iTotal Family Reusable Instrument Tray

• K Number: K170226
• Device Name: iTotal Family Reusable Instrument Tray
• Manufacturer: CONFORMIS, INC
• Date Cleared: 2017-10-25 ( 273 days)
• Product Code: KCT
• Regulation Number: 880.6850

Intended Use

The iTotal Family Reusable Instrument Tray is intended to house the reusable instrumentation associated with ConforMIS knee implant systems and define their organization during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows: Cycle Type: Pre-vacuum Temperature: 132°C (270°F) Exposure Time: 4 minutes Dry Time: 30 minutes

Device Description

The iTotal Family Reusable Instrument Tray is a sterilization tray with perforations and brackets to hold ConforMIS knee implant reusable instrumentation. Label plates are provided to indicate where specific reusable instrumentation should be placed within the tray. The sterilization tray consists of two layers. The base layer of the tray is a full tray which includes an accessory box to hold small items. The top layer of the sterilization tray is made up of one removable tray that is ¾ the length of the overall tray and a second removable tray that is ¼ the length of the overall tray. A lid is provided with the tray and is equipped with handles to allow the user to carry the tray.

Predicate Devices

K161347, K130532

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterilization tray for surgical instruments and the description focuses on its physical design and sterilization validation, with no mention of AI/ML capabilities.

Therapeutic

No.

The device is an instrument tray intended for sterilization, transportation, and storage of reusable instrumentation, not for directly treating a medical condition.

Diagnostic

No

The device is described as a sterilization tray, intended to hold instruments for sterilization and storage, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization tray designed to hold and organize surgical instruments. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the tray is for housing reusable surgical instruments for knee implant systems, facilitating their sterilization, transportation, and storage. This is a function related to the preparation and handling of surgical tools, not the examination of specimens from the human body to provide information for diagnosis, monitoring, or treatment.
• Device Description: The description details a sterilization tray with features for organizing and holding instruments. This aligns with a medical device used in a surgical setting, not an IVD.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, the iTotal Family Reusable Instrument Tray is a medical device used in a surgical context, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The iTotal Family Reusable Instrument Tray is intended to house the ConforMIS reusable instrumentation associated with ConforMIS knee implant systems and define their organization and configuration during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.

The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
Cycle Type: Pre-vacuum
Temperature: 132°C (270°F)
Exposure Time: 4 minutes
Dry Time: 30 minutes

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

The iTotal Family Reusable Instrument Tray is a sterilization tray with perforations and brackets to hold ConforMIS knee implant reusable instrumentation. Label plates are provided to indicate where specific reusable instrumentation should be placed within the tray. The sterilization tray consists of two layers. The base layer of the tray is a full tray which includes an accessory box to hold small items. The top layer of the sterilization tray is made up of one removable tray that is ¾ the length of the overall tray and a second removable tray that is ¼ the length of the overall tray. A lid is provided with the tray and is equipped with handles to allow the user to carry the tray. The tray may contain the following instruments: . Keel punches (not to exceed 6 per load) . Patella clamp (not to exceed 1 per load) . Angel wing resection quide (not to exceed 1 per load) . Alignment rod tapers (not to exceed 2 per load) . Drill bits and adaptors (not to exceed 6 per load) ● Coring tool with adaptors (not to exceed 1 per load) . Pin puller (not to exceed 1 per load) ● Impactor handles, heads, and tips (not to exceed 5 per load) . Townley caliper (not to exceed 1 per load) ● Patellar osteotomy guide (not to exceed 1 per load)

• . Patella trials (not to exceed 5 per load)
• . Patella sizers (not to exceed 5 per load)
• . Guidance plugs (not to exceed 2 per load)
• . Steinman pins (not to exceed 7 per load)
• . Tack pins (not to exceed 3 per load)

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

hospital environment

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)

Non-clinical testing was conducted to confirm that the iTotal Family Reusable Instrument Tray is similar to the predicates.
Specifically, the following testing was performed to establish similarity:

• Cleaning and Disinfection Validation .
• . Sterilization and Dry Time Validation
• . Shelf Life Testing
• Reprocessing Fatigue Simulation .

All testing has demonstrated that the device is similar to the predicate devices.

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.

K161347, K130532

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

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

ConforMIS, Inc Emmaniel Nyakako Sr. Vice President, Quality and Regulatory Affairs 28 Crosby Drive Bedford, Massachusetts 01730

Re: K170226

Trade/Device Name: iTotal Family Reusable Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: September 25, 2017 Received: September 26, 2017

Dear Emmaniel Nyakako:

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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

510(k) Number (if known) K170226

Device Name iTotal Family Reusable Instrument Tray

Indications for Use (Describe)

The iTotal Family Reusable Instrument Tray is intended to house the reusable instrumentation associated with ConforMIS knee implant systems and define their organization during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 171bs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.

The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:

Cycle Type: Pre-vacuum Temperature: 132°C (270°F) Exposure Time: 4 minutes Dry Time: 30 minutes

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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6.0 510(K) SUMMARY (K170226)

| Submitter's Name
and Address: | ConforMIS, Inc.
600 Technology Park Drive
Billerica, MA 01821 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 3009844603 and 3004153240 |
| Date of Summary: | October 17, 2017 |
| Contact Person:
Telephone Number:
Fax Number: | Emmanuel O. Nyakako, Sr. Vice President, Quality and
Regulatory Affairs
[phone]
[phone] |
| Name of the Device: | iTotal® Family Reusable Instrument Tray |
| Common Name: | Sterilization Tray |
| Regulatory Status
and Regulation
Number: | Class II
21 CFR 880.6850 |
| Classification
Name: | Sterilization Wrap Containers, Trays, Cassettes & Other
Accessories |
| Device
Classification: | Product Code:
KCT: Sterilization Wrap Containers, Trays, Cassettes & Other
Accessories |

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510(K) SUMMARY (K170226)

| Indications for Use: | The iTotal Family Reusable Instrument Tray is intended to house the ConforMIS reusable instrumentation associated with ConforMIS knee implant systems and define their organization and configuration during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.
The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows: | | | |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------|------------|
| | Cycle Type | Temperature | Exposure Time | Dry Time |
| | Pre-vacuum | 132°C(270°F) | 4 minutes | 30 minutes |
| Identification of the Legally Marketed Devices (Predicate Devices): | Signia™ Sterilization Tray
Device Class: II
Product Code: KCT
Regulation Number: 21 CFR 888.6850
510(k) Number: K161347

iDrive™ Ultra Sterilization Tray
Device Class: II
Product Code: KCT
Regulation Number: 21 CFR 880.6850
510(k) Number: K130532 | | | |

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510(K) SUMMARY (K170226)

• Device Description: The iTotal Family Reusable Instrument Tray is a sterilization tray with perforations and brackets to hold ConforMIS knee implant reusable instrumentation. Label plates are provided to indicate where specific reusable instrumentation should be placed within the tray. The sterilization tray consists of two layers. The base layer of the tray is a full tray which includes an accessory box to hold small items. The top layer of the sterilization tray is made up of one removable tray that is ¾ the length of the overall tray and a second removable tray that is ¼ the length of the overall tray. A lid is provided with the tray and is equipped with handles to allow the user to carry the tray. The tray may contain the following instruments: . Keel punches (not to exceed 6 per load) . Patella clamp (not to exceed 1 per load) . Angel wing resection quide (not to exceed 1 per load) . Alignment rod tapers (not to exceed 2 per load) . Drill bits and adaptors (not to exceed 6 per load) ● Coring tool with adaptors (not to exceed 1 per load) . Pin puller (not to exceed 1 per load) ● Impactor handles, heads, and tips (not to exceed 5 per load) . Townley caliper (not to exceed 1 per load) ● Patellar osteotomy guide (not to exceed 1 per load)
  • . Patella trials (not to exceed 5 per load)
  • . Patella sizers (not to exceed 5 per load)
  • . Guidance plugs (not to exceed 2 per load)
  • . Steinman pins (not to exceed 7 per load)
  • . Tack pins (not to exceed 3 per load)

The ConforMIS iTotal Family Reusable Instrument Tray is similar to the following cleared devices:

• Signia™ sterilization tray (K161347) .
• . iDrive™ Ultra sterilization tray (K130532)

Summary of The iTotal Family Reusable Instrument Tray is designed to Technological withstand the indicated cleaning and sterilization conditions to aid Characteristics: in storage and sterilization of the iTotal knee accessories. The tray itself is made primarily of aluminum and doesn't require any special storage conditions. Repeated processing according to the instructions for use has been shown to have minimal effect on the sterilization tray.

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510(K) SUMMARY (PAGE 4 OF 4)

| Device Comparison | The iTotal Family Reusable Instrument Tray, subject of this
premarket notification, is similar to the predicate devices: SigniaTM
Sterilization Tray (K161347, cleared September 7, 2016), and
iDriveTM Ultra Sterilization Tray (K130532, cleared May 20, 2013).
Non-clinical testing was conducted to confirm that the iTotal Family
Reusable Instrument Tray is similar to the predicates. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion: | |

Specifically, the following testing was performed to establish similarity:

• Cleaning and Disinfection Validation .
• . Sterilization and Dry Time Validation
• . Shelf Life Testing
• Reprocessing Fatigue Simulation .

All testing has demonstrated that the device is similar to the predicate devices.

A detailed comparison of the subject device with the predicate sterilization trays is provided in the following Device Comparison Section of this document.

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DEVICE COMPARISON

| Characteristic | iTotal Family Reusable Instrument Tray
(This submission) | Signia™ sterilization tray (K161347) | iDrive™ Ultra sterilization tray (K130532) |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The iTotal Family Reusable Instrument Tray is
intended to house the ConforMIS reusable
instrumentation associated with ConforMIS knee
implant systems and define their organization and
configuration during sterilization, transportation,
and storage within the hospital environment. The
iTotal Family Reusable Instrument Tray can hold
up to 17lbs of instruments. The iTotal Family
Reusable Instrument Tray is only intended to
maintain sterility of the enclosed devices if it is
used in conjunction with an FDA cleared
sterilization wrap and has only been evaluated for
a non-stacked configuration.
The tray is intended to allow steam sterilization of
the enclosed medical devices. The validated
sterilization cycle parameters are as follows:
Cycle Type
Temperature
Exposure
Dry Time | The Signia™ sterilization tray is intended to
provide storage for the Signia™ adapters,
Signia™ reusable insertion guide and Signia™
manual retraction tool during sterilization,
storage and transportation within the hospital
environment. The Signia™ sterilization tray is
only intended to maintain sterility of the
enclosed devices if it is used in conjunction with
an FDA cleared sterilization wrap and has only
been evaluated for a non-stacked configuration.
The tray can contain at a maximum: one (1)
Signia™ adapter, one (1) Signia™ reusable
insertion guide and one (1) Signia™ manual
retraction tool. The tray is intended to allow
steam sterilization of the enclosed medical
devices. The validated sterilization cycle
parameters are as follows:
132 °C Pre-vacuum (HiVac) Steam Cycles
Temperature: 270 °F (132 °C)
Exposure: 4 minutes
Dry Time: 20-40 minutes
134 °C Pre-vacuum (HiVac) Steam Cycles
Temperature: 273 °F (134 °C)
Exposure: 3 minutes
Dry Time: 20-40 minutes | The iDrive™ Ultra sterilization tray, an over-
the-counter, accessory, is intended to
provide storage for the iDrive™ Ultra
powered stapling system during
sterilization, storage and transportation
within the hospital environment. The tray
can contain at a maximum: one (1) iDrive™
Ultra powered handle, two (2) Endo GIA™
adapters, two (2) iDrive™ battery insertion
guides and one (1) iDrive™ Ultra manual
adapter tool. The tray is intended to be
sterilized by the following cycles:
Prevacuum Steam Cycles
132 C for 4 minutes
134 C for 3 minutes
Vacuum Dry Time: 20 |
| Enclosed devices for
sterilization | The tray may contain the following instruments:
• Keel punches (not to exceed 6 per load)
• Patella clamp (not to exceed 1 per load)
• Angel wing resection guide (not to
exceed 1 per load) | The tray can contain at maximum:
One (1) Signia™ adapter,
One (1) Signia™ reusable insertion guide
And
One (1) Signia™ manual retraction tool. | The tray can contain at a maximum:
one (1) iDrive™ Ultra powered handle,
two (2) Endo GIATM adapters,
two (2) iDrive™ battery insertion guides and
one (1) iDrive™ Ultra manual adapter tool |
| Characteristic | iTotal Family Reusable Instrument Tray
(This submission) | Signia™ sterilization tray (K161347) | iDrive™ Ultra sterilization tray (K130532) |
| | Alignment rod tapers (not to exceed 2 per load) Drill bits and adaptors (not to exceed 6 per load) Coring tool with adaptors (not to exceed 1 per load) Pin puller (not to exceed 1 per load) Impactor handles, heads, and tips (not to exceed 5 per load) Townley caliper (not to exceed 1 per load) Patellar osteotomy guide (not to exceed 1 per load) Patella trials (not to exceed 5 per load) Patella sizers (not to exceed 5 per load) Guidance plugs (not to exceed 2 per load) Steinman pins (not to exceed 7 per load) Tack pins (not to exceed 3 per load) | | |
| Dimensions | Base layer of the tray: 20.59" (L) X 9.84" (W) X 13.32" (H)
Accessory Box: 6.000" (L) X 2.500" (W) X 1.200" (H) | Approx. 10.0 x 21.4 x 3.0 (H) inches | Approx. 10 x 21x 3 (H) |
| Sterilization methods | Pre-vacuum steam | Pre-vacuum steam | Pre-vacuum steam |
| Steam Sterilization
Parameters | Cycle Type: Pre-vacuum
Temperature: 132°C (270°F)
Exposure: 4 minutes
Dry Time: 30 minutes | Pre-vacuum (HiVac) Steam Cycles
Temperature: 132°C (270°F)
Exposure: 4 minutes
Dry Time: 20 - 40 minutes | Prevacuum Steam Cycles
132 C for 4 minutes
134 C for 3 minutes
Vacuum Dry Time: 20 |
| Base & Lid Materials | Trays and accessory box: Aluminum
Tray Lid: Radel R5000
Base Inserts (Grommets) – Silicone Medical
Grade Class 6 | Stainless Steel | Base - Aluminum
Lid- Aluminum
Base Inserts (Grommets) - Silicone Medical
Grade Class 6 |
| Characteristic | iTotal Family Reusable Instrument Tray
(This submission) | Signia™ sterilization tray (K161347) | iDrive™ Ultra sterilization tray (K130532) |
| Stacking | Do not stack trays in the autoclave chamber.
Stacking of trays will adversely affect sterilization
and drying effectiveness. | Do not stack cases and trays in the sterilization
chamber. | Do not stack cases and trays in the
sterilization chamber. Stacking of cases and
trays will adversely affect sterilization and
drying effectiveness. |
| Max. Load Capacity | 17 pounds | 10 pounds | 15 pounds |
| SAV/Hole Pattern | The ratio of total surface area of openings to
volume (SAV) is: 52.3 in²/641.7 in³ (excluding
accessory caddy).
Accessory Box: Evenly distributed hole pattern | Evenly distributed hole pattern | Evenly distributed hole pattern |
| Product Code | KCT | KCT | KCT |
| Sterilant Penetration | Yes | Yes | Yes |
| Microbial Barrier
Properties | For use with an FDA cleared wrap | For use with an FDA cleared wrap | For use with an FDA cleared wrap |
| Material Compatibility
with Sterilization Method | Yes | Yes | Yes |

Table: Device Comparison Table

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Conclusion: Based upon the supporting data above, the subject device iTotal® Family Reusable Instrument Tray (K170226) is as safe and effective as the legally marketed devices Signia™ Sterilization Tray (K161347) and iDrive™ Ultra Sterilization Tray (K130532).