(112 days)
No
The description focuses on a physical blood collection device and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a blood collection needle used for the collection of venous blood, which is a diagnostic purpose, not a therapeutic one.
No
Explanation: The device is a blood collection needle, which is used to collect blood samples. It does not analyze the blood or provide any diagnostic information itself.
No
The device description clearly states it is a physical product consisting of a needle, tubing, and luer adapter, which are hardware components.
Based on the provided information, the Ecomed® Scalp Vein Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for the collection of venous blood." This describes a device used to obtain a biological sample from the body.
- IVD Definition: IVD devices are used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a needle, tubing, and luer adapter – components for blood collection, not for analyzing the blood itself.
The Ecomed® Scalp Vein Set is a device used in the process of obtaining a sample that could then be used with an IVD device for testing. However, the Scalp Vein Set itself is a blood collection device, not an IVD.
N/A
Intended Use / Indications for Use
The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.
Product codes
FOZ
Device Description
The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end. The ECOMED® needle is stainless steel. The ECOMED® needle protector sleeves covering the short end of the needle are made from rubber, and the needle shields are made from extruded plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Non-cytotoxicity was demonstrated in testing which was performed in accordance with the ISO 10993, along with other tests such as endotoxin testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
OCT 1 4 1999
I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for the Ecomed Scalp Vein Set. The Ecomed® Scalp Vein Set is a sterile winged needle bonded to a flexible tubing with a female luer adapter. The female luer is provided with a protective cap on the end.
Greiner is claiming substantial equivalence to Becton Dickinson's VACUTAINER® Brand Blood Collection Set (K980414). Both scalp vein sets (butterfly needles) have the same intended use (i.e. withdrawal of venous blood) and contain the same material of the ECOMED® needle is stainless steel and is the same material used for the BD needle. Both the ECOMED® and BD needle protector sleeves covering the short end of the needle are made from rubber, and both the ECOMED® and BD needle shields are made from extruded plastic.
Non-cytotoxicity was demonstrated in testing which was performed in accordance with the ISO 10993, along with other tests such as endotoxin testing.
The ECOMED® Scalp Vein Set will be marketed separately and as a kit assembled with Greiner's 510k cleared VACUETTE® Holdex® holder (K980768).
Greiner's 510(k) has been submitted on June 25, 1999, by Douglas L. Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland, 21014 (410-836-8228).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle with three swooping lines representing its wings and a wavy line representing its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Mr. Douglas L. Harris Greiner Meditech, Inc. 260 Gateway Dr., Suite 17A Bel Air, MD 21014
Re : K992145 Ecomed® Scalp Vein Set Trade Name: Regulatory Class: II Product Code: FOZ September 15, 1999 Dated: Received: September 20, 1999
Dear Mr. Harris:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA
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Page 2 - Mr. Harris
may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
f. Susa Ruaros
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known) ________________
Device Name: ECOMED® Scalp Vein Set
Indications for Use: The Ecomed® Scalp Vein Set is a winged blood collection needle with a tubing used for the collection of venous blood.
Prescription Use X
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Palacio Curente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________