iTotal Family Reusable Instrument Tray

K170226 · Conformis, Inc. · KCT · Oct 25, 2017 · General Hospital

Device Facts

• Record ID: K170226
• Device Name: iTotal Family Reusable Instrument Tray
• Applicant: Conformis, Inc.
• Product Code: KCT · General Hospital
• Decision Date: Oct 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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 Story

Sterilization tray designed to house, organize, and protect ConforMIS knee implant reusable instruments during steam sterilization, transport, and storage. Composed of aluminum base/accessory box and Radel R5000 lid with silicone grommets. Features perforated design for steam penetration; includes label plates for instrument placement. Used in hospital environments by sterile processing staff or surgical technicians. Device holds up to 17lbs of specific instruments (e.g., punches, clamps, guides, trials). Requires use with FDA-cleared sterilization wrap; non-stacked configuration mandatory. Steam sterilization performed via pre-vacuum cycle (132°C, 4-minute exposure, 30-minute dry time). Ensures instrument sterility and organization, facilitating efficient surgical preparation and patient safety by maintaining instrument integrity.

Clinical Evidence

Bench testing only. Validation included cleaning and disinfection, sterilization and dry time, shelf life, and reprocessing fatigue simulation. No clinical data presented.

Technological Characteristics

Materials: Aluminum (tray/accessory box), Radel R5000 (lid), Silicone Medical Grade Class 6 (grommets). Dimensions: 20.59" x 9.84" x 13.32". Sterilization: Pre-vacuum steam (132°C). Connectivity: None. Software: None.

Indications for Use

Indicated for housing, organizing, sterilizing, transporting, and storing ConforMIS knee implant system reusable instrumentation in hospital environments. Supports up to 17lbs of instruments. Requires FDA-cleared sterilization wrap; non-stacked configuration only.

Regulatory Classification

Identification

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

Predicate Devices

• Signia™ Sterilization Tray (K161347)
• iDrive™ Ultra Sterilization Tray (K130532)

Submission Summary (Full Text)

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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)

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## 6.0 510(K) SUMMARY (K170226)

| Submitter's Name<br>and Address: | ConforMIS, Inc.<br>600 Technology Park Drive<br>Billerica, MA 01821 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration<br>Number: | 3009844603 and 3004153240 |
| Date of Summary: | October 17, 2017 |
| Contact Person:<br>Telephone Number:<br>Fax Number: | Emmanuel O. Nyakako, Sr. Vice President, Quality and<br>Regulatory Affairs<br>[phone]<br>[phone] |
| Name of the Device: | iTotal® Family Reusable Instrument Tray |
| Common Name: | Sterilization Tray |
| Regulatory Status<br>and Regulation<br>Number: | Class II<br>21 CFR 880.6850 |
| Classification<br>Name: | Sterilization Wrap Containers, Trays, Cassettes & Other<br>Accessories |
| Device<br>Classification: | Product Code:<br>KCT: Sterilization Wrap Containers, Trays, Cassettes & Other<br>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.<br>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<br>Device Class: II<br>Product Code: KCT<br>Regulation Number: 21 CFR 888.6850<br>510(k) Number: K161347<br><br>iDrive™ Ultra Sterilization Tray<br>Device Class: II<br>Product Code: KCT<br>Regulation Number: 21 CFR 880.6850<br>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<br>premarket notification, is similar to the predicate devices: SigniaTM<br>Sterilization Tray (K161347, cleared September 7, 2016), and<br>iDriveTM Ultra Sterilization Tray (K130532, cleared May 20, 2013).<br>Non-clinical testing was conducted to confirm that the iTotal Family<br>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<br>(This submission) | Signia™ sterilization tray (K161347) | iDrive™ Ultra sterilization tray (K130532) |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The iTotal Family Reusable Instrument Tray is<br>intended to house the ConforMIS reusable<br>instrumentation associated with ConforMIS knee<br>implant systems and define their organization and<br>configuration during sterilization, transportation,<br>and storage within the hospital environment. The<br>iTotal Family Reusable Instrument Tray can hold<br>up to 17lbs of instruments. The iTotal Family<br>Reusable Instrument Tray is only intended to<br>maintain sterility of the enclosed devices if it is<br>used in conjunction with an FDA cleared<br>sterilization wrap and has only been evaluated for<br>a non-stacked configuration.<br>The tray is intended to allow steam sterilization of<br>the enclosed medical devices. The validated<br>sterilization cycle parameters are as follows:<br>Cycle Type<br>Temperature<br>Exposure<br>Dry Time | The Signia™ sterilization tray is intended to<br>provide storage for the Signia™ adapters,<br>Signia™ reusable insertion guide and Signia™<br>manual retraction tool during sterilization,<br>storage and transportation within the hospital<br>environment. The Signia™ sterilization tray is<br>only intended to maintain sterility of the<br>enclosed devices if it is used in conjunction with<br>an FDA cleared sterilization wrap and has only<br>been evaluated for a non-stacked configuration.<br>The tray can contain at a maximum: one (1)<br>Signia™ adapter, one (1) Signia™ reusable<br>insertion guide and one (1) Signia™ manual<br>retraction tool. The tray is intended to allow<br>steam sterilization of the enclosed medical<br>devices. The validated sterilization cycle<br>parameters are as follows:<br>132 °C Pre-vacuum (HiVac) Steam Cycles<br>Temperature: 270 °F (132 °C)<br>Exposure: 4 minutes<br>Dry Time: 20-40 minutes<br>134 °C Pre-vacuum (HiVac) Steam Cycles<br>Temperature: 273 °F (134 °C)<br>Exposure: 3 minutes<br>Dry Time: 20-40 minutes | The iDrive™ Ultra sterilization tray, an over-<br>the-counter, accessory, is intended to<br>provide storage for the iDrive™ Ultra<br>powered stapling system during<br>sterilization, storage and transportation<br>within the hospital environment. The tray<br>can contain at a maximum: one (1) iDrive™<br>Ultra powered handle, two (2) Endo GIA™<br>adapters, two (2) iDrive™ battery insertion<br>guides and one (1) iDrive™ Ultra manual<br>adapter tool. The tray is intended to be<br>sterilized by the following cycles:<br>Prevacuum Steam Cycles<br>132 C for 4 minutes<br>134 C for 3 minutes<br>Vacuum Dry Time: 20 |
| Enclosed devices for<br>sterilization | The tray may contain the following instruments:<br>• Keel punches (not to exceed 6 per load)<br>• Patella clamp (not to exceed 1 per load)<br>• Angel wing resection guide (not to<br>exceed 1 per load) | The tray can contain at maximum:<br>One (1) Signia™ adapter,<br>One (1) Signia™ reusable insertion guide<br>And<br>One (1) Signia™ manual retraction tool. | The tray can contain at a maximum:<br>one (1) iDrive™ Ultra powered handle,<br>two (2) Endo GIATM adapters,<br>two (2) iDrive™ battery insertion guides and<br>one (1) iDrive™ Ultra manual adapter tool |
| Characteristic | iTotal Family Reusable Instrument Tray<br>(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)<br>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<br>Parameters | Cycle Type: Pre-vacuum<br>Temperature: 132°C (270°F)<br>Exposure: 4 minutes<br>Dry Time: 30 minutes | Pre-vacuum (HiVac) Steam Cycles<br>Temperature: 132°C (270°F)<br>Exposure: 4 minutes<br>Dry Time: 20 - 40 minutes | Prevacuum Steam Cycles<br>132 C for 4 minutes<br>134 C for 3 minutes<br>Vacuum Dry Time: 20 |
| Base & Lid Materials | Trays and accessory box: Aluminum<br>Tray Lid: Radel R5000<br>Base Inserts (Grommets) – Silicone Medical<br>Grade Class 6 | Stainless Steel | Base - Aluminum<br>Lid- Aluminum<br>Base Inserts (Grommets) - Silicone Medical<br>Grade Class 6 |
| Characteristic | iTotal Family Reusable Instrument Tray<br>(This submission) | Signia™ sterilization tray (K161347) | iDrive™ Ultra sterilization tray (K130532) |
| Stacking | Do not stack trays in the autoclave chamber.<br>Stacking of trays will adversely affect sterilization<br>and drying effectiveness. | Do not stack cases and trays in the sterilization<br>chamber. | Do not stack cases and trays in the<br>sterilization chamber. Stacking of cases and<br>trays will adversely affect sterilization and<br>drying effectiveness. |
| Max. Load Capacity | 17 pounds | 10 pounds | 15 pounds |
| SAV/Hole Pattern | The ratio of total surface area of openings to<br>volume (SAV) is: 52.3 in²/641.7 in³ (excluding<br>accessory caddy).<br>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<br>Properties | For use with an FDA cleared wrap | For use with an FDA cleared wrap | For use with an FDA cleared wrap |
| Material Compatibility<br>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).