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 ( < 38 weeks gestational age) and term newborn (≥ 38 weeks gestational age) from the transport incubator while within a medical facility. This strap(s) is not intended as a vehicular restraint device and will provide minimal protection in the event of a vehicle / aircraft crash or rapid deceleration. This device should be viewed by the user as a positioning aid and safety restraint of the infant's torso, hips and legs while occupying neonatal transport incubator(s). Infants requiring use of a transport incubator should be secured in the transport incubator as the manufacture has designed in order to mitigate falls and internal impact within the incubator chamber. Like the safety straps provided with transport incubators, these straps function in the same manner to prevent falls and trauma of the newborn and to assist in positioning the newborn for needed medical interventions and therapies.

Indications For Use: Securing newborn infants of various sizes and weights within a Neonatal Transport Incubator.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the STATStrap™ Neonatal Incubator Safety Strap. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness.

Therefore, many of the typical acceptance criteria and study components usually associated with a novel device's performance evaluation (like specific accuracy metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies) are not applicable in this context. The focus here is on comparing the new device's characteristics and intended use to an existing, approved device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for the device itself. Instead, the "acceptance criteria" are implied by the demonstration that the STATStrap™ shares the same fundamental design, materials, chemical composition, intended purpose, and attachment mechanism as the identified predicate devices, with only minor differences such as single-patient use labeling. The reported "performance" is that it functions in the same manner as existing safety straps.

Feature / Criterion (Implicit)	Predicate Devices (K031096/K850496A, K001019/K941106)	STATStrap™ SS-001 & SS-002 (K081264)	Assessment
Foam base with fabric laminate	Yes	Yes	Equivalent
Device Labeled with name and company	No	Yes	Minor difference; adds to safety/effectiveness.
Device currently used as a pediatric restraint in a Neonatal Transport Incubator	Yes	Pending 510K / SE (i.e., this submission)	Intended to be equivalent in function.
Attachment mechanism (Hook & Loop / Foam)	Yes	Yes (with specific variations for SS-001/SS-002)	Equivalent in principle; specific mechanism adapted to incubator types.
Intended purpose to restrain neonate against falls / trauma	Yes	Yes	Equivalent
Device labeled as "Single Patient Use"	No	Yes	Minor difference; adds to safe and effectiveness.
Device Section listed (880.5410 Neonatal Transport Incubator (accessory))	Yes	Requested (880.5410)	Equivalent
Product Code assigned (FPL)	Yes	Requested (FPL)	Equivalent
Overall Assessment by Manufacturer	Same function, design, material, chemical composition, physical attributes.	Same function, design, material, chemical composition, physical attributes.	The device is deemed substantially equivalent. The only differences are material length, packaging, labeling, and specific attachment mechanism details to the bed tray (which are handled by different models of STATStrap).

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No test set in the traditional sense of a performance study was conducted. The equivalence was based on a comparison of device characteristics to predicate devices.
The "study" is a comparison to legally marketed predicate devices, not a clinical trial with a test set of patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. There was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. No test set or expert adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. This type of study is not typically required for a 510(k) substantial equivalence submission for a physical accessory device like this.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

Not applicable. This device is a passive physical accessory, not an algorithm or software. Its function inherently involves human interaction (placement by a user).

7. The Type of Ground Truth Used:

Not applicable. No ground truth in the sense of clinical outcomes or pathology was established for the STATStrap™ as part of this submission. The "truth" considered by the FDA in a 510(k) is whether the new device is "substantially equivalent" to an existing, approved predicate device in terms of safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. No training set for an algorithm was used.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set or ground truth for a training set was established.

Summary of the "Study" and Its Findings:

The "study" or evidence provided is a comparison to predicate devices (K031096/K850496A by International Bio Medical / Airborne Life Support, and K001019/K941106 by Hill-ROM Airshield / Draeger Medical Inc.).

Conclusion from Testing: The submission explicitly states "Clinical Data: Not applicable" and "Summary / Conclusion from Testing: Not applicable." This indicates that no new clinical or performance testing was conducted or submitted with this 510(k).
Proof of Meeting Acceptance Criteria: The device met the "acceptance criteria" by demonstrating that its characteristics (design, materials, intended use, function) are substantially equivalent to those of the legally marketed predicate devices. The minor differences (single-patient use labeling, specific attachment mechanisms for different incubator types, and being labeled with the company name) were deemed not to raise new questions of safety or effectiveness. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

Summary

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K081264

Children's Health First, Inc.

PO Box 4056 Carlsbad, CA 92018

"510 (k) Summary " Rev. K081264 5.

P1.	3	970
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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 straps880.5410Part #216-0350 Restraint Straps	International Bio MedicalAirborne Life Support
K001019/K941106	Model TI500 & Ti500 withrestraint straps / 880.5410Part # MU06011	Hill-ROM AirshieldDraeger Medical Inc.

Device Description:

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Intended Use:

The major difference between the safety straps provided by incubator manufactures and the STATStrap™ Neonatal Incubator Safety Strap models is that the latter device is labeled for single patient use, as well as with use and care instructions. We feel that this adds to the safe and effectiveness of the device(s).

STATStrap™ Neonatal Incubator Safety Strap #SS-001 is designed with winged Hook fabric tabs to connect to the transport incubator mattress tray for incubators manufactured with horizontal connection slits.

STATStrap™ Neonatal Incubator Safety Strap #SS-002 is designed with stainless steel metal spring hooks so as to connect to transport incubator mattress tray for incubators manufactured with circular mounting holes,

Both #SS-001 and #SS-002 use hook fabric tabs to facilitate the opposing straps to fasten to each other along the strap's length.

Both #SS-001 and #SS-002 incorporate a final safety "tie strap" which joins the two main straps inorder to keep the main straps in the position that they were placed by the user. Its' application also moraci to more that the main straps are not positioned too tightly on the patient's chest, or have the potential to separate from each other and pose a strangulation hazard.

Summary of Characteristics to predicate devices: Table format

	Foambase withfabriclaminate	DeviceLabeledwith nameandcompany	-Devicecurrentlyused as apediatricrestraint inaNeonatalTransportIncubator	AttachmentmechanismHook &Loop /Foam	Intendedpurpose torestrainneonateagainst falls /trauma
STATStrap™SS-001 & SS-002K081264IB Inc. Airborne LS	yes	yes	Pending510K /SE	yes	yes

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K031096/K850496A	yes	no	yes	yes	yes
Hill-ROM AirshieldDraeger MedicalInc.	yes	no	yes	yes	yes
K001019/K941106

	Devicelabeledas"SinglePatientUse"	DeviceSectionlisted	ProductCodeassigned
STATStrap™SS-001 & SS-002K081264	yes	Request880.5410	RequestFPL
IB Inc. Airborne LSK031096/K850496A	no	880.5410	FPL
Hill-ROM AirshieldDraeger Medical Inc.K001019/K941106	no	880.5410	FPL

As the tables demonstrates, the use of the predicate serve the same function.

The STATStrap™ Neonatal Incubator Safety Strap serves the same purpose as the predicate product compared. All of these devices use the same design, material, chemical composition, and physical oompured. All of the only difference may be in material length of devices, packaging, labeling, and attachment mechanism to the bed tray.

Clinical Data: Not applicable

Summary / Conclusion from Testing:

Not applicable

End of 510K Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Children's Health First, Incorporated Mr. Roger T. Vaughan Vice President Sales & Marketing 5249 Shelley Place Carlsbad, California 92008

FEB 1 3 2009

K081264 Re:

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.

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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

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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

Regulation Number and Section

§ 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.