(62 days)
Not Found
None
No
The summary describes a sterilization wrap, a passive device, and contains no mention of AI or ML.
No
The device is a sterilization wrap, intended to enclose and maintain the sterility of other medical devices, not to provide a therapeutic effect on a patient.
No
Explanation: The device is a sterilization wrap intended to enclose other medical devices for sterilization and maintain sterility. It is not used to diagnose any medical condition.
No
The device description clearly states "Secure-Wrap® Sterilization Wrap," which is a physical product used for enclosing medical devices for sterilization. There is no mention of software components or functionality.
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 enclose another medical device for sterilization and maintain sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Device Description: "Sterilization Wrap" aligns with the intended use and does not suggest an in vitro diagnostic purpose.
- Lack of IVD Characteristics: The description lacks any mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, Secure-Wrap® Sterilization Wrap is a medical device used for sterilization and sterility maintenance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is 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 maintain sterility of the enclosed device until used. It is intended for use with either steam or ethylene oxide sterilization methods.
Product codes
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
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 stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are black and are arranged in a way that suggests movement or progression. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 1997 Ms. Frances Mayhew Ouality Assurance Manaqer American Threshold Industries, Incorporated 240 Sardis Road Enka, North Carolina 28728
K971483 Re : Secure-Wrap® Sterilization Wrap Trade Name: Regulatory Class: II Product Code: FRG Dated: April 23, 1997 Received: April 23, 1997
Dear Ms. Mayhew:
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labelinq, and prohibitions aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Ms. Mayhew
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
Alatrust
Time Ulat Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page -
510(k) Number (if known):
Device Name: _ Secure-Wrap Sterilization Wrap
Indications For Use:
This device is 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 maintain sterility of the enclosed device until used. It is intended for use with either steam or ethylene oxide sterilization methods.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices |
510(k) Number
Prescription Use (Pcc 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)