(563 days)
Not Found
Not Found
No
The device description and intended use clearly indicate that this is a sterilization pouch/reel, a passive device used for packaging medical devices for sterilization. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No.
The device is described as sterilization pouches and reels, indicated to enclose another medical device for sterilization. It does not provide any therapeutic function.
No
Explanation: The device, Claricel sterilization pouches and reels, is used to enclose other medical devices for sterilization. Its function is to facilitate the sterilization process, not to diagnose a condition or disease.
No
The device description clearly states "Claricel Sterilization Pouches and Reels," which are physical products used for sterilization, 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 enclose other medical devices for sterilization. This is a process related to the preparation and handling of medical devices, not for performing tests on biological samples to diagnose, monitor, or treat a disease or condition.
- Device Description: The device is described as "Sterilization Pouches and Reels," which are packaging materials used in the sterilization process.
- 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 treatment based on biological sample analysis.
Therefore, the Claricel sterilization pouches and reels are considered a medical device used in the sterilization process, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Claricel sterilization pouches and reels are indicated to enclose another medical device that is to be steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 or ST-41 sterilization recommendations.
Product codes
KCT, FRG
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 provider
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble a person's profile.
4 1999 FEB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicel S.A. de C.V. C/O T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Incorporated 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
Re : K972719 Claricel Sterilization Pouches and Trade Name: Sterilization Reels Requlatory Class: II Product Code: KCT and FRG December 15, 1998 Dated: December 15, 1998 Received:
Dear Dr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Dr. Athey
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____K972719
Claricel Sterilization Pouches and Reels Device Name:
Indications For Use:
The Claricel sterilization pouches and reels are indicated to enclose another medical device that is to be steam or ethylene oxide sterilized by a health care provider, following the ANSI/AAMI ST-46 or ST-41 sterilization recommendations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qlin S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use