(255 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the warming pack, with no mention of AI or ML.
Yes
The device is intended to increase blood circulation to an infant's heel to aid in the drawing of blood for analysis, which is a therapeutic purpose.
No
The device is a warmer used to increase blood circulation to aid in drawing blood and does not analyze or interpret medical data for diagnosis.
No
The device description clearly outlines physical components (pouch, sodium acetate solution/gel, stainless steel disc, adhesive tape) and describes a physical exothermic reaction to generate heat. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm an infant's heel to increase blood circulation to aid in drawing blood for analysis. This is a physical intervention to facilitate a diagnostic procedure (blood drawing), but the device itself does not perform any diagnostic testing on a sample in vitro (outside the body).
- Device Description: The description details a physical warming device that uses a chemical reaction to generate heat. It does not involve any reagents, assays, or components designed to analyze biological samples.
- Lack of Diagnostic Function: The device's function is purely to warm the skin. It does not measure, detect, or analyze any substance in the blood or any other biological sample.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's role is preparatory to a diagnostic procedure, not the diagnostic procedure itself.
N/A
Intended Use / Indications for Use
An instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
The device is primarily used in hospitals, doctor's offices, and other healthcare facilities.
Product codes (comma separated list FDA assigned to the subject device)
MPO
Device Description
The CooperSurgical Infant Heel Warmer, which is available in both a liquid version (The Infant Heel Warmer, Model 24401) and a gel version (WarmGel® Infant Heel Warmer, Model 20418), is a non-sterile, single-use, disposable device comprised of a biaxially oriented nylon (BON)/polyethylene outer pouch filled with a supersaturated solution of food grade sodium acetate and water (liquid version), or food grade sodium acetate, water, and hydroxyethylcellulose, a common thickener (gel version). An adhesive tape is attached to the pouch, which can hold the warmer in place if desired. The pouch also contains a stainless steel disc that, when flexed, initiates an exothermic crystallization of the sodium acetate, generating heat. When activated at 75° + 1° F, the maximum peak temperature of the CooperSurgical Infant Heel Warmer is 107° F, which is reached in approximately 40 seconds and then gradually decreases over time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heel
Indicated Patient Age Range
infant
Intended User / Care Setting
primarily used in hospitals, doctor's offices, and other healthcare facilities.
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)
Temperature profile testing: performed on the CooperSurgical Infant Heel Warmer and on the predicate DeRoyal Infant Heel Warmer. For each sample, a calibrated thermocouple was attached to the center, the device was activated to allow the exothermic reaction to begin, and temperature readings were taken at 5 second intervals for 30 minutes. The samples were activated at a temperature of 75° + 1° F. The temperature profiles were compared between the CooperSurgical Infant Heel Warmer and the predicate DeRoyal Infant Heel Warmer, and were found to be equivalent.
Stability testing: performed on the CooperSurgical Infant Heel Warmer to confirm its shelf life.
Biocompatibility testing: performed on the patient-contacting components of the device (outer pouch and adhesive tape) per AAMI/ANSI/ISO 10993-5:2003, and AAMI/ANSI/ISO 10993-10:2010.
Animal study: performed to determine the temperature of the skin after application of the device. The study consisted of three light-skinned and three dark-skinned pigs, aged 3 to 3.5 weeks. A WarmGel Infant Heel Warmer was placed on one side of the animal while the opposite side served as a control. Temperatures were measured using thermocouples adhered to the animal, one under the heel warmer and one on the control side, at 1-minute intervals for a total of 22 minutes. The animals were then graded against established criteria for both thermal insult and erythema. There was no evidence of thermal injury in any of the animals, and all but one animal received an erythema score of 0, with the one animal receiving a score of 1, which is barely perceptible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/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 perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 18, 2016
CooperSurgical Inc. c/o Roaida Johnson Associate Director, New Product Development 95 Corporate Drive Trumbull, CT 06611
Re: K151845
Trade/Device Name: Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class I Product Code: MPO Dated: February 16, 2016 Received: February 17, 2016
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J.Hoffmann -A
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151845
Device Name Infant Heel Warmer (Model 24401) WarmGel® Infant Heel Warmer (Model 20418)
Indications for Use (Describe)
An instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.
The device is primarily used in hospitals, doctor's offices, and other healthcare facilities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K151845
Image /page/3/Picture/1 description: The image shows the logo for CooperSurgical. The logo is in black and features the company name in a stylized font. The 'C' in Cooper is stylized with two concentric circles.
510(k) Summary WarmGel® Infant Heel Warmer (Model 20418) Infant Heel Warmer (Model 24401)
Submitter Information
| Company Name: | CooperSurgical Inc. |
|---|---|
| Company Address: | 95 Corporate Drive |
| Trumbull, CT 06611 | |
| Telephone: | 203-601-5200 |
| Fax: | 203-601-9870 |
| Contact Person: | Roaida Johnson |
|---|---|
| Date Prepared: | March 17, 2016 |
Device Information
| Trade Names: | The Infant Heel Warmer (Model 24401)
WarmGel® Infant Heel Warmer (Model 20418) |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Infant Heel Warmer |
| Classification: | Class I per 21 CFR 890.5710 |
| Classification Name: | Hot or cold disposable pack |
| Product Code: | MPO |
Predicate Device Information
The CooperSurgical Infant Heel Warmer is substantially equivalent to the following predicates:
Primary Predicate: Rapid Aid Instant Disposable Infant Heel Warmer - Disc (K150627) Additional Predicate: DeRoyal Industries Infant Heel Warmer (K954716)
Device Description
The CooperSurgical Infant Heel Warmer, which is available in both a liquid version (The Infant Heel Warmer, Model 24401) and a gel version (WarmGel® Infant Heel Warmer, Model 20418), is a non-sterile, single-use, disposable device comprised of a biaxially oriented nylon (BON)/polyethylene outer pouch filled with a supersaturated solution of food grade sodium acetate and water (liquid version), or food grade sodium acetate, water, and hydroxyethylcellulose, a common thickener (gel version). An adhesive tape is attached to the pouch, which can hold the warmer in place if desired. The pouch also contains a stainless steel disc that, when flexed, initiates an exothermic crystallization of the sodium acetate, generating heat. When activated at 75° + 1° F, the maximum peak temperature of the CooperSurgical Infant Heel Warmer is 107° F, which is reached in approximately 40 seconds and then gradually decreases over time.
4
Indications for Use
An instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, disposable warmer.
The device is primarily used in hospitals, doctor's offices, and other healthcare facilities.
Substantial Equivalence Analysis
The substantial equivalence of the CooperSurgical Infant Heel Warmer to the predicates is shown by similarity in intended use, indications for use, materials, and performance. The table below provides a comparison of the technological characteristics of the subject device to the predicates.
| Property | Subject Device
CooperSurgical
Infant Heel Warmer | Primary
Predicate
Instant
Disposable
Infant Heel
Warmer - Disc | Additional
Predicate
Infant Heel
Warmer | Comparison |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CooperSurgical Inc. | Rapid Aid Corp. | DeRoyal
Industries | --- |
| 510(k)
Number | K151845 | K150627 | K954716 | --- |
| Pouch
Material | Poly/nylon | Poly/nylon | Unknown | Same as primary
predicate |
| Solution
Material | Liquid version -
Sodium acetate (food
grade) and water
Gel version - Sodium
acetate (food grade),
water, and
hydroxyethylcellulose | Sodium acetate
(food grade) and
water | Unknown | The
hydroxyethylcellulose
is a non-toxic
thickening agent. The
addition of the material
does not raise new
issues of safety and
effectiveness. |
| Activation
Method | Flexing metal disc | Flexing metal
disc | Squeeze to burst
inner pouch | Same as primary
predicate |
| Average
Maximum
Temperature | 104° F | 104° F | 105° F | Same as primary
predicate |
| Maximum
Peak
Temperature | 107° F | Unknown | Unknown | An animal study was
performed to confirm
no new issues of safety
and effectiveness. |
| Size of Pouch | 5" x 3.5" | 5.5" x 3.75" | 5" x 3.5" | Same as secondary
predicate |
| Method of
Attachment to
Heel | Adhesive strap | Adhesive strap | Adhesive strap | Same as both
predicates |
| Sterility.
Number of
Uses | Non-sterile, Single
Use, Disposable | Non-sterile,
Single Use,
Disposable | Non-sterile,
Single Use,
Disposable | Same as both
predicates |
5
Non-Clinical Performance Testing
Temperature profile testing was performed on the CooperSurgical Infant Heel Warmer and on the predicate DeRoyal Infant Heel Warmer, and the results of this testing were used to determine the substantial equivalence of the Infant Heel Warmer to the predicate. For each sample, a calibrated thermocouple was attached to the center, the device was activated to allow the exothermic reaction to begin, and temperature readings were taken at 5 second intervals for 30 minutes. The samples were activated at a temperature of 75° + 1° F. The temperature profiles were compared between the CooperSurgical Infant Heel Warmer and the predicate DeRoyal Infant Heel Warmer, and were found to be equivalent.
Stability testing was also performed on the CooperSurgical Infant Heel Warmer to confirm its shelf life. Biocompatibility was performed on the patient-contacting components of the device (outer pouch and adhesive tape) per AAMI/ANSI/ISO 10993-5:2003, and AAMI/ANSI/ISO 10993-10:2010.
An animal study was performed to determine the temperature of the skin after application of the device. The study consisted of three light-skinned and three dark-skinned pigs, aged 3 to 3.5 weeks. A WarmGel Infant Heel Warmer was placed on one side of the animal while the opposite side served as a control. Temperatures were measured using thermocouples adhered to the animal, one under the heel warmer and one on the control side, at 1-minute intervals for a total of 22 minutes. The animals were then graded against established criteria for both thermal insult and erythema. There was no evidence of thermal injury in any of the animals, and all but one animal received an erythema score of 0, with the one animal receiving a score of 1, which is barely perceptible.
Conclusion
Based on the indications for use, technological characteristics, performance testing, and comparison to the predicates, the CooperSurgical Infant Heel Warmer has been shown to be substantially equivalent to the predicate devices identified, and does not present any new issues of safety or effectiveness.