(223 days)
Not Found
No
The device description details a passive cryotherapy pack utilizing chemical reactions and phase changes for cooling, with no mention of computational processing, algorithms, or learning capabilities.
Yes
The device is described as treating external hemorrhoids and perianal fissures by reducing inflammation, itching, burning, pain, and swelling through cold therapy, indicating a therapeutic purpose.
No
The device is described as a treatment device for external hemorrhoids and perianal fissures, applying cold therapy to reduce inflammation and provide relief. There is no mention of it being used to diagnose conditions or gather diagnostic information.
No
The device description clearly details a physical product consisting of a sealed plastic bag containing fluids, enclosed in a cloth wrapper. It describes materials, dimensions, and physical properties, indicating it is a hardware device for applying cold therapy. There is no mention of software as a component or the primary 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 for the treatment of external hemorrhoids and perianal fissures by applying cold therapy directly to the affected area. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a physical cold pack designed for external application. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) which is a hallmark of IVD devices.
- Lack of Diagnostic Elements: There is no mention of the device being used to diagnose a condition, measure a substance in a biological sample, or provide information about a patient's health status based on in vitro analysis.
In summary, the device is a therapeutic device for applying cold therapy, not a diagnostic device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.
It is intended for the over-the-counter use.
Product codes
LKX
Device Description
The Cryostat Cold Therapy Pack device consists of a combination of water and chemicals in an anatomically designed sealed plastic bag, enclosed in a cloth outer wrapper for comfort. Six Cold Therapy Packs are packaged in one carton. An individual cold pack is 95mm long and 25mm wide and 26mm in depth.
A cold pack consists of a series of inner plastic containers, one of which contains water and FDA food grade dye (to distinguish it from the other fluid), inside a second container which contains a secondary fluid, consisting of water, USP Food grade Kosher propylene glycol as well as a different color FDA food grade dye.
The freezing temperature of the first fluid is higher than that of the second fluid. This allows a time released cooling process which delivers high performance cold therapy because of conduction and convection following the phase change of the primary fluid from solid to liquid.
The containers are made of formable film common in the food and medical packaging industry. The film is a multi-layer extrusion with one layer being Nylon to add strength and act as a vapor barrier. Visual inspection is performed to verify seal integrity and the dye in the fluids facilitates quality control.
Since the intended use of the device is to treat a specific ailment which requires comfort, the miniature cold pack is then wrapped in a heat sealable fabric for comfort to the affected area. The material chosen is white, so that the device, once used can be seen as soiled and therefore is disposed of.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external hemorrhoids, perianal fissures
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)
A rigorous risk assessment and performance test regimen demonstrated the safety and effectiveness of Cryostat. The tests performed included: temperature longevity, flammability, burst strength, tensile strength, tear strength, a safety/toxicological assessment, irritation, sensitization, and cytotoxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Lil' Drug Store Products, Inc. Cryostat™ 510(k) Premarket Notification Submission
Page 4.1 of 3
K67 2414
510(k) Summary
APR - 7 2008
1. Submitter's Name, Address and Contact Person
Submitter Lil' Drug Store Products, Inc. 1201 Continental Place NE Cedar Rapids, IA 52402 United States
Contact Person Tricia Miller, Director of Quality & Regulatory Telephone: 319-294-3745 Facsimile: 319-393-3494 Email: tmiller@lildrugstore.com
Date Summary Prepared: March 20, 2008
2. Device Information
| Trade name: | Cryostat (for OTC use) |
|---|---|
| Classification name: | Device, Thermal, Hemorrhoids |
| Device classification: | Unclassified |
| Product code: | LKX |
| Review Panel: | Gastroenterology/Urology |
3. Legally Marketed Devices to which Equivalence is Being Claimed
Device Name: 510(k) Number: Applicant:
Hemor-Rite Cryotherapy K042564 Fama Holdings International Corp. 6202 NW 88th Avenue Parkland, FL 33067
1
Lil' Drug Store Products, Inc. Cryostat™ 510(k) Premarket Notification Submission
KO72414
4. Description of Device
.
The Cryostat Cold Therapy Pack device consists of a combination of water and chemicals in an anatomically designed sealed plastic bag, enclosed in a cloth outer wrapper for comfort. Six Cold Therapy Packs are packaged in one carton. An individual cold pack is 95mm long and 25mm wide and 26mm in depth.
A cold pack consists of a series of inner plastic containers, one of which contains water and FDA food grade dye (to distinguish it from the other fluid), inside a second container which contains a secondary fluid, consisting of water, USP Food grade Kosher propylene glycol as well as a different color FDA food grade dye.
The freezing temperature of the first fluid is higher than that of the second fluid. This allows a time released cooling process which delivers high performance cold therapy because of conduction and convection following the phase change of the primary fluid from solid to liquid.
The containers are made of formable film common in the food and medical packaging industry. The film is a multi-layer extrusion with one layer being Nylon to add strength and act as a vapor barrier. Visual inspection is performed to verify seal integrity and the dye in the fluids facilitates quality control.
Since the intended use of the device is to treat a specific ailment which requires comfort, the miniature cold pack is then wrapped in a heat sealable fabric for comfort to the affected area. The material chosen is white, so that the device, once used can be seen as soiled and therefore is disposed of.
5. Statement of Intended Use
The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.
It is intended for the over-the-counter use.
6. Statement of Technological Characteristics of the Device
Cryostat is substantially equivalent to other previously approved cold pack products with respect to its design and materials, principle of operation, function, and intended use; specifically: Hemor-Rite Cryotherapy (Fama Holdings International Corp., Parkland, FL; 510(k) number K042564).
| Cryostat | Hemor-Rite Cryotherapy | |
|---|---|---|
| Design | ease of use, anatomical comfort | ease of use, anatomical comfort |
| Materials | plastic container containing liquid coolants | plastic container containing liquid coolants |
2
Lil' Drug Store Products, Inc. Cryostat™
| Principle of | cooling provided by phase
transition of frozen liquid | cooling provided by phase
transition of frozen liquid |
|--------------|------------------------------------------------------------------|------------------------------------------------------------------|
| Operation | | |
| Function | vasoconstriction and analgesia | vasoconstriction and analgesia |
| Intended Use | provide relief to body areas
affected by external hemorrhoids | provide relief to body areas
affected by external hemorrhoids |
510(k) Premarket Notification Submission
| Cryostat | Cryo-Max | |
|---|---|---|
| Design | ease of use, anatomical comfort | ease of use, anatomical comfort |
| Materials | plastic container containing liquid | |
| coolants | plastic container containing liquid | |
| coolants | ||
| Principle of | ||
| Operation | cooling provided by phase | |
| transition of frozen liquid | cooling provided by phase | |
| transition of frozen liquid | ||
| Function | vasoconstriction and analgesia | vasoconstriction and analgesia |
| Intended Use | provide relief to body areas | |
| affected by external hemorrhoids | provide relief to body areas | |
| affected by external hemorrhoids |
A rigorous risk assessment and performance test regimen demonstrated the safety and effectiveness of Cryostat. The tests performed included: temperature longevity, flammability, burst strength, tensile strength, tear strength, a safety/toxicological assessment, irritation, sensitization, and cytotoxicity.
7. Conclusion
Based on the information presented above it is concluded that Cryostat for OTC use is safe and effective for its proposed indications for treatment of external hemorrhoids and is substantially equivalent in intended use, safety, and labeling to the predicate device and the predicate device labeling.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design of three human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20B50
Ms. Patricia L. Miller Director of Quality & Regulatory Lil' Drug Store Products, Inc. 1201 Continental Place NE P.O. Box 1883 CEDAR RAPIDS IA 52402
APR - 7. 2008
Re: K072414
Trade/Device Name: Cryostat Regulation Number: None Regulatory Class: Unclassified Product Code: LKX Dated: March 25, 2008 Received: March 26, 2008
Dear Ms. Miller:
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.
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.
4
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 one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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.
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
5
Lil' Drug Store Products, Inc. Cryostat™ 510(k) Premarket Notification Submission
STATEMENT OF INDICATIONS FOR USE
KO72414
510(k) Number:
Device Name: Cryostat™
Indications for Use: The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/ extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K072414 |