(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 | |
| Predicate: Normal working ambient temperature: 5 | 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). |
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).