(70 days)
Not Found
Not Found
No
The summary describes a physical patch test delivery system and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is described as a "patch test diagnostic device" used for "allergen patch tests" and "testing individuals suspected of having allergic or irritant contact dermatitis," indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as a patch test diagnostic device."
No
The device is described as a "patch test delivery system and holding device," which strongly implies a physical component for applying allergens to the skin. The description does not mention any software functionality.
Based on the provided information, the Finn Chambers AQUA device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to place allergens in contact with the surface of the skin for patch testing. This is a test performed on the body (in vivo), not in vitro (outside the body, typically on biological samples like blood or tissue).
- Mechanism: The device is a delivery system and holding device for allergens applied to the skin. It doesn't analyze biological samples.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health. The Finn Chambers AQUA device facilitates a diagnostic test performed directly on the patient's skin.
N/A
Intended Use / Indications for Use
Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.
Product codes
KXF, LDH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6025 Absorbent tipped applicator.
(a)
Identification. An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2024
SmartPractice Julee Bankes Quality Assurance Manager 3400 East McDowell Road Phoenix, Arizona 85008
Re: K123184
Trade/Device Name: Finn Chambers Aqua Regulation Number: 21 CFR 880.6025 Regulation Name: Absorbent tipped applicator Regulatory Class: Class I Product Code: KXF
Dear Julee Bankes:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 19, 2012. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code KXF.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480, David.Wolloscheck(@fda.hhs.gov.
Sincerely,
David Wolloscheck -S
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2012
Ms. Julee Bankes Quality Assurance Manager SmartPractice 3400 East McDowell Road Phoenix, Arizona 85008
Re: K123184
Trade/Device Name: Finn Chambers Aqua Regulation Number: Unclassified Regulation Name: System, Delivery, Allergen and Vaccine Regulatory Class: Unclassified Product Code: LDH Dated: December 6, 2012 Received: December 7, 2012
Dear Ms. Bankes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
2
Page 2 - Ms. Bankes
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Cinthom is min
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
3
Indications for Use Form (Text Version)
Indications for Use
510(k) Number (if known): 丝绸 23184
Device Name: Finn Chambers AQUA
Indications for Use:
Finn Chambers AQUA is a patch test delivery system and holding device to place allergens and allergen mixes in contact with the surface of the skin during allergen patch tests. Finn Chambers AQUA patch test chambers are intended for use by, or under the supervision of, a physician for use as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis, photocontact dermatitis and experimental skin testing and allergy protocols.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER
PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anestheslology, General Hospital
Infection Control, Dental Devices
Digitally signed by Richard C. Chapman Date: 2012.12/19 10:10:07 -05'00'
KI73184 510(k) Number: