(153 days)
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
System Software V3.0.0 is being introduced on the ACL TOP family (instrument available with and without the feature of closed tube sampling) to support the conversion from the Windows 2000 Operating System to the Windows XP Operating System. This software also includes additional features and ease-of-use enhancements.
This 510(k) summary is for a software update (System Software V3.0.0) for an existing device, the ACL TOP coagulation analyzer. The purpose of the submission is to support the conversion from Windows 2000 to Windows XP operating system and to introduce additional features and ease-of-use enhancements.
Therefore, the study described here is focused on demonstrating that the updated software does not negatively impact the performance of the device and that it remains substantially equivalent to the predicate device. It is not a study to establish new performance metrics or efficacy.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a table of specific acceptance criteria or reported device performance metrics in the way you might expect for a new device's clinical study. The submission focuses on demonstrating substantial equivalence, meaning the updated software does not alter the existing performance and indications for use.
Instead of quantitative performance metrics, the "acceptance criteria" here are implicitly met by showing that:
- There are no changes in ACL TOP test parameters.
- There are no changes to the labeled indications for use/intended use.
- There are no changes to the performance claims of the instrument or its reagents.
The "reported device performance" is the statement: "The performance of the ACL TOP family with System Software V3.0.0 is substantially equivalent to the performance of the current legally marketed ACL TOP (K063679)."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This is because the submission is for a software update to an existing, cleared device. The focus is on demonstrating that the software change itself doesn't affect the established performance, rather than re-evaluating the device's original performance with a new clinical study.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission is not evaluating a diagnostic algorithm where expert ground truth is established for images or clinical cases. It's a software update for a clinical laboratory instrument.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of diagnostic interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study assesses how AI impacts human reader performance, which is not relevant for a software update to a laboratory instrument that performs automated assays.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study in the context of an algorithm interpreting data (like imaging or patient characteristics) was not explicitly described or performed. The device itself (ACL TOP) is a standalone automated analyzer, but the submission is about its operating software update, not a new diagnostic algorithm.
7. Type of Ground Truth Used
Not applicable/Implicit. For an automated coagulation instrument, the "ground truth" for its measurements would typically come from reference methods or established gold standards for coagulation testing. However, the software update submission focuses on ensuring the new software maintains the accuracy and reliability already established for the device. Therefore, no new "ground truth" was established for this specific submission; it relies on the predicate device's established performance.
8. Sample Size for the Training Set
Not applicable. This submission is not about an AI/machine learning algorithm that requires a training set of data. It's about an operating system and feature update for an existing instrument.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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ACL TOP System Software V3.0.0 510(k) Summary
Applicant Contact Information:
MAY 1 4 2008
| Applicant:Address: | Instrumentation Laboratory Co.113 Hartwell AvenueLexington, MA 02421 |
|---|---|
| Contact Person:Phone Number:Fax Number: | Carol Marble, Regulatory Affairs Director781-861-4467781-861-4207 |
| Preparation Date: | February 4, 2008 |
Device Trade Name:
ACL TOP
Regulatory Information:
| Regulation Section: | Coagulation Instrument (864.5400) |
|---|---|
| Classification: | Class II |
| Product Code: | GKP |
| Panel: | Hematology |
Predicate Device:
K063679 ACL TOP
Device Intended Use / Description:
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
Reason for Submission:
System Software V3.0.0 is being introduced on the ACL TOP family (instrument available with and without the feature of closed tube sampling) to support the conversion from the Windows 2000 Operating System to the Windows XP Operating System. This software also includes additional features and ease-of-use enhancements.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The performance of the ACL TOP family with System Software V3.0.0 is substantially equivalent to the performance of the current legally marketed ACL TOP (K063679).
- There are no changes in the ACL TOP test parameters (which are separate from the . system software) and therefore, no changes to the labeled indications for use/intended use or performance claims of either the instrument or its reagents.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 4 2008
Instrumentation Laboratory Co. C/O Carol Marble 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K073377
Trade/Device Name: ACL TOP (with System Software V3.0.0) Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: GKP Dated: November 30, 2007 Received: December 3, 2007
Dear Ms. Marble:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket
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Page 2 - Instrumentation Laboratory Co.
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
K073377 510(k) Number (if known): ___
Device Name: ACL TOP Family
Indications for Use:
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
Prescription Use
(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 In Vitro Diagnostic Devices (OIVD)
Auyline Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073377
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.