Search Results
Found 5 results
510(k) Data Aggregation
(21 days)
Cold Compression
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). |
Ask a specific question about this device
(326 days)
Cold Compression Wrap Pro
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).
Ask a specific question about this device
(90 days)
Cryopush Cold Compression Device
A02-P-001:
The Cryopush Cold Compression Device 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 by an inflatable wrap.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
A02-P-002:
The Cryopush A02-P-002 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 by an inflatable wrap.
Cryopush Cold Compression 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. The device includes two models A02- P-001 and A02- P-002. The A02- P-001 has one chamber, and A02- P-002 has 2 chambers. The A02- P-001 contains cold pack, and the cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
When the A02- P-001 is used for 30 minutes (Default time) at the operating temperature (5°C~ 40°C) specified in the user manual, the temperature of the cold pack is (-18℃~-4℃) (±2℃).
The provided document is a 510(k) summary for the "Cryopush Cold Compression Device" (K222669). It details the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets specific acceptance criteria in the sense of clinical performance or diagnostic accuracy.
Instead, the document focuses on demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics. The "acceptance criteria" discussed are related to manufacturing standards, electrical safety, electromagnetic compatibility, and basic functional performance, not clinical efficacy or diagnostic accuracy.
Therefore, many of the requested points about "acceptance criteria" for performance, sample size, ground truth, experts, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as it outlines a regulatory submission based on substantial equivalence to a predicate device rather than a de novo clinical trial demonstrating novel performance against defined criteria.
Here's the information that can be extracted based on the provided text, with notes for items not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Internal Standards based on Predicate) | Reported Device Performance/Characteristics |
|---|---|
| Electrical Safety, EMC | Device complies with IEC 60601-1:2005, AMDI:2012, IEC 60601-1-11:2015, IEC 60601-1-2:2014 |
| Software Validation | Software document determined according to FDA guidance (May 11, 2005) for software in medical devices |
| Pressure Range | A02-P-001: 0-100mmHg; A02-P-002: 0-215mmHg (Predicate: 0-240 mmHg) |
| Pressure Levels | A02-P-001: 20, 40, 60, 80, 100 mmHg; A02-P-002: 100, 160, 215 mmHg (Predicate: 150, 185, 215 mmHg) |
| Pressure Error Range | A02-P-001: ±15mmHg; A02-P-002: ±20mmHg (Predicate: ±25mmHg) |
| Cold Pack Temperature (A02-P-001) | -18℃ to -4℃ (±2℃) within 30 minutes of operation at 5°C-40°C operating temperature |
| Noise Level | ≤ 55dB (Predicate: ≤ 65dB) |
| Working Time | A02-P-001: 10-120 min (default 30 min); A02-P-002: 10-60 min (default 30 min) (Predicate: 20 minutes) |
| Keep time (Pressure hold time) | 10s (Predicate: 1-5s) |
| Deflation time | 20s (Predicate: 1-5s) |
| Product Appearance and Size, Wrap Performance, Function Test (Internal Standards) | Tested according to internal standards; specific metrics or results are not provided in this summary. |
| No adverse impact on safety and effectiveness compared to predicate despite differences | Concluded that differences in cold pack (A02-P-001) and treatment time do not raise adverse impact on safety and effectiveness. |
| Overall substantial equivalence to predicate device (K193354) | Concluded based on comparison of intended use, technological characteristics, and performances. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable. The document describes non-clinical engineering and performance testing against standards, not a clinical test set with human subjects for performance evaluation.
- Data provenance: Not applicable. The testing is described as internal testing by the manufacturer ("Chengdu Cryo-Push Medical Technology Co., Ltd") to conform to engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the context of expert consensus, is not relevant for the type of engineering and performance testing described. The "ground truth" here is adherence to specified engineering standards and internal performance metrics.
4. Adjudication method for the test set
- Not applicable. No expert adjudication process is described for this type of non-clinical testing.
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
- Not applicable. This device is a physical medical device (cold compression device), not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies and "human readers improving with AI" are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used
- For engineering and performance tests: The ground truth implicitly refers to the specifications defined by relevant standards (e.g., IEC 60601 series for electrical safety, internal product specifications for pressure, noise, temperature) and the characteristics of the predicate device for comparison of substantial equivalence. There is no "expert consensus," "pathology," or "outcomes data" ground truth established for this type of submission.
8. The sample size for the training set
- Not applicable. There is no software or algorithm that would require a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned or implied.
Ask a specific question about this device
(118 days)
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE
The Squid Active Cold Compression device and Cold Pack for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where cold temperature therapy is necessary or desirable.
The Squid Active Cold Compression device and Cold Pack for OTC Use combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a preprogrammed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.
The device is manufactured with the following components:
-
- A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
-
- A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
-
- Reusable thermogel cold pack
The provided text is a 510(k) Summary for the Portable Therapeutix Squid Active Cold Compression device and Cold Pack for OTC Use. The primary purpose of this 510(k) is to reclassify an existing prescription-use device (K123829) for over-the-counter (OTC) use. Therefore, the "study that proves the device meets the acceptance criteria" largely refers back to the predicate device's clearance information and a specific usability study for the OTC application.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this 510(k) is primarily for reclassifying an existing device to OTC use, the "acceptance criteria" are implied by the substantial equivalence to the predicate device and the specific performance testing performed for the original clearance (K123829), plus a usability study for the OTC shift.
| Acceptance Criteria / Performance Aspect | Reported Device Performance (K133483/K123829) |
|---|---|
| Biocompatibility | Successfully performed and reported in FDA cleared K123829. (Details not provided in this summary). |
| Electrical Safety/EMC (including batteries) | Successfully performed and reported in FDA cleared K1233829. Complies with: IEC 60601-1:1988 + A1:1991 + A2:1995 (Medical Electrical Equipment Part 1: General Requirements for Safety) and IEC 60601-1-2:2007 (Medical Electrical Equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and Tests). (Details not provided in this summary). |
| Bench Testing | Successfully performed and reported in FDA cleared K123829. Includes: Baseline Verification, Compression Bladder Leak Verification Test, Blow out Valve Test, Gel Pack Seal Leak Test, Low Pressure Verification Test, Max Pressure, Total Time, Max Compression Time, Min Compression Time, Max Deflation Time, Min Deflation Time, Pressure Gauge Data, Solenoid Valve Release Test (High pressure release). (Specific numerical acceptance criteria not provided in this summary, but the tests were "successfully performed"). |
| Shelf Life | Successfully performed and reported in FDA cleared K123829 for batteries and gel pack. (Details not provided in this summary). |
| Reprocessing/Sterilization | The device is reusable and not supplied sterile. Cleaning instructions are included in the Instructions for Use. (Demonstrates acceptable cleaning protocol). |
| Usability for OTC Use | A summative Usability Study was successfully conducted on representative users for OTC use. Findings from the study served to validate that the device is usable by its intended users. (Specific metrics or pass/fail criteria for usability not detailed, but the study was "successfully conducted"). |
| Intended Use Equivalence | The device has the same indications for use as the predicate, with the addition of OTC use. (No change in functionality for the specified indications). |
| Mechanical Characteristics | Intermittent compression, 4 intensity settings (1-30 mmHg, 2-50 mmHg, 3-70 mmHg, 4-85 mmHg), pressure range 0-85 mmHg, total treatment time 15 minutes, microprocessor and pressure sensor control, pressurization pump inflation, exhaust valve deflation. These are identical to the predicate device. |
| Components | Same components as the predicate device (portable external pump-controller, wraps with air bladder, reusable thermogel cold pack), with the addition of alignment markers on wraps/gel pack for user assistance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (for Usability Study): "representative users for OTC use." The specific sample size is not disclosed in this summary.
- Data Provenance: Not explicitly stated, but the submission is to the US FDA, implying an expectation of US-centric or internationally recognized standards. The usability study would have been prospective to evaluate OTC use. The original K123829 performance data would have been generated during the device's development/validation.
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)
- There is no mention of "experts" to establish ground truth for a test set in the context of medical image analysis or diagnosis. For this device (cold compression massager), the evaluation is against engineering specifications and user comprehension/safety.
- For the usability study, "representative users" were involved, not "experts" establishing ground truth in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies where there's a need to resolve discrepancies in expert interpretations of data (e.g., medical images). The usability study would likely have involved user observation and task completion rates.
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 MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices (e.g., AI-powered image analysis) where the performance of human readers (e.g., radiologists) is compared with and without AI intervention. The Portable Therapeutix Squid is a physical therapy device, not a diagnostic tool where "human readers" are involved in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable to the Portable Therapeutix Squid device. There is no "algorithm" in the sense of AI or image processing being evaluated in a standalone mode. The device's function is mechanical compression and cold therapy. Its "standalone performance" refers to its ability to meet engineering specifications (e.g., pressure output, safety). These were part of the bench testing for K123829.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For K123829 (Predicate device performance): The ground truth was based on engineering specifications, safety standards compliance (e.g., electrical safety), and the successful execution of various bench tests (e.g., pressure verification, leak tests, shelf life).
- For K133483 (OTC Usability): Ground truth was established by demonstrating that representative lay users could safely and effectively operate the device and understand its instructions for use without professional guidance. This typically involves observing task completion, questionnaire responses, and identifying critical use errors.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning device that requires a "training set" in that context. The "training" for the device's function would be its design, manufacturing, and calibration processes.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the machine learning sense for this device.
Ask a specific question about this device
(112 days)
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK
The Squid Active Cold Compression device and Cold Pack is indicated for the temporary relief of minor muscle aches and pains.
The compression device is indicated for temporary increase in circulation of the treated areas in people who are in good health, and simulates kneeding and stroking of tissues using an inflatable garment.
The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable.
The Squid Active Cold Compression device and Cold Pack combines intermittent compression with cold therapy. The Squid simulates kneading and stroking of tissues using an inflatable garment attached to a gel ice pack and connected to a pre-programmed air pump. The Squid may be used for the leg, foot, feet, arm, shoulders, lower back, and hands.
The device is manufactured with the following components:
- A portable external pump-controller unit containing the pneumatic compressor (air pump) that may be run on AC-DC external power supply or a built-in lithium battery.
- A wrap that contains an air bladder with sequential compression capability and Velcro attachments for the cold pack. The wrap connects to the pump controller via a flexible tube. There may also be an accessory piece to the wrap to provide an additional securing mechanism. Wraps come in two configurations and three sizes.
- Reusable thermogel cold pack
Here's a breakdown of the acceptance criteria and the study information for the Portable Therapeutix Squid Active Cold Compression device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar Intended Use: To the predicate devices. | The device's intended use is "for the temporary relief of minor muscle aches and pains. The compression 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 garment. The cold pack is indicated for localized therapy in situations where a physician determines that cold temperature therapy is necessary or desirable." This aligns sufficiently with the predicate devices which are also indicated for temporary relief of minor muscle aches and pains and temporary increase in circulation, simulating kneading and stroking with an inflatable garment. |
| Similar Target Treatment Areas: To the predicate devices. | Leg, foot, arm, shoulders, lower back, hands. This is largely consistent with the predicate devices which cover leg & foot, feet, arm, neck and shoulders, lower back, back, hands. |
| Similar Mechanical Intermittent Compression: To predicates. | The device provides intermittent compression with intensity settings (mild, medium, intense, extra intense) and a pressurization pump and exhaust valve. This is explicitly stated as similar to predicate devices. The pressure ranges (mild – 20-30 mm Hg, medium – 40-60 mm Hg, intense – 70 – 80 mm Hg for the predicate; mild – 30 mm Hg, medium – 50 mm Hg, intense – 70 mm Hg, extra intense – 85 mm Hg for the subject device) are considered for "patient comfort only, and differences do not raise new issues of safety or effectiveness." |
| No New Issues of Safety or Effectiveness: Compared to predicates, even with differences. | The submission concludes that "Pressure intensities are for patient comfort only, and differences do not raise new issues of safety or effectiveness. The addition of a cold pack also does not raise new issues of safety or effectiveness." This statement directly addresses this acceptance criterion. Additional safety aspects, such as electrical safety, are addressed by conformity to IEC 60601-1. |
| Conformity to IEC 60601-1 (Electrical Safety): | The device "complies with IEC 60601-1:1988 + A1:1991 + A2:1995 Medical Electrical Equipment - Part 1: General Requirements for Safety." |
| Bench and EMC Testing Conducted: | The document states, "Bench and EMC testing has been conducted." However, specific results or detailed acceptance criteria for these tests are not provided in the summary. |
Study Proving Device Meets Acceptance Criteria:
The "study" conducted to demonstrate the device meets acceptance criteria is a substantial equivalence comparison to predicate devices, as documented in the provided 510(k) summary. This is a common regulatory pathway for medical devices.
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable or not explicitly stated in the provided text. The submission relies on a comparison to predicate devices based on their established safety and effectiveness profiles, rather than a separate clinical "test set" for this specific device to demonstrate its intended use. Performance data is primarily from bench and EMC testing, not clinical trials with "test sets" of patients.
- Data Provenance: Not applicable in the context of a clinical test set. The data provenance for the comparison itself is from existing 510(k) submissions of predicate devices (K030437 and K112479) and internal bench/EMC testing for the subject device. There is no mention of country of origin for such data or whether it's retrospective or prospective for a clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts & Qualifications: Not applicable. This type of information is typically related to diagnostic devices or clinical trials where expert consensus is needed to establish ground truth for a test set. For this device, regulatory experts at Portable Therapeutix (via MEDIcept, Inc.) performed the substantial equivalence comparison and FDA reviewers (Victor Krauthamer, Ph.D., Acting Director, Division of Neurological and Physical Medicine Devices) made the final regulatory determination.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical "test set" requiring adjudication in the context of this 510(k) summary.
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
- MRMC Comparative Effectiveness Study: No. This type of study is irrelevant for a physical therapy device like the Squid Active Cold Compression device, which does not involve "readers" or "AI assistance" in a diagnostic context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical therapy device, not an algorithm. Its operation inherently involves human interaction (applying the device, selecting settings).
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this 510(k) submission is the established safety and effectiveness of the predicate devices as previously cleared by the FDA. The submission argues that the subject device is substantially equivalent to these predicates, meaning it shares the same fundamental scientific technology, intended use, and does not raise different questions of safety or effectiveness. For aspects like electrical safety, the ground truth is adherence to internationally recognized standards (IEC 60601-1).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device, so there is no "training set" in the conventional sense. Device development and testing (bench, EMC) would involve engineering samples and prototypes, but not a "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for an algorithm.
Ask a specific question about this device
Page 1 of 1