(119 days)
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No
The document describes a system for organizing and sterilizing medical instruments and does not mention any AI or ML components or functionalities.
No
The device is described as an instrument protection system cassette used to organize and protect other medical devices during sterilization. It does not exert any therapeutic effect on a patient.
No
The device is described as an "Instrument Protection System" used to organize and protect other medical devices during sterilization. Its intended use is to facilitate sterilization, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical system of cassettes used to organize and protect other medical devices during sterilization, not a software application.
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 device is used to "organize and protect other medical devices that are sterilized by a healthcare provider" and to "allow sterilization of the enclosed medical devices". This describes a device used in the process of sterilizing and handling other medical devices, not a device used to perform tests on biological samples to diagnose diseases or conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Measuring analytes or biomarkers
- Providing diagnostic information
- Using reagents or assays
The device's function is related to the sterilization and organization of other medical instruments, which falls under the category of medical device accessories or sterilization equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam or ethylene oxide sterilization cycles. The Instru-Safe System cassettes are intended to be used in conjunction with central legally marketed wrap or with a Genesis rigid The Instru-Safe System cassettes are not intended on the own to maintain container. sterility.
Product codes
KCT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare provider
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/11 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle with three stripes on its wing, symbolizing health, service, and human dignity. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
SEP - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom A. Lopac Micromedics, Incorporated 1270 Eagan Industrial Road Suite 120 Eagan, Minneapolis 55121
Re: K051157
Trade/Device Name: INSTRU-SAFE Instrument Protection Systems Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization wrap Regulatory Class: II Product Code: KCT Dated: August 22, 2005 Received: August 23, 2005
Dear Mr. Lopac:
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 for use stated in the encreations of the enactment date of the Medical Device Amendments, or to oonimer to provision of has need 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 I ou may, aron's brovisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rr your device is classinod (600 as 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_
1
Page 2 - Mr. Lopac
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tease be actived that I Drimination that your device complies with other requirements of the Act that I Dr Hos intatutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Far 80 7), accems (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. product radiation of to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you attire of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gottorers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sunlite Y. Michael Dm.D
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K051157
Device Name: Instru-Safe Instrument Protection Systems
Indications for Use:
Instru-Safe Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instru-Safe System cassettes are intended to allow sterilization of the enclosed medical devices during a pre-vacuum steam or ethylene oxide sterilization cycles. The Instru-Safe System cassettes are intended to be used in conjunction with central legally marketed wrap or with a Genesis rigid The Instru-Safe System cassettes are not intended on the own to maintain container. sterility.
Sterilization methods and configurations
| 140 count woven wrap | Non-woven wrap (Kimberly Clark) | Genesis Container (reference Table 1 for filter paper to use | |
|---|---|---|---|
| Steam | |||
| 8 minute preconditioning at 132°C | 10 minute dry time | 50 minute dry time | 30 minute dry time |
| Ethylene Oxide (EO) | 1 hour preconditioning at 131 °F (55 °C) with relative Humidity of 70±15% 2 hours exposure at 131 °F (55 °C) 12 hours aeration |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sile N. Murphy A/24/05
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control Dental Devices
510(k) Number: K051157