NEO NEST

K112547 · Denovo Proucts, LLC · IMD · Mar 6, 2012 · Physical Medicine

Device Facts

• Record ID: K112547
• Device Name: NEO NEST
• Applicant: Denovo Proucts, LLC
• Product Code: IMD · Physical Medicine
• Decision Date: Mar 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.

Device Story

Neo Nest Gel Infant Transport Mattress provides thermal support for full-term infants during hospital transport. Device functions as a passive warming aid; utilizes gel material to retain and distribute heat to the infant. Used by clinical staff in hospital settings. Output is a stable thermal environment for the patient; assists in maintaining normothermia during transit. Benefits include reduced risk of hypothermia during movement between clinical areas or facilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable gel-based mattress; passive thermal regulation; designed for infant transport; non-powered.

Indications for Use

Indicated for full term infants requiring warmth during transport within or between hospitals.

Regulatory Classification

Identification

A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAR - 6 2012

DeNovo Products, LLC % Mr. Dale Walters 17051 Alico Commerce Court #3 Fort Myers, Florida 33967

Re: K112547

Trade/Device Name: DeNovo Products Neo Nest Gel Infant Transport Mattress Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class II Product Code: IMD Dated: February 28, 2012 Received: February 28, 2012

Dear Mr. Walters:

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.

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.

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## Page 2 - Mr. Dale Walters

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you active operilio adv/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for go to mtp., www.radiological Health's (CDRH's) Office of Compliance. Also, please the Concertify BotTects and Andress of the may by reference to premarket notification" (21CFR Part note the regulation onlined, "Interesting 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 Tou may obtain other generers, 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,

for Doth
Oscar Dr.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K 112547

Neo Nest Infant Transport Mattress Device Name:

Indications For Use:

Provision of warmth during transport of infant within the hospital or between hospitals. Recommended for full term infants.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vance W. Lary

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K112547