(55 days)
Sulopenem SPM 2 μg is an in vitro semi-quantitative method for antimicrobial susceptibility of clinical isolates tested on agar media using overnight incubation.
The Sulopenem SPM 2 μg is intended to determine susceptibility of Enterobacterales to sulopenem, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Sulopenem at concentrations of 2 μg should be interpreted at 16-18 hours of incubation.
The Sulopenem SPM 2 μg demonstrated acceptable performance with the following organisms:
Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii).
Not Found
This FDA 510(k) clearance letter details the clearance of an Antimicrobial Susceptibility Test Disc, not an AI/ML medical device. Therefore, the information typically requested in an AI/ML device acceptance criteria and study section (such as human-in-the-loop performance, expert consensus on ground truth, training set details, or MRMC studies) is not applicable and is not present in the provided text.
The information from the letter describes a Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc, a device used in vitro to determine the susceptibility of Enterobacterales to sulopenem. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance standards and validation studies required for such an in vitro diagnostic (IVD) device.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The Sulopenem SPM 2 µg demonstrated acceptable performance with the following organisms: Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii)."
However, the specific quantitative acceptance criteria (e.g., minimum essential agreement, categorical agreement percentages) and the reported performance values (e.g., actual percentages of agreement achieved) are not detailed in this clearance letter. These would typically be found in the more comprehensive 510(k) submission summary or review memorandum, which is not provided here.
2. Sample sizes used for the test set and the data provenance
The letter does not specify the sample size (number of isolates tested) used for the performance evaluation or the data provenance (e.g., country of origin, retrospective/prospective nature of the isolate collection).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the "ground truth" for an antimicrobial susceptibility test is typically established by a reference method (e.g., broth microdilution or agar dilution) performed by trained laboratory personnel following standardized protocols, not by expert consensus in the way it is for imaging AI.
4. Adjudication method for the test set
Not applicable in the context of an AST device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are relevant for imaging AI devices that assist human readers. This is an in vitro diagnostic disc.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical disc; its "standalone performance" refers to its accuracy against a reference method. The letter confirms "acceptable performance" but does not detail the specific study methodology.
7. The type of ground truth used
The ground truth for antimicrobial susceptibility testing is typically established by comparing the device's results (zone of inhibition for a disc) to a gold standard reference method, such as broth microdilution or agar dilution, which determine the Minimum Inhibitory Concentration (MIC). The letter references the "FDA Susceptibility Test Interpretive Criteria (STIC)," implying these are the standards used for interpretation against a reference method. The letter also specifies "clinical isolates," indicating the testing was performed on real-world samples.
8. The sample size for the training set
This concept (training set) is typically associated with AI/Machine Learning models, not with a physical antimicrobial susceptibility test disc. Therefore, no "training set" or its size is mentioned.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
In summary, based only on the provided FDA 510(k) clearance letter:
The letter confirms the Sulopenem SPM 2 µg Antimicrobial Susceptibility Test Disc has demonstrated "acceptable performance" for determining susceptibility of specific Enterobacterales (listed in the document) to sulopenem, according to FDA Susceptibility Test Interpretive Criteria (STIC) when interpreted at 16-18 hours of incubation. However, the specific quantitative results of the performance study and the details of the study methodology (like exact sample sizes, and the precise nature of the "acceptable performance" criteria in terms of agreement percentages) are not disclosed in this high-level clearance summary. These details would be contained within the full 510(k) submission.
FDA 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 12, 2025
Liofilchem
Emily Hodgkins
Microbiologist
465 Waverley Oaks Road
Suite 317
Waltham, Massachusetts 02452
Re: K251879
Trade/Device Name: Sulopenem SPM 2 µg
Regulation Number: 21 CFR 866.1620
Regulation Name: Antimicrobial Susceptibility Test Disc
Regulatory Class: Class II
Product Code: JTN
Dated: June 12, 2025
Received: June 18, 2025
Dear Emily Hodgkins:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new
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K251879 - Emily Hodgkins Page 2
premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
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K251879 - Emily Hodgkins Page 3
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar -S
Ribhi Shawar, Ph.D. (ABMM)
Chief
General Bacteriology and Antimicrobial Susceptibility Branch
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K251879
Device Name
Sulopenem SPM 2 μg
Indications for Use (Describe)
Sulopenem SPM 2 μg is an in vitro semi-quantitative method for antimicrobial susceptibility of clinical isolates tested on agar media using overnight incubation.
The Sulopenem SPM 2 μg is intended to determine susceptibility of Enterobacterales to sulopenem, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). Sulopenem at concentrations of 2 μg should be interpreted at 16-18 hours of incubation.
The Sulopenem SPM 2 μg demonstrated acceptable performance with the following organisms:
Enterobacterales (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Klebsiella aerogenes, Klebsiella oxytoca, Proteus vulgaris, Providencia alcalifaciens, and Providencia stuartii).
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 866.1620 Antimicrobial susceptibility test disc.
(a)
Identification. An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).