterile Blunt for Single Use, is determined to be Substantially Equivalent (SE) to the predicate device, Blunts (K102328), in respect of safety and effectiveness.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shanghai Double-Dove Industry Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai, CHINA 200237
OCT 1 8 2012
Re: K120420
Trade/Device Name: Sterile Blunt for Single Use Model: Blunt Fill Needle, Blunt Plastic Cannula Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 30, 2012 Received: September 7, 2012
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 Eederal Register.
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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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthem um
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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arket Notification 510(k) Submission
K 12O H2O
Section II Indications for Use
510(k) Number:
Device Name: Sterile Blunt for Single Use Model: Blunt Fill Needle, Blunt Plastic Cannula
Indications for Use:
Sterile Blunt for Single Use includes 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.
OPRESCRIPTION USE (Part 21 CFR 801 Subpart D) ■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)
RC Chap 10/12/12 Page 1 of 1
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesional Devices. Division of AneSthoolors.
Infection Control, Dental Devices.
510(k) Number: K120920
§ 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).