(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.
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K974190
I. 510(k) AMENDMENT SUMMARY
| Submitted by: | NOV 19 1997Consolidated Products and Services100-L Messina DriveBraintree, MA 02184 |
|---|---|
| Contact: | Wayne Kritzman |
| Date: | October 31, 1997 |
| Proprietary Name: | Instant Cold Pack Limb Kit Transporter |
| Classification Name: | Hot/ Cold Disposable Pack (21CFR 890.5710) |
| Predicate Device: | Disposable Instant Cold Pack(current 510(k) K890553 to be amended). |
| Description: | The CP&S Disposable Instant Ice Pack Limb KitTransporter is an instant ice pack with an added pouchfor the insertion of a severed body part for transport to thehospital emergency room or replantation surgery. |
| The Instant Cold Pack Limb Kit Transporter is activated inthe same manner as the Disposable Instant Cold Packand provides cooling for the severed limb within thegauze lined zip lock top bag. A cool environment abovefreezing is maintained for approximately 30 minutes.(Attachment C) | |
| The additional pouch does not affect the safety or efficacyof the disposable Instant Cold Pack. | |
| CP&S feels the Instant Cold Pack Limb Kit Transporter isa tremendous improvement over current practice ofplacing severed limbs in any available container andplacing on ice. | |
| 21CFR 890.5710 identifies a disposable cold pack as a"device intended for medical purposes that consists of asealed plastic bag incorporating chemicals that uponactivation, provides cold therapy for body surfaces."The CP&S Instant Cold Pack Limb Kit Transportercompares exactly to this identification. |
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Also attached are 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).
The above information supports CP&S' request that the Instant Cold Pack Limb Kit Transporter be added to the 510(k) for Disposable Instant Cold Pack.
The CP&S Disposable Ice Pack Limb Kit Transporter Intended Use: provides an environment above freezing for a severed body part while being transported to the hospital emergency room or replantation surgery.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wayne Kritzman Manufacturing Manager Consolidated Products and Services, Inc. 100-L Messina Drive Braintree, Massachusetts 02184
K974190 Re: CP&S Disposable Instant Cold Pack Limb Kit Transporter Requlatory Class: I Product Code: IMD October 31, 1997 Dated: November 4, 1997 Received:
Dear Mr. Kritzman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
NOV | 9
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Page 2 - Mr. Wayne Kritzman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten Ph.D. M.D.
v Cellia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Intended Use:
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The CP&S Disposable Ice Pack Limb Kit Transporter provides an environment above freezing for a provides an offirshinge being transported to the hospital emergency room or replantation surgery.
Over-the-Counter Use
bioseef
16974190
§ 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.