(70 days)
The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The CELL-DYN Sapphire System has the same intended use as previously cleared for the CELL-DYN 4000 System (predicate device).
The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed to provide complete blood count with WBC Differential, NRBC, Reticulocyte and Immature Reticulocyte Fraction enumeration, and CD61 and CD3/4/8 immunofluorescent analysis on EDTA-anticoagulated whole blood.
The CELL-DYN Sapphire System is a benchtop analyzer consisting of the main analyzer with data station, flat panel display, printer, and associated reagents. The data station, display, and printer are stand-alone modules. The system has the capability to sample either from closed collection tubes via the autoloader, or from open collection tubes through the aspiration probe in the Open Tube mode.
The sponsor, Abbott Laboratories, submitted a 510(k) premarket notification for the CELL-DYN Sapphire™ System, an automated hematology analyzer.
Acceptance Criteria and Device Performance:
The document doesn't explicitly list acceptance criteria in a table format with corresponding device performance values like a clinical trial report. However, it states that "The data compiled supports the claim that the CELL-DYN Sapphire System is substantially equivalent to the CELL-DYN 4000 System and includes data for background, carryover, comparability (correlation), imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity." This implies that the acceptance criteria for each of these performance characteristics were met to demonstrate substantial equivalence to the predicate device.
The study aimed to show substantial equivalence to the predicate device, the Abbott CELL-DYN 4000 System. This means the performance of the CELL-DYN Sapphire for various hematological parameters was compared against the CELL-DYN 4000. While specific numerical acceptance criteria and reported performance values are not provided in this summary, the conclusion is that the device met these implicit criteria to be deemed substantially equivalent.
Study Information:
-
Table of Acceptance Criteria and Reported Device Performance:
As noted above, a detailed table with specific numerical acceptance criteria and reported performance values is not provided in this 510(k) summary. The summary broadly states that data for background, carryover, comparability (correlation), imprecision (reproducibility), analytical measurement range (linearity), and sensitivity and specificity were compiled and supported the claim of substantial equivalence. -
Sample Size Used for the Test Set and Data Provenance:
The document mentions "clinical trials" were conducted for comparison, but it does not specify the sample size used for the test set. It also does not specify the country of origin of the data or whether the study was retrospective or prospective. -
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided in the document. Hematology analyzer studies typically use reference methods or expert review of slides to establish ground truth, but the details are absent here. -
Adjudication Method for the Test Set:
This information is not provided in the document. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study is not mentioned. This type of study is more common for imaging devices where human interpretation is a key component, not typically for automated hematology analyzers. The study design focuses on the performance of the device itself against a predicate device. -
Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
Yes, a standalone study was performed. The entire context of the submission and the nature of an automated hematology analyzer indicates that the study evaluates the performance of the algorithm/device only in generating quantitative and differential blood cell parameters. The comparison is between the CELL-DYN Sapphire System and the CELL-DYN 4000 System. -
Type of Ground Truth Used:
The document implies that the predicate device (CELL-DYN 4000 System) served as the primary reference or "ground truth" for comparison in terms of its established performance characteristics (e.g., correlation, imprecision). It's also likely that standard laboratory reference methods were used to establish the true values for the parameters being measured, though this is not explicitly stated. Terms like "comparability (correlation)" suggest comparison against an accepted standard. -
Sample Size for the Training Set:
The sample size for the training set is not specified. This information is typically relevant for machine learning models, but for a traditional automated analyzer based on established measurement methodologies, the concept of a "training set" in the machine learning sense might not apply directly in the same way. The device's algorithms are likely based on fixed rules and thresholds, rather than being "trained" on a large dataset in the modern AI sense. -
How the Ground Truth for the Training Set Was Established:
As the concept of a "training set" in the AI sense is likely not applicable here, the method of establishing ground truth for it is not described. For establishing the device's operational parameters, extensive analytical validation using reference materials and potentially clinical samples with known characteristics would have been performed.
{0}------------------------------------------------
JUL 2 1 2005
| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act 1990 and 21 CFR 807.92. |
|---|---|
| The assigned 510(k) number is: K051215 | |
| CELL-DYN Sapphire™ System | |
| Submitted by | Abbott Laboratories5440 Patrick Henry DriveSanta Clara, CA 95054 |
| Contact Person | Michelle RoedingPhone (408) 567-3781 Fax (408) 982-4863 |
| Date Prepared | May 10, 2005 |
| Proprietary Name | CELL-DYN Sapphire™ System |
| Common Name | Automated Hematology Analyzer |
| Classification Name | Automated Differential Cell Counter (21 CFR 864.5220) |
| Predicate Device | Abbott CELL-DYN 4000 System |
| Device Description | The CELL-DYN Sapphire System is a benchtop analyzer consisting of the main analyzer with data station, flat panel display, printer, and associated reagents. The data station, display, and printer are stand-alone modules. The system has the capability to sample either from closed collection tubes via the autoloader, or from open collection tubes through the aspiration probe in the Open Tube mode. |
... . .....
{1}------------------------------------------------
| Intended Use | The CELL-DYN Sapphire System is a multiparameter,automated hematology analyzer designed for in vitrodiagnostic use in clinical laboratories.The CELL-DYN Sapphire System has the same intended useas previously cleared for the CELL-DYN 4000 System(predicate device). | |
|---|---|---|
| SimilaritiesAndDifferences | The CELL-DYN Sapphire System and the CELL-DYN 4000System are similar in that: | |
| a) | Both systems provide quantitation of the hemogram andautomated WBC differential parameters in EDTA-anticoagulated human whole blood specimens. | |
| b) | Both systems will accept specimens presented automatically bythe autoloader or manually presented by the operator. | |
| c) | Both systems utilize multiple measurement methodologies:impedance, laser optical scatter, fluorescence, and opticalabsorbance methods. | |
| d) | Both systems measure RBC and PLT by laser optical scatterand focused-flow impedance with injection metering. | |
| e) | Both systems measure WBC by laser optical scatter andfluorescence. | |
| f) | Both systems use fluorescence to enumerate reticulocytes,NRBC, CD61, and CD3/4/8. | |
| g) | Both systems provide Dispersional Data Alerts, SuspectParameter Messages, and Suspect Population Flags to assist indata review. | |
| h) | Both systems accept input from keyboard and send data outputto: video screen, hard drive, and printer; and both systemsprovide RS232 Interface to an on-line LIS as well as usingmicroprocessors for systems control, data acquisition, and dataanalysis. | |
| The CELL-DYN Sapphire System and the CELL-DYN 4000System are different in that: | ||
| a) | The CELL-DYN Sapphire System uses a solid state laser tofacilitate both optical scatter and fluorescence measurements | |
| b) | The CELL-DYN Sapphire System uses a Unix based Linuxoperating system, while the CELL-DYN 4000 uses a Unixbased Lynx operating system. | |
| c) | The CELL-DYN Sapphire System has the ability to downloadraw list mode data (FCS type) to media for analysis, while theCELL-DYN 4000 System does not have this capability. | |
| d) | The CELL-DYN Sapphire System has internal pneumaticcomponents, while the CELL-DYN 4000 has a separateexternal pneumatic unit. | |
| Medical - ClinicalStudy Protocol | The Medical - Clinical Study Protocols for the CELL-DYNSapphire are found in Attachment E. | |
| EquivalencyData Summary | The CELL-DYN Sapphire System is a multiparameter,automated hematology analyzer designed for in vitrodiagnostic use in clinical laboratories. The CELL-DYNSapphire System, which includes reagents and software, wascompared in clinical trials to the CELL-DYN 4000 System.The data compiled supports the claim that the CELL-DYNSapphire System is substantially equivalent to the CELL-DYN4000 System and includes data for background, carryover,comparability (correlation), imprecision (reproducibility),analytical measurement range (linearity), and sensitivity andspecificity. The data supporting the claim that theCELL-DYN Sapphire is substantially equivalent to theCELL-DYN 4000 is found in Attachment G. | |
| Conclusion | The CELL-DYN Sapphire System is substantially equivalent tothe CELL-DYN 4000 (predicate device). The differencesnoted do not pose new questions of safety and effectiveness. |
while the CELL-DYN 4000 uses an Argon-ion laser.
:
{2}------------------------------------------------
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Michelle Roeding Section Manager, Regulatory Affairs Abbott Laboratories 5440 Patrick Henry Drive . . . . . . JE E & 2005
JUL 2 1 2005
Hematology Business Unit Santa Clara, CA 95054
=
Re: K051215
Trade/Device Name: CELL- DYN Sapphire™ System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: May 10, 2004 Received: May 12, 2004
Dear Ms. Rocding:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection o re(a) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to regardy the Medical Device Amendments, or to conninered pror to May 20, 2019, 11:25 eccordance with the provisions of the Federal Food, Drug, de necs that have been rout do not require approval of a premarket approval application (PMA). and Cosment Act (710c) that the novice, subject to the general controls provisions of the Act. The r ou may, diererors, mains of the Act include requirements for annual registration, listing of general controls proving practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your de subject to such additional controls. Existing major regulations affecting your device n may oc subject it outer also a and regulations (CFR), Parts 800 to 895. 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 or uny I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in keting your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate device results in a classification for your device and thus, permits your device to proceed to the market.
{4}------------------------------------------------
Page 2 -
If you desire specific information about the application of labeling requirements to your device, If you destro species and advertising of your device, please contact the Office of In or questions on the proce Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (24€PR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PH.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use Statement
510(k) Number (if known): K
510(k) Number (if known): K05/215
. ... . . . . .
Device Name:
CELL-DYN Sapphire™ System
ﺘﺸﻐﻴﻨﺎﺕ ﺑﺘﺤﻘ
Indications for Use:
The CELL-DYN Sapphire System is a multiparameter, automated hematology analyzer designed to provide complete blood count with WBC Differential, NRBC, Reticulocyte and Immature Reticulocyte Fraction enumeration, and CD61 and CD3/4/8 immunofluorescent analysis on EDTA-anticoagulated whole blood.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | X |
|---|---|
| OR | |
| Over-The-Counter Use(Optional Format 1-2-96) |
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K051215 |
|---|---|
| -------- | --------- |
005CELL-DYN Sapphire™ System Traditional 510(k) Submission
§ 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.”