(447 days)
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.
In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffinembedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR).
It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.
Automated Cellular Imaging System (ACIS) for detection of ER/PR
This is an FDA Premarket Notification (510(k)) letter for the Automated Cellular Imaging System (ACIS) for detection of ER/PR receptors. The information provided is a determination of substantial equivalence, and as such, it does not include detailed study data, acceptance criteria, or performance metrics. Therefore, I cannot provide a comprehensive answer to your request based solely on this document.
The document indicates that the device is intended to "detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape," and specifically "to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR)." It is indicated as an aid in the "management, prognosis and prediction of therapy outcomes of breast cancer."
To answer your specific questions, information from the actual 510(k) submission, not just the FDA's decision letter, would be required. The letter confirms that the device was found substantially equivalent to a predicate device, meaning the FDA found it performed as safely and effectively as a legally marketed device and had similar technological characteristics. However, the details of how that equivalence was demonstrated (e.g., specific acceptance criteria, study design, sample sizes, ground truth establishment, etc.) are not contained within this letter.
Without the full 510(k) submission, I can only state what is NOT available in this document regarding your questions:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not present. This type of study is typically associated with AI-assisted diagnostic devices where human interpretation is part of the workflow. The ACIS is described as an "Automated Cellular Imaging System" intended to "measure, count, and quantitate," which suggests a more standalone analytical role rather than an assist to human readers in interpretation. However, without the full submission details, this is an assumption.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The description of the device as an "Automated Cellular Imaging System" strongly suggests standalone performance was evaluated, but the details of such a study are not in this letter.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. David G. Davis SEP 3 0 2002 Manager of Regulatory Affairs ChromaVision Medical Systems, Inc. 33171 Paseo Cerveza San Juan Capistrano, California 92675-4824
Re: K012138
Trade/Device Name: Automated Cellular Imaging System (ACIS) for detection of ER/PR Regulation Number: 21 CFR § 864.1860 Regulation Name: Immunohistochemistry Reagents and Kits Regulatory Class: II Product Code: MYA, MXZ Dated: June 29, 2002 Received: August 5, 2002
Dear Mr. Davis:
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 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 Part 801); 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.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K012138
Device Name: ACIS
Indications for Use:
The Automated Cellular Imaging System (ACIS) device is intended to detect, count, and classify cells of clinical interest based on recognition of cellular objects of particular color, size, and shape.
In this software application the ACIS device is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffinembedded tissue specimens immunohistochemically stained for Estrogen Receptors or Progesterone Receptors (ER/PR).
It is indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.
Deborah M. Moore
510(k) Number KO12/3
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEFIDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
00017
§ 864.1860 Immunohistochemistry reagents and kits.
(a)
Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.