The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, and rinse solutions to that blood smear.

Device Description

The DxH SMS consists of a slidemaking module, a slidestaining module, and a specimen transport module precisely integrated to provide process control, slidemaking and staining, and cassette or single-tube delivery of specimens. The DxH SMS processes patient specimens and sends status data to the System Manager.

The System Manager:

Controls processes, such as making and staining blood smears, and diagnostic procedures.
Manages data, such as test ordering, LIS interface, and logging.

The System Manager resides on a Personal Computer (PC) based workstation running system application specific software. The PC is connected to the DxH SMS via an Ethernet connection. The System Manager provides data management and storage, provides test order management, quality control functionality, diagnostics and maintenance procedures. User interaction is provided via touch screen, keyboard and mouse.

AI/ML Overview

The provided document is a 510(k) premarket notification for a design change to the UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System. This submission is a "Design Change Special 510(k) - Corrective Action Being Effected Submission," meaning the primary purpose is to address a field action (a reported fire within a Stainer module).

Therefore, the document explicitly states that performance testing is not required to demonstrate acceptance criteria for its intended use because the design changes do not impact the intended use or performance claims of the DxH SMS (Page 5, "Comparison to Predicate"). The changes are risk control measures.

Given this, much of the requested information regarding acceptance criteria and performance studies is not applicable or not provided in this specific 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not applicable for performance within this submission)	Reported Device Performance (Not applicable for performance within this submission)
N/A - This submission is for corrective design changes to mitigate identified failure modes related to safety (fire risk), not to demonstrate performance against clinical acceptance criteria. The original device's performance claims are assumed to remain unchanged.	N/A - Performance testing (e.g., differential cell count accuracy, smear quality) was not performed as part of this 510(k) submission. The document states: "Performance testing is not required. Testing was limited to design and software verification testing." (Page 5)

2. Sample size used for the test set and the data provenance

Test set sample size: Not applicable for performance. Design and software verification testing was performed (Page 5), but details on the "sample size" of units or scenarios tested are not provided in this summary.
Data provenance: Not explicitly stated, but given it's a field action by Beckman Coulter, Inc. (a US company), and the submission is to the US FDA, the internal testing would likely be performed by the manufacturer. The initial report of fire was from a "customer's instrument" (Page 4), implying real-world data led to the corrective action.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission focuses on design and software verification related to a safety issue, not clinical performance requiring expert ground truth.

4. Adjudication method for the test set

Not applicable. This submission focuses on design and software verification related to a safety issue, not clinical performance comparison.

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

No. This device is an automated slidemaker stainer, not an AI-assisted diagnostic device for human readers. An MRMC study is not relevant to this device's function or the nature of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the context of clinical performance. The device's function is automated slide preparation and staining. The design changes are focused on mitigating safety risks in its automated operation.

7. The type of ground truth used

Not applicable for clinical performance. The "ground truth" for this submission was the confirmed report of a fire within the Stainer module, which initiated a root cause analysis and led to design changes to mitigate identified failure modes.

8. The sample size for the training set

Not applicable. This device does not appear to involve machine learning, and therefore, a "training set" in that context is not relevant.

9. How the ground truth for the training set was established

Not applicable, as there is no apparent training set for machine learning.

Summary of the Study (as described in the 510(k) summary provided):

This 510(k) submission describes design control activities for a corrective action to the UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System. The study performed was design and software verification testing (Page 5).

Purpose: To implement additional risk control measures to mitigate potential failure modes associated with a reported fire within the Stainer module of a customer's instrument.
Methodology: Design control activities based on risk analysis. Acceptance criteria were set to maintain the efficiency and safety of the device. Testing included:
- Design verification testing
- Temperature testing
- Installation testing
Conclusion: The design changes applied "do not impact the intended use or performance claims of the DxH SMS" (Page 5) and do not alter the device's control mechanism, operating principle, energy type, environmental specifications, ergonomics, dimensional specifications, or packaging (Page 6). The updated device is considered substantially equivalent in terms of safety and effectiveness to the predicate device.

Key takeaway from the document: This 510(k) is about safety improvements and confirming that these changes do not negatively impact the already cleared performance, rather than providing new performance data against clinical acceptance criteria.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 29, 2016

Beckman Coulter, Inc. Ms. Nancy Nadler Director, Regulatory Affairs 11800 SW 147th Avenue Miami, Florida 33196-2500

Re: K162414

Trade Name: UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: October 31, 2016 Received: November 1, 2016

Dear Ms. Nadler:

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

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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 (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 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" (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 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.

Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology 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) K162414

Device Name

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

Indications for Use (Describe)

The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a wholeblood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, and rinse solutions to that blood smear.

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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510(k) Summary for Special 510(k) for the UniCel DxH Slidemaker Stainer Coulter® Cellular Analysis System

510(k) Owner / Submitter Information

Company Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: (305) 380-4191 Fax #: (786) 639-4191 Contact Person: Nancy Nadler Email Address: nancy.nadler@beckmancoulter.com

Date Submitted:

August 26, 2016

Device Information

Trade Name: UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System Common Name: DxH SMS Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: GKZ Panel: Hematology and Pathology Devices Panel

Predicate Device Information

Predicate Product	510(k)Number	DateCleared	Classification	21 CFR	ProductCode
UniCel® DxH SMS Coulter®Cellular Analysis System	K140911	September5, 2014	Class II	864.5220	GKZ

Device Description

The DxH SMS consists of a slidemaking module, a slidestaining module, and a specimen transport module precisely integrated to provide process control, slidemaking and staining,

Beckman Coulter, Inc. DxH SMS Design Change Special 510(k) - Corrective Action Being Effected Submission Section 5, Page 1 of 4

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and cassette or single-tube delivery of specimens. The DxH SMS processes patient specimens and sends status data to the System Manager.

The System Manager:

Controls processes, such as making and staining blood smears, and diagnostic . procedures.
. Manages data, such as test ordering, LIS interface, and logging.

Design Change Description:

This modification to the DxH SMS is being implemented as part of the corrective action for a field action initiated by Beckman Coulter (BEC) in early August 2016. The field action was issued on the DxH SMS to notify customers that BEC received and confirmed a report of a fire within the Stainer module of a customer's instrument. BEC instructed customers to immediately discontinue use of the Stainer module.

As part of the corrective actions, BEC had developed additional risk control measures for the device to mitigate the potential failure modes associated with the reported fire on the DxH SMS.

Intended Use/Indications for Use:

The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Comparison to Predicate:

The design changes applied to the DxH SMS serve as additional risk control measures to mitigate each of the potential failure modes identified in the root cause analysis of the field action that initiated these changes.

These design changes do not impact the intended use or performance claims of the DxH SMS.

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Device Comparison Table:

Characteristic	UniCel DxH Slidemaker Stainer(K140911, Predicate)	Proposed Device
Indications for use	The DxH Slidemaker Stainer is a fullyautomated slide preparation and stainingdevice that aspirates a whole blood sample,smears a blood film on a clean microscopeslide, and delivers a variety of fixatives,stains, buffers, and rinse solutions to thatblood smear.	Same
DeviceClassification &Product Code	21 CFR 864.5220 Automated Cell Counter,GKZ	Same
Manufacturer	Beckman Coulter	Same
SpecimenCollection	Whole venous blood in EDTA	Same
Blood FilmPreparation	Automatically prepared by DxH SMS	Same
Blood FilmRequirements	Section 6.3.1 of CLSI H20-A2	Same

Summary of DxH SMS Performance Testing:

Performance testing is not required. Testing was limited to design and software verification testing.

Design Control Activities

The design development and verification/validation of the device modification have been performed under design control. The design control activities were based on risk analysis, and acceptance criteria were set to maintain the efficiency and safety of the device. Testing included design verification testing, temperature testing, and installation testing.

Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:

The updates to the DxH SMS that are the subject of this submission, do not change the intended use, nor add or delete a contraindication for the device. The changes do not alter

Beckman Coulter, Inc. DxH SMS Design Change Special 510(k) – Corrective Action Being Effected Submission Section 5. Page 3 of 4

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the device control mechanism, operating principle, energy type, environmental specification, ergonomics of the user interface, dimensional specifications, nor packaging. The device does not have expiration dating nor is it subject to sterilization.

In summary, the updated DxH SMS, as described in this submission is substantially equivalent in terms of safety and effectiveness to the predicate device.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.(b)
Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”