(29 days)
The THINK Surgical TCAT® TKA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT® tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.
The TCAT® TKA Instrument Tray Set is intended only for use with TSolution One® Total Knee Application instruments, tools and accessories. These trays are used to enclose and hold the instruments tools and accessories in an organized manner during the sterilization process and subsequent storage and transportation to and from the surgical suite. The trays are designed to fit any standard autoclave and are constructed primarily of anodized aluminum meeting biocompatibility requirements and are compatible with repeated steam sterilizations. The trays have perforations to facilitate sterilant penetration, evacuation and drying. Since the trays are perforated, an FDA-cleared sterilization wrap must be used to maintain sterility of the contents.
The trays have the same size and same basic configuration of the predicate device: a rectangular base with a latchable lid. The trays have perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom surface and interior shelves of the trays contain stanchions designed to separately hold each individual instrument, tool and accessory for effective sterilant exposure, evacuation and drying during the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removal from the tray.
The sterilization trays have been tested only with THINK Surgical instruments, tools and accessories for a 4 minute sterilization cycle of pre-vacuum steam sterilization at 132°C, with a 45 minute dry time. While reuseable, these trays will not be serviced or repaired.
The provided document, K200632, details the 510(k) premarket notification for the THINK Surgical TCAT® TKA Instrument Tray Set. It focuses on demonstrating substantial equivalence to a predicate device (TCAT® THA Instrument Tray Set) through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: TCAT® TKA Instrument Tray Set
Purpose of Device: Intended to protect, organize, and deliver TCAT® tools, instruments, and accessories to the surgical field, allow for their sterilization, and maintain sterility.
1. Table of Acceptance Criteria and Reported Device Performance
| Non-Clinical Performance Testing | Purpose (What was being tested) | Acceptance Criteria | Reported Device Performance/Results |
|---|---|---|---|
| Sterilization Efficacy | To verify the TCAT® TKA Instrument Tray Sets containing the maximum load were inoculated with biological indicators placed in areas of the trays deemed most difficult for sterilant (steam) to penetrate. Following inoculation, the trays were wrapped in FDA-cleared sterilization wraps. | - All biological indicators (BIs) must be incubated for a minimum of 7 days at 55°C-60°C- The positive control for the SAL testing must show characteristic growth of the indicator organism- Valid temperature data must be collected for each product probe location- Temperature probes used during profiling of the test article must be within ±0.5°C of at least one post calibration reference temperature that is representative of the profiling cycles- All directly-inoculated test article components must demonstrate to contain no bacteriostatic properties by showing growth of G. stearothermophilus during method suitability testing | The study indicated that the BI Overkill method provided a six-log reduction of the indicator organism. |
| Packaging | To verify the TCAT® TKA Instrument Tray Sets were evaluated with maximum load, wrapped according to use instructions and in the shipping configuration according to a shipping validation test. | - Is the packaging or parts of the Application Tray damaged?- Is the Packaging or parts of the Base Tray damaged?- Are the labels and packing list still affixed and legible? | PASS |
| Reprocessing | To verify the TCAT® TKA Instrument Tray Sets were evaluated for cleanability according to the user instructions. | - Observer shall provide each participant with an IFU- Observer shall ask each participant to read the IFU carefully- Observer shall ask each user to simulate the reprocessing steps according to the IFU- Observer shall fill out the data collection sheetThe table states "indicates all reprocessing steps PASS" as part of the criteria, implying that the passing of these observational checks constitutes the acceptance. | PASS |
| Biocompatibility | To verify the TCAT® TKA Instrument Tray Sets were evaluated for biocompatibility according to ISO 10993-1. | MEM Elution Study: Test article meets a passing score of 2 or below; test article is not considered to have a cytotoxic potential. | PASS |
| Use and Sterile Processing Guide | To verify the TCAT® TKA Instrument Tray Sets were evaluated in accordance with the appropriate guidances. (This likely refers to ease of use and ability to properly load/unload for sterile processing). | - Participant is able to load components in the tray- Participant is able to load components in the tray with the aid of visual indications showing storage location of each instrument- Participant is able to carry one Instrument Tray- Participant is able to load all components in the tray without requiring an additional toolParticipant is able to remove all components in the tray without requiring an additional tool | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes (number of trays or iterations) used for each test. For tests like "Sterilization Efficacy," it refers to "TCAT® TKA Instrument Tray Sets containing the maximum load," implying multiple units were tested to ensure robustness. Similarly, for "Packaging" and "Reprocessing," the evaluation would involve a certain number of units.
Data Provenance: The document does not specify the country of origin for the data. The studies are non-clinical (laboratory-based) and conducted to regulatory standards (e.g., ANSI/AAMI/ISO, ASTM, ISO 10993), which typically do not involve human subjects or retrospective/prospective data collection from clinical practice. They are "prospective" in the sense that the tests were designed and executed to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of external experts or their qualifications for establishing ground truth for any of the non-clinical tests. For the reprocessing and use guidance tests, an "Observer" is mentioned, who would likely be trained personnel conducting the evaluation according to a defined protocol. These are laboratory-based engineering and performance validation tests, not clinical studies requiring physician or radiologist expertise for ground truth.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for interpretation of imaging or clinical outcomes by multiple experts. Since this submission relates to a non-clinical device performance evaluation (sterilization, packaging, cleaning, biocompatibility, ease of use of a surgical tray), such adjudication methods are not applicable and are not mentioned in the document. The tests have predefined, measurable acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. MRMC studies are relevant for AI/imaging devices where human interpretation of medical images is involved, to assess the impact of AI assistance on human reader performance. This device is a surgical instrument tray (sterilization wrap, not an imaging or diagnostic AI), and as such, MRMC studies are not applicable. The document explicitly states: "No clinical or animal testing were required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. This is a physical medical device (an instrument tray for sterilization), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. The tests described are for the physical properties and performance of the tray itself.
7. The Type of Ground Truth Used
The "ground truth" for these non-clinical tests is established by:
- Physical/Biological Standards: For sterilization efficacy, the ground truth is the complete eradication of specified biological indicators (e.g., 6-log reduction of G. stearothermophilus spores), verified through incubation protocols.
- Engineered Specifications and Standards: For packaging, cleaning, biocompatibility, and use, the ground truth is defined by meeting pre-specified engineering tolerances, regulatory standards (e.g., ISO, ASTM), and user requirements (e.g., no damage, legible labels, cytotoxic potential score, ability to load instruments without additional tools). These are objective, measurable criteria.
8. The Sample Size for the Training Set
Not applicable. This product is a physical device (surgical instrument tray), not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable for the reason stated above.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 8, 2020
THINK Surgical, Inc. George Prendergast Manager, Regulatory Affairs 47201 Lakeview Blvd Fremont, California 94538
Re: K200632
Trade/Device Name: TCAT® TKA Instrument Tray Set Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: March 9, 2020 Received: March 10, 2020
Dear George Prendergast:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Christopher K. Dugard, MS Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
K200632 Device Name TCAT® TKA Instrument Tray Set
Indications for Use (Describe)
The THINK Surgical TCAT® TKA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT® tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.
[See the following page for the THINK Surgical compatible devices, sterilization parameters and description of the TCAT® TKA Instrument Tray Set.]
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.
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FORM FDA 3881 (7/17)
er PSC Publishing Services (301) 443-6740
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FORM FDA 3881 (CONTINUED)
The following is the continuation of FORM FDA 3881 for the TCAT® TKA Instrument Tray Indications for Use
Table 1 lists the lists the THINK Surgical compatible devices:
| Intended instrument tray set contents | Description |
|---|---|
| TCAT General Instruments, Tools and Accessories | Instruments, tools and accessories intendedfor general use with the TSolution One®Surgical System (TCAT®) |
| TCAT TKA Instruments, Tools, and Accessories | Instruments, tools and accessories intendedfor TKA use with the TSolution One®Surgical System (TCAT®) |
Table 2 lists the sterilization parameters under which the TCAT® TKA Instrument Tray Set was validated:
| Cycle | Cycle Temperature | Exposure Time | Dry Time |
|---|---|---|---|
| Pre-vacuum | 132°C (270°F) | 4 minutes | 45 minutes |
Table 3 provides a description of the TCAT® TKA Instrument Tray Set (109154):
| Table 3: Dimensions and weights | |||
|---|---|---|---|
| Tray Name | Dimensions (inches) L x W x H | Weight (lbs) Unloaded: | Loaded |
| TCAT® TKA Base TrayPN 107735 | 20 x 9.8 x 4.5 | 14.21lbs. | 17.33lbs. |
| TCAT® TKA Application TrayPN 107737 | 20 x 9.8 x 4.5 | 7.5lbs. | 18.0lbs. |
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Image /page/4/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with a blue triangle replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest.
SECTION 6
K200632 510(k) SUMMARY
This 510(k) summary is submitted in accordance with 21CFR 807.92
Applicant Information:
| Owner Name: | THINK Surgical, Inc. |
|---|---|
| Address: | 47201 Lakeview Blvd.Fremont, CA 94538 |
| Phone: | 510-249-2337 |
| Fax | 510-249-2396 |
| Establishment Registration Number: | 3000719653 |
| Contact Person: | George J. Prendergast |
| Date Prepared: | March 09, 2020 |
| Device Information: | |
| Classification: | Class II |
| Trade Name: | TCAT® TKA Instrument Tray Set |
| Common name: | Sterilization Wrap |
| Classification name: | Sterilization Wrap |
| Regulation number: | 21 CFR 880.6850 |
| Classification Code: | KCT |
Predicate Device:
TCAT® THA Instrument Tray Set cleared via K180127.
Device Modification:
The changes to the predicated device allow tools, instruments and accessories to be utilized during a total knee arthroplasty (TKA) procedure. The only modification to this device is one tray set (the Application Tray Set) contains new tools, instruments and accessories for a total knee arthroplasty replace those tools instruments and accessories which were included in the TCAT®THA Instrument Tray Set (the predicate device).
Device Description:
The TCAT® TKA Instrument Tray Set is intended only for use with TSolution One® Total Knee Application instruments, tools and accessories. These trays are used to enclose and hold the instruments tools and accessories in an organized manner during the
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Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with a blue, triangular shape replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest.
TCAT®TKA Instrument Tray Set Special 510(k) Submission
sterilization process and subsequent storage and transportation to and from the surgical suite. The trays are designed to fit any standard autoclave and are constructed primarily of anodized aluminum meeting biocompatibility requirements and are compatible with repeated steam sterilizations. The trays have perforations to facilitate sterilant penetration, evacuation and drying. Since the trays are perforated, an FDA-cleared sterilization wrap must be used to maintain sterility of the contents.
The trays have the same size and same basic configuration of the predicate device: a rectangular base with a latchable lid. The trays have perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom surface and interior shelves of the trays contain stanchions designed to separately hold each individual instrument, tool and accessory for effective sterilant exposure, evacuation and drying during the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removal from the tray.
The sterilization trays have been tested only with THINK Surgical instruments, tools and accessories for a 4 minute sterilization cycle of pre-vacuum steam sterilization at 132°C, with a 45 minute dry time. While reuseable, these trays will not be serviced or repaired. The type and maximum number of instruments, tools and accessories for each of the trays follow:
| TCAT® TKA Base Tray (Tray 1 Top) | ||
|---|---|---|
| Part Number | Description | Quantity |
| 103426 | Cutter Motor | 1 |
| 106298-04 | Digitizer Ball Probe | 1 |
| 106382 | Digitizer Probe Hub | 1 |
| 103593 | Recovery Marker Installation Tool | 1 |
| 102940 | Cutter Verification Gauge | 1 |
| 103636 | Cutter Wrench Set | 1 |
| 105716 | Wrench, Hex, 2.5mm | 1 |
| 103279 | Wrench, Hex, 8mm | 1 |
| 101884 | Wrench, T-Handle, Square, 8mm | 1 |
| 104948 | BMM Probe Assembly | 1 |
| Hospital Supplied | Fixation Clamp, Ø4-5mm pin/Ø8mm rod | 2 |
| Hospital Supplied | Fixation Clamp, Ø8mm rod/Ø8mm rod | 1 |
| Hospital Supplied | Fixation Clamp, Ø3-4mm pin/Ø5mm rod | 1 |
| TCAT ® TKA Base Tray (Tray 1 Bottom) | ||
|---|---|---|
| Part Number | Description | Quantity |
| 103205 | Fixation Arm, Straight | 1 |
| 106219 | Fixation Adapter Rod, Right-Angle 4 inch | 1 |
| 103414 | Swivel Block | 1 |
| 100086 | Wrench, Open End, 1-1/8 inch | 1 |
| 103384 | Cutter Motor Cable | 1 |
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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with a blue vertical line replacing the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue line adds a touch of color and visual interest.
| TCAT® TKA Application Tray (Tray 2 top) | ||
|---|---|---|
| Part Number | Description | Quantity |
| 106219 | Fixation Adapter Rod, Right Angle | 1 |
| 104948 | BMM Probe Assembly | 1 |
| 106825 | Spiked Disk, Femoral Epicondylar Clamp | 2 |
| 102613 | Recovery Marker, Tack, Ø1.5x11mm | 2 |
| 106413 | Cutter Bearing Sleeve, 120mm | 1 |
| 106298-03 | Digitizer Percutaneous Probe | 1 |
| 107720 | Recovery Marker, Groove, Ø4x125mm | 2 |
| Hospital Supplied | Fixation Pin, Self-Drilling, Ø3x125mm | 1 |
| Hospital Supplied | Fixation Pin, Self-Drilling, Ø4x125mm | 2 |
| 103454-NS | Cutter, Ø2.0x159mm | 1 |
| 103455 | Cutter, Ball Probe, 151mm | 1 |
| 106428 | Cutter, Flat, Ø6.2x144mm | 1 |
| 103450 | Fixation Adapter Rod, Straight | 2 |
| TCAT® TKA Application Tray (Tray 2 Bottom) | ||
|---|---|---|
| Part Number | Description | Quantity |
| 107714 | Cutter Drive Assembly, TKA | 1 |
| 103206 | Fixation Arm, Straight | 1 |
| 103414 | Swivel Block | 1 |
| Hospital Supplied | Wrench, Nut Driver, 5mm | 1 |
| 106824 | Clamp, Femoral Epicondylar | 1 |
Indications for Use:
The THINK Surgical TCAT®TKA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.
Technological Characteristics Comparison Table
Three fundamental characteristics are the same between the two devices:
-
- Basic design: Both the TCAT®TKA Instrument Tray Set and the predicate device have a basic lid/base design with latches, handles, perforations, and contoured inserts or sections for containing items for sterilization, storage and transport. General size, shape, weight and materials are the same.
-
- Role in sterile barrier system: The TCAT® TKA Instrument Tray Set and the predicate device must be wrapped with an FDA-cleared sterilization wrap to maintain sterility. Neither the subject device or the predicate contains gaskets, valves nor filters.
-
- Fundamental technology: The TCAT®TKA Instrument Tray Set and the predicate device allow the sterilant (steam) to penetrate and render its contents sterile by relying on surface perforations.
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Image /page/7/Picture/1 description: The image shows the logo for "THINK Surgical". The word "THINK" is written in large, bold, sans-serif letters, with the "I" in "THINK" being a blue, elongated triangle. Below the word "THINK" is the word "SURGICAL" in smaller, sans-serif letters. The logo is simple and modern, and the blue "I" adds a touch of color and visual interest.
The following tables provide a comparison of technological characteristics between the subject device and the predicate device (Table 4) and a summary of non-clinical performance testing (Table 5).
| Characteristic | TCAT® TKA InstrumentTray Set(Subject Device) | TCAT® THA InstrumentTray Set (PredicateDevice) | Comparison |
|---|---|---|---|
| 510(k) number | K200632 | K180127 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Intended Use | The THINK SurgicalTCAT® TKA InstrumentTray Set is intended toprotect, organize anddeliver to the surgical fieldTCAT® tools, instrumentsand accessories. Thetrays allow sterilization oftools, instruments andaccessories, and maintainsterility of the encloseddevices until used. Thetrays are wrapped with anFDA-cleared sterilizationwrap during the pre-vacuum autoclavesterilization process. | The THINK SurgicalTCAT® THA InstrumentTray Set is intended toprotect, organize anddeliver to the surgical fieldTCAT® tools, instrumentsand accessories. The traysallow sterilization of tools,instruments andaccessories, and maintainsterility of the encloseddevices until used. Thetrays are wrapped with anFDA-cleared sterilizationwrap during the pre-vacuum autoclavesterilization process. | Same |
| IntendedInstrument TrayContents | TCAT® GeneralInstrument, Tools andAccessories:Instruments, tools andaccessories intended forgeneral use with theTCAT® TSolution One®Total Knee Application.TCAT® TKA Instruments,Tools and Accessories:Instruments, tools andaccessories intended foruse with the TCAT®TSolution One® TotalKnee Application. | TCAT® GeneralInstrument, Tools andAccessories:Instruments, tools andaccessories intended forgeneral use with theTCAT® Surgical System.TCAT® THA Instruments,Tools and Accessories:Instruments, tools andaccessories intended foruse with the TCAT®Surgical System. | Identical |
| IntendedInstrument TraySet ContentsMaximum Load | Medical devices/instruments weighing noless than 7.5lbs-18.0lbs.total including the weightof the trays. | Medical devices/instruments weighing noless than 14.21lbs-14.39lbs. total includingthe weight of the trays. | Similar |
| Design Characteristics | |||
| DeviceComposition | Base, lift out tray, lid | Base, lift out tray, lid | Same |
| Inserts | Yes | Yes | Same |
| Characteristic | TCAT® TKA InstrumentTray Set(Subject Device) | TCAT® THA InstrumentTray Set (PredicateDevice) | Comparison |
| 510(k) number | TBD | K180127 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Handles | Yes | Yes | Same |
| Latches | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Materials | |||
| Lid/base/Lift outtray, not includinginserts | Aluminum | Aluminum | Same |
| Inserts | Silicone, aluminum,stainless steel, nylon | Silicone, aluminum,stainless steel, nylon | Same |
| Latch | Stainless steel | Stainless steel | Same |
| AssembledDimensions | 20" x 9.8" x 4.5" | 20" x 9.8" x 4.5" | Same |
| Weight containingmax load | 18.0lbs. | 19.5lbs. | Similar |
| Sterilization | |||
| Percent of surface perforations | |||
| -lid | 21% | 21% | Same |
| -base | 19% | 19% | Same |
| -lift out tray | 22% | 22% | Same |
| SterilizationMethod | Pre-Vacuum (Steam) | Pre-Vacuum (Steam) | Same |
| Cycle | 132°C (270°F) | 132°C (270°F) | Same |
| Temperature | |||
| Cycle Time | 4 minutes | 4 minutes | Same |
| Drying Time | 45 minutes | 45 minutes | Same |
Table 4: Comparison of Technological Characteristics Between the Subject Device and the Predicate Device
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Image /page/8/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" in "THINK" being a blue triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
Non-Clinical Performance Testing
Table 5 summarizes the non-clinical performance testing of the TCAT® TKA Instrument Tray Set:
- Sterilization Efficacy
- . Packaging
- . Cleaning
- Biocompatibility .
- Use and Sterile Processing Guide .
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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" represented by a blue, elongated triangle. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
TCAT®TKA Instrument Tray Set Special 510(k) Submission
| Table 5: Summary of Non-Clinical Performance Testing | |
|---|---|
| ------------------------------------------------------ | -- |
| Non-ClinicalPerformance Testing | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Sterilization Efficacy(ANSI/AAMI/ISO14937:2013 -Sterilization ofHealthcare Product -General Requirementsfor Characterization of aSterilizing Agent andthe Development,Validation and RoutineControl of a SterilizationProcess for MedicalDevices) | To verify the TCAT® TKAInstrument Tray Sets containingthe maximum load were inoculatedwith biological indicators placed inareas of the trays deemed to bemost difficult for sterilant (steam) topenetrate. Following inoculation,the trays were wrapped in FDA-cleared sterilization wraps. Thetrays indicated that the BI Overkillmethod provided a six-logreduction of the indicator organism. | -All biological indicators(BIs) must be incubatedfor a minimum of 7 daysat 55°C-60°C-The positive control forthe SAL testing mustshow characteristicgrowth of the indicatororganism-Valid temperature datamust be collected foreach product probelocation-Temperature probesused during profiling ofthe test article must bewithin ±0.5°C of at leastone post calibrationreference temperaturethat is representative ofthe profiling cycles-All directly-inoculatedtest article componentsmust demonstrate tocontain no bacteriostaticproperties by showinggrowth of G.stearothermophilusduring method suitabilitytesting | |
| Packaging (ASTMD4169-16 - StandardPractice forPerformance Testing ofShipping Containersand Systems) | To verify the TCAT® TKAInstrument Tray Sets wereevaluated with maximum load,wrapped according to useinstructions and in the shippingconfigurationaccording to a shippingvalidation test. The resultsindicate packagingrequirements were met. | -Is the packaging or partsof the Application Traydamaged-Is the Packaging or partsof the Base Traydamaged-Are the labels andpacking list still affixedand legible | PASS |
| Reprocessing | To verify the TCAT® TKAInstrument Tray Sets wereevaluated for cleanabilityaccording to the userinstructions. The resultsindicated cleanabilityrequirements were met. | -Observer shall provideeach participant with anIFU-Observer shall ask eachparticipant to read the IFUcarefully-Observer shall ask eachuser to simulate thereprocessing stepsaccording to the IFU-Observer shall fill out thedata collection sheet | PASS |
| indicates all reprocessingsteps PASS | |||
| Biocompatibility(ANSI/AAMI/ISO 10993-5:2009 - BiologicalEvaluation of MedicalDevices - Part 5: Testsfor In Vitro Cytotoxicity) | To verify the TCAT® TKA InstrumentTray Sets wereevaluated for biocompatibilityaccording to ISO 10993-1. The results indicatedbiocompatibility requirementswere met. | MEM Elution Study-Test article meets apassing score of 2 orbelow; test article is notconsidered to have acytotoxic potential | PASS |
| Use and SterileProcessing Guide | To verify the TCAT® TKA InstrumentTray Sets were evaluated inaccordance with the appropriateguidances. The resultsindicated use and SterileProcessing Guiderequirements were met. | -Participant is able to loadcomponents in the tray-Participant is able to loadcomponents in the traywith the aid of visualindications showingstorage location of eachinstrument-Participant is able tocarry one Instrument Tray-Participant is able to loadall components in the traywithout requiring anadditional toolParticipant is able toremove all components inthe tray without requiringan additional tool | PASS |
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Image /page/10/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
TCAT®TKA Instrument Tray Set Special 510(k) Submission
Clinical and Animal Testing
No clinical or animal testing were required.
Conclusion
The conclusions drawn from the nonclinical and clinical tests demonstrate that the TCAT® TKA Instrument Tray Set is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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).