The Infant Heel Warmer by Intco is a single use, non-toxic, non-sterile, disposable device. It is an instant warm pack intended to be used on an infant's heel to aid in the drawing of blood for analysis. The device is to be limited to use in hospitals, doctors' offices, and other healthcare facilities that administer health care services to newborns and infants. Prescription Use Only. The Indication for use of the Infant Heel Warmer by Intco is the same to the Rapid Aid Infant Heel Warmer, a legally marketed predicate device.

Device Description

Classified by FDA's Physical Medicine Device Panel as Class I, 21 CFR 890.5710, Pack, Hot or Cold disposable, MPO, and meets all requirements of ISO 7176 and EN 1021.
The Infant Heel Warmer by Intco is a self contained unit comprised of a flexible, poly/nylon outer pouch containing: I) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution. II) Liquid solution of food grade sodium acetate and water contained in I). III) Minute crystals of sodium acetate.
An adhesive tape is attached to the top of the unit. The unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermic reaction causes the unit to heat up to 102 degree F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.

AI/ML Overview

The provided document describes the acceptance criteria and a study for the "Infant Heel Warmer by Intco." However, this is a Class I medical device (Hot or cold disposable pack) which typically relies on substantial equivalence to a predicate device rather than extensive clinical studies with complex acceptance criteria like those for higher-risk devices or AI-powered diagnostics.

Based on the provided text, the device's performance is measured against that of a predicate device, focusing on fundamental physical characteristics rather than diagnostic accuracy or human interpretation.

Here's the breakdown of the information requested, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format that would typically be seen for a diagnostic or AI device. Instead, the acceptance is based on "substantial equivalence" in performance to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Temperature Profile: (i.e., reaches sufficient temperature for intended use, and similar to predicate device)	"The Infant Heel Warmer by Intco was tested against predicate devices for temperature characteristics. They performed very similarly with temperature within the same range, reaching a maximum temperature around 105 F within the first minutes and then steadily decreasing in temperature."
Material Safety: (latex-free, non-sensitizing, non-toxic chemical)	"The outer poly/nylon pouch material has been tested following ASTM standard and is latex free and non-sensitizing." "The chemical mixture claims are based on the results of testing the sodium acetate which is a non-toxic, food grade chemical and has been found to be toxicologically acceptable for its intended use."
Pouch Integrity and Durability: (thickness, tensile strength, seal integrity, burst strength)	"The finished packing material is tested for: thickness following ASTM D1203, tensile strength following ASTM D-882 and seal width." "Pouch packing material is subject to incoming inspection for width/length, seal integrity and burst strength." "Finished product is subject to testing for testing for peak temperature, seal integrity and pressure testing."
Intended Use: (as described for predicate device)	The device's intended use is stated to be "the same to the Rapid Aid Infant Heel Warmer, a legally marketed predicate device."

Study Proving Device Meets Acceptance Criteria:

The study described is primarily a comparative performance study against a predicate device and various material and product integrity tests.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document does not specify a numerical sample size for the "Infant Heel Warmer by Intco" units tested for performance or the predicate devices used for comparison. It refers to "batch production results" for peak temperature, suggesting multiple units from production batches were tested, but no specific number is given.
Data Provenance: Not explicitly stated. The manufacturer is Shanghai Intco Medical Supply Co., Ltd., suggesting testing likely occurred in China or at an associated facility. The document does not describe the origin of subject data (e.g., patient data) as this is not a diagnostic device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable and not provided in the document. The "ground truth" for this device is based on physical properties and performance (e.g., temperature, material strength) measured by instruments and verified by standard tests, not expert interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from multiple human expert opinions in diagnostic studies, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided. This is not an AI-powered diagnostic device, and therefore, an MRMC study or assessment of AI assistance for human readers is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established through:

Physical measurements and laboratory testing: For temperature characteristics, material properties (e.g., thickness, tensile strength, seal integrity, burst strength), and chemical composition analysis.
Conformance to standards: ASTM standards (D1203, D-882), ISO 7176, and EN 1021 are mentioned for material and product testing.
Comparison to a predicate device: The performance (specifically temperature characteristics) was directly compared to the "Rapid Aid Infant Heel Warmer."

8. The Sample Size for the Training Set:

This information is not applicable and not provided. As this is a traditional medical device, there is no "training set" in the context of machine learning or AI. The product validation relies on engineering tests and comparison to a predicate device.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided for the same reasons as #8.

Summary

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SEP 1 9 2006

EXHIBIT #1 Page 1 of 2

510(K)SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: K053254

Submitter's Identification: Mr. Fangyi Liu Shanghai Intco Medical Supply Co., Ltd. 1299 Hubin Road Fengxian, Shanghai, 201417 P.R. China Date Summary Prepared: Nov. 18, 2005
Name of the Device: Shanghai Intco Medical Supply Co., Ltd.

Infant Heel Warmer by Intco

Predicate Device Information and Substantial Equivalence:

The Infant Heel Warmer by Intco is substantially equivalent in safety and effectiveness to the Rapid Aid Ltd., the Rapid Aid Infant Heel Warmer.

4. Intended Use:

5. Device Description:

Classified by FDA's Physical Medicine Device Panel as Class I, 21 CFR ત્વ. 890.5710, Pack, Hot or Cold disposable, MPO, and meets all requirements of ISO 7176 and EN 1021.
The Infant Heel Warmer by Intco is a self contained unit comprised of a b. flexible, poly/nylon outer pouch containing: I) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution.

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II) Liquid solution of food grade sodium acetate and water contained in I).

III) Minute crystals of sodium acetate.

An adhesive tape is attached to the top of the unit. The unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermic reaction causes the unit to heat up to 102 degree F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.

6. Testing Report:

a. Summary of Testing:
- All materials used in the composition of the formulation are subject to . testing at the supplier site and are accepted based on results from a Certificate of Analysis.
- The outer poly/nylon pouch material has been tested following ASTM . standard and is latex free and non-sensitizing.
- The finished packing material is tested for: thickness following ASTM ● D1203, tensile strength following ASTM D-882 and seal width.
- Pouch packing material is subject to incoming inspection for ● width/length, seal integrity and burst strength.
- The chemical mixture claims are based on the results of testing the ● sodium acetate which is a non-toxic, food grade chemical and has been found to be toxicologically acceptable for it's intended use.
- Finished product is subject to testing for testing for peak temperature, . seal integrity and pressure testing. Summary of peak temperature from batch production results is attached.

b. Performance Data:

The Infant Heel Warmer by Intco was tested against predicate devices for temperature characteristics. They performed very similarly with temperature within the same range, reaching a maximum temperature around 105 F within the first minutes and then steadily decreasing in temperature.

c. Conclusions drawn from testing:

The data from testing demonstrates that the performance of the Infant Heel Warmer by Intco is very similar to and substantially equivalent to that of other commercially available Infant Heel Warmers.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Shanghai Intco Medical Supply Co., Ltd. % Mr. John Zhao Basic Medical Industries, Inc. 12390 East End Avenue Chino, California 91710

SEP 1 9 2006

Re: K053254

Trade/Device Name: Infant Heel Warmer by Intco Regulation Number: 21 CFR 890.5710 Regulation Name: Hot or cold disposable pack Regulatory Class: Class I Product Code: MPO Dated: September 12, 2006 Received: September 13, 2006

Dear Mr. Zhao:

We have reviewed your Section 510(k) premarket notification of intent to market the device refercnced 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.

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John Zhao

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Barbara Pneuma

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment A

Page 1 of 1

510(k) NUMBER (IF KNOWN) : DEVICE NAME: Shanghai Intco Medical Supply Co., Ltd. INDICATIONS FOR USE: Infant Heel Warmer by Intco

Prescription Use Only V (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use (21 CFR 807 Subpart C)

Note: The device is to be limited to use in hospitals, doctor's offices, and other healthcare facilities that administer health care services to newborns and infants.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Salvare Bruenup $

Concurrent of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K053254

Regulation Number and Section

§ 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.