(284 days)
The MyoSure™ Instrument Tray is intended to enclose, protect, and organize the MyoSure Rod Lens Hysteroscope, MyoSure Removable Outflow Channel, and associated components during sterilization and storage. The MyoSure Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer's instructions.
The MyoSure™ Instrument Tray has been validated for the following sterilization cycles:
| Prevacuum Steam | Gravity Steam | STERRAD 100S |
|---|---|---|
| 132°C (270°F) | 132 °C (270 °F) | 59% H2O2 |
| 4 minutes exposure | 15 minutes exposure | Normal Cycle Setting |
| 30 minutes dry time | 30 minutes dry time | 30 minutes dry time |
| Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens |
| Hysteroscope, 1 Removable | Hysteroscope, 1 Removable | Hysteroscope, 1 Removable |
| Outflow Channel, 2 Seal Caps, 2 | Outflow Channel, 2 Seal Caps, 2 | Outflow Channel, 2 Seal Caps, 2 |
| Light Guides | Light Guides | Light Guides |
The MyoSure Instrument Tray consists of an approximate 13.45 inch x 8.41 inch x 2.0 inch plastic, perforated base and lid with posts and cradles to position the devices to be sterilized. Each tray and lid has an evenly distributed hole pattern that allows sterilant penetration and air removal.
Here's an analysis of the acceptance criteria and study details for the MyoSure Instrument Tray, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Sterilization Type) | Specific Parameters | Required Performance | Reported Device Performance |
|---|---|---|---|
| Prevacuum Steam Sterilization | Temperature: 132°C (270°F) | 6 log reduction of all spore strips and inoculated devices; Excellent sterilant penetration | Achieved 6 log reduction; Excellent sterilant penetration demonstrated by thermocouple data |
| Exposure time: 4 minutes | |||
| Dry time: 30 minutes | |||
| Contents: 1 MyoSure Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides | |||
| Gravity Steam Sterilization | Temperature: 132°C (270°F) | 6 log reduction of all spore strips and inoculated devices; Excellent sterilant penetration | Achieved 6 log reduction; Excellent sterilant penetration demonstrated by thermocouple data |
| Exposure time: 15 minutes | |||
| Dry time: 30 minutes | |||
| Contents: 1 MyoSure Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides | |||
| STERRAD 100S Sterilization | Sterilant: 59% H2O2 | 6 log reduction of all spore strips and inoculated devices; Excellent sterilant penetration | Achieved 6 log reduction; Excellent sterilant penetration demonstrated by chemical indicator data |
| Cycle Setting: Normal | |||
| Dry time: 30 minutes (implied, mentioned once for other cycles) | |||
| Contents: 1 MyoSure Rod Lens Hysteroscope, 1 Removable Outflow Channel, 2 Seal Caps, 2 Light Guides | |||
| Materials Compatibility | Post-processing | Not explicitly stated but implied successful results for use with sterilization process | Indicated successful results |
| Biocompatibility | Intracutaneous irritation | Not explicitly stated but implied successful results | Indicated successful results |
| Hemolysis | Not explicitly stated but implied successful results | Indicated successful results |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the test set in terms of the number of individual devices or sterilization cycles performed beyond "all spores strips and inoculated devices." However, it refers to "half cycle testing" for STERRAD.
The data provenance is a validation study performed by the manufacturer, Hologic, Inc., to demonstrate the effectiveness of the MyoSure Instrument Tray with specific sterilization methods. It is an internal prospective study conducted for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. For sterilization validation, ground truth is typically established through quantitative microbial inactivation assays (e.g., spore strip testing) and physical measurements (e.g., thermocouple data, chemical indicators), rather than expert consensus on subjective interpretations. The expertise would lie in microbiology and sterilization science to design and interpret these tests, but specific "experts" for ground truth establishment are not mentioned for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable/provided for this type of device validation. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., reading medical images) where there can be disagreement among experts. For sterilization validation, the results are generally objective and quantifiable (e.g., counting colony-forming units from spore strips, temperature readings).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is compared. The MyoSure Instrument Tray is a sterilization tray, which does not involve human interpretation or AI assistance in its primary function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This device does not involve an algorithm. The "performance" being evaluated is the ability of the tray to facilitate sterilization, which is assessed through direct physical and microbiological tests, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this validation study is primarily microbiological validation (6 log reduction of spore strips and inoculated devices) combined with physical measurements (thermocouple data for steam sterilization, chemical indicator data for STERRAD). This is standard for sterilization efficacy testing.
8. The Sample Size for the Training Set
This information is not applicable/provided. The MyoSure Instrument Tray is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, there is no training set for this type of device.
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K1 2.12.80
FEB 8 2013
510(k) Summary
10.1 Submitter: Hologic, Inc 250 Campus Drive Marlborough, MA 01752 USA
Contact: Sarah Fairfield GYN-Surgical Division 250 Campus Drive Marlborough, MA 01752 USA 508-263-8857
Date prepared: January 16, 2013
10.2 Device Information: Trade Name: MyoSure Instrument Tray Common Name: Sterilization Tray Classification II (21 CFR 880.6850) Product Code: KCT
- 10.3 Predicate Device:
Trade Name: PolyVac Surgical Instrument Delivery System Submitter/510(k) holder: Symmetry Medical, Inc. 510(k) Numbers: K012105 and K040223
10.4 Device Description
The MyoSure Instrument Tray consists of an approximate 13.45 inch x 8.41 inch x 2.0 inch plastic, perforated base and lid with posts and cradles to position the devices to be sterilized. Each tray and lid has an evenly distributed hole pattern that allows sterilant penetration and air removal.
10.5 Indications for Use
The MyoSure™ Instrument Tray is intended to enclose, protect, and organize the MyoSure Rod Lens Hysteroscope, MyoSure Removable Outflow Channel, and associated components during sterilization and storage. The MyoSure Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer's instructions.
10-1
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| Prevacuum Steam | Gravity Steam | STERRAD 100S |
|---|---|---|
| 132°C (270°F) | 132 °C (270 °F) | 59% H2O2 |
| 4 minutes exposure | 15 minutes exposure | Normal Cycle Setting |
| 30 minutes dry time | 30 minutes dry time | 30 minutes dry time |
| Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens |
| Hysteroscope, 1 Removable | Hysteroscope, 1 Removable | Hysteroscope, 1 Removable |
| Outflow Channel, 2 Seal Caps, 2 | Outflow Channel, 2 Seal Caps, 2 | Outflow Channel, 2 Seal Caps, 2 |
| Light Guides | Light Guides | Light Guides |
The MyoSure™ Instrument Tray has been validated for the following sterilization cycles:
10.6 Comparison to Predicate
The design, principles of operation, primary functional specifications, and materials of composition of the MyoSure Instrument Tray are identical to those of the predicate PolyVac Surgical Instrument Delivery System. Both travs are made from the same materials, have the same dimensions, and are designed to be compatible with the same sterilization methods and parameters. Verification and Validation testing confirm that the MyoSure Instrument Tray meets the same performance specifications as the predicate PolyVac Surgical Instrument Delivery System.
Summary of Performance Testing: 10.7
Steam sterilization qualification:
The MyoSure Instrument Tray was successfully validated in the following steam sterilization cycles. Test results demonstrated a 6 log reduction of all spores strips and inoculated devices. Thermocouple data shows excellent sterilant penetration within the wrapped packages.
Validated Steam Sterilization Cycles:
Pre-Vacuum: 4 minutes @ 132C
Gravity Air Displacement: 15 minutes @ 132C
STERRAD Sterilization qualification
Successful completion of half cycle testing demonstrated that the MyoSure™ Instrument Tray containing a MyoSure Rod Lens Hysteroscope, Removable Outflow Channel, 2 Seal Caps, and 2 Light Guides components can be effectively sterilized using a the Sterrad® 100S System, full hospital cycle. The sterilization tests demonstrated a six log reduction capability of all spore strips and inoculated devices. Chemical indicator data indicated excellent sterilant penetration within the wrapped packages
Additional testing also included post-processing materials compatibility, intracutaneous irritation and hemolysis biocompatibility testing, all of which indicated successful results.
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10.8 Conclusion
Based on the intended use, descriptive information, and performance evaluation provided in this submission, the MyoSure Instrument Tray has been shown to be substantially equivalent in materials, technology, method of operation, functional performance, and intended use to the predicate PolyVac Surgical Instrument Delivery System.
10-3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2013
Mr. Daniel F. Phelan Regulatory Affairs Manager Hologic, Incorporated 250 Campus Drive MARLBOROUGH MA 01752
Re: K121280
Trade/Device Name: MyoSure Instrument Tray Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: January 17, 2013 Received: January 18, 2013
Dear Mr. Phelan:
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 of medical devicerelated 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/CDRH0ffices/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.
hor
Theth
Harshita.D.
Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement
K121280 510(k) Number:
Device Name: MyoSure Instrument Tray
Indications for Use:
The MyoSure™ Instrument Tray is intended to enclose, protect, and organize the MyoSure Rod Lens Hysteroscope, MyoSure Removable Outflow Channel, and associated components during sterilization and storage. The MyoSure Instrument Tray must be used in conjunction with a sterilization wrap that is cleared by FDA for the indicated sterilization cycle, and may be stored for up to 30 days in accordance with the wrap manufacturer's instructions.
The MyoSure™ Instrument Tray has been validated for the following sterilization cycles:
| Prevacuum Steam | Gravity Steam | STERRAD 100S |
|---|---|---|
| 132°C (270°F) | 132 °C (270 °F) | 59% H2O2 |
| 4 minutes exposure | 15 minutes exposure | Normal Cycle Setting |
| 30 minutes dry time | 30 minutes dry time | |
| Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens | Contents - 1 MyoSure Rod Lens |
| Hysteroscope and accessories | Hysteroscope and accessories | Hysteroscope and accessories |
Prescription Use (per CFR 801.109) Over-the-counter use X
Concurrence of CDRH
OL
Elizabeth F. Claverie
2013.02.07 18:33:18 -05'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K121480
§ 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).