(284 days)
Not Found
No
The device is a sterilization tray and the summary focuses on sterilization validation, not AI/ML capabilities.
No.
The device is an instrument tray intended for sterilization and storage of other medical components, not for direct therapeutic use on a patient.
No
The device is an instrument tray used to enclose, protect, and organize medical instruments during sterilization and storage. Its function is not to diagnose conditions, but rather to facilitate the sterilization and handling of other medical devices.
No
The device is a physical instrument tray made of plastic, designed to hold and organize other medical devices for sterilization. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MyoSure Instrument Tray is for enclosing, protecting, and organizing surgical instruments (specifically a hysteroscope and associated components) during sterilization and storage. This is a function related to the preparation and handling of surgical tools, not the diagnosis of disease or conditions using samples from the human body.
- Device Description: The description details a plastic tray with features for holding and sterilizing instruments. This aligns with a surgical instrument accessory, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
- Reagents, calibrators, or controls used in laboratory testing
The focus of the document is entirely on the sterilization and storage of surgical instruments.
N/A
Intended Use / 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 Hysteroscope and accessories | Contents - 1 MyoSure Rod Lens Hysteroscope and accessories | Contents - 1 MyoSure Rod Lens Hysteroscope and accessories |
Product codes (comma separated list FDA assigned to the subject device)
KCT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
| 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.
2
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
3
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.
4
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
5
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