(15 days)
Not Found
No
The device description and intended use clearly describe a simple, non-electronic instant ice pack with a pouch for transport, with no mention of any computational or data-driven components.
No
The device is described as an instant ice pack designed for transporting severed body parts, maintaining a cool environment to preserve them, but it does not directly treat a medical condition or ailment. Its function is preservation during transport, not therapy.
No
The device is described as an instant ice pack designed for transporting severed body parts, providing a cool environment above freezing. Its purpose is preservation during transport, not diagnosis.
No
The device description clearly states it is an "instant ice pack with an added pouch," indicating a physical, hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body.
- Device Function: The CP&S Disposable Ice Pack Limb Kit Transporter is designed to provide a controlled temperature environment for a severed body part during transport. It is a physical device used to preserve a biological specimen (the severed limb) outside the body, but its purpose is preservation, not diagnostic testing of the specimen itself.
- Intended Use: The intended use is for transporting a severed body part, not for performing any diagnostic tests on it.
- Device Description: The description focuses on the physical components and how it provides cooling, not on any analytical or diagnostic capabilities.
- Lack of Diagnostic Elements: There is no mention of analyzing the severed body part, detecting biomarkers, or providing any diagnostic information about the patient or the limb.
Therefore, the CP&S Disposable Ice Pack Limb Kit Transporter falls under the category of a medical device used for preservation and transport, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
IMD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital emergency room or replantation surgery.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K974190
I. 510(k) AMENDMENT SUMMARY
| Submitted by: | NOV 19 1997
Consolidated Products and Services
100-L Messina Drive
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
(current 510(k) K890553 to be amended). |
| Description: | 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.
(Attachment C) |
| | The additional pouch does not affect the safety or efficacy
of the disposable Instant Cold Pack. |
| | CP&S feels the Instant Cold Pack Limb Kit Transporter is
a tremendous improvement over current practice of
placing severed limbs in any available container and
placing on ice. |
| | 21CFR 890.5710 identifies a disposable cold pack as a
"device intended for medical purposes that consists of a
sealed plastic bag incorporating chemicals that upon
activation, provides cold therapy for body surfaces."
The CP&S Instant Cold Pack Limb Kit Transporter
compares exactly to this identification. |
1
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.
2
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
3
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
4
Intended Use:
.. #
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