(163 days)
No
The device description and intended use clearly define the device as a physical container for organizing, sterilizing, transporting, and storing medical devices. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML. The performance studies focus on physical properties and sterilization efficacy, not algorithmic performance.
No
The device is described as a cassette for organizing, enclosing, sterilizing, transporting, and storing medical devices, not for treating a disease or condition in a patient.
No
The device is described as a transportation/sterilization cassette for organizing, enclosing, sterilizing, transporting, and storing medical devices. There is no indication or mention that its function involves diagnosing any medical condition.
No
The device description clearly states it is fabricated from physical materials (metals and thermoplastic polymers) and is a physical container system for sterilization and transport. It does not describe any software components.
Based on the provided information, the Medtronic Transportation/Sterilization Cassettes are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the cassettes are for organizing, enclosing, sterilizing, transporting, and storing medical devices and other instrumentation. This is related to the handling and preparation of medical devices, not for performing diagnostic tests on samples taken from the human body.
- Device Description: The description details the physical components and materials of the cassettes, focusing on their function in protecting and facilitating the sterilization of other medical devices. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays
- Measuring specific analytes
The Medtronic Transportation/Sterilization Cassettes are accessories used in the process of preparing and handling other medical devices, specifically for sterilization and transport. They do not perform any diagnostic function themselves.
N/A
Intended Use / Indications for Use
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
Product codes (comma separated list FDA assigned to the subject device)
KCT
Device Description
The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices which meet national or international specifications. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation/Sterilization Cassettes design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components of the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for sterilization via steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Thus allowing the Medtronic Transportation/Sterilization Cassettes to be effective for sterilization and are designed such that they withstand the environment of repeated steam sterilization cycles.
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)
The testing of the Medtronic Transportation/Sterilization Cassettes is supported by packaging testing, sterilization validations, and biocompatibility testing. The performance testing performed on the Medtronic Transportation/Sterilization Cassettes was tested and validated to the greatest challenge (worst case).
Medtronic Transportation/Sterilization Cassettes were evaluated on the ability to withstand the distribution environment. The distribution testing concluded that the Medtronic Transportation/Sterilization Cassettes were able to withstand the distribution environment. The testing was conducting in accordance with ASTM D4169: 2009 – "Standard Practice for Performance Testing of Shipping Containers and Systems".
To establish substantial equivalence with a predicate device, the performance testing was conducted to confirm that SAL (10 %) sterility level was achieved at the validated sterilization parameters. The testing was conducting in accordance with the following standards: AAMI TIR39: 2009, AAMI TIR30: 2011, AAMI TIR17: 2008, AAMI TIR12: 2010, ANSI/AAMI ST81: 2004, ANSI/AAMI ST79: 2010 (R) 2014, ANSI/AAMI/ISO TIR17665-2: 2009, ANSI/AAMI/ISO 17665-1: 2006, ISO 17664: 2004, ANSI/AAMI/ISO 14161: 2009, ANSI/AAMI/ISO 11737-2: 2009.
The Medtronic Transportation/Sterilization Cassettes do not have direct patient contact. The Medtronic Transportation/Sterilization Cassette components are fabricated from a variety of intrinsically stable metals and thermoplastics. Based on the testing performed, should substances transfer from the Medtronic Transportation/Sterilization Cassettes they would not present a chemical hazard. The assessment was conducted based on ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process".
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.
K131455, K033222, K993535, K120947
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.
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
Image /page/0/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 a human figure, represented by three overlapping profiles, suggesting a sense of community and care. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 20, 2016
Medtronic Sofamor Danek Ms. Victoria Scheitlin Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K152241
Trade/Device Name: Medtronic Transportation/Sterilization Cassettes Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: Class II Product Code: KCT Dated: December 18, 2015 Received: December 21, 2015
Dear Ms. Scheitlin:
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.
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152241
Device Name Medtronic Transportation/Sterilization Cassettes
Indications for Use (Describe)
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
Sterilization validations for the worst case Medtronic Transportation Cassette (22.75 x 11.26 x 5.5 inches) included implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated total weight was 28.4lbs. The validated worst case loading configurations of the Medtronic Transportation/ Sterilization Cassette included the following worst case lumen dimensions.
- 363 x 1.575mm - 247.5 x 4.1mm
Device List:
1850060 Case - Triple Generic Outer Base (22.74 x 11.260 x 5.040 inches) 1850064 Lid - Generic Outer Lid (22.75 x 11.260 x 0.470 inches) 7022101L Tray Lid (21 x 10.13 x 0.075 inches) P1850061 Tray 1 (20.75 x 9.79 x 1.32 inches) P1850062 Tray 2 (21 x 10.13 x 1.69 inches) P1850063 Tray 3 (21 x 10.13 x 1.38 inches) 7059532 Large Caddy (9.47 x 6.37 x 1.3 inches) 7059532L Large Lid (5.85 x 4.725 x 0.095 inches) P9213018 Small Caddy (2 x 1.5 x 1.025 inches) P9213018 Small Lid (2 x 1.29 x 0.095 inches)
Sterilization Parameters:
| Cycle | Temperature | Exposure time | Minimum dry time |
|---|---|---|---|
| Gravity Displacement | 250°F (121°C) | 30 Minutes | 30 Minutes |
| Gravity Displacement | 270°F (132°C) | 15 Minutes | 30 Minutes |
| Gravity Displacement | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Dynamic-Air-Removal | |||
| (4 Pre-conditioning pulses) | 270°F (132°C) | 4 Minutes | 30 Minutes |
| Dynamic-Air-Removal | |||
| (4 Pre-conditioning pulses) | 275°F (135°C) | 3 Minutes | 30 Minutes |
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) SUMMARY
MEDTRONIC Sofamor Danek Medtronic Transportation/Sterilization Cassettes January 19, 2015
| Company: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, Tennessee 38132
(800) 876-3133 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Victoria Scheitlin
Regulatory Affairs Specialist
Telephone: (901) 344-0706 |
| Date Prepared: | Fax: (901) 346-9738
January 19, 2015 |
| Device: | |
| Name of Device: | Medtronic Transportation/Sterilization Cassettes |
| 510(k) Number: | K152241 |
| Classification Name: | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (21 CFR 880.6850) |
| Class: | II |
| Product Code: | KCT |
| Predicate Devices: | K131455 (Primary Predicate) – Restore Modular Sterilization Tray System (S.E. 08/30/2013)K033222 – Olympus Sterilization Trays (S.E. 08/02/2004)K993535 – Metapak Multi-Purpose Instrument Tray (S.E. 12/07/2001)K120947 – THS Sterilization Tray |
- K120947 THS Sterilization Tray . (S.E. 10/17/2012)
Additionally, this submission contains a reference device K130720 -Synthes Reusable Sterilization Container Systems (S.E. 08/14/2014). The Synthes Reusable Sterilization Container Systems are fabricated from similar materials to those used in the Medtronic Transportation/Sterilization Cassettes, specifically nylon and polypropylene. The reference device also has a similar sterilization method, design configuration options and sizes. The predicates have not been subject to a design related recall that
Medtronic is aware.
IV. Description:
The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a
5
variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices which meet national or international specifications. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation/Sterilization Cassettes design consists of multiple components designed to be integrated into a single unit, which protects the interior components during transportation, sterilization, and storage. These components consist of: an outer base, internal individual trays with or without lids, caddies and an outer locking lid. The components of the Medtronic Transportation/Sterilization Cassettes are fabricated from intrinsically stable metals and thermoplastic polymers. All of the components of the Medtronic Transportation/Sterilization Cassettes are perforated with an evenly distributed hole pattern, and are designed to be used for sterilization via steam sterilization. Since the Medtronic Transportation/Sterilization Cassettes are perforated, an FDA cleared wrap must be used for sterilization purposes and to maintain the sterility of the contents. The Medtronic Transportation/Sterilization Cassettes are designed to be used with standard autoclaves used in hospitals and healthcare facilities. Thus allowing the Medtronic Transportation/Sterilization Cassettes to be effective for sterilization and are designed such that they withstand the environment of repeated steam sterilization cycles.
V. Indications For Use:
The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap.
Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassette (22.75 x 11.26 x 5.5 inches) included implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated total weight was 28.4lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassette included the following worst case lumen dimensions:
- 363 x 1.575mm - 247.5 x 4.1mm
Device List: 1850060 Case - Triple Generic Outer Base (22.74 x 11.260 x 5.040 inches) 1850064 Lid - Generic Outer Lid (22.75 x 11.260 x 0.470 inches)
6
7022101L Tray Lid (21 x 10.13 x 0.075 inches) P1850061 Tray 1 (20.75 x 9.79 x 1.32 inches) P1850062 Tray 2 (21 x 10.13 x 1.69 inches) P1850063 Tray 3 (21 x 10.13 x 1.38 inches) 7059532 Large Caddy (9.47 x 6.37 x 1.3 inches) 7059532L Large Lid (5.85 x 4.725 x 0.095 inches) P9213018 Small Caddy (2 x 1.5 x 1.025 inches) P9213018 Small Lid (2 x 1.29 x 0.095 inches)
Sterilization Parameters:
| Cycle | Temperature | Exposure time | Minimum dry time |
|---|---|---|---|
| Gravity | |||
| Displacement | 250°F (121°C) | 30 Minutes | 30 Minutes |
| Gravity | |||
| Displacement | 270°F (132°C) | 15 Minutes | 30 Minutes |
| Gravity | |||
| Displacement | 275°F (135°C) | 10 Minutes | 30 Minutes |
| Dynamic-Air- | |||
| Removal | |||
| (4 Pre-conditioning | |||
| pulses) | 270°F (132°C) | 4 Minutes | 30 Minutes |
| Dynamic-Air- | |||
| Removal | |||
| (4 Pre-conditioning | |||
| pulses) | 275°F (135°C) | 3 Minutes | 30 Minutes |
VI. Comparison of Technological Characteristics and Performance Data with the Predicate Devices:
Table 2 and Table 3 display the comparison of the Medtronic Transportation/Sterilization Cassettes compared against the predicates. The comparison analysis was performed to support the substantial equivalence of the Medtronic Transportation/Sterilization Cassettes and trays to the listed predicates.
The Medtronic Transportation/Sterilization Cassettes were validated to be the greatest challenge (worst case). The Medtronic Transportation/Sterilization Cassettes described within this submission were determined to be the worst case configuration for sterilization and reprocessing due to the weight, percent perforation, and the number of trays and caddies included within the final configuration in the entirety.
7
| Feature | | Subject Device | K131455
(Primary
Predicate) | K033222 | K993535 | K120947 |
|---------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1. Trade Name | Medtronic Transportation/Sterilization Cassettes | Restore™
Modular
Sterilization
Tray System | Olympus
Sterilization
Trays | Metapak
Multi-Purpose
Instrument
Tray | THS
Sterilization
Tray |
| 2. | Fundamental
Scientific
Technology | Sterilization Cassette | Same | Same | Same | Same |
| 2. | Intended Use | The Medtronic Transportation/Sterilization Cassettes
are intended for use in healthcare facilities to organize,
enclose, sterilize, transport, and store medical devices
and other instrumentation between surgical and other
medical uses. The Medtronic
Transportation/Sterilization Cassettes are not intended
on their own to maintain sterility; it is intended to be
used in conjunction with a legally marketed, validated,
FDA-cleared sterilization wrap. | 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 Olympus
sterilization
trays are
intended to
be used to
enclose
Olympus
medical
devices
including
hand
instruments,
trocars,
camera
heads,
adapter, and
endoscopes
to be
sterilized by a
health care
provider. It is
intended to
allow steam
sterilization of
the enclosed
medical | The Riley
Metapak
Multi-Purpose
Instrument
Tray is used
for loading
surgical
instruments in
order to
conveniently
organize,
sterilizes,
transports
and store the
instruments
between use.
The Riley
Metapak
Multi-Purpose
Instrument
Tray can be
used in pre-
vacuum
steam and
ethylene
oxide | The THS
Sterilization
Tray is used
to enclose,
protect, and
organize the
THS scopes,
diagnostic
sheath, and
associated
accessory
components,
and to
facilitate the
sterilization
process by
allowing
sterilant
penetration
and air
removal when
used in
conjunction
with an
approved
sterilization |
| | Feature | Subject Device | K131455
(Primary
Predicate) | K033222 | K993535 | K120947 |
| | | | | device. | sterilization | wrap. |
| 3. | Product Code | KCT | KCT | KCT | KCT | KCT |
| 4. | Material
Composition | Thermoplastic polymers, aluminum, and stainless steel | Thermoplastic
polymers,
aluminum, and
stainless steel | Thermoplasti
c polymers
and stainless
steel | Thermoplasti
c polymers,
aluminum,
and stainless
steel | Thermoplasti
c polymers,
aluminum,
and stainless
steel |
| 5. | Design | A base, a lid with a locking latch, and individual inserts | A base, a lid,
and individual
inserts | A bottom, a
lid with
locking tabs,
and individual
inserts | A base, a lid
with latches,
and individual
inserts | A base, a lid,
and individual
inserts |
| 6. | Dimensions | The greatest challenge dimension was assessed to be:
22.75 x 11.26 x 5.51 inches
The inserts are offered in different sizes | 10 x 20 x 4
inches or
a 10 x 10 x 4
inches tray with
a lid.
The inserts
are offered in
different sizes
(not specified
in summary.) | A wide variety
of dimensions
and
configurations
ranging from:
405 x 95 x
200mm (16 x
4 x 8 inches)
to
665 x 52 x
204mm (26 x
2 x 8 inches) | Bases and
lids are
offered in 3
sizes:
• 22 x 10 x 6
inches
• 22 x 10 x 4
inches
• 26 x 10 x 6
inches
Insert trays
are offered in
2 sizes:
• 21 x 9.5 x
2.5 inches
• 10 x 9.5 x
2.5 inches
The inserts
are offered
in different
sizes (not
specified in
summary.) | The "base"
tray is
17.3 x 7.25 x
4 inches
The inserts
are offered in
different sizes
(not specified
in summary.) |
Table 2: Substantial Equivalence - Comparison of Medtronic Transportation/Sterilization Cassettes with Predicates on Technological Characteristics
8
9
| Feature | Subject Device | K131455
(Primary
Predicate) | K033222 | K993535 | K120947 | | | |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7. Configuration | Perforated bases, lids, and inserts | Perforated
bases, lids,
and inserts | • Perforated
or Solid
Lids
• Perforated
Bottoms | Perforated
bases, lids,
and inserts | Perforated
bases, lids,
and inserts | | | |
| 8. Air Permeance | Yes | Yes | Yes | Yes | Yes | | | |
| 9. Percent
Perforation | Evenly distributed hole pattern. | Evenly
distributed hole
pattern. | Evenly
distributed
hole pattern. | Evenly
distributed
hole pattern. | Evenly
distributed
hole pattern. | | | |
| 10. Sterilization
Method | • Pre-Vacuum
• Gravity Displacement | High Vacuum
Steam | Pre-
vacuum
Steam | • Pre-vacuum
Steam
• Ethylene
Oxide
Sterilization | •Pre-Vacuum
•Gravity
Displacement | | | |
| 11. Sterilization
Parameters | Cycle
Gravity
Displacement
Gravity
Displacement
Gravity
Displacement
Dynamic-Air-
Removal
(4 Pre-
conditioning
pulses)
Dynamic-Air-
Removal
(4 Pre-
conditioning
pulses) | Temperature
250°F
(121°C)
270°F
(132°C)
275°F
(135°C)
270°F
(132°C)
275°F
(135°C) | Exposure
time
30
Minutes
15
Minutes
10
Minutes
4
Minutes
3
Minutes | Minimum
dry time
30
Minutes
30
Minutes
30
Minutes
30
Minutes
30
Minutes | 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 | Prevacuum
Steam: 132°C
- 134°C
5 minutes
minimum
Drying Time:
10 –20
minutes as
needed. | Not provided
in 510(k)
Summary | Pre-Vacuum
Parameters:
270°F for 4
minutes
Pre-Vacuum
Dry Time: 30
minutes
Gravity
Parameters:
250°F for 30
minutes
Gravity Dry
Time: 30
minutes |
| 12. Reusable | Yes | Yes | Yes | Yes | Yes | | | |
10
| | Feature | Subject Device | K131455
(Primary
Predicate) | K033222 | K993535 | K120947 |
|----|--------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|-----------------------------------------|-----------------------------------------|
| 1. | Sterilant
Penetration | Yes | Yes | Yes | Yes | Yes |
| 2. | Microbial
Barrier
Properties | To be used with an
FDA approved
sterilization wrap | To be used with an
FDA approved
sterilization wrap | To be used with an
FDA approved
sterilization wrap | No claims are
made in the
summary | No claims are
made in the
summary |
| 3. | Material
Compatibility
with
Sterilization
Method | Materials are
compatible with
sterilization
method | Yes | Compatible to
Steam Sterilization
at 132°C | Yes | Yes |
| 4. | Toxicological
Properties | Materials are
biocompatible | Materials are
biocompatible | Materials are
biocompatible | Not stated in
summary | Not stated in
summary |
Table 3: Substantial Equivalence - Comparison of Medtronic Transportation/Sterilization Cassettes with Predicates on Performance Data
No new issues of safety or effectiveness have been raised, based on the nonclinical tests performed. There are no differences between the subject and predicate devices. The subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices.
11
VII. Performance Testing
The testing of the Medtronic Transportation/Sterilization Cassettes is supported by packaging testing, sterilization validations, and biocompatibility testing. . The performance testing performed on the Medtronic Transportation/Sterilization Cassettes was tested and validated to the greatest challenge (worst case).
Medtronic Transportation/Sterilization Cassettes were evaluated on the ability to withstand the distribution environment. The distribution testing concluded that the Medtronic Transportation/Sterilization Cassettes were able to with stand the distribution environment. The testing was conducting in accordance with ASTM D4169: 2009 – "Standard Practice for Performance Testing of Shipping Containers and Systems".
To establish substantial equivalence with a predicate device, the performance testing was conducted to confirm that SAL (10 %) sterility level was achieved at the validated sterilization parameters. The testing was conducting in accordance with the following standards:
- . AAMI TIR39: 2009 "Guidance On Selecting A Microbial Challenge And Inoculation Sites For Sterilization Validation Of Medical Devices"
- AAMI TIR30: 2011 "A Compendium Of Processes, Materials, Test ● Methods, And Acceptance Criteria For Cleaning Reusable Medical Devices"
- AAMI TIR17: 2008 "Compatibility Of Materials Subject To ● Sterilization"
- AAMI TIR12: 2010 "Designing, Testing, And Labeling Reusable . Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers"
- ANSI/AAMI ST81: 2004 "Sterilization Of Medical Devices-. Information To Be Provided By The Manufacturer For The Processing Of Resterilizable Medical Devices"
- ANSI/AAMI ST79: 2010 (R) 2014 "Comprehensive Guide To Steam ● Sterilization And Sterility Assurance In Health Care Facilities -Incorporates "
- ANSI/AAMI/ISO TIR17665-2: 2009 "Sterilization Of Health Care ● Products - Moist Heat - Part 2"
- ANSI/AAMI/ISO 17665-1: 2006 "Sterilization Of Health Care ● Products-Moist Heat-Part 1: Requirements For The Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices"
- ISO 17664: 2004 "Sterilization Of Medical Devices Information To ● Be Provided By The Manufacturer For The Processing Of Resterilizable Medical Device"
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- ANSI/AAMI/ISO 14161: 2009 "Sterilization Of Health Care Products ● — Biological Indicators — Guidance For The Selection, Use And Interpretation Of Results "
- ANSI/AAMI/ISO 11737-2: 2009 "Sterilization Of Medical Devices ● Microbiological Methods — Part 2: Tests Of Sterility Performed In The Definition, Validation And Maintenance Of A Sterilization Process "
The Medtronic Transportation/Sterilization Cassettes do not have direct patient contact. The Medtronic Transportation/Sterilization Cassette components are fabricated from a variety of intrinsically stable metals and thermoplastics. Based on the testing performed, should substances transfer from the Medtronic Transportation/Sterilization Cassettes they would not present a chemical hazard. The assessment was conducted based on ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process".
VIII. Conclusion:
Results of performance testing, and the similarities with legally marketed predicate devices it can be concluded that the Medtronic Transportation/Sterilization Cassettes will perform to the intended use. Medtronic believes that the subject Transportation/Sterilization Cassettes is substantially equivalent to the following predicates:
- Predicate 1 Restore Modular Sterilization Tray System ● K131455 (S.E. 08/30/2013)
- Predicate 2 Olympus Sterilization Trays K033222 (S.E. ● 08/02/2004)
- Predicate 3 Metapak Multi-Purpose Instrument Tray . K993535 (S.E. 12/07/2001)
- Predicate 4 THS Sterilization Tray K120947 (S.E. ● 10/17/2012)
- Reference Device K130720 Synthes Reusable ● Sterilization Container Systems (S.E. 08/14/2014) for the fabrication of nylon and polypropylene as materials.
No new issues of safety or effectiveness have been raised, based on the nonclinical tests performed. The subject device is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices. Therefore, the Medtronic Transportation/Sterilization Cassettes are considered to be substantially equivalent to the predicate devices, Class II (21 CFR 880.6850), Product code KCT.