(234 days)
Not Found
Not Found
No
The summary describes a reusable sterilization container system, a purely mechanical device, with no mention of AI, ML, image processing, or data analysis.
No
The device is a sterilization container system used for surgical instruments and does not directly provide therapy to a patient.
No
Explanation: The device is described as a "reusable sterilization container system" for surgical instruments. Its purpose is to sterilize and maintain the sterility of instruments, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "reusable sterilization container system," which is a physical hardware device, 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 for the sterilization and maintenance of sterility of surgical instruments. This is a process related to preparing instruments for use in medical procedures, not for testing samples from the human body to diagnose or monitor a condition.
- Device Description: The device is described as a "reusable sterilization container system." This aligns with its intended use for sterilization, not for in vitro diagnostic testing.
- 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 those samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
Therefore, the ULTRA SYSTEM falls under the category of a medical device used for sterilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ULTRA SYSTEM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in ethylene oxide sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments.
Product codes
KCT
Device Description
Not Found
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
health care providers
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)
Not Found
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with three stylized wing or feather shapes.
MAR 2 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Mr. Richard Bloom Vice President Promedica, Incorporated 114 Douglas Road East Oldsmar, Florida 34677
Re: K032445
Trade/Device Name: Ultra System Regulation Number: 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: I Product Code: KCT Dated: March 1, 2004 Received: March 2, 2004
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) 594-5618. 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,
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
Indications for Use
510(k) Number: K032445
Device Name: ULTRA SYSTEM
Indications for Use:
The ULTRA SYSTEM is a reusable sterilization container system intended to allow sterilization of enclosed surgical instruments by health care providers in ethylene oxide sterilizers and to maintain sterility of the enclosed instruments until they are used. Baskets are used with the container to facilitate placement of the enclosed surgical instruments.
| Ultra System Container Sizes (in inches) | ||||
|---|---|---|---|---|
| 13 x 8.5 x 4 | 13 x 8.5 x 5 | 13 x 8.5 x 6 | 13 x 8.5 x 8 | |
| 13 x 13 x 4 | 13 x 13 x 5 | 13 x 13 x 6 | 13 x 13 x 8 | |
| 18 x 13 x 4 | 18 x 13 x 5 | 18 x 13 x 6 | 18 x 13 x 8 | 18 x 13 x 9 |
| 22 x 8.5 x 4 | 22 x 8.5 x 5 | 22 x 8.5 x 6 | 22 x 8.5 x 8 | |
| 24 x 13 x 4 | 24 x 13 x 5 | 24 x 13 x 6 | 24 x 13 x 8 |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Ques
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K032445