HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS

K102783 · Hinson and Hale Medical Technologies, Inc. · FRG · Dec 22, 2010 · General Hospital

Device Facts

• Record ID: K102783
• Device Name: HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS
• Applicant: Hinson and Hale Medical Technologies, Inc.
• Product Code: FRG · General Hospital
• Decision Date: Dec 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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).

Device Story

Infused® Polyester Wrappers (Models PJ2020, SP3158) serve as protective barriers for medical devices during steam sterilization; maintain sterility of contents for 30 days post-sterilization. Used in clinical settings by healthcare staff. Provided non-sterile; require industrial laundering and steam sterilization (pre-vacuum, 270°F, 4 min exposure, 20 min dry) before initial use and between re-uses. Reusable up to 100 cycles. Benefit: provides durable, reprocessable containment for surgical instruments/devices, ensuring sterility maintenance until point of use.

Clinical Evidence

No clinical data. Bench testing only, focusing on sterilization efficacy and sterility maintenance over 30 days, and durability through 100 reprocessing cycles (industrial laundering and steam sterilization).

Technological Characteristics

Polyester textile sterilization wrap. Reusable (up to 100 cycles). Compatible with industrial laundering and steam sterilization (pre-vacuum, 270°F).

Indications for Use

Indicated for use by healthcare providers to enclose medical devices requiring sterilization. Maintains sterility of enclosed devices for up to 30 days. Suitable for re-use up to 100 cycles when laundered and steam-sterilized per instructions.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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# 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).

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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