(422 days)
The THINK Surgical TCAT® THA 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 THAT Instrument Tray Set is intended only for use with TSolution One® Surgical System 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 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: a rectangular base with 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 removing from the tray.
The presented document describes the non-clinical testing performed on the TCAT® THA Instrument Tray Set to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Sterilization Efficacy (ISO 17665-1: 2006, Sterilization of health care products-Moist Heat Part 1 Requirements for the development, validation and routine control of sterilization process for medical devices.) Purpose: Demonstrate sterilization efficacy of the TCAT THA Instrument Tray Sets containing the maximum inoculated load. | The test resulted in no growth and a six-log reduction at the half-cycle for both devices (TCAT® Base Instrument Tray and TCAT® THA Instrument Tray) of the indicator organism. |
| Packaging (ASTM D4169-16 Standard Practice for Performance Testing in Shipping Containers and Systems) Purpose: Demonstrate that the THINK Surgical TCAT® THA Instrument Tray Set was evaluated with maximum load, wrapped according to use instructions and in the shipping configurations according to a shipping validation test. | The results for both trays indicate packaging endpoints were met. |
| Cleaning (FDA. 2015. Guidance for Industry and FDA Staff-Processing/Reprocessing Medical Devices in Health Care Settings: Validation and Labeling) Purpose: Demonstrate that the cleaning instructions for the TCAT THA Instrument Tray Set are valid. | The results for both trays indicated cleaning endpoints were met. |
| Biocompatibility (ISO 10993-5:2009 Cytotoxicity Test) Purpose: Demonstrate that the TCAT THA Instrument Tray Set is biocompatible. | Under the conditions of the test, the device extract was not cytotoxic. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., number of trays tested for sterilization efficacy). However, it consistently refers to "both devices" or "both trays" in the results, implying that at least one of each of the two different tray types (TCAT® Base Instrument Tray and TCAT® THA Instrument Tray) were tested for each criterion where applicable. For "maximum inoculated load" and "maximum load," it implies that the trays were loaded to their full capacity when tested.
- Data Provenance: The studies are described as "non-clinical performance testing," indicating they were conducted in a controlled, laboratory environment. The provenance is internal to the manufacturer or a contracted testing facility, following established international (ISO, ASTM) and FDA guidance standards. This is prospective testing to validate the device's design and performance. There is no mention of country of origin for the data beyond the standards applied.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not applicable as the document describes non-clinical performance testing (e.g., sterilization efficacy, packaging, cleaning, biocompatibility). These tests do not involve human interpretation of medical images or diagnoses, and, therefore, do not require medical experts to establish a "ground truth" in that context. The "ground truth" for these tests comes from objective laboratory measurements and adherence to specified scientific standards (e.g., absence of microbial growth, meeting packaging integrity metrics, non-cytotoxicity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are used in studies where human reviewers provide initial assessments, and a consensus or tie-breaking mechanism is needed to establish a definitive ground truth, typically in image interpretation or clinical trial settings. The non-clinical tests described here rely on objective, quantifiable results from laboratory procedures.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. The device under review is an instrument tray set for sterilization, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance would not be relevant to its evaluation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- This information is not applicable. The device is a physical medical device (sterilization tray), not an algorithm or software. Its performance is evaluated through physical and biological tests described, not through standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used for these non-clinical tests is based on objective scientific and engineering standards and measurements:
- Sterilization Efficacy: Absence of microbial growth and a 6-log reduction of the indicator organism, as per ISO 17665-1.
- Packaging: Meeting predefined "packaging endpoints" which are likely quantitative metrics for package integrity after simulated shipping (e.g., no damage, seals intact), as per ASTM D4169-16.
- Cleaning: Meeting predefined "cleaning endpoints" which are likely quantitative metrics for residual soil (e.g., protein, hemoglobin levels below specified limits), as per FDA guidance.
- Biocompatibility: Absence of cytotoxicity (i.e., no adverse cellular response to device extracts), as per ISO 10993-5:2009.
8. The sample size for the training set:
- This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI that would be relevant to these non-clinical validation tests. The testing performed is to validate the manufactured product against performance criteria.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 15, 2019
THINK Surgical Inc. % George Prendergast Manager of Regulatory Affairs THINK Surgical, Incorporated 47201 Lakeview Blvd. Fremont, California 94538
Re: K180127
Trade/Device Name: TCAT® THA Instrument Tray Set Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: KCT Dated: February 13, 2019 Received: February 14, 2019
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -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
51O(k) Number (if known) K180127
Device Name TCAT® THA Instrument Tray Set
Indications for Use (Describe)
The THINK Surgical TCAT® THA Instrument Tray Set is intended to protect, organize, and deliver 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 FDAcleared sterilization wrap during the pre-vacuum autoclave sterilization process.
Table 1 lists the THINK Surgical compatible devices:
Table 1: THINK Surgical Compatible devices
| Intended Instrument Tray Set Contents | Description |
|---|---|
| TCAT General Instruments, Tools and Accessories | Instruments, tools and accessories intended forgeneral use with the TSolution One® SurgicalSystem (TCAT) |
| TCAT THA Instruments, Tools, and Accessories | Instruments, tools and accessories intended for THAuse with the TSolution One® Surgical System(TCAT) |
Table 2 lists the sterilization parameters under which the TCAT® THA Instrument Tray Set was validated:
Table 2: Sterilization Parameters
| 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® THA Instrument Tray Set (107985):
Table 3: Description of the TCAT THA Instrument Tray Set
| Tray Name | Intended InstrumentTray Set Contents | Dimensions, L x W x H(inches) | Weight |
|---|---|---|---|
| TCAT® BaseInstrument TrayPN 107735 | TCAT general useinstruments, tool andaccessories | 20 x 9.8 x 4.5 | Unloaded: 14.21lbs.Loaded: 17.33lbs. |
| TCAT® THAInstrument TrayPN107736 | Instruments, tools andaccessories for THAonly | 20 x 9.8 x 4.5 | Unloaded: 14.39lbs.Loaded: 19.50lbs. |
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Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for "THINK Surgical". The word "THINK" is in large, gray, block letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in smaller, blue letters. The logo is simple and modern, with a focus on the company name.
510(k) Summary of K180127
| Submitter Name: | THINK Surgical, Inc. |
|---|---|
| Submitter Address: | 47201 Lakeview Blvd., Fremont, CA 94538 |
| Contact Person: | George J. Prendergast |
| Phone Number: | (510) 249-2323 |
| Fax Number: | (510) 249-2396 |
| Date Prepared: | March8, 2019 |
| Device Trade Name: | TCAT ®THA Instrument Tray Set |
| Device Common Name: | Sterilization Cassettes, Instrument Tray, Sterilization Tray.Instrument Delivery System |
| Classification Name: | Sterilization wrap, |
| Product Code | KCT |
| Regulation Number: | 21 CFR 880.6850 |
| Predicate Device: | Intuitive Surgical® Instrument and Accessory SterilizationTrays (K072211) |
Device Description:
The TCAT THAT Instrument Tray Set is intended only for use with TSolution One® Surgical System 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 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: a rectangular base with 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 removing from the tray.
The sterilization trays have been tested for use only with THINK Surgical instruments. tools and accessories for a sterilization cycle of pre-vacuum steam sterilization at 132 °C,
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Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. Below the logo, the text "4 min cycle with 45-min dry time" is present. The logo is in gray and blue.
The type and maximum number of instruments, tool and accessories for each of the trays listed above are as follows:
| TCAT® 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 Set | 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 |
| TCAT® 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 |
| TCAT® THA Application Tray (Tray 2) Top | ||
|---|---|---|
| Part Number | Description | Quantity |
| 105653 | Cutter Bearing Sleeve, 244mm | 1 |
| 102613 | Recovery Marker, Tack Ø1.5 x 11mm | 1 |
| 102709 | Cutter Ball Probe, 276mm | 1 |
| 102862-NS | Cutter, Flat, Ø8.25x268mm | 1 |
| 106298-03 | Digitizer Percutaneous Probe | 1 |
| 107720 | Recovery Marker, Groove, Ø4x125mm | 2 |
| 105734 | Cuter, Ball, Ø6x268mm | 1 |
| 107719 | Recovery Marker, Divot, Ø4x70mm | 1 |
| HospitalSupplied | Fixation Screw, Self-Drilling, Ø5x150mm | 3 |
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Image /page/6/Picture/0 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters. Above the "I" is a small, blue square. Below the word "THINK" is the word "SURGICAL" in smaller, blue letters.
| TCAT® THA Application Tray (Tray 2) Bottom | ||
|---|---|---|
| Part Number | Description | Quantity |
| 107645 | Cutter Drive Assembly | 1 |
| 105751 | Impactor Coupler Assembly, | 1 |
| Magnetic | ||
| 107667 | Impactor, Acetabular Cup, 010 | 1 |
| 107666 | Reamer Driver, Acetabular Cup, 001 | 2 |
| 107642 | Arm Tool Coupler | 1 |
Indications for Use:
The THINK Surgical TCAT® THA 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.
Table 1 lists the THINK Surgical compatible devices:
| Intended Instrument Tray SetContents | Description |
|---|---|
| TCAT General Instruments, Toolsand Accessories | Instruments, tools andaccessories intended for generaluse with the TSolution One®Surgical System (TCAT) |
| TCAT THA Instruments, Tools,and Accessories | Instruments, tools andaccessories intended for THA usewith the TSolution One®Surgical System (TCAT) |
Table 1: THINK Surgical Compatible Devices
Table 2 lists the sterilization parameters under which the TCAT® THA Instrument Tray Set was validated:
Table 2: Sterilization Parameters
| Cycle Type | CycleTemperature | Exposure Time | Dry Time |
|---|---|---|---|
| Pre-vacuum | 132°C (270°F) | 4 minutes | 45 minutes |
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Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in gray block letters, with a small blue square above the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, blue font. The logo is simple and modern, and the use of color is effective in creating a visual hierarchy.
Table 3 provides a description of the TCAT® THA Instrument Tray Set (107985):
| Tray Name | IntendedInstrument TraySet Contents | Dimensions,L x W x H(inches) | Weight |
|---|---|---|---|
| TCAT® BaseInstrument TrayPN 107735 | TCAT generaluse instruments,tool andaccessories | 20x9.8x4.5 | Unloaded:14.21lbs.Loaded:17.33lbs. |
| TCAT® THAInstrument TrayPN107736 | Instruments,tools andaccessories forTHA only | 20x9.8x4.5 | Unloaded:14.39lbs.Loaded:19.50lbs. |
Table 3: Description of the TCAT® THA Instrument Tray Set
Predicate Device:
The TCAT® THA Instrument Tray Sets are similar to the Intuitive Surgical® Instrument Accessory Trays, K072211.
Technological Characteristics Comparison:
Table 4 provides a comparison of technological characteristics and principles of operation between the TCAT THA Instrument Tray Set System and its predicate devices.
| Feature | TCAT® THAInstrument Tray Set(Subject Device) | Intuitive Surgical®Instrument AccessoryTrays, K072211 | Comparison |
|---|---|---|---|
| Intended Use | A sterilization tray is adevice intended to beused to enclose anothermedical device that is tobe sterilized by a healthcare provider. It isintended to allowsterilization of theenclosed medical device. | A sterilization tray is adevice intended to be used toenclose another medicaldevice that is to be sterilizedby a health care provider. Itis intended to allowsterilization of the enclosedmedical device. | Same |
| LoadContents | TCAT GeneralInstrument, Tools andAccessories:Instruments, tools andaccessories intended forgeneral use with theTCAT Surgical SystemTCAT THA,Instruments Toolsand Accessories:Instruments, tools andaccessories intended forTHA use with theTCAT Surgical System | Intuitive SurgicalEndoWrist Instruments:DaVinci and DaVinci Sfamilies of 8mm and45mm Endo WristInstrumentsIntuitive SurgicalReusable Accessories:DaVinci and Davinci Sfamilies of 8mm and 5mmaccessories includingcanulae, obturators,cannula mounts, sterileadapters, etc. | |
| ContentsMaximumLoad | Medicaldevices/instrumentsweighing a maximumof 17.33lbs for TCATbase instrument trayandweighing a maximumof 19.50lbs for theTHA instrument tray. | Medicaldevices/instrumentsweighing a maximum of1lbs for Endo Wristinstrument trayandweighing a maximum of7lbs for DaVinci andDavinci S trays. | Similar |
| Design Characteristics | |||
| DeviceComposition | Base, lift out tray, lid | Base, lid | Similar |
| Inserts | Yes | Yes | Same |
| Handles | Yes | Yes | Same |
| Latches | Yes | Yes | Same |
| Reusable | Yes | Yes | Same |
| Materials | |||
| Lid/base/liftout tray, notincludinginserts | Aluminum | Aluminum | Same |
| Inserts | Silicone, aluminum,stainless steel, nylon | - | - |
| Latch | Stainless steel | - | - |
| AssembledDimensions | 20" x 9.8" x 4.5" | 24.1" x 9.7" x 5.5" | Similar |
| Max loadweight | 17lbs for TCAT basetray19.5lbs for THAinstrument tray | 21lbs. | Similar |
| Sterilization | |||
| Percent of surface perforations forboth subject devices: | Percent of surface perforations for thepredicate device: | ||
| -lid | 21% | -lid, base | - |
| -base | 19% | - | - |
| -lift out tray | 22% | - | - |
| SterilizationMethod | Pre-vacuum (Steam) | Pre-vacuum (Steam) | Same |
| CycleTemperature | 132°C (270°F) | 132°C (270°F) | Same |
| Cycle Time | 4 minutes | 4 minutes | Same |
| Drying time | 45 minutes | 30 minutes | Similar |
Table 4:Technological Characteristics Comparison Table
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Image /page/8/Picture/0 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters, with a blue square above the "T". Below "THINK" is the word "SURGICAL" in smaller, blue letters.
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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The word "THINK" is in large, gray, block letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in a smaller, blue font.
The TCAT® THA Instrument Tray Sets were found to be similar to the predicate. Three fundamental similarities are:
-
Basic design: Both the TCAT THA Instrument Trays and the predicate 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 not identical but are similar.
-
Fundamental Technology: The TCAT THA Instrument Tray Sets and the predicate allow the sterilant (steam) to penetrate and render its contents sterile by relying on surface perforations.
Primary differences are related to size, shape, intended contents, surface perforations, and appearance.
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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 large, bold, gray letters, with a blue square above the "I". Below "THINK" is the word "SURGICAL" in smaller, blue letters. The logo is simple and modern, and it conveys a sense of innovation and precision.
Summary of Non-Clinical Testing:
Table 5 summarizes the non-clinical performance testing of the TCAT® THA Instrument Tray Sets:
- Sterilization Efficacy ●
- . Packaging
- Cleaning
- Biocompatibility ●
| Table 5: Summary of Non-Clinical Performance Testing | ||
|---|---|---|
| Non-ClinicalPerformanceTesting | Purpose | Results |
| Sterilization Efficacy(ISO 17665-1: 2006Sterilization of healthcare products-Moist HeatPart 1 Requirements forthe development,validation and routinecontrol of sterilizationprocess for medicaldevices.) | Demonstrate sterilization efficacy ofthe TCAT THA Instrument TraySets containing the maximuminoculated load. | The testresulted in nogrowth andsix-logreduction atthe half-cyclefor bothdevices |
Table 5: Summary of Non-Clinical Performance Testing
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Image /page/11/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in gray, block letters, with a small blue square above the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, blue font. The logo is simple and modern, and the colors are clean and professional.
| of the indicator organism. | ||
|---|---|---|
| Packaging(ASTM D4169-16Standard Practice forPerformance Testing inShipping Containers andSystems) | Demonstrate that the THINKSurgical TCAT® THA InstrumentTray Set was evaluated withmaximum load, wrapped accordingto use instructions and in theshipping configurations accordingto a shipping validation test. | The resultsfor bothtraysindicatepackagingendpointswere met. |
| Cleaning(FDA. 2015.Guidance forIndustry and FDA Staff-Processing/ReprocessingMedical Devices in HealthCare Settings: Validationand Labeling) | Demonstrate that that the cleaninginstructions for the TCAT THAInstrument Tray Set are valid. | The resultsfor bothtrayindicatedcleaningendpointswere met. |
| Biocompatibility(ISO 10993-5:2009Cytotoxicity Test) | Demonstrate that the TCATTHA Instrument Tray Set isbiocompatible. | Under theconditionsof the test,the deviceextract wasnotcytotoxic. |
Conclusions
The conclusions drawn from the nonclinical that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device Intuitive Surgical® Instrument and Accessory Sterilization Trays (K072211).
§ 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).