(157 days)
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No
The document describes a physical sterilization container system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a sterilization container system, not a device used for treating disease or injury.
No
Explanation: The device is a sterilization container system, not a diagnostic device. Its purpose is to sterilize and maintain the sterility of surgical instruments.
No
The device is described as a "reusable sterilization container system," which is a physical hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to sterilize surgical instruments and maintain their sterility. This is a process performed on medical devices (surgical instruments), not on biological samples from a human body for diagnostic purposes.
- Lack of IVD Characteristics: The description 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 or conditions
The device is clearly intended for the sterilization of surgical instruments, which falls under the category of medical devices used in healthcare settings, but not specifically for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to fecilitate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.
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
health care providers
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare and medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
Mr. Richard Bloom VP/GM of Contract Partnerships Promedica, Incorporated 114 Douglas Road East Oldsmar, Florida 34677-2939
Re: K032813
Trade/Device Name: Ultra System SPTM Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: KCT Dated: December 23, 2003 Received: December 24, 2003
Dear Mr. Bloom:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
1
Page 2 -Mr. Bloom
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); 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.
This letter will allow you 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 marketed 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 contact the Office of Compliance at (301) 594-4618. 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 Manufacturers, 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/dsma/dsmamain.html
Sincerely yours,
fosththasen
1, 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
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Indications for Use
510(k) Number: K032813
Device Name: ULTRA SYSTEM SPTM
Indications for Use:
The ULTRA SYSTEM SP™ is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in the STERRAD™ 50 and 100S Sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to feciliate placement of the enclosed surgical instruments. The maximum load is 8.35 pounds in the STERRAD™ 50 or 16.70 pounds in the STERRAD™ 100S. A maximum of Junens may be sterilized in each load.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use ※ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
16032813 510(k) Number:________________________________________________________________________________________________________________________________________________________________