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 a healthcare provider, following the ANSI/AAMI ST-46 sterilization recommendations. The Self Seal Sterilization Pouches maintain the enclosed device's sterility until used.

Device Description

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 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.

AI/ML Overview

The provided text describes a 510(k) summary for Granton® Medical 121-135°C Self-Seal Sterilization Pouches. However, it does not contain the detailed performance testing results, acceptance criteria, or study specifics typically found in a full study report.

The document states: "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."

Based on the provided text, I can infer the general nature of the performance testing but cannot extract specific numeric acceptance criteria or detailed study parameters.

Here's what can be inferred and what cannot, based on the input:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred):
- Functionality with higher temperature sterilization: The pouches must withstand and function correctly during steam sterilization cycles up to 135°C.
- Package integrity: Seal strength and seal integrity must be maintained after steam sterilization at 135°C.
- Process indicator functionality: The throughput process indicator must correctly distinguish between processed and unprocessed units after sterilization at 135°C.
Reported Device Performance (Inferred): The document states "Data was provided that demonstrates that the proposed 121-135°C Sterilization Pouches can be used for sterilization... Package integrity testing was also performed to confirm that the seal strength and seal integrity... are not affected..." This implies the device met the unstated acceptance criteria for these aspects. However, no specific performance metrics (e.g., actual seal strength values, visual change of indicator) are reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified.
Data Provenance: Not specified, but the manufacturer is Granton® Medical Ltd. in Sheffield, England, suggesting the studies likely originated from or were sponsored by this UK-based company. The submission is to the US FDA.
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., medical imaging devices), not for a sterilization pouch. The "ground truth" here would be objective measurements of physical properties and indicator changes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not specified. This typically refers to resolving discrepancies among human readers, which is not relevant for this device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a sterilization pouch, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm. The performance testing described relates to the physical and chemical properties of the pouch.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Inferred: The "ground truth" would be established through objective laboratory testing and measurements. This includes:
- Verified high-temperature steam sterilization conditions (e.g., using calibrated autoclaves and temperature probes).
- Standardized methods for measuring seal strength and integrity (e.g., peel tests, burst tests).
- Visual or instrumental assessment of the process indicator color change under verified sterilization conditions.

8. The sample size for the training set

Not applicable. This device does not employ machine learning or AI, so there is no training set in this context.

9. How the ground truth for the training set was established

Not applicable. (See point 8).

Summary of available information regarding the study:

Purpose of Study: To demonstrate that the Granton® Medical 121-135°C Self-Seal Sterilization Pouches can be used for steam sterilization cycles up to 135°C and that their package integrity is maintained at this temperature. It also implies functionality of the new throughput process indicator at this temperature.
Tests Performed:
- Sterilization efficacy demonstration at temperatures up to 135°C.
- Package integrity testing (seal strength and seal integrity) after steam sterilization at 135°C.
Outcome: The data provided "demonstrates" and "confirms" that the pouches meet the intended performance for these new conditions.

To get the specific numeric acceptance criteria and detailed study parameters, one would typically need access to the full 510(k) submission document, which often includes the testing protocols and results in more detail than the summarized version readily available.

Summary

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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 SterilizationPouches
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.

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DEVICE DESCRIPTION 5.

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.

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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.

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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 (240) 276-0115. 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 (301) 443-6597 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

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Indications for Use

510(k) Number: K052665

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

Indications for Use:

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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

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
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.(b)
Classification. Class II (performance standards).