BPOS-IVAD STABILIZER

K983480 · Bpos, Inc. · LJT · Nov 23, 1998 · General Hospital

Device Facts

• Record ID: K983480
• Device Name: BPOS-IVAD STABILIZER
• Applicant: Bpos, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Nov 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2

Indications for Use

The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.

Device Story

BPOS-IVAD STABILIZER is a non-invasive, two-pronged plastic tool; used by healthcare workers to stabilize skin over an implanted vascular access device site. Device provides leverage and guidance during manual needle removal; prevents direct hand contact with the access site. Operates via manual hand pressure applied to the platform. Benefits include improved stability and reduced risk of contact during procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Non-invasive, two-pronged platform; material: plastic; manual operation; no energy source; standalone device.

Indications for Use

Indicated for healthcare workers to stabilize skin over an implanted vascular access device during manual needle removal.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• vein stabilizer

Submission Summary (Full Text)

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K9834/80

NOV 2 3 1998

Summary 510(k)

## BPOS-IVAD STABILLIZER

- DATE PREPARED 1. September, 1998
- SPONSOR INFORMATION: 2.

Bob Burns, Terry Shaffer, Jean Perlick Address: #7 Coralwind Aliso Viejo, CA 92656-1428

| Contact Person: | Ms. Terry Shaffer |
|---------------------|-------------------|
| Ph: [phone] | |
| Fax: [phone] | |

## BPOS-IVAD STABILIZER

510(k) Summary

Page 1

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- 3. DEVICE NAME:
· ,

ਜ

## BPOS-IVAD STABILIZER

Common Usual Name:

Grade/Proprietary Name:

Classification Name:

Vein Stabilizer

Implanted

Stabilizer

CFR 880.6980 Product Code 80 LBJ E Class I

Vascular

Access

Device

- DEVICE DESCRIPTION AND INTENDED USE: 4.
The BPOS-IVAD STABILIZER is a non-invasive two-pronged device used to stabilize an area of the skin over an implanted vascular access device while performing a procedure on that immediate area.

- 5. PREDICATE DEVICE
The BPOS-IVAD STABILIZER is similar in design, function and intended use to a vein stabilizer. The vein stabilizer is a non-invasive two-pronged device that stabilizes an area of skin while performing a procedure on that immediate area.

- DEVICE TESTING 6.
No testing has been done.

Both devices utilize a plastic platform to stabilize the area while a procedure is performed on the immediate area between the prongs. Both devices are made of plastic. Both devices use hand pressure to the device to guide and provide leverage to assist in the procedure performed between the prongs. The anatomical site (needle insertion site) target patient and use populations (HCW) are the same for each device.

BSOD-IVAD STABILIZER September, 1998 Page 2 510(k) Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1998

Terry Shaffer, R.N. Principal BPOS, Incorporated #7 Coralwind Aliso Viejo, California 92656-1428

Re : K983480 BPOS-IVAD STABILIZER Trade Name: Requlatory Class: Unclassified Product Code: LJT October 2, 1998 Dated: Received: October 2, 1998

Dear Ms. Shaffer:

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 able beated in the 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Shaffer

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberined in four alence of your device to a legally rinding of babban device results in a classification for your marketca predicate and the your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in riguradiagnostic 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 ene regaranotification" (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 [phone] or [phone] or at its internet address "http://www.fdal.gov/cdrh/dsmamain.html".

Sincerely yours,

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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## K983480 510(k)

BPOS-IVAD STABILIZER Device Name:

Indications for Use:

The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.

Concurrence of CDRN, Office of Device Evaluation (ODE)

Prescription Use Or (Per 21 CNR 801.109)

. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..............................................

Over-the-Counter Use

Patricia Crescenti
(Division Sign-Off)

( - Fision of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infection
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Final Devices
510(k) Number K983480