(206 days)
No
The device description focuses on passive cooling and physical protection mechanisms, with no mention of computational or adaptive elements.
No.
The device is designed to protect insulin bottles and keep them cool, acting as a container for medication, not as a device that directly or indirectly treats or diagnoses a medical condition or affects the structure or function of the body.
No
The device is designed to protect and keep insulin cool, not to diagnose medical conditions, analyze biological samples, or detect diseases. Its function is purely for the physical protection and temperature control of insulin bottles.
No
The device description clearly outlines physical components (cooling tray, foam insulation, outer casing, zipper, pockets) and their functions, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the Medicool Insulin Protector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "protect bottles of insulin while keeping them cool." This is a physical function related to storage and transport, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details a container with cooling and protective features. It does not describe any components or processes for analyzing biological samples.
- Performance Studies: The performance studies focus on the device's ability to protect the insulin bottles from physical stress and maintain a cool temperature. These are performance characteristics of a storage/transport device, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Insulin Protector does not perform any such analysis.
N/A
Intended Use / Indications for Use
The Insulin Protector is designed to protect bottles of insulin while keeping them cool. It is not designed to carry or store human organs, fluids, or tissue in any form.
This device's target population is people who require insulin.
Product codes
IQG
Device Description
The Medicool Insulin Protector™ is a capsule-like portable container designed to transport insulin in a temperature controlled environment and protect it from environmental shock and other trauma. The Insulin Protector™ essentially consists of three main parts: the cooling tray, the foam insulation, and the outer casing.
The cooling tray is a hollow-walled plastic container which has a cavity formed therein. The cooling tray is filled with water, which can be refrigerated in an ordinary household refrigerator. The cavity in the cooling tray receives up to two bottles of liquid insulin. The bottom and sides of the cavity include a plurality of ribbed members to prevent direct contact between the insulin bottles and the side walls of the cooling tray.
The cooling tray fits inside the foam insulation snuggly to minimize heat transfer and loss, thus effectively stabilizing the inside temperature. This sleeve insulating foam is manufactured by Marko Foam and referenced as BI-99. The foam is flexible and helps provide protection from shock and trauma to the insulin bottles being stored in the cooling tray. The foam has cavities in both the top and bottom sections to receive the removable cooling tray. When the cooling tray is inserted into the cavity, a portion of the cooling tray extends above the surface of the foam. However, when the top section is closed, the cooling tray extends into the cavity of the top foam.
The foam insulation containing the cooling tray fits snuggly inside the outer casing. The outer casing is stitched together using Cordura material, which is cuality fabric known for its durability and resistance to abrasion. A zipper is used to open and close the main compartment that holds the foam insulation and the cooling tray. On the outside of the bag are two smaller pockets that close the cooling these pockets are designed to hold accessories, such as syringes, alcohol wipes, swabs, etc.
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
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)
In the durability experiment (Nonclinical Test: Verification Testing Of Cooling Times For Medicool Insulin Protector® Case Determining Whether a Medicool Insulin Protector® Protects Inside Contents Under Physical Stress), the Insulin Protector's ability to protect the bottles of insulin (which was made of glass that could potentially shatter) was challenged through a series of intensive abusive trials using various insulin bottle types. After several trials using different methods of generating shock, it was concluded that the device resisted damage and preserved the contents inside perfectly.
In the insulin cooling experiment (Nonclinical Test: Verification Testing Of Cooling Times For Medicool Insulin Protector® case), the Insulin Protector®'s ability to keep insulin below the manufactures safe limit was 12 hours. Our test was conducted with Insulin vials in the only 2 variations that we have seen in our 22 years in business, a 10mL US vial and a 10mL EU vial.
In conclusion, the Insulin Protector™ performs adequately for what it is designed and marketed to do.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Insucozi (K072174)
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
§ 890.5050 Daily activity assist device.
(a)
Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. If the device is not labeled or otherwise represented as sterile, the device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
K 473555 (C. 10. F2)
510(K) SUMMARY [21 CFR 807.92]
Submitter:
Medicool, Inc. 20460 Gramercy Place Torrance, CA 90501 (800) 433-2469
| Contact Person: | Michael Mahon |
|---|---|
| Date prepared: | November 12, 2007 |
| Date last revised: | May16, 2008 |
Insulin Protector™ Proprietary Device Name: Comparable Device(s): N/A
I. Device Description
The Medicool Insulin Protector™ is a capsule-like portable container designed to transport insulin in a temperature controlled environment and protect it from environmental shock and other trauma. The Insulin Protector™ essentially consists of three main parts: the cooling tray, the foam insulation, and the outer casing.
The cooling tray is a hollow-walled plastic container which has a cavity formed therein. The cooling tray is filled with water, which can be refrigerated in an ordinary household refrigerator. The cavity in the cooling tray receives up to two bottles of liquid insulin. The bottom and sides of the cavity include a plurality of ribbed members to prevent direct contact between the insulin bottles and the side walls of the cooling tray.
The cooling tray fits inside the foam insulation snuggly to minimize heat transfer and loss, thus effectively stabilizing the inside temperature. This sleeve insulating foam is manufactured by Marko Foam and referenced as BI-99. The foam is flexible and helps provide protection from shock and trauma to the insulin bottles being stored in the cooling tray. The foam has cavities in both the top and bottom sections to receive the removable cooling tray. When the cooling tray is inserted into the cavity, a portion of the cooling tray extends above the surface of the foam. However, when the top section is closed, the cooling tray extends into the cavity of the top foam.
The foam insulation containing the cooling tray fits snuggly inside the outer casing. The outer casing is stitched together using Cordura material, which is cuality fabric known for its durability and resistance to abrasion. A zipper is used to open and close the main compartment that holds the foam insulation and the cooling tray. On the outside of the bag are two smaller pockets that close the cooling these pockets are designed to hold accessories, such as syringes, alcohol wipes, swabs, etc.
1
Kw73555 (p.2 of 2)
II. Statement of Intended Use
The Insulin Protector is designed to protect bottles of insulin while keeping them cool. It is not designed to carry or store human organs, fluids. or tissue in any form.
This device's target population is people who require insulin.
III. Summary of Similar Technological Characteristics
Insucozi (K072174)
IV. Discussion and Conclusions of Submitted Testing
In the durability experiment (Nonclinical Test: Verification Testing Of Cooling Times For Medicool Insulin Protector® Case Determining Whether a Medicool Insulin Protector® Protects Inside Contents Under Physical Stress), the Insulin Protector's ability to protect the bottles of insulin (which was made of glass that could potentially shatter) was challenged through a series of intensive abusive trials using various insulin bottle types. After several trials using different methods of generating shock, it was concluded that the device resisted damage and preserved the contents inside perfectly.
In the insulin cooling experiment (Nonclinical Test: Verification Testing Of Cooling Times For Medicool Insulin Protector® case), the Insulin Protector®'s ability to keep insulin below the manufactures safe limit was 12 hours. Our test was conducted with Insulin vials in the only 2 variations that we have seen in our 22 years in business, a 10mL US vial and a 10mL EU vial.
In conclusion, the Insulin Protector™ performs adequately for what it is designed and marketed to do.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 11 2008
Mr. Michael Mahon Medicool, Incorporated 20460 Gramercy Place Torrance, California 90501
Rc: K073555
Trade/Device Name: Insulin Protector Regulation Number: 21 CFR 890.5050 Regulation Name: Daily Activity Assist Device Regulatory Class: I Product Code: IQG Dated: May 16, 2008 Received: May 30, 2008
Dear Mr. Mahon:
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 t 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Mahon
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 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 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). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-JSee Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073555
Device Name: INSULIN PROTECTOR
Indications For Use:
The Insulin Protector is designed to protect bottles of insulin while keeping them cool. It is not designed to carry or store human organs, fluids, or tissue in any form.
This device's target population is people who require insulin.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ x (21 CFR 801 Subpart C)
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
:
Cim
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number: _______________________________________________________________________________________________________________________________________________________________