(44 days)
Not Found
No
The summary describes a simple mechanical blood collection needle and does not mention any AI or ML components or functionalities.
No
The device is a blood collection needle used for routine blood collection, which is a diagnostic or procedural tool, not a therapeutic intervention.
No
The device is a blood collection needle used for routine blood collection, not for diagnosing conditions.
No
The device description explicitly states it is a sterile and disposable medical device consisting of physical components like needles, a needle holder, caps, and a latex cover. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the daily blood collection routine". This describes a device used to collect a biological sample (blood).
- Device Description: The description details the physical components of a needle used for drawing blood. It does not mention any components or processes related to analyzing the collected blood sample.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body to provide information about a physiological state, health, or disease. This device's function is solely the collection of the sample, not the analysis of it.
Therefore, this device is a blood collection device, which is a medical device but not an IVD.
N/A
Intended Use / Indications for Use
Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
Blood collection needle is a sterile and disposable medical device. It is consist of a puncturing needle which is punctured into vein, a bottle needle which is insert to the blood collection bottle to collect blood, a needle holder which connects the puncturing needle and bottle needle, two needle caps which protect puncturing needle and bottle needle and a latex cover to protect bottle needle.
The applicant device of blood collection needle is available in 20G, 21G and 22G.
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
qualified practitioner
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)
Effectiveness: All the variant models of the applicant device are evaluated regarding the performance.
Safety Considerations: With accordance with the Table 1 Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization or Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemo-compatibility.
Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510(k) Number is:
1. Applicant Device Information
Trade/Proprietary Name: Blood Collection Needle Classification Information:
DEC 2 0 2007
(1) Classification Name: Needle, Hypodermic, Single Lumen
(2) Regulation Number: 880.5570
(3) Product Code: FMI
(4) Class: II
(5) Review Panel: General Hospital
2. Submitter Information
Manufacturer Name:
ShanDong WeiGao Group Medical Polymer Products Co., LTD No.312, Shichang Road Weihai, Shandong, China, 264209
Contact Person of the Submission:
Ms. Diana. Hong Mr. Eric. Chen Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, China 20030 Phone: +86-21-64264467 x 152
Fax: +86-21-64264468 x 809
Email: Diana.hong@mid-link.net Eric.chen@mid-link.net
3. Predicate Device
K number: K061483
Trade Name: VACUETTE® VISIO PLUS Blood Collection Needles Common Name: Blood Collection Needles
Shanghai Midlink Business Consulting Co.,Ltd
1
Kop3107; 062
Classification Name: Needle, Hypodermic, Single Lumen Product Code: FMI
4. Device Description
Blood collection needle is a sterile and disposable medical device. It is consist of a puncturing needle which is punctured into vein, a bottle needle which is insert to the blood collection bottle to collect blood, a needle holder which connects the puncturing needle and bottle needle, two needle caps which protect puncturing needle and bottle needle and a latex cover to protect bottle needle.
The performances of the applicant device of blood collection needle comply with ISO 7864:1993 and ISO9626:1991/AMD: 2001.
The applicant device of blood collection needle is available in 20G, 21G and 22G.
5. Substantially Equivalence Determination
Comparison Analysis:
The applicant device has same classification information, same indications and intended use, similar product design, same performance effectiveness, performance safety as the predicate device.
Conclusion:
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
6. Effectiveness and Safety Considerations
Effectiveness:
All the variant models of the applicant device are evaluated regarding the performance.
Safety Considerations:
With accordance with the Table 1 Initial Evaluation Tests for Consideration and Table 2 Supplementary Evaluation Tests for Consideration in ISO 10993-1:2003(E), Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing, the necessary tests for Biocompatibility Testing includes: Cytotoxicity, Sensitization or Intracutaneous Reactivity, Systemic Toxicity (Acute), Haemo-compatibility.
Conclusion: The all conducted Biological Evaluation Tests are in compliance with the standards of ISO
2
K(0.310) 33
10993, "Biological Evaluation of Medical Devices". The compatibility of all the possible skin-contact component material in the finished product meets the requirement of Biocompatibility
The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the applicant device is determined as safe and effectiveness.
Shanghai Midlink Business Consulting Co.,Ltd
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three curved lines representing its body and wings, giving it a modern and abstract appearance. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2007
ShanDong WeiGao Group Medical Polymer Products Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No. 19, Lane 999 Zhongshan No. 2 Road Shanghai CHINA 200030
Re: K073127
Trade/Device Name: Blood Collection Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 31, 2007 Received: November 6, 2007
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.
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 - 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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) 276-0115. 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,
Susan Runne
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
Korgu 121
Indications for Use
510(k) Number:_
Device Name: _ Blood Collection Needle
Indications for Use:
Blood Collection Needles is designed for use in the daily blood collection routine when delegated by a qualified practitioner.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
Anthony D. Mnt
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________