(15 days)
The CP&S Disposable Ice Pack Limb Kit Transporter provides an environment above freezing for a severed body part while being transported to the hospital emergency room or replantation surgery.
The CP&S Disposable Instant Ice Pack Limb Kit Transporter is an instant ice pack with an added pouch for the insertion of a severed body part for transport to the hospital emergency room or replantation surgery. The Instant Cold Pack Limb Kit Transporter is activated in the same manner as the Disposable Instant Cold Pack and provides cooling for the severed limb within the gauze lined zip lock top bag. A cool environment above freezing is maintained for approximately 30 minutes. The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack.
This submission describes a medical device, the "Instant Cold Pack Limb Kit Transporter," which is essentially an instant cold pack with an added pouch for transporting severed body parts. The key claim is that it maintains a cool, above-freezing environment for approximately 30 minutes, which is crucial for limb preservation.
Here's an analysis of the acceptance criteria and the study as described in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Function: Provide cooling for a severed limb. | The Instant Cold Pack Limb Kit Transporter is activated in the same manner as the Disposable Instant Cold Pack and provides cooling for the severed limb within the gauze-lined zip-lock top bag. |
| Temperature Maintenance: Maintain a cool environment above freezing. | A cool environment above freezing is maintained for approximately 30 minutes. |
| Impact on Cold Pack Efficacy: The additional pouch should not affect safety or efficacy of the disposable Instant Cold Pack. | The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack. |
| Compliance with 21CFR 890.5710: Device should meet the definition of a "disposable cold pack." | The CP&S Instant Cold Pack Limb Kit Transporter compares exactly to this identification, being a "device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that upon activation, provides cold therapy for body surfaces." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set or data provenance. The "study" mentioned appears to be an internal verification (Attachment C) and a reference to general medical studies (Attachment D) rather than a formal pre-market clinical study on this specific device with a defined test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention using experts to establish ground truth for a test set related to the device's performance. The "ground truth" for the medical necessity of above-freezing temperatures for severed limbs is based on general medical knowledge, as implied by "studies showing that the severed limb should be stored at above freezing temperatures" (Attachment D).
4. Adjudication Method for the Test Set
No test set for expert adjudication is mentioned, therefore, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. This device is a physical product designed for basic physiological effect (cooling), not a diagnostic algorithm where human-in-the-loop performance would typically be evaluated.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is a physical product, not an algorithm. Therefore, no standalone algorithm performance study was conducted or is applicable. The "standalone" performance here refers to the physical cold pack's ability to maintain temperature, which is described in the Acceptance Criteria table.
7. Type of Ground Truth Used
The "ground truth" referred to in the context of this submission is:
- Performance of the predicate device: The instant cold pack component's efficacy is assumed to be similar to the predicate Disposable Instant Cold Pack (K890553).
- General Medical Knowledge/Literature: Expert consensus and outcome data from existing medical literature regarding the optimal storage temperature for severed limbs, as indicated by "studies showing that the severed limb should be stored at above freezing temperatures and that proper techniques for preservation of the amputated part are important for survival" (Attachment D).
8. Sample Size for the Training Set
No training set is mentioned as this is a physical medical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
Summary of the "Study" that Proves Acceptance Criteria:
The "study" referenced in the 510(k) submission to demonstrate the device meets acceptance criteria is primarily based on:
- Assertion of Equivalence: The manufacturer asserts that the "Instant Cold Pack Limb Kit Transporter" is activated in the same manner as their existing "Disposable Instant Cold Pack" (predicate device K890553) and provides cooling.
- Internal Testing/Verification (Attachment C): The text states, "A cool environment above freezing is maintained for approximately 30 minutes. (Attachment C)". This indicates some form of internal testing or verification was conducted to determine the duration of cooling and temperature maintenance. Details of this testing (methodology, number of units tested, conditions, etc.) are not provided in the summary.
- Assertion of Non-Interference: The manufacturer states, "The additional pouch does not affect the safety or efficacy of the disposable Instant Cold Pack." This is likely based on design analysis and potentially additional testing similar to the above.
- Reference to Established Medical Practice (Attachment D): The submission leverages existing medical knowledge, stating, "studies showing that the severed limb should be stored at above freezing temperatures and that proper techniques for preservation of the amputated part are important for survival. (Attachment D)." This supports the rationale for the device's design (maintaining above-freezing temperatures) rather than directly proving the device's performance through a clinical trial.
In essence, this 510(k) submission relies heavily on the substantial equivalence to a predicate device and internal performance claims, rather than a large-scale clinical study with a defined test set, expert adjudication, or comparative effectiveness. The "study" mentioned for performance focuses on the physical properties of the cold pack.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.