(24 days)
Not Found
Not Found
No
The description focuses on a chemical indicator changing color based on temperature and time, with no mention of AI or ML.
No
The device is described as an autoclave tape used to indicate sterilization. It does not treat or diagnose any medical condition.
No
The device is a process indicator for sterilization, not a diagnostic tool for medical conditions.
No
The device described is a physical product (autoclave tapes) used as a process indicator, 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 is to hold sterilization packs together and act as a process indicator for steam sterilization. It indicates whether an item has been exposed to the sterilization process, not whether a biological sample contains a specific analyte or condition.
- Mechanism: The mechanism is a chemical reaction (color change) triggered by heat and steam, not a test performed on a biological sample to diagnose a disease or condition.
- Lack of Biological Sample Interaction: IVDs are designed to be used in vitro (outside the body) on biological samples (like blood, urine, tissue). This device interacts with the sterilization environment and the packaging, not a biological sample.
Therefore, Nev's Ink Autoclave Tapes fall under the category of sterilization process indicators, not IVDs.
N/A
Intended Use / Indications for Use
Nev's Ink Autoclave Tapes are used to hold sterilization packs together and as a process indicator in steam sterilizers. When exposed to gravity steam sterilizers operating at 121℃ for 10 minutes and pre-vacuum steam sterilizers operating at 134℃ for 2 minutes, the word "Autoclaved" turns pink. This provides identification of processed items.
Product codes
JOJ
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
Not Found
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
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a logo and the word "DEPARTMENT". The logo is a stylized representation of a human figure with three curved lines forming the body and head. The text "DEPARTMENT" is printed in bold, sans-serif font, and is positioned to the right of the logo. A horizontal line is present under the word "DEPARTMENT".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nev's Ink, Incorporated C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
JUL - 1 2010
Re: K101580
Trade/Device Name: Nev's Ink Autoclave Tapes Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: II Product Code: JOJ Dated: June 23, 2010 Received: June 24, 2010
Dear Mr. Job:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Job
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Moore
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Nev's Ink, Inc. Autoclave Tapes 510(k) Premarket Notification
2. Indications for Use Statement
Indications for Use
510(k) Number : _ K101580 Device Name: Nev's Ink Autoclave Tapes Product numbers: LFA-5BP, LFA-75BP, LFA-1BP, LFA-50BP, LFA-750BP, LFA-10BP
Indications for Use:
Nev's Ink Autoclave Tapes are used to hold sterilization packs together and as a process indicator in steam sterilizers. When exposed to gravity steam sterilizers operating at 121℃ for 10 minutes and pre-vacuum steam sterilizers operating at 134℃ for 2 minutes, the word "Autoclaved" turns pink. This provides identification of processed items.
Prescription Use (Part 21 CFR 801 Subpart D) Over-the-Counter-Use X (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off)
Division of Anesthesiology, General Hospital nfection Control, Dental Devices
K 101580 510(k) Number:
Page 7 of 48
June 22, 2010