The THS Sterilization Tray is used to enclose, protect, and organize the THS scopes, diagnostic sheath, and associated accessory components, and to facilitate the sterilization process by allowing sterilant penetration and air removal when used in conjunction with an approved sterilization wrap.

The THS Instrument tray is not designed to maintain sterility by itself, but when used in conjunction with an approved sterilization wrap sterility of the enclosed medical device is maintained based on the specific time that the maintenance of sterility for that specific wrap as cleared by the FDA.

The THS Sterilization Tray is to be sterilized using one of the following cycles:

Steam Autoclave Wrapped Pre-Vacuum Parameters: 270°F for 4 minutes
Pre-Vacuum Dry Time: 30 minutes
Gravity Parameters: 250°F for 30 minutes
Gravity Dry Time: 30 minutes

Device Description

The THS Sterilization Tray will secure the reusable THS components during autoclave sterilization in preparation for future procedures. The THS Sterilization Tray described in this submission contains no components or materials that directly contact the patient and/or patient body fluids.

AI/ML Overview

Here's an analysis of the provided text regarding the THS Sterilization Tray, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Intended Use/Sterilization Parameters)	Reported Device Performance (Validation Statement)
To enclose, protect, and organize THS components.	The device is described as securing reusable THS components. (Implied)
To facilitate sterilant penetration and air removal.	The device "allows sterilant penetration and air removal." (Direct statement)
To be used in conjunction with an approved sterilization wrap to maintain sterility until use.	"When used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used." (Direct statement)
Steam Autoclave Wrapped Pre-Vacuum Parameters:	Has been validated to be sterilized using:
Temperature: 270°F	Temperature: 270°F
Time: 4 minutes	Time: 4 minutes
Dry Time: 30 minutes	Dry Time: 30 minutes
Gravity Parameters:	Has been validated to be sterilized using:
Temperature: 250°F	Temperature: 250°F
Time: 30 minutes	Time: 30 minutes
Dry Time: 30 minutes	Dry Time: 30 minutes

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state a quantitative sample size for a "test set" in the traditional sense of a clinical or performance study involving human subjects or a large dataset. The performance testing described is likely based on laboratory validation of the sterilization parameters.

Sample Size: Not specified.
Data Provenance: The study is an internal validation conducted by Hologic, Inc. (the manufacturer). The country of origin would be the USA (Marlborough, MA). It is a prospective assessment in the sense that the device was specifically tested to confirm its compatibility with the sterilization cycles.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a sterilization tray, "ground truth" would typically be established by established sterilization standards and validated by microbiological or chemical indicator testing performed by qualified laboratory personnel, rather than medical experts in a clinical setting.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 typically apply to studies where human reviewers assess data (e.g., medical images) and disagreements need to be resolved. For a sterilization tray, performance is assessed against predefined physical and microbiological criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a sterilization tray, not a diagnostic tool requiring human interpretation of results.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, a standalone validation was done. The performance testing described (Section 7: "Performance Testing") assesses the device's ability to withstand and facilitate the sterilization process according to specified parameters, independent of human interaction during the sterilization cycle itself. While there's no "algorithm" in the sense of AI, the device's intrinsic characteristics are tested in a standalone manner.

7. The Type of Ground Truth Used

For a sterilization tray, the "ground truth" would be the successful completion of the sterilization process, demonstrating:

Sterilant Penetration: Evidence that the sterilant reached all surfaces within the tray.
Air Removal: Confirmation that air was effectively removed, allowing proper sterilant contact.
Maintenance of Device Integrity: The tray and its contents withstand the sterilization cycles without damage.
Microbiological Inactivation: (Implied by standard sterilization validation) Assurance that a sterility assurance level (SAL) is achieved, typically through the use of biological indicators in conjunction with the validation of the chosen sterilization cycles.

The document states the tray "has been validated to be sterilized using" the specified cycles, implying that these aspects of ground truth were confirmed.

8. The Sample Size for the Training Set

This information is not applicable or provided. The THS Sterilization Tray is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or data-driven model development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided for the reasons stated above (no training set for a physical device).

Summary

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HOLOGIC, Inc.

K120947

OCT 1 7 2012

Premarket Notification

5. 510(k) SUMMARY

1. Submitter:

Hologic, Inc. 250 Campus Dr. Marlborough, MA 01752 Telephone: 508.263.8857

Contact: Sarah Fairfield, Sr. Regulatory Affairs Specialist

2. Device:

Trade Name: THS Sterilization Tray Common Name: Instrument Sterilization Tray and Accessories Classification Name: 880.6850 Sterilization Wrap Product Code: KCT Class: II

3. Predicate Device:

Tradename: PolyVac Surgical Instrument Delivery System Submitter / 510(k) Holder: Symmetry Medical, Inc. 510(k) #'s: K012105 and K040223

4. Device Description:

5. Intended Use:

The THS Sterilization Tray is not designed to maintain sterility by itself, but when used in conjunction with an approved sterilization wrap, sterility of the enclosed medical device is maintained until used.

The THS Sterilization Tray is to be sterilized using one of the following cycles:

న-I

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Steam Autoclave Wrapped Pre-Vacuum Parameters: Pre-Vacuum Dry Time: Gravity Parameters: Gravity Dry Time:

270°F for 4 minutes 30 minutes 250°F for 30 minutes 30 minutes

6. Comparison of Characteristics:

The design, principles of operation, primary functional specifications and materials of composition of the THS Sterilization Tray are identical to those of the predicate PolyVac Surgical Instrument Delivery System (Standard Modultainer - ¾ size system and accessories) in that:

all trays are fabricated from identical plastic and/or metal materials, .
all trays are autoclavable and reusable, .
both the THS and PolyVac devices are identical in dimension and . design features.

The THS Sterilization Tray's intended use is identical to that of the predicate PolyVac Surgical Instrument Delivery System (K012105 and K040223).

7. Performance Testing:

The THS Sterilization Tray has been validated to be sterilized using one of the following cycles:

Steam Autoclave Wrapped Pre-Vacuum Parameters: Pre-Vacuum Dry Time: Gravity Parameters: Gravity Dry Time:

270ºF for 4 minutes 30 minutes 250ºF for 30 minutes 30 minutes

8. Conclusion:

Based on the intended use, descriptive information and performance evaluation provided in this submission, the THS Sterilization Tray has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicate Poly Vac Surgical Instrument Delivery System (Standard Modultainer - 3/4 size system and accessories).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

2012

Hologic, Incorporated Ms. Sarah Fairfield Senior Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752

Re: K120947

Trade/Device Name: THS Sterilization Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: September 27, 2012 Received: September 27, 2012

Dear Ms. Fairfield:

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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Page 2- Ms. Fairfield

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Antony O'Neill

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K120947

Device Name: THS Sterilization Tray

Indications For Use:

The THS Sterilization Tray is to be sterilized using one of the following cycles:

Steam Autoclave Wrapped Pre-Vacuum Parameters: Pre-Vacuum Dry Time: Gravity Parameters: Gravity Dry Time:

270°F for 4 minutes 30 minutes 250°F for 30 minutes 30 minutes

Prescription Use _ (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alvin Whitaker

of Anesthesiology, General Hospital tion Control. Dental Device

510(k) Number: K120947

Regulation Number and Section

§ 880.6850 Sterilization wrap.

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