RESTORE MODULAR STERILIZATION TRAY SYSTEM

K131455 · Restore Medical Solutions, Inc. · KCT · Aug 30, 2013 · General Hospital

Device Facts

• Record ID: K131455
• Device Name: RESTORE MODULAR STERILIZATION TRAY SYSTEM
• Applicant: Restore Medical Solutions, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses when used in conjunction with a FDA cleared sterilization wrap. The Modular Sterilization Tray System may be used with common surgical instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds.

Device Story

Restore™ Modular Sterilization Tray System is a reusable aluminum tray system designed for organizing and protecting surgical instruments during steam sterilization, transport, and storage. The system includes base trays (10x20x4 or 10x10x4 inches), lids, insert tray assemblies, silicone dividers, and an adjustable racking/stringer device. It features an evenly distributed perforated hole pattern to facilitate steam penetration and air removal. Used in healthcare facilities by sterile processing staff; instruments are placed in the tray, which is then wrapped in FDA-cleared sterilization wrap or placed in a rigid container. The system is processed via high-vacuum steam sterilization (270°F, 4-minute exposure). The tray ensures organized instrument delivery to the OR, maintaining sterility until use. Benefits include improved instrument organization, protection during handling, and validated sterilization efficacy for complex instrument sets.

Clinical Evidence

Bench testing only. Cleaning and sterilization validation performed under GLP conditions per AAMI TIR30:2011 and AAMI TIR12:2010. Validated parameters include high-vacuum steam sterilization (270°F, 4-minute exposure, 20-minute dry time) for a 20-pound load. Biocompatibility confirmed per ISO 10993.

Technological Characteristics

Materials: Aluminum trays/lids, 300 series stainless steel, biomedical grade silicone, Ultem HU1004 resin (stringer). Design: Perforated aluminum tray with modular inserts and adjustable racking. Energy: Steam sterilization (high vacuum). Connectivity: None. Sterilization: Steam (autoclave).

Indications for Use

Indicated for use in healthcare facilities to organize, enclose, sterilize, transport, and store surgical instruments (e.g., hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, short-lumened devices) weighing up to 20 lbs. Must be used with FDA-cleared sterilization wrap.

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

• PolyVac Surgical Instrument Delivery System (K012105)
• PolyVac Surgical Instrument Delivery System (K040223)

Submission Summary (Full Text)

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

# KIJ1455

Restore™ Modular Sterilization Tray System Traditional 510(k) — K131455

| | 510(k) SUMMARY | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Submitter Name: | Restore Medical Solutions, Inc. | | | | | | |
| Submitter Address: | 100 Peabody PL STE 150<br>P.O. Box 3118<br>Memphis, TN 38103 | | | | | | |
| Contact Person: | Shawn M. Flynn, President | | | | | | |
| Phone Number: | 404-805-8305 | | | | | | |
| Fax: | 636-680-3644 | | | | | | |
| Date Prepared: | May 20, 2013 | | | | | | |
| Device Trade Name: | Restore™ Modular Sterilization Tray System | | | | | | |
| Classification Name: | Sterilization Wrap Containers, Cassettes, and Accessories | | | | | | |
| Classification Class and Regulation Number: | Class II<br>21 CFR 880.6850 | | | | | | |
| Product Code: | KCT | | | | | | |
| Predicate Device(s): | K012105, PolyVac Inc., PolyVac Surgical Instrument Delivery System<br>K040223, Symmetry Medical Inc., PolyVac Surgical Instrument Delivery System | | | | | | |
| Statement of Intended Use: | The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses when used in conjunction with a FDA cleared sterilization wrap.<br><br>The Modular Sterilization Tray System may be used with common surgical instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds. | | | | | | |
| Reusable Medical Device Challenge Conditions | | | | | | | |
| | Minimum Inner Diameter Maximum Length Number of lumens 1.8 mm 4 inches 2 | | | | | | |
| High Vacuum (pre-vacuum, three pulse, standard):<br>Temp: 270° F | | | | | | | |
| Exposure Time: 4 Minutes<br>Cycle Dry Time (wrapped): 20 Minutes (minimum)<br>Cool Time: Varies according to load contents | | | | | | | |
| NOTE: Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome. | | | | | | | |

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

| Device Description: | The Restore ™ Modular Sterilization Tray System is designed using<br>materials that can be reused with steam sterilization methods. The<br>Restore ™ system has an even distribution of holes in relation to its<br>size for optimal steam penetration.<br><br>The basic system includes either a 10 x 20 x 4 inch or 10 x 10 x 4 inch<br>aluminum tray with lids and a variety of insert tray assemblies and lids.<br>The central function is an adjustable racking and multi-functioning<br>stringer device, which is designed for the organization and alignment<br>of surgical instruments for pre-sterilization cleaning decontamination,<br>and sterilization cycles of surgical devices in healthcare facilities.<br><br>For the sterilization process, the tray system may be either wrapped in<br>FDA-cleared sterilization wrap designed for this purpose or placed in a<br>rigid container. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Testing: | Cleaning and Sterilization Validation testing was performed by under<br>GLP conditions by a contract test laboratory according to AAMI<br>TIR30:2011 and AAMI TIR12:2010 standards. The testing validated<br>the parameters for vacuum settings, temperature, exposure time, cycle<br>dry time wrapped and in a sterilization container, and cool time. |
| Comparison to the<br>Predicate Devices: | The Restore ™ Modular Sterilization Tray System was compared to the<br>predicate devices by review of intended use and technological<br>characteristics - product design, device characteristics and materials.<br>Please refer to the Comparison Table for Substantial Equivalence on<br>pages 3 and 4 for the comparison parameters. |
| Substantial<br>Equivalence<br>Discussion: | The Restore tray system was found to be substantially equivalent<br>based on the same intended use and the side-by-side comparison of<br>the technological characteristics.<br><br>The additional Stringer feature offered by the Restore ™ Modular<br>Sterilization Tray System does not impact the intended use in<br>comparison to the predicate devices.<br><br>Further the validation testing of the loaded Restore tray system<br>assures the device is safe and effective for its intended use. |
| Verifications<br>regarding this 510(k)<br>Summary: | The summary includes only information that is also covered in the<br>body of the 510(k). The summary does not contain any puffery or<br>unsubstantiated labeling claims. The summary does not contain any<br>raw data, i.e., contains only summary data. The summary does not<br>contain any trade secret or confidential commercial information. The<br>summary does not contain any patient identification information |
| Substantial<br>Equivalence<br>Conclusion: | It is concluded that the Restore ™ Modular Sterilization Tray System is<br>substantially equivalent, based on the nonclinical testing (discussed<br>above) that demonstrates that the device is as safe, as effective, and<br>performs as well as or better than the predicate device. |

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

·

| | Proposed Device | Predicates | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Name | Restore™ Modular Sterilization Tray System | PolyVac Surgical Instrument Delivery System<br>K040223, K012105 | |
| 510(k) Number | | | |
| Product Code,<br>Regulation #,<br>Name | KCT<br>21 CFR 880.6850<br>Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT<br>21 CFR 880.6850<br>Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | |
| Manufacturer | Restore Medical Solutions, Inc. | Symmetry Medical, Inc. (Previously PolyVac, Inc for K012105) | |
| Indications for<br>Use Statement: | The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses when used in conjunction with a FDA cleared sterilization wrap.<br><br>The Modular Sterilization Tray System may be used with common surgical instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds. | The PolyVac's delivery systems consist of perforated trays with lids, which are intended to enclose and protect medical device instrumentation, and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical devices is maintained until used.<br><br>PolyVac's delivery systems are to be sterilized in one of the following cycles:<br>Prevacuum Steam: 132°C - 4 minutes minimum<br>Gravity Stream: 132°C - 30 minutes minimum<br>Gravity Stream: 121°C - 55 minutes minimum | |
| | | | |
| | | Sterilization Method: Ethylene Oxide (for K040223) | |
| | Reusable Medical Device Challenge Conditions | | |
| | Minimum Inner Diameter | Maximum Length | Number of lumens |
| | 1.8 mm | 4 inches | 2 |
| | High Vacuum (pre-vacuum, three pulse, | | |
| | standard):<br>Temp: 270° F | | |
| | Exposure Time: 4 Minutes | | |
| | Cycle Dry Time (wrapped): 20 Minutes (minimum)<br>Cool Time: Varies according to load contents | | |
| | NOTE: Cool drafts from air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome. | | |
| Device<br>Description:<br>Design,<br>Components,<br>Configurations,<br>Dimensions | Base trays (10 x 20 x 4 & 10 x 10 x 4 inches) Modular insert trays and lids. Evenly distributed perforated hole pattern. Silicone Dividers In-situ Racking Device/Stringer | Base tray (17.3 x 7.25 x 4 inches) Modular insert trays and lids. Evenly distributed perforated hole pattern. Silicone mats | |
| Material<br>Composition | Trays & Lids: Aluminum, 300 Series<br>stainless steel, biomedical grade<br>silicone<br>Stringer: Ultem*HU1004 Resin | Trays & Lids: Aluminum, 300 Series<br>stainless steel, biomedical grade<br>silicone; or Radal® R Plastic | |
| Sterilant<br>penetration | Each tray and lid contains evenly<br>distributed hole pattern in relation to its<br>size. | Each trays and lids contains evenly<br>distributed hole pattern in relation to its<br>size. | |
| Pre-Vac Steam<br>Sterilization<br>Validation<br>Parameters | High Vacuum (pre-vacuum, three pulse,<br>standard):<br>Temp: 270°F<br>Exposure Time: 4 Minutes<br>Cycle Dry Time: 15 Minutes (minimum)<br>Cool Time: Varies according to load<br>contents | Prevacuum Steam: 132°C - 4 minutes<br>minimum<br>Gravity Stream: 132°C - 30 minutes<br>minimum<br>Gravity Stream: 121°C - 55 minutes<br>minimum | |
| Reusable | Yes | Yes | |
| Material<br>Compatibility<br>with sterilization<br>process | Yes | Yes | |
| ISO 10993<br>Biocompatible | Yes | Yes | |

# Comparison Table for Substantial Equivalence

(table continues to next page)

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Public Health Service

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

#### August 30, 2013

Restore Medical Solutions, Incorporated C/O Ms. Patsy J. Trisler President Consultant Trisler Consulting 5600 Wisconsin Ave. #509 CHEVY CHASE Maryland 20815

Re: K131455

Trade/Device Name: Restore™ Modular Sterilization Tray System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: July 24, 2013 Received: July 26, 2013

## Dear Ms. Trisler:

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.

{5}------------------------------------------------

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Kwame Ulmer

# Lester W. Schultheis Jr

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

### Indications for Use Form

510(k) Number (if known): K131455

#### Device Name: Restore™ Modular Sterilization Tray System

Indications for Use:

The Restore™ Modular Sterilization Tray System is intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses when used in conjunction with a FDA cleared sterilization wrap.

The Modular Sterilization Tray System may be used with common surgical instruments such as hammers, rasps, drivers, chisels, ringed-handled instruments, rongeurs, pickups, including but not limited to short-lumened devices etc. The validated total weight for tray and contents was 20 pounds.

| Reusable Medical Device Challenge Conditions | | |
|----------------------------------------------|-------------------|---------------------|
| Minimum Inner<br>Diameter | Maximum<br>Length | Number of<br>lumens |
| 1.8 mm | 4 inches | 2 |

High Vacuum (pre-vacuum, three pulse, standard): Temp: 270° F Exposure Time: 4 Minutes Cycle Dry Time (wrapped): 20 Minutes (minimum) Cool Time: Varies according to load contents

NOTE: Cool drafts from alr ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Sreekanth Gutala -S Sreekanth Gutala -5
2013.08.29 14:43:28 -04'00' - 14:00 -

(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: ≤1314555

Section 4.0

Page 1 of 1