(80 days)
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.
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PUNCTUR-GUARD REVOLUTION™ Blood Collection Needle Holder:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional Aspect) | Reported Device Performance |
|---|---|
| Holder Integrity: Retains integrity under expected forces. | Retains its integrity under forces that can be expected to occur in practical use. |
| Needle Insertion: Allows needle insertion in an acceptable torque range. | Allows needle insertion by the health care worker in an acceptable torque range. |
| Blood Draws: Allows blood draws reliably. | Allows blood draws in a reliable fashion. |
| Safety Feature Activation: Performs activation of the PUNCTUR-GUARD® safety feature consistently and fault-free. | Performs activation of the safety feature of PUNCTUR-GUARD® Blood Collection Needles in a consistent and fault-free manner. |
| Needle Disposal: Allows needle disposal by pushing a release button. | Allows needle disposal by pushing a release button. |
| Reusability: Can be used for up to 100 uses, including 20 cleanings. | Can be used for up to 100 uses, including 20 cleanings. |
| Substantial Equivalence: Quantitative test values demonstrate substantial equivalence to the predicate device (DROP-IT® holder). | Quantitative test values demonstrated the substantial equivalence of the REVOLUTION holder to the predicate device, the DROP-IT holder. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document states, "Sample sizes reflected the significance of the particular functions, expressed in appropriate AQL levels." It does not provide specific numerical sample sizes for each test.
- Data Provenance: The tests were conducted internally by Bio-Plexus technical staff and externally by "outside health care workers." The country of origin is not explicitly stated, but Bio-Plexus, Inc. is located in Vernon, CT, USA, suggesting the testing was likely conducted in the US. The testing appears to be prospective as it's part of the development and validation of the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document mentions "outside health care workers" participated in "complete functional testing in blood drawing procedures."
- Number of Experts: Not specified.
- Qualifications of Experts: The term "health care workers" is broad. More specific qualifications (e.g., phlebotomists with X years of experience, nurses, physicians) are not provided.
4. Adjudication Method for the Test Set
- The document describes "pass/fail evaluations" and mentions "functional testing." It does not provide details on an adjudication method like 2+1 or 3+1 for resolving discrepancies in evaluations. It implicitly suggests that the tests were designed with clear pass/fail criteria, possibly eliminating the need for complex adjudication for objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was NOT performed. The tests focused on the performance of the device itself and its equivalence to a predicate, not on how human readers (or users) improve their performance with or without AI assistance. The device is a mechanical blood collection holder, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a form of standalone testing was done. The device itself was tested for its mechanical and functional performance (holder integrity, needle insertion torque, safety feature activation, reusability) separate from a human operator, with human users primarily verifying the functionality during simulated use. Since this is a mechanical device and not an algorithm, "standalone" here refers to the device's inherent function rather than an algorithm's performance.
7. The Type of Ground Truth Used
- The ground truth was established through objective measurements (force and torque measurements), pass/fail evaluations against predefined design specifications, and simulated use testing verified by technical staff and healthcare workers. This constitutes a combination of engineering specifications and direct observational evidence of function. It does not involve "expert consensus" in the sense of interpreting medical images or pathology.
8. The Sample Size for the Training Set
- Not Applicable. The device is a mechanical blood collection holder, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (as there is no training set for a mechanical device).
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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
| CompanyAddress | Bio-Plexus, Inc.129 Reservoir RoadVernon, CT 06066 |
|---|---|
| Registration Number | 1224632 |
| Contact | Paul A. TenthoreyRegulatory Affairs ManagerPhone 860 870 6111Fax 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.
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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
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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
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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
§ 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).