GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES

K052665 · Granton Medical , Ltd. · FRG · Feb 27, 2006 · General Hospital

Device Facts

• Record ID: K052665
• Device Name: GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES
• Applicant: Granton Medical , Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Feb 27, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Granton® Medical 121-135°C Self-Seal Sterilization Pouches are intended to be used to enclose another medical device that is to be steam sterilized at 121-135°C by following the ANSI/AAMI ST-46 sterilization healthcare provider, a recommendations. The Self Seal Sterilization Pouches maintain the enclosed device's sterility until used.

Device Story

Single-use sterilization pouches; adhesive strip for sealing; paper web includes throughput process indicator ink. Used by healthcare providers to enclose medical devices prior to steam sterilization (121-135°C). Process indicator provides visual distinction between processed and unprocessed units. Maintains sterility of enclosed device until point of use.

Clinical Evidence

Bench testing only. Testing demonstrated pouch suitability for steam sterilization cycles up to 135°C. Package integrity testing confirmed seal strength and integrity are maintained after exposure to 135°C steam sterilization.

Technological Characteristics

Single-use sterilization pouch; paper web construction; adhesive seal. Includes flexographic printed process indicator ink. Compatible with steam sterilization 121-135°C per ANSI/AAMI ST-46.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for steam sterilization at temperatures between 121°C and 135°C, maintaining 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

• Self-Seal Sterilization Pouch (K023025)

Reference Devices

• Albert Browne Modified Packaging and Label Steam Indicator (K032801)

Submission Summary (Full Text)

{0}------------------------------------------------

# FEB 2 7 2006

# 510(k) SUMMARY

## Granton® Medical Ltd. 121-135°C Self-Seal Sterilization Pouches

#### SUBMITTER NAME AND ADDRESS 1.

Mr. John Bowler Granton® Medical Limited Parkway Close Parkway Industrial Estate Sheffield S9 4WJ England

Date Prepared: February 22, 2006

#### 2. DEVICE NAME

| Proprietary Name: | Granton® Medical 121-135°C Self-Seal Sterilization<br>Pouches |
|----------------------|---------------------------------------------------------------|
| Common/Usual Name: | Sterilization Pouches |
| Classification Name: | Sterilization wrap |

#### 3. PREDICATE DEVICES

- Self-Seal Sterilization Pouch (K023025) .
#### 4. INTENDED USE

The Granton® Medical 121-135°C Self-Seal Sterilization Pouches are intended to be used to enclose another medical device that is to be steam sterilized at 121-135°C by following the ANSI/AAMI ST-46 sterilization healthcare provider, a recommendations. The Self Seal Sterilization Pouches maintain the enclosed device's sterility until used.

{1}------------------------------------------------

#### DEVICE DESCRIPTION 5.

The proposed Granton® Medical 121-135°C Self-Seal Sterilization Pouches (121-135°C Sterilization Pouches) are essentially identical in design and materials to Granton Medical's Self Seal Sterilization Pouch (Self Seal Sterilization Pouch) described in K023025. Like the predicate Self Seal Sterilization Pouch, the 121-135°C Sterilization Pouches are single use bags with an adhesive strip on the open end for sealing the bag prior to sterilization. The six pouch sizes available for the proposed 121-135°C Sterilization Pouches are identical to those of the predicate Self Seal Sterilization Pouch.

The purpose of this submission is to:

- Extend the indications for use to include steam sterilization cycles with . temperatures up to 135°C
- Add a throughput process indicator to the paper web of the pouch to . distinguish between processed and unprocessed units

### TECHNOLOGICAL CHARACTERISTICS 6.

The design and materials used for construction of the proposed 121-135°C Sterilization Pouches are identical to those of the parent Self Seal Sterilization Pouch. The proposed 121-135°C Sterilization Pouches are manufactured with a throughput process indicator applied to the paper surface of the pouch using a flexographic printing method. The process indicator ink applied to the proposed 121-135°C Sterilization Pouches is identical in composition to the ink used for the Albert Browne Modified Packaging and Label Steam Indicator (Packaging Steam Indicator) that was the subject of K032801.

### 7. PERFORMANCE TESTING

Data was provided that demonstrates that the proposed 121-135°C Sterilization Pouches can be used for sterilization of the enclosed medical device in cycles with temperatures up to 135°C. Package integrity testing was also performed to confirm that the seal strength and seal integrity of the proposed 121-135°C Sterilization Pouches are not affected by steam sterilization at 135°C.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2006

Granton Medical Limited C/O Ms. Cynthia J.M. Nolte, Ph.D., RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760

Re: K052665

Trade/Device Name: Granton® Medical 121-135°C Self-Seal Sterilization Pouches Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: February 8, 2006 Received: February 10, 2006

Dear Ms. Nolte:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rottewed your cessatermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mensiale conments, or to devices that have been reclassified in accordance with the provisions of Antichditeris, or to de roos and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppreation (the Act. The general controls provisions of the Act include controls providents or 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it may of subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be fountish further announcements concerning your device in the Federal Register.

{3}------------------------------------------------

## Page 2 -- Ms. Cynthia J.M. Nolte, Ph.D., RAC

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DX 3 issualled of a basecurities with other requirements mean that FDA has made a decommance hatin's administered by other Federal agencies. of the Act of ally I ederal statutes and regarments, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practice and listing (21 CFR Part 607), laceiing (21 CFR Partial requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to oegn manating your substantial equivalence of your device 510(K) prematked 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), II you desire specific advice for your de at [phone]. Also, please note the regulation in entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general missmanteners, International and Consumer Assistance at its toll-free Division of Dinas 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Quares
for Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital , Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number: K052665

Device Name: Granton® Medical 121-135°C Self-Seal Sterilization Pouches

Indications for Use:

ಕಾ

The Granton® Medical 121-135°C Self-Seal Sterilization Pouches (Self Seal The "Stanton's "Moursered to enclose another medical device that is to be Otchlization Founder, are 5 C by a healthcare provider, following the ANSI/AAMI Steam Storilization recommendations. The Self Seal Sterilization Pouches maintain the enclosed device's sterility until used.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shula M. Murphy, R.D. 2/27/04

logy General Hosp
and Dental Devices
K052665

Page 1 of 1