(58 days)
- (1) May Provide Temporary Relief of Low Back Pain;
- May Provide Temporary Relief of Minor Aches and Pains Due to Muscular Fatirue (2) or: Overexertion;
- May Provide Temporary Relief of Edema or Swelling of the Legs; (3)
- May Provide Temporary Relief of Poor Local Blood Circulation of the Legs;" (4)
- May Provide Temporary Relief from Symptoms of Hiatus Hernia; (5)
- May Provide Temporary Relief from the Symptoms of Gastric Reflux; (6)
- May Provide Temporary Relief of Nighttime Heattburn; (7)
- The Optional Heating Accessory Provides Temporary Relief from Mild Arthritis (8) and Joint Pain, as well as Muscle Pain Associated with Stress and Tension; and
- Sleeping in an Upright Position May Reduce or Fase Light and Occasional (ව) Snoring. **
Craftmatic® Adjustable Beds are electrically powered adjustable beds for home use that adjust into 1001 various positions (e.g., raising the torso, the legs, or both to various heights). The beds have three primary components: (1) a steel bed frame with lift motors, (2) a mattress, and (3) a pendant control. Powered heating pads, which cover the entire mattress, and physical therapy pulsators (built-in massage units) are optional.
This 510(k) premarket notification (K022387) for the Craftmatic® Adjustable Beds with Optional Heat and Massage does not contain the detailed study information typically found for devices that rely on performance data against acceptance criteria. The submission primarily focuses on establishing substantial equivalence to a previously cleared predicate device (K840787B) rather than presenting new performance studies with acceptance criteria for the "new" device.
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.
Here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This section is not applicable in the traditional sense for this submission. The "new" Craftmatic® Adjustable Beds are stated to be "essentially identical" to the predicate device in structural and functional features. The new indications for use are also described as "similar to, based upon the same principles as, and substantially equivalent to the indications for use for the predicate bed."
The submission argues for equivalence based on the technological and functional similarity to a previously cleared device, not on meeting specific, quantifiable performance acceptance criteria from a new study.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified, as the submission relies on substantial equivalence to a predicate device. | Not specified, as the submission relies on substantial equivalence to a predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable. The submission does not describe a new test set or performance study that would involve a sample size or data provenance. The focus is on the technological comparison to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. No new test set or ground truth establishment by experts is described in the provided text.
4. Adjudication Method for the Test Set
Not Applicable. No new test set or adjudication process is described in the provided text.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. A Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The submission is not focused on comparing human reader performance with or without AI assistance, as the device is an adjustable bed, not an AI-driven diagnostic or therapeutic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This device is an adjustable bed and does not involve an algorithm or AI component that would perform standalone functions.
7. The Type of Ground Truth Used
Not Applicable. No specific ground truth was established for the "new" device's performance in this submission. The basis for clearance is the substantial equivalence to a predicate device that was previously cleared for similar indications. The original predicate device's clearance (K840787B) in 1984 would have been based on the understanding of the underlying physiological principles for adjustable beds and their ability to provide temporary relief for certain conditions.
8. The Sample Size for the Training Set
Not Applicable. This device does not involve a training set as it is not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set mentioned, there is no ground truth establishment for it.
Summary of Approach in K022387:
The provided 510(k) summary for K022387 indicates that the Craftmatic® Adjustable Beds with Optional Heat and Massage seek clearance through substantial equivalence to a previously cleared predicate device (Craftmatic® Adjustable Bed, K840787B). The argument for substantial equivalence is based on:
- Technological Similarity: The "new" beds are described as "essentially identical" to the predicate, sharing the same general structural and functional features (electrically powered adjustable beds, steel frame, lift motors, mattress, pendant control, optional heating pads, and pulsators). Minor technological upgrades (memory positioning, timers, mattress quality improvements) are noted but are considered not to alter the fundamental functions or safety.
- Similarity of Intended Uses: The new indications for use are described as "similar to, based upon the same principles as, and substantially equivalent to the indications for use for the predicate bed." The predicate device was already cleared for temporary relief of low back pain, minor aches, edema, and poor local blood circulation of the legs. The new indications extend this to temporary relief from symptoms of hiatus hernia, gastric reflux, nighttime heartburn, mild arthritis/joint pain (with heating accessory), and reduction of light snoring (sleeping upright).
Therefore, this submission does not present new performance data against specific acceptance criteria but rather leverages the regulatory precedent established by the predicate device.
§ 880.5100 AC-powered adjustable hospital bed.
(a)
Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.(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.