(120 days)
Rachel's Remedy is designed to provide moist heat and/or cooling relief to relieve symptoms associated with clogged ducts, mastitis, milk blisters, blebs and engorgement. It is also designed to encourage let-down and milk flow, and can help prevent mastitis.
Rachel's Remedy is a hot/cold therapy pack composed of a 100% cotton flannel pillow filled with all natural flaxseed. It is designed to provide heating or cooling relief to soothe breastfeeding pain and discomfort. The pillow is inserted into a food-safe water-resistant pouch. There is a removable 100% organic cotton layer that may be moistened and used for moist heat, or the therapy pack may be used alone for heating and/or cooling relief. The flaxseed filled pillow can either be microwaved for heating relief, or put in the freezer for cooling relief.
Rachel's Remedy is made from materials manufactured in the United States. The removable cotton layer is 100% organic cotton, the pouch is CPSIA certified and foodsafe PUL, and the flaxseed filled pillow is made from 100% cotton flannel and is filled with 100% all natural flaxseed. All of the fabrics used in Rachel's Remedy are made in the United States and are CPSIA certified and made specifically for baby products.
The provided document does not contain details about specific acceptance criteria or a study designed to prove the device, "Rachel's Remedy," meets those criteria in a typical medical device performance study context. Instead, the document discusses substantial equivalence to predicate devices and provides a literature review to support its indications for use.
Here's an analysis based on the information provided, tailored to your requested categories, with "N/A" where the information is absent:
Acceptance Criteria and Device Performance
The document does not explicitly define acceptance criteria in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy, temperature ranges, duration of heat retention with specific tolerances) that the device must meet to be considered effective for its intended uses. The "Performance Data" section primarily references peer-reviewed literature and general statements about heat retention.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A | N/A |
- However, the document states generally:
- "Rachel's Remedy consistently maintains its warm temperature for a minimum of 20-minute intervals." (This is a performance claim, but without a defined acceptance criterion for what constitutes "warm temperature" or variability, it's not a formal acceptance criterion.)
- The literature review implies that the device's ability to provide moist heat and/or cooling relief for symptoms like clogged ducts, mastitis, milk blisters, blebs, engorgement, and to encourage let-down and milk flow, and help prevent mastitis, is comparable to methods recommended in those articles.
Study Information Based on Document Content
Since a formal clinical study or specific performance test with delineated acceptance criteria is not described in a way that allows for filling out most of these sections, many will be "N/A." The "Performance Data" section primarily relies on a literature review.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: N/A (No separate test set for a performance study is described. The "performance testing" mentioned for heat retention is a general statement, not a formal study with a defined sample size).
- Data Provenance: N/A (The literature cited is from various sources, but no specific study of this device with origin details is provided.)
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A (No specific test set or ground truth establishment by experts for a performance study of this device is described.)
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A (No test set or adjudication process for a performance study of this device is described.)
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A (This device is a physical therapy pack, not an AI or diagnostic tool, so an MRMC study is not applicable.)
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A (This device is a physical therapy pack, not an algorithm. Its described use is "human-in-the-loop" application.)
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- N/A (No formal ground truth for a performance study of this device is described. The indications for use are supported by referencing existing general medical literature and guidelines for moist heat/cold therapy for breastfeeding-related issues.)
-
The sample size for the training set:
- N/A (No training set is applicable as this is not a machine learning or diagnostic device.)
-
How the ground truth for the training set was established:
- N/A (No training set or ground truth establishment for a training set is applicable.)
Summary of "Study" and Evidence for Rachel's Remedy:
The document relies on substantial equivalence to predicate devices (K832803, K841698) for its basic functionality as a moist heat pack. For its specific indications for use, beyond a general moist heat pack, the submission references peer-reviewed literature, studies, and online reference materials that support the use of warm compress applications (like Rachel's Remedy) for conditions such as let-down, milk flow, clogged ducts, mastitis, blebs, milk blisters, and engorgement. It also mentions "performance testing by placing Rachel's Remedy in the microwave, putting it in it's waterproof pouch and placing it on the body with and without moistening the removable cotton layer" which "consistently maintains its warm temperature for a minimum of 20-minute intervals." This "performance testing" appears to be an internal verification rather than a formal, statistically powered study against pre-defined acceptance criteria.
The conclusion states that its summary of nonclinical and clinical information supports the conclusion that the device is "as safe and effective and performs as well as the predicate device." This indicates that the device's efficacy is largely extrapolated from the known benefits of moist heat/cold therapy and its similarity to existing cleared devices, rather than demonstrated through a comprehensive, de novo clinical performance study with specific acceptance criteria.
§ 890.5730 Moist heat pack.
(a)
Identification. A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat therapy for body surfaces.(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 § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.