(102 days)
Not Found
No
The document describes a physical sterilization tray system and its validation for steam sterilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a sterilization tray system designed to organize, enclose, sterilize, transport, and store medical devices and other instrumentation, not to provide therapy itself.
No
Explanation: The device is described as a "Modular Sterilization Tray System" intended to "organize, enclose, sterilize, transport, and store medical devices". Its purpose is to facilitate the sterilization of surgical instruments, not to diagnose medical conditions or analyze health data.
No
The device description clearly outlines physical components made of aluminum and other materials, designed for organizing and sterilizing surgical instruments. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses". This describes a device used in the process of preparing and handling medical instruments, not for testing samples from the human body to diagnose conditions.
- Device Description: The description focuses on the physical components of the tray system and its function in organizing and facilitating the sterilization of surgical instruments. There is no mention of reagents, calibrators, controls, or any other components typically associated with IVD devices.
- Lack of IVD-related information: The document does not contain any information related to:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information
- Performance metrics like sensitivity, specificity, PPV, NPV, which are crucial for evaluating the accuracy of diagnostic tests.
The device is a sterilization tray system, which is a type of medical device used in the sterilization process of other medical instruments.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The Restore tray system was found to be substantially equivalent based on the same intended use and the side-by-side comparison of the technological characteristics.
The additional Stringer feature offered by the Restore ™ Modular Sterilization Tray System does not impact the intended use in comparison to the predicate devices.
Further the validation testing of the loaded Restore tray system assures the device is safe and effective for its intended use.
It is concluded that the Restore ™ Modular Sterilization Tray System is substantially equivalent, based on the nonclinical testing (discussed above) that demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 | ||||||
| P.O. Box 3118 | |||||||
| 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 | ||||||
| 21 CFR 880.6850 | |||||||
| Product Code: | KCT | ||||||
| Predicate Device(s): | K012105, PolyVac Inc., PolyVac Surgical Instrument Delivery System | ||||||
| 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. |
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 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. | | | | | | | |
1
| Device Description: | 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. |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Testing: | 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. |
| Comparison to the
Predicate Devices: | The Restore ™ Modular Sterilization Tray System was compared to the
predicate devices by review of intended use and technological
characteristics - product design, device characteristics and materials.
Please refer to the Comparison Table for Substantial Equivalence on
pages 3 and 4 for the comparison parameters. |
| Substantial
Equivalence
Discussion: | The Restore tray system was found to be substantially equivalent
based on the same intended use and the side-by-side comparison of
the technological characteristics.
The additional Stringer feature offered by the Restore ™ Modular
Sterilization Tray System does not impact the intended use in
comparison to the predicate devices.
Further the validation testing of the loaded Restore tray system
assures the device is safe and effective for its intended use. |
| Verifications
regarding this 510(k)
Summary: | The summary includes only information that is also covered in the
body of the 510(k). The summary does not contain any puffery or
unsubstantiated labeling claims. The summary does not contain any
raw data, i.e., contains only summary data. The summary does not
contain any trade secret or confidential commercial information. The
summary does not contain any patient identification information |
| Substantial
Equivalence
Conclusion: | It is concluded that the Restore ™ Modular Sterilization Tray System is
substantially equivalent, based on the nonclinical testing (discussed
above) that demonstrates that the device is as safe, as effective, and
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 | |
| K040223, K012105 | |||
| 510(k) Number | |||
| Product Code, | |||
| Regulation #, | |||
| Name | KCT | ||
| 21 CFR 880.6850 | |||
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | ||
| 21 CFR 880.6850 | |||
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | |||
| Manufacturer | Restore Medical Solutions, Inc. | Symmetry Medical, Inc. (Previously PolyVac, Inc for K012105) | |
| Indications for | |||
| 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. |
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 minimum
Gravity Stream: 132°C - 30 minutes minimum
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):
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. | | |
| Device
Description:
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 | |
| Material
Composition | Trays & Lids: Aluminum, 300 Series
stainless steel, biomedical grade
silicone
Stringer: Ultem*HU1004 Resin | Trays & Lids: Aluminum, 300 Series
stainless steel, biomedical grade
silicone; or Radal® R Plastic | |
| Sterilant
penetration | Each tray and lid contains evenly
distributed hole pattern in relation to its
size. | Each trays and lids contains evenly
distributed hole pattern in relation to its
size. | |
| Pre-Vac Steam
Sterilization
Validation
Parameters | High Vacuum (pre-vacuum, three pulse,
standard):
Temp: 270°F
Exposure Time: 4 Minutes
Cycle Dry Time: 15 Minutes (minimum)
Cool Time: Varies according to load
contents | Prevacuum Steam: 132°C - 4 minutes
minimum
Gravity Stream: 132°C - 30 minutes
minimum
Gravity Stream: 121°C - 55 minutes
minimum | |
| Reusable | Yes | Yes | |
| Material
Compatibility
with sterilization
process | Yes | Yes | |
| ISO 10993
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 (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
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 | ||
| 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 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
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