PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750

K992091 · Bio-Plexus, Inc. · FMI · Sep 9, 1999 · General Hospital

Device Facts

• Record ID: K992091
• Device Name: PUNCTUR-GUARD REVOLUTION HOLDER, MODEL 4750
• Applicant: Bio-Plexus, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Blood collection needle holder; holds PUNCTUR-GUARD® needles during phlebotomy; compatible with standard blood tubes and pediatric inserts. Features integrated safety mechanism; dial rotation (90° clockwise) blunts needle tip to prevent accidental needle sticks; manual push-button release for needle disposal. Used by experienced healthcare workers in clinical settings. Reusable for up to 100 blood draws (including 20 cleaning cycles). Benefits patient and clinician by reducing risk of HIV/hepatitis transmission via accidental needle sticks.

Clinical Evidence

Bench testing only. Testing performed in accordance with 21 CFR 820.30 and ISO 9001:1994. Evaluated holder integrity, needle insertion, blunting, and release mechanisms using force and torque measurements. Functional testing conducted by technical staff and healthcare workers. Results confirmed device integrity, acceptable torque ranges, reliable blood draw performance, and consistent safety activation over 100 uses.

Technological Characteristics

Non-sterile blood collection needle holder. Mechanical design features manual dial-actuated needle blunting and push-button needle release. Constructed for reusability (up to 100 uses/20 cleanings). Operates via manual mechanical force. No electronic components or software.

Indications for Use

Indicated for use by experienced health care workers in phlebotomy procedures for blood collection using PUNCTUR-GUARD® needles.

Regulatory Classification

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.

Predicate Devices

• DROP-IT® Needle Holder (K963748)

Submission Summary (Full Text)

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SEP 9 1999

K992091

#### 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<br>Address | Bio-Plexus, Inc.<br>129 Reservoir Road<br>Vernon, CT 06066 |
|---------------------|-------------------------------------------------------------------------------------------|
| Registration Number | 1224632 |
| Contact | Paul A. Tenthorey<br>Regulatory Affairs Manager<br>Phone [phone]<br>Fax [phone] |

#### 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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
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