NATURE'S CRADLE MODEL C1500

K960747 · Infant Advantage, Inc. · FMS · May 22, 1996 · General Hospital

Device Facts

• Record ID: K960747
• Device Name: NATURE'S CRADLE MODEL C1500
• Applicant: Infant Advantage, Inc.
• Product Code: FMS · General Hospital
• Decision Date: May 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5140
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Nature’s Cradle® Model C1500, when used as directed, is designed to provide a safe and effective transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. The mattress is equipped with motion and sound designed to simulate the mother’s heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. Nature’s Cradle® Model C1500 is intended to be used for healthy, full term infants at home from 0-16 weeks. The Nature’s Cradle® Model C1500 is non-sterile and reusable.

Device Story

Device is a mattress designed to simulate maternal heartbeat and circulatory system to reduce infant stress. Input: none (pre-programmed motion/sound). Transformation: low-voltage DC motor drives worm gear reduction for motion; speaker cable transmits sound from external control box. Output: rhythmic motion and sound. Used in home setting by parents/caregivers. Healthcare provider uses clinical outcomes (e.g., Brazelton Neonatal Behavior Assessment Scale) to evaluate efficacy. Benefits: increased infant alertness, longer sleep duration, reduced crying, lower incidence of colic.

Clinical Evidence

Clinical trial (Journal of Perinatology, 1995) at Kaiser Medical Center, Santa Clara, CA, involving 90 full-term infants. Evaluated using Brazelton Neonatal Behavior Assessment Scale. Results: Nature’s Cradle group showed increased adaptivity, 65% less crying, increased alertness, longer sleep duration, and lower incidence of colic compared to control group.

Technological Characteristics

Mattress dimensions: 27.5" x 51.875" x 4.5". Motion generated by low-voltage DC motor with worm gear reduction. Sound delivered via speaker cable from external control box. Power: double-insulated transformer. Non-sterile, reusable.

Indications for Use

Indicated for healthy, full-term infants aged 0-16 weeks for use in the home environment to assist in transition after birth.

Regulatory Classification

Identification

A pediatric medical crib is a prescription device intended for medical purposes for use with a pediatric patient that consists of an open crib, fixed end rails, movable and latchable side rail components, and possibly an accompanying mattress. The contour of the crib surface may be adjustable.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9. The special controls for this device are:(1) Crib design and performance testing shall demonstrate the mechanical and structural stability of the crib under expected conditions of use, including the security of latches and other locking mechanisms when engaged; (2) Materials used shall be appropriate for the conditions of use, allow for proper sanitation, and be free from surface defects that could result in injuries; (3) The height of the rail and end panel as measured from the top of the rail or panel in its highest position to the top of the mattress support in its lowest position shall be at least 26 inches (66 centimeters). Any mattress used in this crib must not exceed a thickness of 6 inches; (4) Hardware and fasteners shall be designed and constructed to eliminate mechanical hazards to the patient; (5) The distance between components of the side rail ( *i.e.,* slats, spindles, and corner posts) shall not be greater than 23/8 inches (6 centimeters) apart at any point;(6) The mattress must fit tightly around all four sides of the crib base, such that entrapment or impingement of occupant is prevented; (7) The mattress for the crib shall meet the Consumer Product Safety Commission (CPSC) Standard for the flammability of mattresses and mattress pads (FF 4-72, amended) and Standard for the flammability (open flame) of mattress sets, 16 CFR parts 1632 and 1633, respectively; and (8) Each device must have the following label(s) affixed: (i) Adequate instructions for users to care for, maintain, and clean the crib; and (ii) A warning label on at least two sides of the medical crib with the following language in text of at least 9 millimeters in height: WARNING: Never leave a child unsupervised when the moveable side is open or not secured.

Predicate Devices

• Nature’s Cradle® Infant Bassinet, Model M-1 (K901763)

Submission Summary (Full Text)

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MAY 22 1996 K96-0747
Infant Advantage, Inc.

16. 510(k) SUMMARY

The Nature’s Cradle® Model C1500, when used as directed, is designed to provide a safe and effective transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. The mattress is equipped with motion and sound designed to simulate the mother’s heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. Nature’s Cradle® Model C1500 is intended to be used for healthy, full term infants at home from 0-16 weeks. The Nature’s Cradle® Model C1500 is non-sterile and reusable.

The Nature’s Cradle® Model C1500 is a new device that is based on the same technology and the same indications for use as Nature’s Cradle® Infant Bassinet, Model M-1, 510(k) Premarket Notification # K901763. The moving platform is now embedded in the mattress, thus omitting the bassinett. The new mattress fits standard crib size (27 1/2 wide, 51 7/8” long, 4 1/2” high.) The sounds are fed to the mattress through a speaker cable from a control box located outside the mattress. The motions are generated by a low voltage DC (direct current) motor located underneath the platform and connected to a worm drive gear reduction located in the control module. Control module and moving platform are connected with a tube including speaker wire and power supply for the DC motor. Reliability testing shows this product to be as safe and effective as predicate device, Nature’s Cradle® Model M-1, Premarket Notification # K901763.

The Nature’s Cradle® Model C1500 has the same device classification product code (80FMS), the same technology and fundamentals of principles, and the same indications for use as the legally marketed, predicate device.

Laboratory and bench testing of Nature’s Cradle® Model C1500 demonstrated that the new device performance is suitable for use in homes.

A clinical trial, published in the Journal of Perinatology Vol. 15, No. 3, 1995, involving 90 full term infants was performed at Kaiser Medical Center, Santa Clara, CA. The infants were evaluated utilizing the Brazelton Neonatal Behavior Assessment Scale. The study found that infants who sleep in the Nature’s Cradle® environment were more adaptive, less irritable, and cried approximately 65% less. Additionally, they were more attentive, and alert, slept for longer periods, and slept through the night sooner, plus experienced a lower incidence of colic when compared to the control group.

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16. 510(k) SUMMARY, continued

Clinical data submitted for predicate device, Model M-1, demonstrated that the device is safe and effective for use with healthy, full-term infants at home.

The device is available without a prescription, the same as predicate device, Nature’s Cradle® infant bassinet, Model M-1, Premarket Notification # K901763.

The Nature’s Cradle® Model C1500 uses the same software for motion and sound as predicate device, Model M-1, and uses the same control panel functions for motion and sound as predicate device, Model M-1. It also uses the same double-insulated transformer as proven safe and effective in predicate device Model M-1.

The labeling includes adequate warnings and cautions for safe and effective use of the product also have been incorporated in the product labeling.

Nature’s Cradle® Model C1500 performs in the same manner as Model M-1. Manufacturing and testing of hardware and software remain unchanged to predicate device. The new device has proven safe and effective when used as directed.

Substantial equivalence to the legally marketed predicate device with the same indications for use has been demonstrated by comparison of product features, as described in 510(k) Premarket Notification # K901763 for Nature’s Cradle® Model M-1, product labeling and promotional materials.

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