(80 days)
Not Found
No
The device description and performance studies focus on mechanical functions (rotating a dial, pushing a button) and physical properties (integrity, force, torque). There is no mention of data processing, algorithms, or learning capabilities.
No.
This device is designed to hold blood collection needles and activate their safety mechanism, not to treat a disease or condition. Its primary function is to facilitate blood drawing and enhance safety for healthcare workers.
No
The device is a holder for blood collection needles used in blood drawing procedures, which is a part of sample collection, not diagnostic analysis. Its primary function is to facilitate blood drawing and activate needle safety mechanisms.
No
The device description clearly indicates it is a physical holder used in blood drawing procedures, designed to hold needles and activate a safety mechanism through mechanical rotation and button pushes. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for holding a needle during blood drawing procedures and activating a safety mechanism to prevent needle sticks. This is a procedural device used during the collection of a sample, not a device used to perform a test on a sample.
- Device Description: The description focuses on the mechanical function of holding the needle, activating the safety feature, and releasing the needle. It does not mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies described focus on the mechanical integrity and functionality of the holder (needle insertion, blunting, release, durability). They do not involve testing or analyzing biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is solely related to the collection of the blood sample, not the analysis of it.
N/A
Intended Use / Indications for Use
The REVOLUTION Holder is designed for use in blood drawing procedures. It is intended exclusively for use PUNCTUR-GUARD® Blood Collection Needles, and is compatible with standard blood collection tubes as well as pediatric inserts.
The REVOLUTION Holder is used in blood drawing procedures. It is used with PUNCTUR-GUARD® Blood Collection Needles only, and is compatible with standard blood sample tubes as well as pediatric inserts.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The REVOLUTION Holder is designed to hold PUNCTUR-GUARD® Blood Collection Needles during blood drawing procedures, and to allow blunting of PUNCTUR-GUARD® needles prior to removal from the patient. Blunting reduces the probability of accidental needle sticks which are a major risk for infection with HIV or hepatitis. Blunting is performed by turning the dial at the holder's end.
The REVOLUTION Holder is non-sterile and can be used for up to 100 blood draws, including 20 cleanings. Contaminated needles can be released quickly in a one-handed operation by a manual push on the release button.
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
The REVOLUTION Holder should be used by health care workers experienced in phlebotomy.
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
Design and performance testing were executed in accordance with Design Control procedures (21 CFR 820.30; ISO 9001:1994). Tests were performed for holder integrity, needle insertion, holder/needle integrity, blunting and needle release. Tests included pass/fail evaluations and force and torque measurements. Complete functional testing in blood drawing procedures was performed by Bio-Plexus technical staff as well as by outside health care workers. Sample sizes reflected the significance of the particular functions, expressed in appropriate AQL levels. Potential failure modes and user errors were investigated and discussed in a risk analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test results demonstrated that the REVOLUTION Holder
- retains its integrity under forces that can be expected to occur in practical ● use.
- allows needle insertion by the health care worker in an acceptable torque ● range.
- allows blood draws in a reliable fashion, ●
- . performs activation of the safety feature of PUNCTUR-GUARD® Blood Collection Needles in a consistent and fault-free manner,
- allows needle disposal by pushing a release button, and .
- can be used for up to 100 uses, including 20 cleanings. .
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
SEP 9 1999
510 (k) SUMMARY 10
This summary of Safety and Effectiveness is submitted in accordance with the requirements of 21 CFR 807 92
10.1 Establishment
| Company
Address | Bio-Plexus, Inc.
129 Reservoir Road
Vernon, CT 06066 |
|---------------------|-------------------------------------------------------------------------------------------|
| Registration Number | 1224632 |
| Contact | Paul A. Tenthorey
Regulatory Affairs Manager
Phone 860 870 6111
Fax 860 870 6111 |
10.2 Device
| Trade name | PUNCTUR-GUARD REVOLUTION™ |
|---|---|
| Common Name | Blood Collection Needle Holder |
| Class | II |
| Performance Standard | Not listed in 21 CFR 860 - 897 |
10.3 Predicate Device
| Trade Name | DROP-IT® Needle Holder |
|---|---|
| Company | Bio-Plexus, Inc. |
| 510(k) Number | K963748 |
| Marketing Approval | Received June 6, 1997 |
10.4 Description
The REVOLUTION Holder is designed to hold PUNCTUR-GUARD® Blood Collection Needles during blood drawing procedures, and to allow blunting of PUNCTUR-GUARD® needles prior to removal from the patient. Blunting reduces the probability of accidental needle sticks which are a major risk for infection with HIV or hepatitis. Blunting is performed by turning the dial at the holder's end.
The REVOLUTION Holder is non-sterile and can be used for up to 100 blood draws, including 20 cleanings. Contaminated needles can be released quickly in a one-handed operation by a manual push on the release button.
1
10.5 Intended Use
The REVOLUTION Holder is designed for use in blood drawing procedures. It is intended exclusively for use PUNCTUR-GUARD® Blood Collection Needles, and is compatible with standard blood collection tubes as well as pediatric inserts.
10.6 Performance Tests
Design and performance testing were executed in accordance with Design Control procedures (21 CFR 820.30; ISO 9001:1994). Tests were performed for holder integrity, needle insertion, holder/needle integrity, blunting and needle release. Tests included pass/fail evaluations and force and torque measurements. Complete functional testing in blood drawing procedures was performed by Bio-Plexus technical staff as well as by outside health care workers. Sample sizes reflected the significance of the particular functions, expressed in appropriate AQL levels. Potential failure modes and user errors were investigated and discussed in a risk analysis.
The test results demonstrated that the REVOLUTION Holder
- retains its integrity under forces that can be expected to occur in practical ● use.
- allows needle insertion by the health care worker in an acceptable torque ● range.
- allows blood draws in a reliable fashion, ●
- . performs activation of the safety feature of PUNCTUR-GUARD® Blood Collection Needles in a consistent and fault-free manner,
- allows needle disposal by pushing a release button, and .
- can be used for up to 100 uses, including 20 cleanings. .
10.7 Conclusion; Substantial Equivalence
Safety, effectiveness and acceptability of the REVOLUTION holder were demonstrated by bench testing and simulated use testing.
Quantitative test values demonstrated the substantial equivalence of the REVOLUTION holder to the predicate device, the DROP-IT holder.
Paul A. Tenthorey
Paul A. Tenthorey, Ph.D.
Date: 6/12/99
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 1999 SEP
Paul A. Tenthorey, Ph.D. Regulatory Affairs Manager Bio-Plexus, Incorporated 129 Reservoir Road 06066-5705 Vernon, Connecticut
Re : K992091
Punctur-Guard Revolution™ Holder, Model Trade Name: 4750 Regulatory Class: II Product Code: FMI Dated: June 18, 1999 Received: June 21, 1999
Dear Dr. Tenthorey:
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, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ 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 Failure to comply with the GMP verify such assumptions. requlation may result in regulatory action. In addition, FDA 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
3
Page 2 - Dr. Tenthorey
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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 qeneral 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,
Timothy A. Ulatowski
othy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3.3 Indications for Use Statement
K992091 510(k) Number
PUNCTUR-GUARD REVOLUTION™ Device Name
The REVOLUTION Holder is used in blood drawing Indications for Use It is used with PUNCTUR-GUARD® procedures. Blood Collection Needles only, and is compatible with standard blood sample tubes as well as pediatric inserts.
The REVOLUTION Holder should be used by health care workers experienced in phlebotomy.
At the end of a blood draw, the holder dial is rotated clockwise 90°. This rotation activates the safety mechanism of the PUNCTUR-GUARD® needle, which reduces the probability of an accidental needle stick.
The needle can be eliminated quickly by a push on the release button. The holder is re-usable for up to 100 draws, including 20 cleanings.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
alent
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 4992091
Bio-Plexus, Inc.
Non-Confidential
510(k) PUNCTUR-GUARD REVOLUTION™ Holder
11