FlashPak® is a reusable rigid container system to be used during flash sterilization by hospitals and healthcare facilities. It is intended to enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravitydisplacement flash sterilization using a 10 minute cycle at 132° C and with pre-vacuum flash sterilization using a 4 minute cycle at 132° C. FlashPak is recommended for surface sterilization of stainless steel instruments and for lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).

Device Description

The FlashPak Container System consists of a family of rigid reusable containers that provide an effective sterilization packaging method for surgical instruments requiring flash steam sterilization. Each FlashPak system is comprised of an upper lid that seals by means of a silicone gasket and latches to a lower base creating a totally enclosed environment. A stainless steel wire basket is utilized inside the container to facilitate handling of sterilized items. The lid and base incorporate pressure actuated valves that open to allow sterilant to enter the container during the pressurization portion of the sterilization cycle and then close to seal the container once the cycle is over so the container and its contents can be removed from the sterilizer and immediately transported to the point of use without the risk of recontamination.

AI/ML Overview

This is not an AI-enabled device. This is a medical device, specifically a sterilization container system, for which the submitted information confirms its substantial equivalence to a predicate device.

Therefore, questions regarding AI-specific elements such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established are not applicable.

Here's the relevant information based on the provided text for the FlashPak® Sterilization Container System:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are established by demonstrating that it functions as intended and is substantially equivalent to a legally marketed predicate device (K871202) by meeting applicable standards, specifically ANSI/AAMI ST77:2006 "Containment Devices for Reusable Medical Device Sterilization".

The "performance" section of the 510(k) summary (page 2) outlines the key performance aspects that were evaluated.

Acceptance Criteria (Performance Aspect)	Reported Device Performance (New Device)	Discussion (Comparison to Predicate)
Sterilant Penetration (Sterilization Efficacy)	Gravity-displacement Cycle: 10 minutes at 132°C (270°F) for porous and cannulated devices. Dynamic-air-removal Cycle: 4 minutes at 132°C (270°F) for porous and cannulated devices. Thermal mapping studies demonstrating container temperature closely matches sterilizer chamber.	Equivalent (to predicate's 10 min gravity, 5 min dynamic-air-removal cycles, and thermal mapping performance). The new device has a shorter dynamic-air-removal cycle.
Microbial Barrier Properties (Packaging Integrity)	The container completely encapsulates the items sterilized inside and prevents recontamination during transport to the point of use immediately after sterilization.	Same as predicate
Material Compatibility	Materials used are compatible with the recommended sterilization method and cleansers.	Same as predicate
Toxicological Properties (Biocompatibility)	Cytotoxicity per ISO 10993-5. Irritation per ISO 10993-10.	Equivalent (to predicate which used medical grade polymers or stainless steel, with no patient contact).
Drying Time	Intended for flash sterilization and immediate use, implying no specific drying time acceptance criterion for a separate dry storage period.	Same as predicate

Study Information

The study demonstrating the device meets the acceptance criteria is a series of performance tests and validations adhering to the ANSI/AAMI ST77:2006 standard.

Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for each test (e.g., number of containers tested, number of sterilization cycles). It states that "Testing to applicable standard, ANSVAAMI ST77:2006... has been completed with acceptable outcomes."
- Data provenance: Not explicitly stated, but assumed to be from internal laboratory testing conducted by Symmetry Medical Inc. (the device manufacturer). This would typically be prospective testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of device is defined by passing specific physical, chemical, and biological performance tests according to established standards. This is not a diagnostic device requiring expert interpretation of results.
Adjudication method for the test set: Not applicable. Test results are objectively measured against predefined criteria in the standard.
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 is not an AI-enabled device and does not involve human readers interpreting data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used:
- Performance against established standards: The ground truth is determined by objective measurements and biological indicators (e.g., sterility assurance level for sterilization validation, absence of cytotoxicity/irritation for biocompatibility, physical integrity for handle strength/valve life) as defined in ANSI/AAMI ST77:2006 and ISO 10993 standards.
The sample size for the training set: Not applicable. There is no "training set" in the context of an AI/machine learning device. The design and manufacturing process for the physical device are based on engineering principles and material science.
How the ground truth for the training set was established: Not applicable. No training set is used for a physical medical device like this.

Summary

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K113776

510K Summary

8 2012 AUG

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807-92(c).

1. The submitter of this pre-market notification is:

Symmetry Medical Inc. 61 John Vertente Blvd. New Bedford, MA 02745 United States Tel: 508-998-4464 Fax: 508-995-9597

Contact : Robert Johnson Director of Quality Email: rob.johnson@symmetrymedical.com

2. Device Name:

Common Name	Sterilization Container
Trade Name	FlashPak® or FlashPak® Sterilization Container System

3. Device Classification Information:

Device Panel	Classification	Prod Code	Description
General Hospital	880.6850Class II	FRG	Wrap, Sterilization

4. Predicate Device

Name	FlashPak® Sterilization Container System
Classification	Class II
510(k) Number	K871202

5. Device Description:

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6. Intended Use Statement:

FlashPak® is a reusable rigid container system to be used during flash sterilization by hospitals and healthcare facilities. It is intended to enable flash sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement flash sterilization using a 10 minute cycle at 132° C and with pre-vacuum flash sterilization using a 4 minute cycle at 132° C. FlashPak is recommended for surface sterilization of stainless steel instruments and for lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre-vacuum (1mm inner diameter or larger and up to 203mm in length).

7. Summary of Technological Characteristics of the Device Compared to the Predicate Device

ELEMENT	PREDICATE	NEW DEVICE	DISCUSSION
Intended Use	Note: No formal intended usestatement was included in theK871202 submission. Thefollowing is taken from thedescription:'The product is a containersystem to be used in the FlashSterilizer to sterilizeinstruments and to preventrecontamination while theinstruments are transported tothe operating room.'	FlashPak® is a reusable rigidcontainer system to be usedduring flash sterilization byhospitals and healthcarefacilities. It is intended toenable flash sterilization of theenclosed devices and preventrecontamination duringimmediate transport to the pointof use. The container iscompatible with gravity-displacement flash sterilizationusing a 10 minute cycle at 132°C and with pre-vacuum flashsterilization using a 4 minutecycle at 132° C. FlashPak isrecommended for surfacesterilization of stainless steelinstruments and for lumenswith the following limits:gravity-displacement (5.5mminner diameter or larger and upto 184mm in length), pre-vacuum (1mm inner diameteror larger and up to 203mm inlength).	Intended Usestatement isequivalent albeitadditional relevantdetail has beenincluded.
MaterialComposition	Ultem Base and Lid	Radel Base and Lid	Both rigid & durable
	Ultem Instrument Tray	SS Instrument Basket	Both rigid & durable
	SS Latches	SS Latches	Same
	Silicone Gasket and Valve Seal	Silicone Gasket and Valve Seal	Same
	SS Hardware	SS Hardware	Same
	SS Microfilter Disk	SS Microfilter Disk	Same
	N/A	Silicone Lid Vent	Same as gasket/seal
	Radel Valve Body	SS Bellows	Both rigid & durable
	Silicone Diaphragm	N/A	N/A
	RTV Silicone Sealant	N/A	N/A
	N/A	SS Bracket	Rigid & durable
Ammended 510(k) Summary, 02/10/2012

Physical Properties	Materials are compatible with steam sterilization.Materials are commonly used in sterilization trays and cases.	Same as predicate	Equivalent
Chemical Properties	Materials are non-reactive and are compatible with recommended cleansers.Materials are commonly used in sterilization trays and cases.	Same as predicate	Equivalent
Configurations/Dimensions	Container Sizes:(10" x 7" x 2")(10" x 10" x 2")	Container Sizes:(11" x 11" x 7") #9020(20" x 11" x 8"), #9030(24" x 11" x 9") #9040(24" x 13" x 9") #9050	Subject device offers larger sizes within the product family that all function in the same manner.
Air Permeance	N/A	N/A	N/A
Percent of SurfacePerforations	N/A	N/A	N/A
PERFORMANCE	PREDICATE	NEW DEVICE	DISCUSSION
Sterilant Penetration	Sterilization EfficacyGravity-displacement Cycle:• 10 minutes at 132°C(270°F) for porous and cannulated devicesDynamic-air-removal Cycle• 5 minutes at 132°C(270°F) for porous and cannulated devicesSterilant PenetrationThermal mapping studies demonstrating container temperature closely matches sterilizer chamber.	Sterilization EfficacyGravity-displacement Cycle:• 10 minutes at 132°C(270°F) for porous and cannulated devicesDynamic-air-removal Cycle• 4 minutes at 132°C(270°F) for porous and cannulated devicesSterilant PenetrationThermal mapping studies demonstrating container temperature closely matches sterilizer chamber.	Equivalent
Microbial BarrierProperties(PackagingIntegrity)	The container completely encapsulates the items sterilized inside and prevents recontamination during transport to the point of use immediately after sterilization.	Same as predicate	Equivalent
MaterialCompatibility	Materials used are compatible with the recommended sterilization method and cleansers.	Same as predicate	Equivalent
ToxicologicalProperties(Biocompatibility,including SterilantResidue Limits)	Materials used are either medical grade polymers or stainless steel. Instruments placed in the container only come in contact with the Ultem tray. No patient contact.	Cytotoxicity per ISO 10993-5Irritation per ISO 10993-10	Equivalent
N/A	N/A	N/A	N/A
Drying Time	N/AFlashPak is intended for flashsterilization and immediate use	Same as predicate	Equivalent
Aeration time	N/A	N/A

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Ammended 510(k) Summary, 02/10/2012

・

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1. The major modifications are as follows:
  Re-designed pressure actuated valve to be more robust. The valves, one in the o container lid and one in the container base, allow ingress and egress of sterilant. The new valve design which is hermetically sealed also eliminated the need to periodically equalize the internal valve pressure to ambient due to porosity of the predicate valve materials.
Changed base and lid material from vacuum formed Ultem to vacuum formed Radel o which performs in a similar manner within steam sterilization environments.
0 Added larger size containers to the FlashPak product family of containers.
Added a silicone rubber lid vent button that can be used by the healthcare personnel o to release any vacuum created within the container during cooling thereby making it easier to remove the lid.
Changed the inner instrument tray from Ultem to a stainless steel wire basket. O
Modified the lid gasket profile from one with two sealing ridges to one with a smooth o conforming edge design.
Modified the container latches from hinged lock down clamps to a spring steel clip. O
Modified the shape of the container body to allow more room for instruments. 0
Modified labeling on the device and in the IFU to include more extensive 0 instructions.

These recognized differences between the subject container and the predicate are intended to make the device more robust and better meet users needs; they do not represent changes that effect the safety or effectiveness of the device.

1. Testing to applicable standard, ANSVAAMI ST77:2006 "Containment Devices for Reusable Medical Device Sterilization" has been completed with acceptable outcomes. The following testing has been performed:
- Sterilization validation gravity-displacement mode using a half cycle of the . recommended parameters for flash sterilization demonstrating a 10° SAL for the half cycle.
- Sterilization validation dynamic-air-removal (pre-vacuum) mode using a half cycle . of the recommended parameters for flash sterilization demonstrating a 10° SAL for the half cycle.
- Biocompatibility testing including cytotoxicity and irritation. .
- Thermal mapping studies for both gravity-displacement and pre-vacuum sterilization. .
- Performance Testing handle strength testing and valve life testing .

These tests demonstrate that the FlashPak Sterilization Container System functions as intended and is substantially equivalent to the legally marketed predicate device.

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10. Substantial Equivalence:

The FlashPak Sterilization Container System has the same indications for use as the predicate device, FlashPak Container System. While there are technological differences between the devices, such as the device material and dimensions, these differences do not raise new types of safety and effectiveness questions when all listed warnings and cautions are followed. The FlashPak Sterilization Container System is substantially equivalent to the marketed FlashPak Container System.

Symmetry Medical Inc.

Robert Johnson, Director of Quality

02-16-2012 Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three overlapping, curved lines forming the body and wings. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Mr. Robert Johnson Symmetry Medical Director of Quality 61 John Vertente Blvd New Bedford, Massachusetts 02745

AUG 8 2012

Re: K113776

Trade/Device Name: FlashPak® Sterilization Container System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: July 9, 2012 Received: July 16, 2012

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 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 controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

For

M.Dr.

Anthony D. Watson, B.S., M.S., M.B.A. 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 Form

Indications for Use

510(k) Number (if known): K113776

Device Name: FlashPak® Sterilization Container System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eli, Little B. Uamie-Webb

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: _ K113 アフレ

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).