(102 days)
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 Diameter: 1.8 mm
Maximum Length: 4 inches
Number of lumens: 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 air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome.
The Restore ™ Modular Sterilization Tray System is designed using materials that can be reused with steam sterilization methods. The Restore ™ system has an even distribution of holes in relation to its size for optimal steam penetration.
The basic system includes either a 10 x 20 x 4 inch or 10 x 10 x 4 inch aluminum tray with lids and a variety of insert tray assemblies and lids. The central function is an adjustable racking and multi-functioning stringer device, which is designed for the organization and alignment of surgical instruments for pre-sterilization cleaning decontamination, and sterilization cycles of surgical devices in healthcare facilities.
For the sterilization process, the tray system may be either wrapped in FDA-cleared sterilization wrap designed for this purpose or placed in a rigid container.
This request is regarding the K131455 510(k) submission for the Restore™ Modular Sterilization Tray System. The document provided outlines the device's intended use and performance within the context of sterilization, but does not describe an AI/ML-driven medical device.
Therefore, I cannot populate the table or provide information for questions 2-9 as the provided text relates to a physical medical device (sterilization tray) and does not involve AI/ML performance metrics, studies with human readers, or ground truth establishment for a diagnostic algorithm.
The core of the documentation focuses on physical device performance related to sterilization efficacy (e.g., steam penetration, dry time, material compatibility).
Here's the closest interpretation of the acceptance criteria and study that can be extracted from the provided text, focusing on the device's primary function of sterilization.
Acceptance Criteria and Device Performance (Based on Sterilization Validation):
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance/Validation |
|---|---|---|
| Sterilization Efficacy (High Vacuum Steam) | Successful sterilization of common surgical instruments, including but not limited to short-lumened devices, when used in conjunction with an FDA cleared sterilization wrap. Validated total weight for tray and contents: 20 pounds. | Validated Parameters:- 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 air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome).- Reusable Medical Device Challenge Conditions: Minimum Inner Diameter 1.8 mm, Maximum Length 4 inches, Number of lumens 2.- Pre-Vac Steam Sterilization Validation Parameters: High Vacuum (three pulse, standard).Study Execution: "Cleaning and Sterilization Validation testing was performed by under GLP conditions by a contract test laboratory according to AAMI TIR30:2011 and AAMI TIR12:2010 standards. The testing validated the parameters for vacuum settings, temperature, exposure time, cycle dry time wrapped and in a sterilization container, and cool time." |
| Material Compatibility/Reusability | Device materials (aluminum, stainless steel, biomedical grade silicone, Ultem*HU1004 Resin) must be compatible with steam sterilization methods and allow for reuse. | "Designed using materials that can be reused with steam sterilization methods.""Material Compatibility with sterilization process: Yes""ISO 10993 Biocompatible: Yes""Reusable: Yes" |
| Steam Penetration | Even distribution of holes in relation to its size for optimal steam penetration. | "The Restore ™ system has an even distribution of holes in relation to its size for optimal steam penetration.""Each tray and lid contains evenly distributed hole pattern in relation to its size." |
Since this is not an AI/ML device, the following questions are not applicable to the provided document. I will state why for each:
- Sample sizes used for the test set and the data provenance: Not applicable. This is a physical device. "Test set" here refers to physical validation tests (e.g., sterilization cycles, material durability assays), not a data set for an algorithm. Data provenance (country of origin, retrospective/prospective) is irrelevant for this type of device validation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical sterilization tray is established through objective physical and microbiological testing (e.g., sterility testing, Bowie-Dick tests, temperature mapping), not expert consensus on images or diagnostic interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic image interpretation, which is not relevant for this device.
- 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 a physical medical device, not an AI/ML algorithm intended to assist human readers in tasks like image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective physical and microbiological validation of sterilization efficacy, material integrity, and reusability, based on established industry standards (AAMI TIR30:2011 and AAMI TIR12:2010). It's not a diagnostic "ground truth" derived from expert consensus or pathology.
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable. As there's no AI/ML training set, there's no ground truth to establish for it.
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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 150P.O. Box 3118Memphis, 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 II21 CFR 880.6850 | ||||||
| Product Code: | KCT | ||||||
| Predicate Device(s): | K012105, PolyVac Inc., PolyVac Surgical Instrument Delivery SystemK040223, 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.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):Temp: 270° F | |||||||
| Exposure Time: 4 MinutesCycle Dry Time (wrapped): 20 Minutes (minimum)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. |
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| Device Description: | The Restore ™ Modular Sterilization Tray System is designed usingmaterials that can be reused with steam sterilization methods. TheRestore ™ system has an even distribution of holes in relation to itssize for optimal steam penetration.The basic system includes either a 10 x 20 x 4 inch or 10 x 10 x 4 inchaluminum tray with lids and a variety of insert tray assemblies and lids.The central function is an adjustable racking and multi-functioningstringer device, which is designed for the organization and alignmentof surgical instruments for pre-sterilization cleaning decontamination,and sterilization cycles of surgical devices in healthcare facilities.For the sterilization process, the tray system may be either wrapped inFDA-cleared sterilization wrap designed for this purpose or placed in arigid container. |
|---|---|
| Summary ofTesting: | Cleaning and Sterilization Validation testing was performed by underGLP conditions by a contract test laboratory according to AAMITIR30:2011 and AAMI TIR12:2010 standards. The testing validatedthe parameters for vacuum settings, temperature, exposure time, cycledry time wrapped and in a sterilization container, and cool time. |
| Comparison to thePredicate Devices: | The Restore ™ Modular Sterilization Tray System was compared to thepredicate devices by review of intended use and technologicalcharacteristics - product design, device characteristics and materials.Please refer to the Comparison Table for Substantial Equivalence onpages 3 and 4 for the comparison parameters. |
| SubstantialEquivalenceDiscussion: | The Restore tray system was found to be substantially equivalentbased on the same intended use and the side-by-side comparison ofthe technological characteristics.The additional Stringer feature offered by the Restore ™ ModularSterilization Tray System does not impact the intended use incomparison to the predicate devices.Further the validation testing of the loaded Restore tray systemassures the device is safe and effective for its intended use. |
| Verificationsregarding this 510(k)Summary: | The summary includes only information that is also covered in thebody of the 510(k). The summary does not contain any puffery orunsubstantiated labeling claims. The summary does not contain anyraw data, i.e., contains only summary data. The summary does notcontain any trade secret or confidential commercial information. Thesummary does not contain any patient identification information |
| SubstantialEquivalenceConclusion: | It is concluded that the Restore ™ Modular Sterilization Tray System issubstantially equivalent, based on the nonclinical testing (discussedabove) that demonstrates that the device is as safe, as effective, andperforms as well as or better than the predicate device. |
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·
| Proposed Device | Predicates | ||
|---|---|---|---|
| Product Name | Restore™ Modular Sterilization Tray System | PolyVac Surgical Instrument Delivery SystemK040223, K012105 | |
| 510(k) Number | |||
| Product Code,Regulation #,Name | KCT21 CFR 880.6850Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT21 CFR 880.6850Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | |
| Manufacturer | Restore Medical Solutions, Inc. | Symmetry Medical, Inc. (Previously PolyVac, Inc for K012105) | |
| Indications forUse 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.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.PolyVac's delivery systems are to be sterilized in one of the following cycles:Prevacuum Steam: 132°C - 4 minutes minimumGravity Stream: 132°C - 30 minutes minimumGravity 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):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 air ducts or other air currents should be avoided during the cooling phase to avoid post-sterilization moisture caused by rapid cooling syndrome. | |||
| DeviceDescription:Design,Components,Configurations,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 | |
| MaterialComposition | Trays & Lids: Aluminum, 300 Seriesstainless steel, biomedical gradesiliconeStringer: Ultem*HU1004 Resin | Trays & Lids: Aluminum, 300 Seriesstainless steel, biomedical gradesilicone; or Radal® R Plastic | |
| Sterilantpenetration | Each tray and lid contains evenlydistributed hole pattern in relation to itssize. | Each trays and lids contains evenlydistributed hole pattern in relation to itssize. | |
| Pre-Vac SteamSterilizationValidationParameters | High Vacuum (pre-vacuum, three pulse,standard):Temp: 270°FExposure Time: 4 MinutesCycle Dry Time: 15 Minutes (minimum)Cool Time: Varies according to loadcontents | Prevacuum Steam: 132°C - 4 minutesminimumGravity Stream: 132°C - 30 minutesminimumGravity Stream: 121°C - 55 minutesminimum | |
| Reusable | Yes | Yes | |
| MaterialCompatibilitywith sterilizationprocess | Yes | Yes | |
| ISO 10993Biocompatible | Yes | Yes |
Comparison Table for Substantial Equivalence
(table continues to next page)
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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.
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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 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 (800) 638-2041 or (301) 796-7100 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 (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 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
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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 InnerDiameter | MaximumLength | Number oflumens |
| 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
§ 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).