(87 days)
Not Found
No
The summary describes a mechanical infant motion and sound system with safety checks, but there is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies rely on predicate devices and clinical trials from the 1990s, predating widespread medical AI/ML applications.
No.
The intended use is to simulate processes familiar to the infant during pregnancy to facilitate transition and minimize stress, rather than treat a disease or condition. The clinical study mentions behavioral and sleep improvements, but these are not presented as treatments for a medical condition.
No
The device is described as an "infant motion and sound system" designed to simulate a mother's heartbeat and circulatory system to help infants transition to their new environment. Its purpose is to provide comfort and aid in adaptation, not to diagnose a medical condition or disease.
No
The device description explicitly mentions hardware components such as a mechanism, control module, transformer, moving platform, and safety checks, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Nature's Cradle® C2000 Series is described as an "infant motion and sound system" designed to simulate the mother's heartbeat and circulatory system. Its purpose is to provide a comforting environment for infants and help them transition to their new surroundings.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples from the infant. The device interacts with the infant externally through motion and sound.
- Intended Use: The intended use is to provide a comforting environment and minimize stress for healthy, full-term infants, not to diagnose or detect any medical condition.
Therefore, the Nature's Cradle® C2000 Series falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Nature's Cradle® C2000 Series, when used as directed, is an infant motion and sound system designed to closely simulate the mother's heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. This provides a transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. Nature's Cradle C2000 Series can be used with Infant Advantage approved bassinets and hospital nursery tubs or bassinets. Nature's Cradle® C2000 Series is indicated for healthy, full term infants at home or hospital.
Product codes
80FMS
Device Description
Nature's Cradle® C2000 Series uses the same motion and the same sound as predicate devices, Nature's Cradle® Model C1500, Premarket Notification # K960747, and Nature's Cradle® Model M-1, Premarket Notification # 901763. Nature's Cradle C2000 Series uses the same mechanism as predicate device, Nature's Cradle® Model C1500. Premarket Notification # K960747.
The size of the moving platform of Nature's Cradle® C2000 Series has been reduced to allow the plastic case (containing mechanism and moving platform) to fit Infant Advantage approved bassinets and hospital nursery tubs/bassinets.
Contrary to predicate devices (Nature's Cradle® Model C1500, Premarket Notification # K960747), the mechanism is no longer embedded in a 4 1/2" high mattress, or cabinet with 2" high mattress (Nature's Cradle® Model M-1, Premarket Notification # K901763). The modification of Nature's Cradle® C2000 Series makes the mechanism a stand alone device weighing approximately 5 pounds that is covered with a 1" high mattress.
The mechanism of Nature's Cradle® C2000 Series is connected to the same control module and the same low voltage wall-mount transformer as predicate device, Nature's Cradle® Model C1500, Premarket Notification # K960747.
A mattress is provided separately and placed on top of the platform, the same as predicate device. Nature's Cradle® Model M-1, Premarket Notification # K901763. To further enhance the safety of the device, the fitted sheet is placed over the top of the bassinet or tub and secured with a cord. This feature keeps the infant in a "Hammock"-like surrounding, on the mattress, and away from the walls of the bassinet or tub. Furthermore, the Nature's Cradle® C2000 Series includes the same safety checks in the mechanism as predicate devices, Nature's Cradle Model C1500, Premarket Notification # K960747, and Nature's Cradle® Model M-1, Premarket Notification # K901763: any excessive weight or obtrusion of the moving platform will immediately stop the mechanism.
All components of Nature's Cradle® C2000 Series are non-sterile and reusable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
0 - 16 weeks
Intended User / Care Setting
home or hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory and bench testing of predicate device, Nature's Cradle® Model C1500, Premarket Notification # K960747 demonstrated the device to be safe and effective when used as described. The new Nature's Cradle® C2000 Series has not been modified significantly and has the same fundamentals of principles as predicate device, Nature's Cradle Model C1500, Premarket Notification # K960747, except for a smaller size platform. This change does not require additional testing and reliability data was submitted with predicate device, Nature's Cradle Model C1500, Premarket Notification # K960747 and is included in Section 18, Attachment IV.
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.
Clinical data submitted for predicate device, Nature's Cradle® Model M-1, Premarket Notification # K901763 demonstrated that the device is safe and effective for use with healthy, full-term infants at home. The same data was used for Nature's Cradle® Model C1500, Premarket Notification # K960747. Clinical data are enclosed in Section 19, Attachments I - VI.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5140 Pediatric medical crib.
(a)
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.(b)
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.
0
510(k) SUMMARY 16.
APR 25 1997
Nature's Cradle® C2000 Series, when used as directed, is an infant motion and sound system designed to closely simulate the mother's heartbeat and circulatory system familiar to the infant during the last trimester of pregnancy. This provides a transition to infants after birth, allowing them to grow accustomed to their new environment at a pace that minimizes stress. Nature's Cradle C2000 Series can be used with Infant Advantage approved bassinets and hospital nursery tubs or bassinets. Nature's Cradle® C2000 Series is indicated for healthy, full term infants at home or hospital.
Nature's Cradle® C2000 Series uses the same motion and the same sound as predicate devices, Nature's Cradle® Model C1500, Premarket Notification # K960747, and Nature's Cradle® Model M-1, Premarket Notification # 901763. Nature's Cradle C2000 Series uses the same mechanism as predicate device, Nature's Cradle® Model C1500. Premarket Notification # K960747.
The size of the moving platform of Nature's Cradle® C2000 Series has been reduced to allow the plastic case (containing mechanism and moving platform) to fit Infant Advantage approved bassinets and hospital nursery tubs/bassinets.
Contrary to predicate devices (Nature's Cradle® Model C1500, Premarket Notification # K960747), the mechanism is no longer embedded in a 4 1/2" high mattress, or cabinet with 2" high mattress (Nature's Cradle® Model M-1, Premarket Notification # K901763). The modification of Nature's Cradle® C2000 Series makes the mechanism a stand alone device weighing approximately 5 pounds that is covered with a 1" high mattress.
Contrary to predicate devices, Nature's Cradle® Model C1500, Premarket Notification # K960747 and Nature's Cradle® M-1 , Premarket Notification # K901763 which are intended to be used at home only, the new Nature's Cradle C2000 Series can be used for healthy, full term infants at home or hospital from 0 - 16 weeks. The fundamentals of the principles remain the same as with predicate devices, Nature's Cradle® Model C1500, Premarket Notification # K960747, and Nature's Cradle® Model M-1, Premarket Notification # K901763.
The mechanism of Nature's Cradle® C2000 Series is connected to the same control module and the same low voltage wall-mount transformer as predicate device, Nature's Cradle® Model C1500, Premarket Notification # K960747.
1
510(k) SUMMARY, continued 16.
A mattress is provided separately and placed on top of the platform, the same as predicate device. Nature's Cradle® Model M-1, Premarket Notification # K901763. To further enhance the safety of the device, the fitted sheet is placed over the top of the bassinet or tub and secured with a cord. To further enhance the safety of the device, the fitted sheet is placed over the top of the bassinet or tub and secured with a cord. This feature keeps the infant in a "Hammock"-like surrounding, on the mattress, and away from the walls of the bassinet or tub. Furthermore, the Nature's Cradle® C2000 Series includes the same safety checks in the mechanism as predicate devices, Nature's Cradle Model C1500, Premarket Notification # K960747, and Nature's Cradle® Model M-1, Premarket Notification # K901763: any excessive weight or obtrusion of the moving platform will immediately stop the mechanism.
All components of Nature's Cradle® C2000 Series are non-sterile and reusable.
The Nature's Cradle® C2000 Series has the same device classification product code (80FMS), the same technology and fundamentals of principles, and the same indications for use as legally marketed, predicate devices, Nature's Cradle® Model C1500, Premarket Notification # K960747, and Nature's Cradle® Model M-1, Premarket Notification # K901763.
Laboratory and bench testing of predicate device, Nature's Cradle® Model C1500, Premarket Notification # K960747 demonstrated the device to be safe and effective when used as described. The new Nature's Cradle® C2000 Series has not been modified significantly and has the same fundamentals of principles as predicate device, Nature's Cradle Model C1500, Premarket Notification # K960747, except for a smaller size platform. This change does not require additional testing and reliability data was submitted with predicate device, Nature's Cradle Model C1500, Premarket Notification # K960747 and is included in Section 18, Attachment IV.
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.
2
510(k) SUMMARY, continued 16.
Clinical data submitted for predicate device, Nature's Cradle® Model M-1, Premarket Notification # K901763 demonstrated that the device is safe and effective for use with healthy, full-term infants at home. The same data was used for Nature's Cradle® Model C1500, Premarket Notification # K960747. Clinical data are enclosed in Section 19, Attachments I - VI.
The device is available without a prescription, the same as predicate devices, Nature's Cradle® Model C1500, Premarket Notification # K960747, and Nature's Cradle® Model M-1, Premarket Notification # K901763.
Adequate warnings and cautions for safe and effective use of the product have been incorporated in the product labeling.
Substantial equivalence to legally marketed predicate devices with the same indications for use has been demonstrated by comparison of product features as described in Premarket Notification # K960747 for Nature's Cradle® Model C1500, and Premarket Notification # K901763 for Nature's Cradle® Model M-1, product labeling and promotional materials. Copies of the labeling of predicate device, Nature's Cradle Model C1500, Premarket Notification # K960747 is included in Section 18, Attachment IX, and labeling of predicate device, Nature's Cradle® Model M-1, Premarket Notification # K901763, is included in Section 18, Attachment X.