(284 days)
K031096, K850496A
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance metrics associated with AI/ML indicate it is a purely mechanical restraint device.
No
The device is designed to secure newborn infants within an incubator to prevent movement and falls, not to treat a disease or condition.
No
The device description indicates that the STATStrap™ is used to secure newborn infants within a Neonatal Transport Incubator to prevent gross body movement or falls, acting as a positioning aid. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description clearly details physical components made of foam, fabric, and wire, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure newborn infants within a transport incubator. This is a physical restraint and positioning device.
- Device Description: The description details a physical strap made of foam and fabric, designed for securing a patient.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (blood, urine, tissue, etc.) to provide information for the diagnosis, prevention, or treatment of disease.
- No Mention of Biological Samples: The device interacts directly with the patient's body for positioning, not with biological samples.
IVD devices are specifically designed for testing biological samples to gain diagnostic information. This device's function is purely mechanical and related to patient safety and positioning during transport.
N/A
Intended Use / Indications for Use
The intended use of this (single patient use) safety strap set is to act as a positioning aid and to prevent accidental falls of the pre-term (
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Children's Health First, Inc.
PO Box 4056 Carlsbad, CA 92018
"510 (k) Summary " Rev. K081264 5.
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70 |
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(757) 416-8240
Children's Health First Inc. PO Box 4056 Carlsbad, CA 92018
5249 Shelley Place Carlsbad, CA92008
(757) 499-2543 Fax
Contact: Roger T. Vaughan
April 28, 2008 / December 20th, 2008/February 12,2009 Submission preparation date:
STATStrap ™ Neonatal Incubator Safety Strap Device Trade name: Common name: Neonatal Incubator restraint strap Classification name: Neonatal Transport Incubator (accessory);(21CFR880.5410), Product code: FPL)
Substantial Equivalence:
| K031096/K850496A | Model 185 with restraint straps
880.5410
Part #216-0350 Restraint Straps | International Bio Medical
Airborne Life Support |
|------------------|--------------------------------------------------------------------------------|----------------------------------------------------|
| K001019/K941106 | Model TI500 & Ti500 with
restraint straps / 880.5410
Part # MU06011 | Hill-ROM Airshield
Draeger Medical Inc. |
Device Description:
The STATStrap™ Neonatal Incubator Safety Strap is a soft closed cell foam material covered with a laminate of soft fabric that allows Hook (Velcro® style) fabric to attach to it along the straps entire length. The end of each strap incorporates a hook fabric wing tab or a wire spring hook, so as to attach each strap to the infant incubator tray. These 13 inch straps are positioned in four positions altation our carp to the menthess tray so as to fit the patient's size. Once the straps are in place and securely fastened to the mattress tray, the straps cross over the neonate ( infant's ) body in a "X" pattern and attach to each other so as to provide positioning aid, prevent gross body movement or falls of the patient. A hook "tie strap" is included on both models to secure the two main straps together into a single unit. These straps are single patient use disposable items. Labeling states the disposable nature of the strap, precautions and the use instructions.
1
Intended Use:
The intended use of this (single patient use) safety strap set is to act as a positioning aid and to prevent accidental falls of the pre-term ( Trade/Device Name: STATStrap™ Neonatal Transport Incubator Safety Strap Regulation Number: 21 CFR 880.5410 Regulation Name; Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: January 27, 2009 Received: February 10, 2009
Dear Mr. Vaughan:
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 genera! 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. Vaughan
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony O. maton for
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
K081264 510(k) Number (if known):
Device Name: STATStrap™ Neonatal Transport Incubator Safety Strap
Indications For Use: Securing newborn infants of various sizes and weights within a Neonatal Transport Incubator.
Patient population: Newborn infants / Gestation age of 24 weeks- 40 weeks
Condition of usel Normal Use of device: Inner hospital transports only, not intended as a motor vehicle restraint device. Used to position newborn infant, and help to prevent falls from, and gross movement within, transport incubators.
Rx Only
"Caution: Federal law restricts this device to sale by or on the order of a licensed physician"
Pescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jod. A. Oele fer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081264