MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH

K993764 · Medipack Medical Packaging Mfg. Co. · KCT · Dec 16, 1999 · General Hospital

Device Facts

• Record ID: K993764
• Device Name: MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH
• Applicant: Medipack Medical Packaging Mfg. Co.
• Product Code: KCT · General Hospital
• Decision Date: Dec 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is intended to be used to enclose another medical device that is to be sterilized by a health provider by steam or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Device Story

Device is a see-through sterilization pouch composed of bleached wet-strength medical paper; used by healthcare providers to enclose medical instruments prior to sterilization. Pouch allows penetration of steam or ethylene oxide gas during sterilization cycles; maintains sterile barrier for enclosed contents until point of use. Device is a passive packaging accessory; no electronic or mechanical components.

Clinical Evidence

No clinical data. Substantial equivalence is based on identical material composition and manufacturing specifications to predicate devices.

Technological Characteristics

Bleached wet-strength medical paper; see-through design. Compatible with steam, ethylene oxide, and irradiation sterilization methods. Passive packaging device.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via steam or ethylene oxide (EtO) and to maintain sterility until use.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• Global Healthcare Self-Sealing Sterilization Pouch (K990567)
• Defend Self-Sealing Sterilization Pouch (K932056)

Submission Summary (Full Text)

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MEDIPACK MEDICAL PACI

Lin-Kuo 4" Industrial Guel. Shan Helang, Tac

Image /page/0/Picture/2 description: The image shows a circular seal with the text "ISO9002-EN46002 CERTIFIED FACTOR" around the perimeter. In the center of the seal are two overlapping shapes that appear to be stylized letters. Above the seal, the text "MFG. CO." is printed in a smaller font size.

K993764

DEC I 6 1999

### 3. SUMMARY OF SAFETY AND EFFECTIVENESS

### SPONSOR IDENTIFICATION: A.

Medipack Medical Packaging Manufacturing Co. Lin-Kuo 4th Industrial Park No. 13, Tin Hu Road Guei-Shan Hsiang Tao-Yuan Hsien 333 Taiwan

Tel: [phone] Fax: [phone] [e-mail]

#### ESTABLISHMENT REGISTRATION NUMBER: B. 9880261

### C. OFFICIAL CONTACT PERSON

Norman F. Estrin, Ph. D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac . MD 20854

Tel. : [phone] Fax : [phone]

#### DATE OF PREPARATION OF THIS SUMMARY: D. November 4, 1999

## MEDIPACK® SEE-THROUGH PROPRIETARY (TRADE) NAME: E. SELF SEAL STERILIZATION POUCH

00001:

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| F. | COMMON NAME: | Sterilization Pouch |
|----|----------------------------|-----------------------------------------------------|
| G. | CLASSIFICATION NAME: | Pack, Sterilization Wrapper, Bag<br>and Accessories |
| H. | PROPOSED REGULATORY CLASS: | Class II |
| I. | DEVICE PRODUCT CODE: | KCT |
| J. | REFERENCE: | 21CFR par.880.6850 |
| K. | PANEL: | General Hospital |

### DESCRIPTION: L.

# The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION

POUCH is a device composed of medical paper. It is a bleached wet strength paper conforming to recognized material standards and can be sterilized by steam, ethylene oxide gas and irradiation.

### M. INDICATIONS FOR USE:

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is intended to be used to enclose another medical device that is to be sterilized by a health provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

### N. PREDICATE DEVICE:

The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is substantially equivalent to the Global Healthcare Self-Sealing Sterilization Pouch (K990567) and the Defend Self-Sealing Sterilization Pouch (K932056).

### 0. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

Both the The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH and the predicate devices have the same intended use and all are composed of the identical materials and have identical Indications for Use. All are produced by the same manufacturer!

### P. SUMMARY OF STUDIES:

Since the manufacturer, Medical Corporation, produces the identical product for the Global Healthcare and Carl Parker Associates (Defend Selfsealing Pouch), all specifications and test results are applicable to each as well as
to the MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH

00001

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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" arranged around the upper half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 6 1999

Medipack - Medical Packing Manufacturing Co. c/o Mr. Norman F. Estrin Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD -20854

Re: K993764

> Medipack® See-Through Self Seal Trade Name: Sterilization Pouch Requlatory Class: II Product Code: KCT November 4, 1999 Dated: Received: November 8, 1999

Dear Mr. Estrin:

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. 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

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Page 2 - Mr. Estrin

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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 Punger

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):

## MEDIPACK® SEE-THROUGH Device Name: SELF SEAL STERILIZATION POUCH

Indications for Use:

# The MEDIPACK® SEE-THROUGH SELF SEAL STERILIZATION POUCH is

intended to be used to enclose another medical device that is to be sterilized by a health provider by steam or ethylene oxide (EtO). It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

(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

(Optional Format 1-2-96)

Olin S. Lin

Division Sign-Off) invision of Dental, Infection Co and General Hospita ി(k) Number