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.

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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Submission for the Lil' Drug Store Products, Inc. Cryostat™, a device for treating external hemorrhoids with cold therapy. This document focuses on demonstrating substantial equivalence to a predicate device, not on conducting a study with specific acceptance criteria related to a new device performance metric for diagnosis or treatment effectiveness that would involve clinical trials, expert adjudication, or AI.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The "study" here refers to a battery of technical tests, not a clinical study involving human participants in the way the questions imply.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of specific thresholds for clinical performance metrics (like sensitivity, specificity, accuracy). Instead, it lists technical tests performed to demonstrate safety and effectiveness, and implicitly, the device "met" these tests for the FDA to issue a substantial equivalence determination.

Test Performed	Reported Device Performance (Implicitly Met for Substantial Equivalence)
Temperature longevity	Demonstrated adequate duration of cold therapy.
Flammability	Met safety standards for flammability.
Burst strength	Met safety standards for burst strength.
Tensile strength	Met safety standards for tensile strength.
Tear strength	Met safety standards for tear strength.
Safety/toxicological	Demonstrated safety regarding materials and potential toxicity.
Irritation	Demonstrated no or acceptable irritation.
Sensitization	Demonstrated no or acceptable sensitization.
Cytotoxicity	Demonstrated no cytotoxicity.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes engineering and materials testing, not a clinical test set with human subjects. The "tests performed" (temperature longevity, flammability, etc.) would be conducted on samples of the device itself. Specific sample sizes for these engineering tests are not mentioned in this summary. Data provenance is not relevant in this context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert ground truth for diagnostic or clinical evaluation. The "ground truth" for the engineering tests would be established by standard engineering and safety protocols and measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring expert adjudication of clinical outcomes or interpretations.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device (cold therapy pack), not an AI algorithm or a diagnostic tool that involves human readers/interpreters.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the technical tests (flammability, burst strength, etc.), the "ground truth" is defined by established engineering standards, material science properties, and safety thresholds. For example, flammability testing would have a pass/fail criterion based on material burning characteristics. For the toxicological assessment, it would be based on established toxicology protocols.
The sample size for the training set

Not applicable. There is no "training set" in the context of this device and its regulatory submission. This is not an AI/machine learning device.
How the ground truth for the training set was established

Not applicable. There is no "training set."

Summary of the Device's "Study" and Basis for Acceptance:

The "study" described in this 510(k) submission is a "rigorous risk assessment and performance test regimen" designed to demonstrate the safety and effectiveness of the Cryostat device. The submission’s primary goal is to prove substantial equivalence to a previously legally marketed predicate device (Hemor-Rite Cryotherapy, K042564).

The tests performed were:

Temperature longevity
Flammability
Burst strength
Tensile strength
Tear strength
Safety/toxicological assessment
Irritation
Sensitization
Cytotoxicity

The device "met" these performance criteria implicitly, as "The FDA finding of substantial equivalence of your device... permits your device to proceed to the market." The detailed results or specific thresholds for these tests are not provided in this summary but would have been part of the full 510(k) submission reviewed by the FDA. The "acceptance criteria" here are inherent to meeting relevant safety and performance standards for a medical device of this type, allowing the FDA to determine it is "safe and effective for its proposed indications" and "substantially equivalent" to predicate devices.

Summary

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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

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Lil' Drug Store Products, Inc. Cryostat™ 510(k) Premarket Notification Submission

KO72414

4. Description of Device

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

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

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Lil' Drug Store Products, Inc. Cryostat™

Principle of	cooling provided by phasetransition of frozen liquid	cooling provided by phasetransition of frozen liquid
Operation
Function	vasoconstriction and analgesia	vasoconstriction and analgesia
Intended Use	provide relief to body areasaffected by external hemorrhoids	provide relief to body areasaffected 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 liquidcoolants	plastic container containing liquidcoolants
Principle ofOperation	cooling provided by phasetransition of frozen liquid	cooling provided by phasetransition of frozen liquid
Function	vasoconstriction and analgesia	vasoconstriction and analgesia
Intended Use	provide relief to body areasaffected by external hemorrhoids	provide relief to body areasaffected 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.

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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.

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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

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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

Regulation Number and Section

N/A