(164 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical strength of a blood collection needle, with no mention of AI or ML.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is intended for venous blood collection, which is a diagnostic procedure, not a therapeutic one.
No
This device is described as a blood collection needle used to withdraw blood for venous blood collection, not to diagnose a condition.
No
The device description clearly describes a physical medical device (blood collection needles) made of stainless steel with a hub and caps, and includes performance testing related to the physical properties of the needle.
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 venous blood collection." This describes a device used to collect a sample, not to perform a diagnostic test on a sample.
- Device Description: The description details a needle and its components for the physical act of drawing blood. It does not mention any reagents, assays, or analytical processes typically associated with IVDs.
- Lack of Diagnostic Information: There is no mention of analyzing blood, detecting substances, or providing diagnostic information.
- Performance Studies: The performance study focuses on the physical strength of the needle (hub/needle bond strength), which is relevant to the function of blood collection, not diagnostic performance.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely the collection of the specimen.
N/A
Intended Use / Indications for Use
This device is intended for use in venous blood collection.
Product codes
FMI
Device Description
IMC blood collection needles are manufactured from stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is shorter end and is fitted with a protective rubber sleeve. And a needle cap. The opposite end of the needle is 1" or 1 ½" for withdrawing blood. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity.
IMC blood collection needles are a sterile single use disposable product. The needles are nontoxic and non-pyrogenic and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1 ½').
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)
Performance Characteristics: Hub/needle bond strength
Test Method: ISO 7894 : 1993
Acceptance Criteria: 20G : >54N; 21G: >44N; 22G: >40N
IMC Blood Collection Needle: Meets Standard Criteria
VACUETTE VISION PLUS Blood Collection Needle K061483: Meets Standard Criteria
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
AUG 1 8 2011
K 110656
8. 510(K) SUMMARY
| Trade Name: | IMC Blood Collection Needle (non-sterile and sterile) |
|---|---|
| Common Name: | Blood Collection Needle |
| Classification Name: | 21 CFR 880.5570 |
| Submitter Information: | International Medsurg Connection |
| 935 N Plum Grove Rd, STE F | |
| Schaumburg, Illinois 60173 | |
| Summary Prepared By: | Peter Kim |
| Director of Quality Assurance | |
| International Medsurg Connection | |
| 935 N Plum Grove Rd, STE F | |
| Schaumburg, Illinois 60173 | |
| Telephone: 847-619-9926 | |
| Fax: 847-619-9927 | |
| e-mail: peterkim@intlmedsurg.com | |
| Date Prepared: | December 22, 2010 |
| Predicate Devices: | • VACUETTE VISIO PLUS blood collection needle (K061483) |
Device Name(s):
IMC Blood Collection Needle (non-sterile and sterile)
Classification Panel:
General Hospital
Legally Marketed Device Under Which Substantial Equivalence is Being Claimed:
International Medsurg Connections, Inc is claiming substantial equivalence of the IMC Blood Collection Needle with the currently marketed:
| Description | 510(k) Number |
|---|---|
| VACUETTE VISIO PLUS Blood Collection Needle | K061483 |
Device Description
This device is intended for use in venous blood collection.
IMC blood collection needles are manufactured from stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is shorter end and is fitted with a protective rubber sleeve. And a needle cap. The opposite end of the needle is 1" or 1 ½" for withdrawing blood. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that simplifies identification and acts as a seal of integrity.
1
IMC blood collection needles are a sterile single use disposable product. The needles are nontoxic and non-pyrogenic and are available in a variety of combinations of needle sizes (20 to 22 gauge) and needle lengths (1" and 1 ½').
Statement of Intended Use
Indications For Use: This device is intended for use in venous blood collection
Name/Description
. .. .
| Description | Size | Sterility |
|---|---|---|
| 20 Gauge Blood collection needle | 1"and 1 ½" | Sterile & Non-sterile |
| 21 Gauge Blood collection needle | 1"and 1 ½" | Sterile & Non-sterile |
| 22 Gauge Blood collection needle | 1"and 1 ½" | Sterile & Non-sterile |
New Devices as Compared to Marketed Device(s)
The IMC Blood Collection Needle and the predicate device are intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.
| Feature/Characteristic | IMC Blood Collection Needle | VACUETTE VISIO PLUS Blood Collection Needle: K061483 (Predicate) |
|---|---|---|
| Intended Use | This device is intended for use in venous blood collection. | This device is intended for use in venous blood collection. |
| Material | ||
| Needle cap | HDPE | Similar |
| Resistance cover | Rubber (Synthetic) | Similar |
| Hub | ABS | Similar |
| Label | 30g/m2 paper | Similar |
| Needle (Cannula) | SUS 304 | Similar |
| Needle cap | Polypropylene | Similar |
| colors | ||
| 20G | Yellow color | Yellow color |
| 21G | Deep green color | Green color |
| 22G | Black color | Black color |
| Length | 1"and 1 ½" | 1"and 1 ½" |
| Gauge | 20G, 21G & 22G | 21G & 22G |
| Cover dimension | 1" size: 47mm | |
| 1 ½" size: 47mm | 1" size: 47mm | |
| 1 ½" size: 47mm | ||
| Cover color | White (for all gauges) | Clear (for all gauges) |
2
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|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| | | |
Performance Data:
| Performance Characteristics | Test Method | Acceptance
Criteria | IMC Blood
Collection Needle | VACUETTE VISION
PLUS Blood Collection
Needle
K061483 |
|-----------------------------|-----------------|--------------------------------------|--------------------------------|----------------------------------------------------------------|
| Hub/needle bond strength | ISO 7894 : 1993 | 20G : >54N
21G: >44N
22G: >40N | Meets Standard
Criteria | Meets Standard Criteria |
Conclusions:
The indications for use, technology, specification, safety of the IMC Blood Collection Needle and the predicate devices K061483 are essentially the same. The differences between the Blood Collection Needle are minor and do not raise new issues of safety or effectiveness. Hence, the IMC Blood Collection Needles are substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows a black and white logo. The logo consists of a symbol on the right and text on the left. The symbol appears to be three curved lines stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & H.", arranged vertically along the left side of the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Peter Kim Director of Quality Assurance International Medsurg Connection 935 North Plum Grove Road, Suite F Schaumburg, Illinois 60173
AUG 1 8 2011
Re: K110656
Trade/Device Name: IMC Blood Collection Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: August 3, 2011 Received: August 8, 2011
Dear Mr. Kim:
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 docs 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- Mr. Kim
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), 1 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,
Anthony La Rue
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
Indications for Use
510(k) Number :
Device Name: IMC Blood collection needle
Indications For Use: This device is intended for use in venous blood collection.
Name/Description
| Gauge | Size | Sterility |
|---|---|---|
| 20 Gauge Blood Collection needle | 1" and 1 ½" | Sterile & Non-sterile |
| 21 Gauge Blood Collection needle | 1" and 1 ½" | Sterile & Non-sterile |
| 22 Gauge Blood Collection needle | 1" and 1 ½" | Sterile & Non-sterile |
X Prescription Use __ (Part 21 CFR 801 Subpart D) (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)
Ri C. 8/18/4
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
110656 510(k) Number: _______________________________________________________________________________________________________________________________________________________________