(149 days)
Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for use in healthcare facilities to store, transport, organize, and sterilize surgical instruments such as retractor frame components, lighting accessories, and blade or frame accessories between used in combination with an FDA cleared sterilization wrap. Validated sterilization parameters include pre-vacuum steam and gravity.
| CYCLE | CYCLE TEMP | EXPOSURE TIME | DRY TIME |
|---|---|---|---|
| Prevacuum | 132°C (270°F) | 4 Minutes | 30 Minutes |
| Gravity | 121°C (250°F) | 30 Minutes | 30 Minutes |
Thompson Surgical Instruments “MIS Spine Frame Instrument Case,” model 50000MSF, is intended to hold surgical instruments such as retractor blades, retractor frame components, lighting accessories, and blade or frame accessories during storage, transportation, and sterilization, as indicated. It is composed of materials that can be reused with steam sterilization methods and DCG graphics may be used. It has a distribution of perforations on the outer surfaces and between case levels that allow for optimal steam penetration. Vent to volume is .110. It is reusable and provided to the customer in a non-sterile conditions. This case can be described as an accessory for the Thompson Retractor.
The provided document describes the Thompson Surgical Instruments MIS Spine Frame Instrument Case (K151347), which is a device for storing, transporting, organizing, and sterilizing surgical instruments. The testing focuses on its ability to perform sterilization effectively.
Here's an analysis of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this device appears to be its ability to achieve a six-log reduction of an indicator organism during sterilization cycles, demonstrating effective sterilization. The cleaning and biocompatibility tests also represent criteria for safety and effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sterilization Efficacy (Pre-vacuum Steam): Effective sterilization, demonstrating a six-log reduction of indicator organism. Validated parameters: 132°C (270°F) for 4 minutes with 30 minutes dry time. | The MIS Spine Frame Instrument Case, containing the maximum load and wrapped in an FDA cleared sterilization wrap, was exposed to the specified steam sterilization half cycles. Results indicated that half cycles provided a six-log reduction of the indicator organism. |
| Sterilization Efficacy (Gravity Steam): Effective sterilization, demonstrating a six-log reduction of indicator organism. Validated parameters: 121°C (250°F) for 30 minutes with 30 minutes dry time. | The MIS Spine Frame Instrument Case, containing the maximum load and wrapped in an FDA cleared sterilization wrap, was exposed to the specified steam sterilization half cycles. Results indicated that half cycles provided a six-log reduction of the indicator organism. (Though not explicitly separated for gravity, the general statement implies both validated cycles were tested and passed.) |
| Cleanability: The device must be cleanable. | The MIS Spine Frame Instrument Case was tested for cleanability, and the results indicated a pass. |
| Biocompatibility: The device should be non-cytotoxic. | The MIS Spine Frame Instrument Case is considered non-cytotoxic as based on MEM elution test results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a precise numerical sample size for the "test set" (i.e., the number of MIS Spine Frame Instrument Cases or biological indicators used). It states that the device "and the predicate containing the maximum load were inoculated with biological indicators." This implies at least one of each device type was used per sterilization cycle condition. Given the nature of sterilization validation, multiple runs for each cycle condition would typically be performed, but the exact number isn't provided.
- Data Provenance: The study was conducted by Thompson Surgical Instruments, Inc. as part of their 510(k) submission to the FDA. This indicates the testing was performed internally or by a contracted lab for the manufacturer. The data is prospective as it was generated specifically to demonstrate the performance of this device for regulatory submission. The country of origin of the data is implicitly the United States, where the submitting company is based and where FDA regulations apply.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This type of device does not typically involve expert review for ground truth in its performance testing. The "ground truth" for sterilization efficacy is established by the biological indicators (BIs) which contain a known quantity of resistant microorganisms. A six-log reduction is a quantitatively measurable outcome. For cleaning, "pass" indicates meeting pre-defined cleanliness criteria. For biocompatibility, MEM elution test results are directly interpreted. Human experts are not used to establish a subjective "ground truth" for these performance characteristics.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (like 2+1, 3+1) are typically used for studies involving subjective human interpretation of data, such as medical image analysis, where discrepancies between expert opinions need to be resolved. For objective tests like biological indicator reduction, cleanability pass/fail, and cytotoxicity, an adjudication method is not relevant. The results are based on direct measurement against defined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This device is a medical instrument case, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance in interpretation is not applicable. The study assesses the physical and functional performance of the device itself.
6. Standalone (Algorithm Only) Performance Study
N/A. This device does not involve an algorithm or AI. Its performance is entirely physical and functional, assessed through empirical laboratory testing.
7. Type of Ground Truth Used
The ground truth for the performance studies is primarily:
- Biological Indicators: For sterilization efficacy, the ground truth is the complete kill of a known concentration of highly resistant test microorganisms (e.g., Geobacillus stearothermophilus spores for steam sterilization), quantifiable by a log reduction.
- Defined Cleanliness Criteria: For cleanability, the ground truth is adherence to established visual and/or analytical criteria for cleanliness (e.g., no visible soil, acceptable levels of residual protein, hemoglobin, etc.).
- Standardized Cytotoxicity Assays: For biocompatibility (MEM elution test), the ground truth is based on the cellular response to leachables from the material, interpreted against standard reference controls.
8. Sample Size for the Training Set
N/A. This device does not involve machine learning or AI, and therefore no "training set" is applicable. The studies are empirical tests of the manufactured device.
9. How Ground Truth for the Training Set was Established
N/A. As there is no training set, this question is not applicable.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000
October 16, 2015
Thompson Surgical Instruments, Inc. Stephanie Myers, Product Manager 10170 East Cherry Bend Road, Traverse City, MI 49684
Re: K151347
Trade/Device Name: MIS Spine Frame Instrument Case Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 15, 2015 Received: September 18, 2015
Dear Ms. Myers,
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.
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151347
Device Name MIS Spine Frame Instrument Case
Indications for Use (Describe)
Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended for use in healthcare facilities to store, transport, organize, and sterilize surgical instruments such as retractor frame components, lighting accessories, and blade or frame accessories between used in combination with an FDA cleared sterilization wrap. Validated sterilization parameters include pre-vacuum steam and gravity.
| CYCLE | CYCLE TEMP | EXPOSURE TIME | DRY TIME |
|---|---|---|---|
| Prevacuum | 132°C (270°F) | 4 Minutes | 30 Minutes |
| Gravity | 121°C (250°F) | 30 Minutes | 30 Minutes |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Submitter: Thompson Surgical Instruments, Inc.
Product: MIS Spine Frame Instrument Case
Image /page/3/Picture/2 description: The image shows the logo for Thompson Surgical Instruments. The logo has the company name in bold, black letters, with the words "SURGICAL INSTRUMENTS" in a smaller font size below the name. To the right of the company name is a blue symbol. Below the logo is the text "K151347".
510(k) Summary
| Submitter Name: | Thompson Surgical Instruments, Inc. | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Submitter Address: | 10170 E Cherry Bend RdTraverse City, MI 49684 | ||||||||||||
| Contact Person: | Stephanie Myers, Research & Development /Product Manager | ||||||||||||
| Phone Number: | 231-922-5170 | ||||||||||||
| Fax: | 231-922-0174 | ||||||||||||
| Date Prepared: | September 14, 2015 | ||||||||||||
| Device Trade Name: | MIS Spine Frame Instrument Case | ||||||||||||
| Classification Name: | Sterilization Wrap Containers, Cassettes, and Accessories | ||||||||||||
| Device Class: | Class II | ||||||||||||
| ClassificationRegulation: | 21 CFR 880.6850 | ||||||||||||
| Product Code: | KCT | ||||||||||||
| Predicate Device: | The instrument case described in this submission was compared and found to besubstantially equivalent to the K3131170 Sonicision™ Sterilization Traymanufactured by Covidien. K3131170 was cleared August 28th, 2013. | ||||||||||||
| Statement of IntendedUse: | Thompson Surgical Instruments MIS Spine Frame Instrument Case is intended foruse in healthcare facilities to store, transport, organize, and sterilize surgicalinstruments such as retractor blades, retractor frame components, lightingaccessories, and blade or frame accessories between uses when used in combinationwith an FDA cleared sterilization wrap. Validated sterilization parameters includepre-vacuum steam and gravity.CYCLECYCLE TEMPEXPOSURE TIMEDRY TIME Prevacuum132°C (270ºF)4 Minutes30 Minutes Gravity121ºC (250ºF)30 Minutes30 Minutes | ||||||||||||
| Device Description: | Thompson Surgical Instruments “MIS Spine Frame Instrument Case,” model50000MSF, is intended to hold surgical instruments such as retractor blades,retractor frame components, lighting accessories, and blade or frame accessoriesduring storage, transportation, and sterilization, as indicated. It is composed ofmaterials that can be reused with steam sterilization methods and DCG graphics maybe used. It has a distribution of perforations on the outer surfaces and between caselevels that allow for optimal steam penetration. Vent to volume is .110. It is reusable |
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Submitter: Product: Thompson Surgical Instruments, MIS Spine Frame Instrument Case Inc. and provided to the customer in a non-sterile conditions. This case can be described as an accessory for the Thompson Retractor. Technological and The MIS Spine Frame Instrument Case was found to be similar to the predicate. Performance Three fundamental similarities are: Characteristics: Basic design: Both the MIS Spine Frame Instrument Case and the predicate 1. 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. 2. Role in sterile barrier system: The MIS Spine Frame Instrument Case and the predicate must be enclosed with a qualified FDA cleared sterilization wrap to maintain sterility. Neither contains gaskets, valves, or filters. 3. Fundamental Technology: The MIS Spine Frame Instrument Case and the predicate allow the sterilant (steam) to penetrate and render its contents sterile by relying on surface perforations.
Primary differences are related to minor variances in size, shape, intended contents, surface perforations, and overall look. However, performance data demonstrate that the differences do not adversely affect safety and effectiveness. Please see further comparison below.
| Proposed: MIS Spine FrameInstrument Case | Predicate: Sonicision™ Sterilization Tray K131170 | |
|---|---|---|
| Intended Use: | Thompson SurgicalInstruments MIS Spine FrameInstrument Case is intendedfor use in healthcare facilitiesto store, transport, organize,and sterilize medical devicesand other instrumentationbetween uses when used incombination with a FDAcleared sterilization wrap. | To encase and protectreusable batteries andgenerators of the Sonicisionsystem during sterilizationand storage. Compatiblesterilization systems areindicated as follows:STERRATD® 100s, STERRAD®NX ®, STERRAD® 100NX®,STERIS Amsco® V-PRO® 1,STERIS Amsco® V-PRO® 1Plus, STERIS Amsco® V-PRO®max |
| DesignCharacteristics: | ||
| -Composition: | Base, lift out tray, and lid | Base and lid |
Comparison to Predicate Devi
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Submitter:
Inc.
Thompson Surgical Instruments,
Product: MIS Spine Frame Instrument Case
Image /page/5/Picture/2 description: The image contains the logo for Thompson Surgical Instruments. The logo features the company name in bold, sans-serif font, with "Thompson" on the top line and "SURGICAL INSTRUMENTS" on the bottom line. To the right of the name is a stylized blue symbol. Below the logo is the alphanumeric code "K151347".
| -Intended content(max load): | Medical devices/instrumentsweighing no less than 25lbstotal including the weight ofthe MIS Spine FrameInstrument Case. | One Sonicision generator andone battery pack |
|---|---|---|
| -Inserts: | Yes | Yes |
| -Handles: | Yes | Yes |
| -Latches: | Yes | Yes |
| -Reusable: | Yes | Yes |
| Materials: | ||
| -Lid/base/lift outtray not includinginserts: | Aluminum | Polysulfone |
| -Inserts: | Silicone, Aluminum, StainlessSteel, Nylon | Silicone |
| -Latch: | Stainless steel | Polysulfone |
| AssembledDimensions: | 11" x 23.5" | 5.9" X 8.1" |
| Weight containingmax load: | 25 lbs | 1.58 lbs |
| Percent of surfaceperforations on lid,base, lift out tray: | Lid has 15.7%, lift out tray has19.2%, and base has 13.6% | 9.7% |
Non-Clinical Performance Studies:
The MIS Spine Frame Instrument Case was evaluated in accordance with applicable clauses/criteria specified in AAMI 5T77:2006. Test evidence supporting sterilization efficacy, cleaning, and biocompatibility are provided in the submission. A brief discussion of tests used to support the conclusion of substantial equivalence with the predicate device is provided below.
Sterilization efficacy: The MIS Spine Frame Instrument Case and the predicate containing the maximum load were inoculated with biological indicators placed in areas of the trays deemed to be most difficult for sterilant (steam) to penetrate. Following inoculation, the trays were wrapped in FDA cleared sterilization wraps.
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| Submitter:Thompson Surgical Instruments, Inc. | Product:MIS Spine Frame Instrument Case | ThompsonSURGICAL INSTRUMENTSK151347 |
|---|---|---|
| They trays were then exposed to the sterilization cycles (Steam sterilization for theMIS Spine Frame Instrument Case and STERRAD or STERIS sterilization for thepredicate). The results for both trays indicated that half cycles provided a six logreduction of the indicator organism. | ||
| Cleaning: The MIS Spine Frame Instrument Case was tested for cleanability. Theresults indicated a pass. Supporting evidence is included in the submission. | ||
| Biocompatibility: The MIS Spine Frame Instrument Case is considered non-cytotoxicas based on MEM elution test results. Supporting evidence is found in thesubmission. | ||
| Clinical PerformanceStudies: | This premarket notification report does not rely on the assessment of clinicalperformance data to demonstrate substantial equivalence. | |
| Conclusion: | The MIS Spine Frame Instrument Case is substantially equivalent to the Sonicision™Sterilization Tray, K131170. None of the differences between the MIS Spine FrameInstrument Case and the predicate change the intended use or raise new questionsof safety or effectiveness. |
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Submitter: Thompson Surgical Instruments, Inc.
Product: MIS Spine Frame Instrument Case
Image /page/7/Picture/2 description: The image shows the logo for Thompson Surgical Instruments. The logo features the word "Thompson" in bold, black letters, with the words "SURGICAL INSTRUMENTS" in smaller, thinner letters underneath. To the right of the word "Thompson" is a blue symbol that appears to be a stylized "T". Below the logo is the alphanumeric code "K151347".
5
§ 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).