(59 days)
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No
The summary describes a disposable probe cap for an ear thermometer, which is a passive, non-electronic device. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No
Explanation: This device is a probe cap for an ear thermometer, designed to prevent cross-infection and protect the probe. It does not directly treat or diagnose any medical condition, which are characteristics of a therapeutic device.
No
The device is a probe cap designed to protect the ear thermometer and prevent cross-infection, not to diagnose medical conditions.
No
The device description clearly states it is a "disposable PACK & PROPER Ear-Thermometer Prove Cap," which is a physical component (a cap) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the probe of an ear thermometer and prevent cross-infection. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's a "Probe Cap," which aligns with its function as a protective cover.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This probe cap does not perform such a test.
N/A
Intended Use / Indications for Use
The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.
Product codes
FLL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized, curved shapes that resemble birds in flight.
Public Health Service
JAN 3 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pack & Proper Company Limited C/O Dr. Jen Ke-Min Official Correspondent ROC Chinese-European Industrial Research Society No. 58 Fu-Chiun Street Hsin Chu City CHINA (TAIWAN) 300
Re: K042653
Trade/Device Name: Pack & Proper, Ear-Thermometer Probe Cap Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 2, 2004 Received: December 17, 2004
Dear Dr. Ke-Min:
This letter corrects our substantially equivalent letter of November 26, 2004, regarding the trade name for your device.
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 (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 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.
1
Page-2 Mr. Ken-Min
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 continue 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) 276-0115. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chris Lins, Ph.D.
Chiu Lin. Ph.D. Director Division of Dental. Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
4. INDICATIONS FOR USE STATEMENT
Applicant: 510(k) Number : ______________________________________________________________________________________________________________________________________________________________
Device Name : Pack & Proper Pack & Proper, Ear-Thermometer Probe Cap
Indications for Use :
The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter √
(Optional Format 1-2-96)
Anak Vina
(Division Sign-Off) Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
594265 510(k) Number
3
4. INDICATIONS FOR USE STATEMENT
| Applicant : | PACK & PROPER CO., LTD. |
|---|---|
| 510(k) Number : | K042653 |
Device Name : Pack & Proper Pack & Proper, Ear-Thermometer Probe Cap
Indications for Use :
The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter
(Optional Format 1-2-96)
Anak Vima
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
254765 510(k) Number: ـ