(86 days)
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Not Found
No
The 510(k) summary describes a medical device wrapper for sterilization and maintaining sterility, with no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No
The device is a wrapper used for sterilizing and maintaining the sterility of other medical devices, not for therapeutic purposes.
No
The provided text describes a polyester wrapper intended for sterilizing and maintaining the sterility of other medical devices. It does not describe a device used to diagnose medical conditions.
No
The device is described as "Polyester Wrappers" which are physical products intended to enclose other medical devices for sterilization and maintaining sterility. This description clearly indicates a hardware component, not a software-only device.
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 maintaining sterility. This is a function related to the preparation and storage of medical devices, not the diagnosis of diseases or conditions based on in vitro examination of specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on specimen analysis.
- Reagents, calibrators, or controls used in laboratory testing.
The device is a medical device used in the healthcare setting for sterilization and sterility maintenance of other medical devices.
N/A
Intended Use / Indications for Use
The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158, are devices 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 up until 30 days. The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158. are provided non-sterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum, 270oF, 4 minutes with 20 minutes drying time).
Product codes
FRG
Device Description
Models PJ2020 and SP3158, are devices intended to be used to enclose another medical device that is to be sterilized by a health care provider.
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 provider
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)
Not Found
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
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hinson and Hale Medical Technologies, Incorporated C/O Mr. Jeffrey O. Stull International Personnel Protection, Incorporated 7809 Adelaide Drive Austin, Texas 78739
DEC 2 2 2010
Re: K102783
Trade/Device Name: Hinson and Hale Medical Technologies, Inc. Infused® Polyester Wrappers
Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II
Product Code: FRG
Dated: September 21, 2010 Received: September 27, 2010
Dear Mr. Stull:
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. Stull
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 reportugio (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,
Joms & Robe
Anthony 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
DEC 2 2 2010
510(k) Number (if known): K102783
Device Name: Hinson and Hale Medical Technologies, Inc. Infused® Polyester Wrappers
Indications for Use:
The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158, are devices 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 up until 30 days. The Hinson and Hale Medical Technologies, Inc. Infused(R) Polyester Wrappers. Models PJ2020 and SP3158. are provided non-sterile and must be processed before use. These wrappers may be reprocessed for a total of 100 uses when laundered and sterilized according to the label and instructions provided with the product. Reprocessing instructions are based on industrial laundering procedures and steam sterilization (pre-vacuum, 270oF, 4 minutes with 20 minutes drying time).
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabet SClavin-Wells
ivision Sion-Off Division of Dental, Infection Control, and General Hospital Devices
OR
510(k) Number K 102783
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
X