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510(k) Data Aggregation
(21 days)
Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
Cold Compression is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device is an AC powered, software-controlled multimodality device, and is intended to be used by or on the order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings.
The subject device features cold therapy and compression therapy. Cold Compression is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.
The device has a power/time button, temperature adjustment button, pressure setting button; Patients can adjust the temperature, compression pressure, and duration of treatment according to their needs.
The device has a bucket body and a lid. The ice and water can be added by opening the lid, and the loading level of the ice and water can be indicated/seen.
The subject device and its packaging/clothing are clean and non-sterile. A connecting tube is used to connect the subject device to the wraps come with a variety of reusable cold treatment inflators for cold and compression treatment of the universal, back, shoulder, ankle/foot, hip, and knee.
The provided text is a 510(k) Summary for a medical device called "Cold Compression". This document aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on a study of its performance in a clinical or analytical setting.
Therefore, the input document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that "Clinical testing was not needed in support of this 510(k) application." (Section 8) and focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests for electrical safety and electromagnetic compatibility.
Instead, the document provides:
Non-Clinical Tests Performed:
- Tests: Non-clinical tests were performed to validate the design and assure conformance with voluntary design standards related to medical device electrical safety and electromagnetic compatibility.
- Standards:
- IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".
- IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
Comparison Table (Table 1):
This table compares the subject device ("Cold Compression") with two predicate devices (K223541 and K183702) across various technical characteristics and specifications to establish substantial equivalence. While it doesn't present "acceptance criteria" in the traditional sense of a performance study, it details the characteristics where the device's performance parameters are deemed acceptable due to their similarity to a legally marketed device.
| Characteristic | Subject Device Performance | Predicate Device Performance (relevant to equivalence) | Equivalence Conclusion |
|---|---|---|---|
| Product Codes | IRP and ILO | Primary Predicate: IRP, ILO, and JOW Predicate: IRP and ILO | The subject device has the product codes covered by the primary predicate device, and also identical to the predicate device. |
| Indications for Use | To treat post-surgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated. Used by or on order of licensed healthcare professionals in rehabilitation facilities/hospitals, outpatient clinics, athletic training settings, and home settings. | Primary Predicate: Combines cold, heat, contrast, and compression therapy. Intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain. Also provides DVT therapy. Used by or on order of licensed healthcare professionals in rehabilitation facilities, outpatient clinics, athletic training settings, and home settings. Predicate: To treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. Used by or on order of licensed healthcare professionals in hospitals, outpatient clinics, athletic training settings, or home settings. | The subject device has the Indications for Use covered by the primary predicate device, and also substantially equivalent to the predicate device. |
| Intended Users | Health Care Professionals and lay users (under prescription), with adult use; children and elderly under direct medical professional supervision. | Primary Predicate and Predicate: Identical. | Identical |
| Prescription or OTC | Prescription | Primary Predicate and Predicate: Prescription | Identical |
| Power Source(s) | 100-240 VAC, 50/60 Hz | Primary Predicate and Predicate: 100-240 VAC, 50/60 Hz | Identical |
| Compliance with Voluntary Standards | Yes | Primary Predicate and Predicate: Yes | Identical |
| Safety (Electrical, Mechanical, Chemical, Thermal, Radiation) | Yes | Primary Predicate and Predicate: Yes | Identical |
| Therapy | Cold and Compression. Work together or independently. | Primary Predicate: Cold, Heat, Contrast and Compression. Predicate: Cold and Compression. Work together or independently. | The subject device has the therapy covered by the primary predicate device, and also identical to the predicate device. The difference between the subject device and the primary predicate device is the former does not provide heat or contrast therapy. |
| Cold Therapy Temperature | 45°F - 55°F | Primary Predicate: Default: 50°F; Custom: 41°F-55°F Predicate: 45°F - 60°F | Equivalent Note 1: The temperature range of cold therapy for the subject device is within that of the primary predicate device and the predicate device. Adjustable by healthcare professionals. Insignificant difference. |
| Heat Therapy | Not Available | Primary Predicate: Default: 105°F; Custom: 105°F-109°F Predicate: Not Available | Identical to the predicate device. The difference from the primary predicate device (lack of heat/contrast therapy) is noted but does not raise new safety/effectiveness issues for this specific device. |
| Compression Setting | 0 - 60 mmHg | Primary Predicate: Alternate mode: 15 -75 mm Hg; Continuous mode: 15 -75 mm Hg Predicate: Low (0-25 mmHg), Regular (0-50 mmHg) | Equivalent Note 2: The pressure range for the subject device is within that of the primary predicate device and slightly higher than the predicate device. Adjustable by healthcare professionals. Insignificant difference. |
| Reservoir Fluid Capacity | 620 mL | Primary Predicate: 350 mL Predicate: Not Available | Different, but it will not raise any new issue of safety or effectiveness. |
| Recommended Coolant | Tap Water | Primary Predicate: 90% Distilled Water, 10% Isopropyl Alcohol Predicate: Tap Water | Identical to the predicate device. The difference from the primary predicate is noted but does not raise new safety/effectiveness issues. |
| Water Cooling Source | Ice | Primary Predicate: Vapor compression Predicate: Ice | Identical to the predicate device. The difference from the primary predicate is noted but does not raise new safety/effectiveness issues. |
| User Interface | Keypad with indicator lights or LCD screen | Primary Predicate: Touch Screen Predicate: Keypad with indicator lights | Different from the primary predicate device and similar to the predicate device. It will not raise any new issue of safety or effectiveness. |
| Dimensions | L235xW235xH280mm | Primary Predicate: L295xW285xH295 mm Predicate: Not Available | Different. The difference of dimensions does not change the product performance or parameters, which will not raise any new issue of the safety or effectiveness. |
| Weight Approx. | 2.4kg | Primary Predicate: 8.2kg Predicate: Not Available | Different. The difference of weight does not change the product performance or parameters, which will not raise any new issue of the safety or effectiveness. |
| Types of Garments | Various anatomical thermal garments for: Back, Elbow/Universal, Shoulder, Knee, Ankle, Hip. | Primary Predicate: Various anatomical thermal garments for: Back, Elbow, Shoulder, Knee, Ankle, Hip. DVT Garments: Calf and Foot. Predicate: Various anatomical thermal garments for: Back, Universal, Shoulder, Knee, Foot/Ankle, Hip. | The subject device has the garments covered by the primary predicate device, and also substantially equivalent to the predicate device. |
| Biocompatibility of Patient Contacting Material | Biocompatible | Primary Predicate and Predicate: Biocompatible | Identical |
| Sterile/Non-Sterile | Non-sterile | Primary Predicate and Predicate: Non-sterile | Identical |
| Cleaning Disinfection Validation of Labeling | Yes | Primary Predicate and Predicate: Yes | Identical |
| Operational and Environmental Conditions | Normal working ambient temperature: 5 | Primary Predicate: Normal working ambient temperature: 16 | Identical to the predicate device. The difference between the subject device and the primary predicate device is the former does not provide heat or contrast therapy. (Note: The operational and environmental conditions are listed as identical to the second predicate device, not the primary one, despite the "difference between the subject device and the primary predicate device" wording). |
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(326 days)
The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains.
The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
Cold Compression Wrap Pro Device consists of a main unit and wraps which simulates kneading and stroking of tissue with the hands by use of inflatable pressure wraps. It is for temporary increase in circulation of the treated areas and temporary relief of minor muscle aches and pains. By inflating the air chambers and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient.
There are 4 different wraps for Shoulder, elbow/arm, low limbs (Calf and upper leg), ankle/foot. The wrap contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
When the device is used for 30 minutes (Default time) at the operature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18°C ~-4℃) (±2℃).
The provided document, K230524, is a 510(k) Premarket Notification for a medical device called "Cold Compression Wrap Pro". This document, issued by the FDA, determines the substantial equivalence of the new device to existing legally marketed predicate devices.
Based on the provided document, here's a breakdown of the acceptance criteria and the study proving the device meets them:
Crucially, this is not a clinical study report for an AI/ML medical device. It's a 510(k) submission for a physical medical device (cold compression wrap) with embedded software. Therefore, many of the typical acceptance criteria and study details for AI/ML performance (like MRMC studies, ground truth establishment by experts, and large training/test sets of medical data) are not applicable or present in this document.
The "study" here refers to the non-clinical performance testing conducted to demonstrate that the device functions as intended and is safe.
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" with quantitative performance metrics for the device's therapeutic effect (e.g., pain reduction scores, circulation improvement). Instead, it focuses on the device's technical specifications and safety parameters, which serve as its de facto acceptance criteria for this type of device.
Here's an attempt to extract the closest equivalents to acceptance criteria and reported performance based on the "510(k) Summary" section, particularly the "Substantial Equivalence Comparison" table and "Summary of Non-clinical Performance Testing":
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (Subject Device) | Comments / Basis for Performance Claims |
|---|---|---|
| Electrical Safety | Complies with IEC 60601-1:2005, AMDI:2012 | Non-clinical testing |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014 | Non-clinical testing |
| Software Validation | Software verification and validation testing conducted; considered "moderate" level of concern. | Non-clinical testing; followed FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" |
| Product Appearance and Size | Tested according to internal standards | Non-clinical testing |
| Wrap Performance | Tested according to internal standards | Non-clinical testing |
| Function Test | Tested according to internal standards | Non-clinical testing |
| Intended Use Equivalence | "The Cold Compression Wrap Pro is indicated for the temporary relief of minor muscle aches and pains. The device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneading and stroking of tissues using an inflatable wrap. The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable." | Claimed "Identical" to predicate devices (K222669 & K133483). |
| Operating Temperature of Cold Pack | -18℃ ~ -4℃ (±2℃) | Maintained consistency with predicate (K222669). |
| Main Unit Operating Temperature Range | 5℃ ~ 40℃ (41°F ~ 104°F) | Identical to predicate (K222669). |
| Pressure Range | 0-100 mmHg | Identical to predicate (K222669). |
| Pressure Levels | 20, 40, 60, 80, 100 mmHg | Identical to predicate (K222669). |
| Pressure Error Range | ±15 mmHg | Identical to predicate (K222669). |
| Noise Level | ≤ 55dB | Identical to predicate (K222669). |
| Biocompatibility | Not conducted due to use of same patient contact material as predicate device with same nature and duration of contact. | Equivalence argument; implied acceptance criteria met by predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document describes non-clinical performance testing (electrical safety, EMC, software validation, product appearance/size, wrap performance, function tests). These tests are typically performed on a small sample of manufactured devices (e.g., a few units, or internal test benches). The specific number is not specified in this summary.
- Data Provenance: The tests are "non-clinical" and likely conducted in a lab setting by the manufacturer, Chengdu Cryo-Push Medical Technology Co.,Ltd, which is located in China. The data is prospective, in the sense that the company specifically conducted these tests for the 510(k) submission.
3. 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)
This is a physical device, not an AI/ML diagnostic algorithm. Therefore, the concept of "experts establishing ground truth" in the clinical sense (e.g., radiologists interpreting images) is not applicable. The "ground truth" for this device's performance is established by engineering measurements and adherence to recognized standards (e.g., IEC 60601-1 for electrical safety). The qualifications of the testing personnel are not disclosed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human review or adjudication of data points in the way it would occur for AI/ML diagnostic algorithms (e.g., reviewing medical images). The testing involves objective measurements against predefined engineering specifications.
5. 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
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic tools that assist human readers (e.g., radiologists). This product is a physical therapeutic device, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of an AI/ML algorithm. The device has "embedded software" which underwent "software validation". This is a test of the embedded software's functionality and safety (e.g., reliably controlling pressure and time settings), not a standalone diagnostic AI performance evaluation. The device itself operates "as is" when used by a patient, meaning the "algorithm" (software) operates in a standalone manner as part of the device's function, but not as a diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications, recognized international safety standards (e.g., IEC 60601 series), and the functional requirements for a cold compression system. For instance, the ground truth for electrical safety is whether the device actually meets the voltage leakage limits of IEC 60601-1. For the cold pack temperature, it's whether the internal temperature sensor actually registers within the specified range after 30 minutes of operation. This is determined by instrumental measurements and adherence to test protocols, not clinical outcomes or expert consensus on medical data.
8. The sample size for the training set
The device is a physical product with embedded software. It is not an AI/ML device that requires a "training set" of data in the common sense (e.g., images for deep learning). The software is likely programmed deterministically or based on engineered control logic, not "trained" on data. Therefore, the concept of a "training set sample size" is not applicable.
9. How the ground truth for the training set was established
Since there is no "training set" in the AI/ML sense, this question is not applicable. The "ground truth" for the device's design and software functionality is rooted in engineering requirements, safety standards, and the intended physiological effects of cold compression therapy (which are well-established prior to this device's development).
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