(113 days)
allergEAZE clear Patch Test Chambers are an allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin. allergEAZE clear Patch Test Chambers are a intended for use by, or under the supervision of, a physician as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis.
Not Found
Here's an analysis of the provided text regarding the AllergEAZE™ Clear Patch Test Chambers, focusing on the absence of specific details related to device performance studies and acceptance criteria:
The provided FDA communication letters (K103409) do not contain information about acceptance criteria or a study proving the device meets those criteria, nor do they detail performance metrics, sample sizes, ground truth establishment, or expert involvement for such studies.
These letters primarily concern:
- An administrative change in the device's product code (K103409, a letter from November 1, 2024, updating the code from LDH to KXF).
- The original substantial equivalence (SE) determination (K103409, a letter from March 15, 2011).
The March 15, 2011, letter confirms that the device was found substantially equivalent to predicate devices, meaning it has similar intended use and technological characteristics to a legally marketed device and does not raise different questions of safety and effectiveness. This determination generally implies that the performance of the AllergEAZE™ Clear Patch Test Chambers is considered acceptable based on its similarity to existing, approved devices, rather than through a new, comprehensive performance study explicitly detailed within these documents.
Therefore, I cannot provide the requested information as it is not present in the provided input.
In a typical submission for a device requiring performance data, you would expect to see sections discussing:
- A table of acceptance criteria and the reported device performance: This would list specific quantitative or qualitative targets (e.g., sensitivity, specificity, accuracy, precision, durability, sterility, biocompatibility) and the results obtained from testing.
- Sample size and data provenance: Details on the number of samples (patients, test units) used, whether the data was collected prospectively or retrospectively, and origin information.
- Number and qualifications of experts: For studies involving expert review (e.g., image interpretation), information on the number of experts, their specialty, and experience.
- Adjudication method: How disagreements among experts were resolved.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: If the device assists human interpretation, this would compare human performance with and without the device.
- Standalone performance: The performance of the algorithm or device without human intervention.
- Type of ground truth: How the true status of each case was determined (e.g., biopsy, clinical follow-up, consensus of multiple experts).
- Training set sample size and ground truth establishment: For AI/ML-driven devices, information about the data used to train the model, and how its ground truth was established.
Conclusion based on the provided documents:
The provided FDA letters for AllergEAZE™ Clear Patch Test Chambers do not contain the details necessary to answer your specific questions regarding acceptance criteria and performance study outcomes. The regulatory action is based on substantial equivalence to a predicate device, which usually means the detailed performance studies (if they were performed for the 510(k)) were not fully articulated in these summary letters, or that the performance was considered "substantially equivalent" rather than requiring new, detailed clinical performance data compared against specific metrics.
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November 1, 2024
SmartPractice Kim Sullivan 3400 East McDowell Road Phoenix, Arizona 85008
Re: K103409
Trade/Device Name: AllergEAZE™ Clear Patch Test Chambers Regulation Number: 21 CFR 880.6025 Regulation Name: Absorbent tipped applicator Regulatory Class: Class I Product Code: KXF
Dear Kim Sullivan:
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 March 15, 2011. 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
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Ms. Kim Sullivan SmartPractice 3400 East McDowll Road Phoenix, Arizona 85008
MAR 1 5 201
Re: K103409
Trade/Device Name: allergEAZE® clear Patch Test Chambers Regulation Number: Unclassified Regulatory Class: II Product Code: LDH Dated: March 3, 2011 Received: March 4, 2011
Dear Ms. Sullivan:
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.
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Page 2- Ms. Sullivan
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
dums d Rosat
fer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
·Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K103409
Device Name: allergEAZE® clear Patch Test Chambers
Indications For Use:
allergEAZE clear Patch Test Chambers are an allergen delivery system which provides a means to place allergens or allergen mixes in contact with the surface of the skin. allergEAZE clear Patch Test Chambers are a intended for use by, or under the supervision of, a physician as a patch test diagnostic device used in the testing of individuals suspected of having allergic or irritant contact dermatitis.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
f Device Evaluation (ODE)
3/15/11
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Rouises Infection Control, De
510(k) Number
§ 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.