CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER

K974190 · Consolidated Products & Services, Inc. · IMD · Nov 19, 1997 · Physical Medicine

Device Facts

• Record ID: K974190
• Device Name: CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER
• Applicant: Consolidated Products & Services, Inc.
• Product Code: IMD · Physical Medicine
• Decision Date: Nov 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5710
• Device Class: Class 1

Intended Use

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.

Device Story

Device consists of a disposable instant cold pack integrated with a gauze-lined, zip-lock pouch. Designed for transport of severed body parts. Activated by user; chemical reaction provides cooling. Maintains environment above freezing for approximately 30 minutes. Used in emergency settings or during transit to medical facilities. Provides a controlled, cool environment to aid in the preservation of amputated tissue prior to surgical intervention.

Clinical Evidence

No clinical data. Evidence consists of literature supporting the necessity of storing severed limbs at above-freezing temperatures for preservation prior to replantation surgery.

Technological Characteristics

Disposable instant cold pack with integrated zip-lock pouch. Chemical-based cooling mechanism. Non-sterile. Standalone device. No software or electronic components.

Indications for Use

Indicated for the preservation of severed body parts during transport to a hospital emergency room or for replantation surgery.

Regulatory Classification

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.

Predicate Devices

• Disposable Instant Cold Pack (K890553)

Submission Summary (Full Text)

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## K974190

## I. 510(k) AMENDMENT SUMMARY

| Submitted by: | NOV 19 1997<br>Consolidated Products and Services<br>100-L Messina Drive<br>Braintree, 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<br>(current 510(k) K890553 to be amended). |
| Description: | The CP&S Disposable Instant Ice Pack Limb Kit<br>Transporter is an instant ice pack with an added pouch<br>for the insertion of a severed body part for transport to the<br>hospital emergency room or replantation surgery. |
| | The Instant Cold Pack Limb Kit Transporter is activated in<br>the same manner as the Disposable Instant Cold Pack<br>and provides cooling for the severed limb within the<br>gauze lined zip lock top bag. A cool environment above<br>freezing is maintained for approximately 30 minutes.<br>(Attachment C) |
| | The additional pouch does not affect the safety or efficacy<br>of the disposable Instant Cold Pack. |
| | CP&S feels the Instant Cold Pack Limb Kit Transporter is<br>a tremendous improvement over current practice of<br>placing severed limbs in any available container and<br>placing on ice. |
| | 21CFR 890.5710 identifies a disposable cold pack as a<br>"device intended for medical purposes that consists of a<br>sealed plastic bag incorporating chemicals that upon<br>activation, provides cold therapy for body surfaces."<br>The CP&S Instant Cold Pack Limb Kit Transporter<br>compares 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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