STERI-TAMP

K974180 · Pharmacy, Inc. · KPE · Feb 24, 1998 · General Hospital

Device Facts

• Record ID: K974180
• Device Name: STERI-TAMP
• Applicant: Pharmacy, Inc.
• Product Code: KPE · General Hospital
• Decision Date: Feb 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5025
• Device Class: Class 2

Indications for Use

The product is a tamper evident, sterile seal used to cover opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.

Device Story

Steri-Tamp is a tamper-evident, sterile adhesive seal designed to cover the septum surface of previously opened pharmacy drug containers (vials, IV bottles, IV bags). The device consists of a metalized polyester top layer and a polypropylene bottom layer. It is applied manually by pharmacy personnel to provide visual evidence of tampering; once removed, the seal cannot be reattached to the septum. The device serves as a protective barrier for opened containers. It is supplied in roll stock within a dispenser box.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Metalized polyester (top layer), polypropylene (bottom layer). Form factor: Roll stock on 3-inch core in dispenser box. Sterilization: ETO. Function: Tamper-evident adhesive seal. Connectivity: None. Software: None.

Indications for Use

Indicated for use as a tamper-evident, sterile seal for opened pharmacy drug containers, including vials, IV bottles, and IV bags.

Regulatory Classification

Identification

An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

Predicate Devices

• IVA Seal II

Submission Summary (Full Text)

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K974180C

## 510(K) SUMMARY (as required by 807.92(c))

FEB 24 1998

| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)<br>3234 Ella Lane<br>New Port Richey, Florida 34655 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| Phone: | 813-376-4154 |
| Fax: | 813-376-7186 |
| Contact Person: | Ed Ransom |
| Date of Summary: | November 3, 1997 |
| Trade Name: | Steri-Tamp |
| Classification Name: | Seal, adhesive, accessory to IV container |
| Predicate Device: | IVA Seal II |
| Device Description/Comparison: | The device is a seal used to cover and protect the septum<br>surface of a previously opened vial, IV bottle or bag. The<br>seal serves as a tamper resistant seal in that, once the seal;<br>is removed, it can not be reattached to the septum. |

| | Pharmacy, Inc. | U.S. Clinical Products |
|----------------------|------------------------------------------|------------------------|
| Materials: Top Layer | Metalized Polyester | Metal |
| Bottom Layer | Polypropylene | Metal |
| Packaging: | Roll Stock on 3" core in a dispenser box | Same |
| Seals per roll | 1000 | Same |
| Dispenser Box | Sealed in a vented polypropylene bag | Same |
| Sterilization | ETO | Gamma Radiation |
| Reattach | Can not be reattached | Same |
| Coding | Multi-color | Same |
| Tampering | Tamper evident | Same |
| Removal | Pull Tab | Same |

The product is a tamper evident, sterile seal used to cover Intended Use: opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three overlapping profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 4 1998

Mr. Ed Ransom President Pharmacy, Incorporated Fiarmacy) incorporary & Marketing Services, Incorporated 3234 Ella Lane New Port Richey, Florida 34655

K974180 Re : Steri-Tamp Trade Name: Requlatory Class: II Product Code: KPE Dated: February 4, 1998 February 6, 1998 Received:

Dear Mr. Ransom: :

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, 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 (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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition; FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Ransom

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 requlations.

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 requlation (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 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Runner

by 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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510(k) Number (if known): __

STERI-TAMP Device Name:

Indications For Use:

The product is a tamper evident, sterile seal used to cover opened pharmacy type drug containers. Such as vials, IV bottles, IV bags, etc.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Pattraux Accenite
(Division Sign Off)

Division of Dental, Infection Control, and General Hospital Decil

510(k) Number 1974180

Prescription Use (Per 21 CFR 801.109)

.. .

OR

Over-The-Counter Use ✓

(Optional Format 1-2-96)