(302 days)
Not Found
Not Found
No
The device description details a simple chemical reaction for heat generation and does not mention any computational or data-driven processes.
No.
The device warms an infant's heel to aid in blood drawing, which is a diagnostic or procedural aid, not a treatment for a disease or condition.
No.
The device is an instant warm pack intended to be used on an infant's heel to aid in the drawing of blood for analysis, not to diagnose a condition.
No
The device description clearly outlines a physical, disposable unit containing chemicals and an adhesive, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Intended Use: The Intco Infant Heel Warmer's intended use is to warm an infant's heel to aid in the drawing of blood. It does not perform any analysis or testing of the blood itself. Its function is purely physical – to increase blood flow to the heel.
- Device Description: The description details a physical warming mechanism based on a chemical reaction. There is no mention of any components or processes related to analyzing biological samples.
- Classification: The device is classified as a "Pack, Hot or Cold disposable" under the Physical Medicine Device Panel. This classification is for devices that apply heat or cold to the body, not for diagnostic testing.
In summary, the Intco Infant Heel Warmer is a therapeutic or procedural aid, not a diagnostic device. It facilitates the collection of a sample that will be used for in vitro diagnostic testing, but it is not the IVD device itself.
N/A
Intended Use / Indications for Use
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.
Product codes
MPO
Device Description
- Classified by FDA's Physical Medicine Device Panel as Class I, 21 CFR త్వ. 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infant's heel
Indicated Patient Age Range
infants, newborns
Intended User / Care Setting
hospitals, doctors' offices, and other healthcare facilities that administer health care services to newborns and infants.
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
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Summary of Performance Studies
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. 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.
Key Metrics
Not Found
Predicate Device(s)
The Infant Heel Warmer by Intco is substantially equivalent in safety and effectiveness to the Rapid Aid Ltd., the Rapid Aid Infant Heel Warmer.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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
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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
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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:
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.
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.
1
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
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.
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