(113 days)
Not Found
No
The device description and performance studies focus on the mechanical aspects of a blood collection needle and do not mention any AI or ML components or functionalities.
No
The device is a blood collection needle used for routine blood withdrawal, not for treating or diagnosing a medical condition.
No
The device is a blood collection needle, which is used to withdraw blood. It is not designed to diagnose any condition.
No
The device description clearly outlines physical components like stainless steel needles, plastic hubs, rubber sleeves, and plastic covers, indicating it is a hardware device.
Based on the provided information, the VAKU-8™ Blood Collection Needles are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "routine blood collection by a qualified practitioner." This describes a procedure for obtaining a sample from the patient, not a test performed on a sample in vitro (outside the body).
- Device Description: The description details a needle designed to withdraw blood from a patient and facilitate collection into a tube. It does not describe any components or functions related to analyzing or testing the blood sample itself.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Measurement of analytes
- Interpretation of results for diagnostic purposes
- Calibration or quality control procedures for testing
The device is a tool for collecting a biological sample, which is a necessary step before in vitro diagnostic testing can be performed, but the needle itself is not the diagnostic device.
N/A
Intended Use / Indications for Use
VAKU-8™ Blood Collection Needles are designed for routine blood collection by a qualified practitioner
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
VAKU-8™ Single use Multi Sample blood collection needles are composed of a stainless steel needle tube that is ground at both ends and affixed to a plastic hub. A rubber sleeve covers the backend needle tube and hub tip. The front end needle is used to withdraw blood once placed in the patient. The needle tube is protected by a plastic needle cover on either end. The "front end needle" is designed to withdraw blood from the patient. The "back end needle" is covered by a rubber sleeve and is designed with a threaded hub that can be attached to a blood collection tube holder. The tube holder facilitates attachment to a evacuated blood collection tube. Each needle is individually packaged sterile utilizing two plastic end covers. A perforated label serves to simplify identification of needle size and also acts as a seal of integrity.
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 practitoner
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)
Not Found
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
510K Summary Letter
February 10, 2009
JUN 1 2 2009
Food and Drug Administration Center for Devices and Radiological Health 510K Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850
RE: Traditional 510 (K) Submission
Dear Madam/Sir:
In accordance with Section 510 (K) of the U.S. Food, Drug and Cosmetic Act (21 U.S.C. 301), Myco Medical Supplies, Inc. ("Myco Medical, Inc.") hereby submits a premarket notification for VAKU-8™ Brand Sterile Multi Sample Blood Collection Needle. The reason for the 510 (K) is that VAKU-8™ brand Blood Collection Needles are a new device to the US Market.
42 Fed. Reg. 807.87 Required Information
Submitter Information 1.
Manufacturer Name: Hindustan Syringes And Medical Devices LTD. FDA Registeration No: 8040227
Contact Person of the Submission:
Sam Kumar MYCO Medical Supplies, Inc. 158 Towerview Ct. Cary, NC USA, 27513 Phone:919-4602535 Ext-105 Fax: 919-460 2536 Email: skumar@mycomedical.com
2. Establishment
.
Myco Medical Supplies Inc.'s Owner/Operator # is 9007658 Registration # : 1058382.
Classification Information 3.
a) Product: Sterile Multi Sample Blood Collection Needle. b) Trade Name: VAKU-8™ Blood Collection Needle
1
- c) Device Common Name: Blood Collection Needle
- d) Class II device
- e) Requlation No: 880.5570
- f) Classification Panel and Product Code: FMI
-
- Section 514 Requirements No action is required to comply with requirements of the act under Section 514.
- . 5. Predicate Device
510K K992699
Trade Name: Nipro Blood Collection Needle Classification Name: Needle , Hypodermic, Single Lumen Product Code: FMI
Device Description 6.
Intended Use: VAKU-8™ Blood Collection Needles are designed for routine blood collection by a qualified practitoner.
Product Description: VAKU-8™ Single use Multi Sample blood collection needles are composed of a stainless steel needle tube that is ground at both ends and affixed to a plastic hub. A rubber sleeve covers the backend needle tube and hub tip. The front end needle is used to withdraw blood once placed in the patient. The needle tube is protected by a plastic needle cover on either end. The "front end needle" is designed to withdraw blood from the patient. The "back end needle" is covered by a rubber sleeve and is designed with a threaded hub that can be attached to a blood collection tube holder. The tube holder facilitates attachment to a evacuated blood collection tube. Each needle is individually packaged sterile utilizing two plastic end covers. A perforated label serves to simplify identification of needle size and also acts as a seal of integrity.
7. Measurements
VAKU-8™ Blood Collection Needle measurements and tolerances are as specified in British Standard 4843. They are color coded for identification according to ISO 6009.
VAKU-8™ Blood collection needles are available in six configurations.
Please find attached Annexure -1 for available meaurement and sizes
8. SMDA Statement
Safety and effectiveness information will be made available to interested persons upon request.
ல் Samples
.
Samples of VAKU-8™ Blood Collection Needles are included with submission.
10. Similarities & Differences
The following table compares the VAKU-8™ brand Blood collection Needle to the predicate device.
2
KO9042C
BENCH MARK STUDY OF BLOOD COLLECTION NEEDLE
| SL.
NO. | COMPONENT | ELEMENT OF
COMPARISON | PROPOSED - VAKU-8™ | PREDICATE |
|------------|-----------------------------|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | NA | Intended Use | Sterile, Single Use Needle to be
used for Blood Collection | Sterile, Single Use Needle to be
used for Blood Collection |
| 2 | Front End
Needle | Gauges | 21G, 22G, 23 G | 21G, 22 G |
| | | Lengths | 1" and 1.5" | 1" and 1.5" |
| 3 | NA | Lumen | Single | Single |
| 4 | Unit Pack Label | Labelling | Brand Name
Size
Lot No
Exp. Date
Symbol of single use
Mode of Sterilization - EtO Gas
Single dotted cut line on label & 1
mm gap left between the corner of
label ( for EO penetration )
Only Brand Name Mentioned | Brand Name
Size
Lot No
Exp. Date - Not mentioned on unit
Symbol of Single use - Not
mentioned on unit
Mode of Sterilization - EtO Gas
three dotted cut line on label ( for
EO penetration ) & label
overlapped from the corner
Name of Manufacturer Mentioned |
| 5 | Bottom Cover
(Tube Side) | Total length of
Device | 79.20-79.30mm | 75.60-75.70mm |
| | | Maximum O.D.
of Device | 9.20-9.30mm | 9.30-9.35mm |
| | | Material | PP | PP |
| | | Colour | Natural | Green |
| | | Transparency | Transparent | Transparent |
| 6 | Top Cover
(Patient Side) | Material | H.D.P.E | PP |
| | | Colour | Off white | Natural |
| | | Transparency | Translucent | Transparent |
| 7 | Rubber Sleeve | Colour | Gray | Gray |
| | | Transparency | Opaque | Opaque |
| | | Material | Latex free Isoprene | Latex free Isoprene |
| 8 | Hub | Design | Threaded | Threaded |
| | | Colour | Green | Green |
| | | Transparency | Transparent | Opaque |
| SL.NO | COMPONENT | ELEMENT OF
COMPARISON | PROPOSED - VAKU-8™ | PREDICATE |
| 9 | Cannula | Material | SUS304 Stainless Steel | SUS304 Stainless Steel |
| | | O.D. | 0.810-0.820mm | 0.810-0.812mm |
| | | Effective Length | | |
| | | -Front End Needle | 25.00-25.50mm | 22.60-23.00mm |
| | | -Back End Needle | 15.0-15.50mm | 14.60-14.80mm |
| | | Front End Bevel
length | 3.55-3.65mm | 3.69-3.80mm |
| | | Front section
bevel length | 1.60-1.66mm | 1.55-1.60mm |
| | | Front angle of
bevel | $10° 30' - 11° 30'$ | $9° 30' - 10° 00'$ |
| 10 | Performance
test | Removal of
Covers | Comfortable | Comfortable |
| | | Fitment with
holder | Comfortable | Comfortable |
| | | Maximum load | 0.67-0.88N | 0.83-1.00N |
| | | Shaft friction | 0.10-0.15N | 0.13-1.5N |
| | | Retraction of
tube over the
cannula | OK | OK |
| | | Cannula
penetration
over rubber
sleeve | OK | OK |
3
.
:
4
1090420
11. Substantial Equivalence Determination: Comparison Analysis
Based on the comparison, it is our conclusion that VAKU-8™ Blood Collection needles are substantially equivalent in intended use, design, technology, materials and performance to the predicate device.
12. Conclusion:
The applicant device is Substantially Equivalent (SE) to the Predicate Device which is US legally marketed device. Therefore , the applicant device is determined as safe & effective.
No action is required to comply with relevant voluntary performance standards.
-
- VAKU-8™ Blood collection Needles are manufactured in compliance with BS 4843. Samples are drawn from each batch produced as per defined sampling plan, performance tests are conducted as per the standards cited above and defined criteria for acceptance are applied. Records of in-process and final performance tests for each batch are maintained by the Quality Assurance Department. A sample of the tests and validations for Blood Collection needles is enclosed in Annexure 6 and 7.
14. Biocompatibility Data
1801 (Topilene) PP used in the Hub , has been tested and it mets all requirements of a USP Class VI Plastic. Certificate of Compliance included in Annexure 2.
The materials used to produce Multi Sample Blood Collection Needle are identical to materials that are being used in the predicate device under the same conditions.
15. Sterilization
VAKU-8™ Blood collection needles are sterilized by ethylene gas at the manufacturer's in-house validation sterilization facility ( as per EN 550). Validation Report is enclosed in Annexure 3. Bio-sterilization cycles are validated by using biological indicators. Samples are drawn from each sterilization load and subjected to the tests for sterility as per USP.
Manufacturer complies with SAL requirements as per guidance document. Manufacturer's sterilization cycles(exposure time. temperature and pressure) have been prepared to achieve a minimum 10 probability of survival of viable micro organisms and validated as per EN 550.
Freedom from Pyrogen is determined by taking samples from each sterilizer load and subjected to the test "freedom from Pyrogenic materials" as per USP(Annexure 10).
5
16. Labeling
Sample labels and packaging are displayed in Annexure 4. Samples of unit pack are enclosed. packaging is enclosed.
17. Expiration Date
The expiration date of 3 years post manufacture is derived on recommendation of the supplier of sealable medical grade tape and real time studies. The shelf life is valid for 3 years and this is also time period for which manufacturer maintains counter samples.
18. Performance and Principle of Operation
The performance and principle of Operation are identical for the VAKU-8 ™ Blood collection Needle and the predicate device.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Sanjiv Kumar President and Chief Executive Officer Myco Medical Supplies, Incorporated 158 Towerview Court Cary, North Carolina 27513
JUN 1 2 2009
Re: K090426
Trade/Device Name: VAKU-8TM Blood Collection Needle Regulation Number: 21 CFR 880.5570 . Regulation Name: Hypodermic single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 29, 2009 Received: June 3, 2009
Dear Mr. Kumar:
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 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.
7
Page 2- Mr. Kumar
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/Centers Offices/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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthm O. mace br
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known):
Device Name: VAKU-8™ Blood Collection Needle
Indications for Use: VAKU-8™ Blood Collection Needles are designed for routine blood collection by a qualified practitioner
Prescription Use AND/OR × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Whal Qele fer
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K090426