(86 days)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. This 510(k) is for the addition of newly approved Dalbavancin for the dilution range of 0.0005-2ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. The approved primary "Indications for Use" and clinical significance for Streptococus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus
Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC plates with Dalbavancin at a concentration of 0.0005-2ug/ml
This document is a 510(k) clearance letter from the FDA for a specific antimicrobial susceptibility test. It does not contain information about acceptance criteria or a study proving device performance in the way typically expected for a medical imaging AI/ML device.
The provided text pertains to a Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC plate with Dalbavancin used for in vitro diagnostic clinical susceptibility testing of fastidious isolates. This is a laboratory diagnostic product, not a medical imaging or AI/ML device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to the type of device described in this FDA clearance.
However, I can extract the following relevant information based on the context of an in vitro diagnostic device:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly list a table of acceptance criteria and reported device performance in the way a clinical study report would. For antimicrobial susceptibility tests, performance is typically evaluated through Essential Agreement (EA) and Categorical Agreement (CA) with a reference method, which are standard metrics for these devices. The clearance indicates that the device has been deemed "substantially equivalent" to a legally marketed predicate device, implying its performance met the necessary criteria for this type of in vitro diagnostic device. The "Indications for Use" section specifies the species for which the device is intended.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the clearance letter. For an in vitro diagnostic, this would typically refer to the number of bacterial isolates tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable in the context of an antimicrobial susceptibility test. "Ground truth" for these devices is established by a reference method (e.g., broth microdilution or agar dilution according to CLSI standards), not by human expert interpretation in the same way as medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as this is not an AI/ML-driven medical imaging device that uses human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as this is not an AI/ML device. The device itself performs the susceptibility testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an antimicrobial susceptibility test, the "ground truth" (or reference method) is typically the CLSI (Clinical and Laboratory Standards Institute) broth microdilution or agar dilution method. This is an objective, standardized laboratory test, not an interpretive one like expert consensus or pathology in a medical imaging context.
8. The sample size for the training set
This information is not applicable as this is not an AI/ML device which requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/ML device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
THERMO FISHER SCIENTIFIC CYNTHIA KNAPP DIRECTOR OF CLINICAL OPERATIONS 1 THERMO FISHER WAY OAKWOOD VILLAGE OH 44014-6
February 19, 2015
Re: K143381
Trade/Device Name: Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC plates with Dalbavancin (0.0005- 2 ug/ml) Regulation Number: 21 CFR 866.1640
Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY, LRG, LTT, LTW Dated: November 24, 2014 Received: November 25, 2014
Dear Ms. Knapp:
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.
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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,
Uwe Scherf -S for
Sally Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143381
Device Name
Sensititre Haemophilus / Streptococcus pneumoniae (HP) MIC plates with Dalbavancin at a concentration of 0.0005-2ug/ml
Indications for Use (Describe)
The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates.
This 510(k) is for the addition of newly approved Dalbavancin for the dilution range of 0.0005-2ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp.
The approved primary "Indications for Use" and clinical significance for Streptococus spp. is for the following species: Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).