(59 days)
Allegiance Peri KTM Perineal Cold Pack, Jack Frost Perineal Cold Pack, Florida Medical Perineal Cool Comfort Pack, Hospital Medical Services Peri + Plus Peri Cold Pack
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a cold pack, with no mention of AI or ML technologies.
Yes.
The device is intended to provide cold therapy to relieve edema and inflammation, which are therapeutic effects.
No.
The device is a cold therapy pack intended to provide pain relief and reduce swelling, not to diagnose a condition.
No
The device is a physical cold pack comprised of a multi-layer pouch, perineal pad, and chemical components (ammonium nitrate and water) for generating cold therapy. It does not involve any software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing cold therapy and absorbing postpartum lochea. This is a physical therapy and absorption function, not a diagnostic test performed in vitro (outside the body) on biological samples to determine the presence of a disease or condition.
- Device Description: The device description details a physical cold pack and absorbent pad. It does not involve any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Diagnostic claims or interpretations
The device is clearly described as a physical therapy and absorbent product for external use.
N/A
Intended Use / Indications for Use
The Allegiance Kwik Kold™ Peri Cold Pack is an over-thecounter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.
Product codes
Not Found
Device Description
The Allegiance Kwik Kold™ Peri Cold Pack is comprised of a multi layer pouch which is secured to a perineal pad and then wrapped in a one ply polyester material The cold source pouch consist of ammonium nitrate and water. The water "bubble" is housed in a separate plastic pouch surrounded by ammonium nitrate. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the cold source occurs by folding and shaking the unit, thus resulting in a cooled solution from an endothermic reaction lasting approximately 30 to 35 minutes with a coldest temperature of approximately 33° F.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perineal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the composition of this cold pack are evaluated and tested as identified in ISO Standard 10993 Part 1. The materials were subjected to skin sensitization (guinea pig maximization), primary skin irritation and cytotoxicity testing. Physical tests performed include: coldest temperature, time at coldest temperature, and temperature at five minutes. The active chemical mixture was subjected to Primary Skin Irritation testing. This mixture was found to be toxicologically acceptable for its intended usage. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Allegiance Peri KTM Perineal Cold Pack, Jack Frost Perineal Cold Pack, Florida Medical Perineal Cool Comfort Pack, Hospital Medical Services Peri + Plus Peri Cold Pack
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
Allegiance
Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, IL 60085 847.473.1500
APR -3 1997
SUMMARY OF SAFETY AND EFFECTIVENESS Appendix F
Manufacturer:
Allegiance Healthcare Corporation Surgical Group Thermal Business Unit 808 Highwav 24 West Moberly, Missouri 65270
Maryalice Smith 1500 Waukegan Road McGaw Park, Illinois 60085
(847) 785-3322
November, 1996
Allegiance Kwik Kold™ Peri Cold Pack
Perineal Cold Pack
Cold and Hot Disposable Pack
Allegiance Peri KTM Perineal Cold Pack
The Allegiance Kwik Kold™ Peri Cold Pack is comprised of a multi layer pouch which is secured to a perineal pad and then wrapped in a one ply polyester material The cold source pouch consist of ammonium nitrate and water. The water "bubble" is housed in a separate plastic pouch surrounded by ammonium nitrate. The perineal pad is made of a non-woven wrapped cellulose wood pulp fiber. Activation of the cold source occurs by folding and shaking the unit, thus resulting in a cooled solution from an endothermic reaction lasting approximately 30 to 35 minutes with a coldest temperature of approximately 33° F.
The Allegiance Kwik Kold™ Peri Cold Pack is an over-thecounter, single-use, non-sterile device. It is a cold therapy pack intended to be used post delivery to absorb postpartum lochea while providing cold therapy relieving edema and inflammation associated with an episiotomy incision.
Regulatory Affairs Contact
Telephone:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification:"
Predicate Device:
Description:
Intended Use:
1
The Alleaiance Kwik Kold™ Peri Cold Pack is substantially Substantial Equivalence: equivalent to the Allegiance Peri K™ Perineal Cold Pack, Jack Frost Perineal Cold Pack, Florida Medical Perineal Cool Comfort Pack, and Hospital Medical Services Peri + Plus Peri Cold Pack in that the - intended use is the same
- -performance attributes are equal -chemical composition is the same -method of activation is the same
- -coldest temperatures achieved are comparable
All materials used in the composition of this cold pack are evaluated and tested as identified in ISO Standard 10993 Part 1. The materials were subjected to skin sensitization (guinea pig maximization), primary skin irritation and cytotoxicity testing. Physical tests performed include: coldest temperature, time at coldest temperature, and temperature at five minutes. The active chemical mixture was subjected to Primary Skin Irritation testing. This mixture was found to be toxicologically acceptable for its intended usage. This product is in compliance with established standards, where applicable, and was deemed acceptable for its intended use.