PINTLER PATIENT WARMING SYSTEM

K113705 · Pintler Medical · DWJ · Aug 31, 2012 · Cardiovascular

Device Facts

• Record ID: K113705
• Device Name: PINTLER PATIENT WARMING SYSTEM
• Applicant: Pintler Medical
• Product Code: DWJ · Cardiovascular
• Decision Date: Aug 31, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.

Device Story

Pintler Patient Warming System consists of a conductive operating room pad and a power control unit mounted to an IV pole. Device utilizes low-voltage DC power and resistant heating elements to provide conductive warming to patients. Operated by clinical personnel in hospitals or surgery centers. Microprocessor monitors operational functionality and safety. System aids in maintaining patient normothermia during perioperative experiences. Clinical personnel determine use based on facility protocols; output is thermal regulation of the patient surface.

Clinical Evidence

Bench testing only. Testing demonstrated the device met performance, effectiveness, and safety parameters.

Technological Characteristics

Conductive warming system; resistant heating element; low voltage DC power; IV-pole mounted control unit; microprocessor-controlled; compliant with EN60601-1-2.

Indications for Use

Indicated for pediatric (5kg+) and adult patients requiring perioperative warming as determined by clinical personnel per facility normothermia protocol. Contraindicated for procedures where hypothermic treatment is prescribed.

Regulatory Classification

Identification

A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

Predicate Devices

• PRN ThermalCare 3000 Control Unit and Power (K062794)

Submission Summary (Full Text)

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# K113705

AUG 3 1 2012

### Section III

### Premarket Notification (510 (k)) Summary (Per·21 CFR 807.92)

Date:

### March 14, 2012

Submitted by:

Pintler Medical 3220 South Hanford Street Seattle, WA. 98144 (206 660 9020)

Contact Person:

Maribeth Macintyre-Ellis President Phone: [phone] [e-mail]

#### Device Name

| Trade Name: | |
|-------------------------|--|
| Common Name: | |
| Classification Name: | |
| Product Code & Reg. No. | |

Pintler Patient Warmer System Thermal Maintenance System Thermal Regulating System DWJ, 21 CFR870.5900

Substantially Equivalent: The Pintler Patient Warming System is substantially equivalent to the following devices:

PRN ThermalCare 3000 Control Unit and Power Also known as PerfecTemp K062794

Description of the Device: The Pintler Patient Warming System a thermal regulating operating room pad, and a power control unit mounted to a standard IV pole. The operating room pad utilizes a low voltage resistant heating element , DC power and warms patients with conductive warming technology.

Indication for use: The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.

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Place the unit OFF in all procedures where hypothermic treatment or Contraindications: administration is prescribed or facility procedure. Patient care procedures prescribing hypothermic treatment can or may exhibit an adverse event, i. e. skin damage, skin tissue burns or other types of skin tissue damage from heat.

Patient Population: Pediatric (5 kilo) and Adult (capability of the table to bear weight)

Environment of Use: Hospitals, surgery center and/or other sites designated for surgical · procedures

#### Comparison of Predicated Devices:

The differences between the Pintler Patient Warmer and the predicated device is minimal. Both devices are conductive warmers. Both devices use a resistant warming technology. Both devices require a IV mounted or separate power input. Both devices use a microprocessor for operational functionality and safety. Both devices are required to be compliant to EN60601-1-2.

Testing Safety and Effectiveness: Bench testing for safety of the Pintler Patient Warming System has been completed. Testing was conducted, demonstrated the device met the performance/effectiveness/safety parameters.

Conclusion: Testing and comparison of the Pintler Patient Warming System found the product to be substantially equivalent to the predicated device and there are no new safety or effectiveness issues introduced.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 3 1 2012

Pintler Medical c/o Ms. Paula Wilkerson Senior Staff Engineer, Senior Reviewer Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087

K113705 Re:

> Pintler Patient Warming System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulating System Regulatory Class: Class II Product Code: DWJ Dated: August 22, 2012 Received: August 23, 2012

Dear Ms. Wilkerson:

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

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Page 2 - Ms. Paula Wilkerson

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.

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M. A. Alleman

Co Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section II

### Statement: Indication for Use

K 113705 510 (k) Number

Device Name: Pintler Patient Warming System

Patient Population: Pediatric to Adult

Environment of use: Hospitals, Surgery Centers, and other surgical sites

Indication of Use: The Pintler Patient Warming System aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired as determined by clinical personnel, in accordance with facility normo-thermia protocol.

Prescription Use X Part 21 CFR 801 Subpart D and /or Over the counter use 21CFR 801 Subpart C

(PLEASE SO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGES IF NEEDED)

C.Y. Killian

(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

儿115705 510(k) Number_

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