(479 days)
VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (VENTANA anti-H. pylori (SP48)) is designed to qualitatively detect the presence of Helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of Helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.
This antibody is intended for in vitro diagnostic (IVD) use.
IHC in vitro diagnostic antibody directed against H. pylori organisms and visualized though the application of either of two standard chromogenic secondary detection kits to locate and bind primary antibodies bound to tissue samples. Use of either detection system results in a dark brown colored precipitate at the site of specific antibody binding.
Here's an analysis of the provided text regarding the acceptance criteria and study for the VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state pre-defined acceptance criteria (e.g., "the device must achieve X sensitivity and Y specificity"). Instead, it presents a comparison study against an existing method (Ventana Giemsa Staining Kit) and mentions the predicate device (Pylo-Plus). The performance is reported in terms of agreement rates.
| Acceptance Criteria (Implicit) | Reported Device Performance (VENTANA anti-H. pylori (SP48)) |
|---|---|
| Positive Agreement | Demonstrated in the method comparison study (specific percentage not explicitly stated in this summary portion, but confirmed as "demonstrated positive agreement"). |
| Negative Agreement | Demonstrated in the method comparison study (specific percentage not explicitly stated in this summary portion, but confirmed as "demonstrated negative agreement"). |
| Substantial Equivalence | Concluded to be substantially equivalent to the predicate device, Pylo-Plus, based on relevant characteristics and performance differences not adversely affecting safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: A total of 294 cases were considered evaluable and included in the analyses of agreement rates.
- Data Provenance: The study was conducted at three independent clinical sites. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, so it is likely either U.S. data or data from regions with comparable medical practices. The study is described as a "Method Comparison study," implying it is prospective or at least utilizes current samples for comparison rather than solely historical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
However, the "Intended Use" section for the proposed device states: "This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls." This implies that the interpretation of both the proposed device and likely the comparator (Giemsa staining) for establishing agreement would involve qualified pathologists, consistent with standard practice in pathology.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies in the test set. It mentions "agreement rates between VENTANA anti-H. pylori (SP48) and Ventana Giemsa Staining Kit," suggesting a direct comparison of results rather than a complex arbitration process involving multiple independent interpretations to establish a gold standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. The study described is a direct comparison of the proposed immunohistochemistry (IHC) stain (an in vitro diagnostic antibody) against a traditional histologic stain (Giemsa) for detecting H. pylori. This is a comparison of diagnostic methods, not an assessment of human reader performance improvement with an AI device. Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. Standalone (Algorithm Only) Performance
This product is an immunohistochemistry (IHC) antibody, not an AI algorithm. Therefore, no standalone (algorithm only) performance was conducted or reported as it's not applicable to this type of diagnostic device. The interpretation of the stained slides is performed by a qualified pathologist.
7. Type of Ground Truth Used
The primary "ground truth" or reference standard used in the method comparison study was the Ventana Giemsa Staining Kit for determining the presence of H. pylori. The summary also mentions "H. pylori diagnosis obtained from enrollment pathology reports," which suggests that the initial selection of cases might have been based on clinical diagnoses or previous pathology reads. However, the direct comparison for evaluating the new device’s performance was against the Giemsa stain results.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This is because the device is an in vitro diagnostic reagent (antibody), not an AI algorithm or a device that requires machine learning training. The "training" for this type of product development would typically involve optimization of the antibody and staining protocol, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there is no mention of a "training set" in the context of machine learning. The "ground truth" for the development and validation of an IHC antibody would traditionally derive from:
- Known positive and negative control tissues: Tissues confirmed by established methods (e.g., bacterial culture, PCR, or highly experienced pathologist review with other stains) to either contain or be free of H. pylori.
- Pathological assessment: Confirmation by qualified pathologists using established diagnostic criteria and other relevant techniques.
The focus is on the antibody's specificity and sensitivity to H. pylori organisms in situ, rather than training an algorithm to identify them.
{0}------------------------------------------------
510(k) Summary
AUG 25 2011
Submitter: Ventana Medical Systems, Inc. Judy Howe Contact: (original): 30-Apr-2010 Date Prepared Date Revised: 26-Jul-2011
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K101234
| Device Name | VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody | ||
|---|---|---|---|
| Common name: | IHC laboratory test for detection of Helicobacter pylori | ||
| Classification: | 21CFR866.3110, Immunology and Microbiology Devices | ||
| Product Code: | LYR | ||
| Device Description | IHC in vitro diagnostic antibody directed against H. pylori organisms and visualizedthough the application of either of two standard chromogenic secondary detection kitsto locate and bind primary antibodies bound to tissue samples. Use of either detectionsystem results in a dark brown colored precipitate at the site of specific antibodybinding. | ||
| Intended Use | VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody isdesigned to qualitatively detect the presence of Helicobacter pylori in formalin-fixed,paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemicalstaining with this antibody product may aid in the diagnosis of Helicobacter pyloriinfection. This product should be interpreted by a qualified pathologist in conjunctionwith histological examination, relevant clinical information and proper controls.This antibody is intended for in vitro diagnostic (IVD) use. | ||
| Summary of the new devices | VENTANA anti-Helicobacter pylori (SP48) is substantially equivalent to a commerciallyavailable predicate device.Ventana has evaluated the performance of VENTANA anti-Helicobacter pylori (SP48)by comparing it with Ventana Giemsa Staining Kit and H. pylori diagnosis obtainedfrom enrollment pathology reports for the detection of H. pylori infection in gastricbiopsy tissue for patients. The Ventana Giemsa Staining Kit is a qualitative histologicstain to differentiate leukocytes in bone marrow and other hematopoietic tissue (lymphnodes) in formalin fixed, paraffin embedded tissue and can also be used todemonstrate some microorganisms, including H. pylori .Geimsa stains all enteric bacteria blue while VENTANA anti-Helicobacter pylori (SP48)detects the whole H. pylori organism in situ . The characteristic helical shape andlocalization of the organisms within the crypts of the mucosa assist the clinician inmaking an accurate diagnosis of infection. | ||
| Non-clinical performance data | Non-clinical performance testing has been conducted to demonstrate performancecharacteristics of VENTANA anti-Helicobacter pylori (SP48). Results of tissue-specificity and precision testing are noted in the product package insert. | ||
| Clinical performance data | A Method Comparison study was conducted to demonstrate the percent positive andnegative agreement rates for the comparison of VENTANA anti- H. pylori (SP48)Rabbit Monoclonal Primary Antibody with Ventana Giemsa Staining Kit for determiningthe presence of H. pylori at three independent clinical sites. A total of 294 cases wereconsidered evaluable by both assay methods and were therefore included in theanalyses of agreement rates between VENTANA anti- H. pylori (SP48) and VentanaGiemsa Staining Kit. Pooled data from all sites demonstrated positive agreement in | ||
| COMPARISON OF VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYTO PREDICATE DEVICE, PYLO-PLUS, K052708 | |||
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE | |
| PROPRIETARYNAME | PYLO-PLUS, K052708 | VENTANA ANTI-HELICOBACTER PYLORI (SP48)RABBIT MONOCLONAL PRIMARY ANTIBODY | |
| FDACLASSIFICATION | CLASS I, NON-EXEMPT | CLASS I, NON-EXEMPT | |
| INTENDED USE | PYLO-PLUS IS INTENDED FORQUALITATIVE DETECTION OF THEUREASE ENZYME IN GASTRIC MUCOSALBIOPSY SPECIMENS AND FOR THEPRESUMPTIVE DETERMINATION OFHELICOBACTER PYLORI INSYMPTOMATIC ADULT PATIENTS. | VENTANA MEDICAL SYSTEMS' VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBITMONOCLONAL PRIMARY ANTIBODY IS DESIGNEDTO QUALITATIVELY DETECT THE PRESENCE OFHELICOBACTER PYLORI IN FORMALIN FIXED,PARAFFIN EMBEDDED GASTRIC BIOPSY TISSUE VIALIGHT MICROSCOPY. IMMUNOHISTOCHEMICALSTAINING WITH THIS ANTIBODY PRODUCT MAY AIDIN THE DIAGNOSIS OF HELICOBACTER PYLORIINFECTION. THIS PRODUCT SHOULD BEINTERPRETED BY A QUALIFIED PATHOLOGIST INCONJUNCTION WITH HISTOLOGICAL EXAMINATION,RELEVANT CLINICAL INFORMATION AND PROPERCONTROLS.THIS ANTIBODY IS INTENDED FOR IN VITRODIAGNOSTIC (IVD) USE. | |
| SAMPLE | GASTRIC MUCOSAL BIOPSYSPECIMENS | FORMALIN-FIXED, PARAFFIN-EMBEDDED GASTRICBIOPSY TISSUE | |
| ASSAY METHOD | SEROLOGICAL REAGENT | IHC WITH SECONDARY DETECTION | |
| TARGET | UREASE ENZYME | WHOLE ORGANISM | |
| ASSAY FORMAT | MANUAL | AUTOMATED | |
| DETECTIONSYSTEM | DIRECT | INDIRECT | |
| VISUALIZATION | INTERPRETATION BY COLORIMETRIC | INTERPRETATION BY LIGHT MICROSCOPY | |
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE | |
| PROPRIETARYNAME | Pylo-Plus, K052708 | VENTANA ANTI-HELICOBACTER PYLORI (SP48)RABBIT MONOCLONAL PRIMARY ANTIBODY | |
| MAGENTA | |||
| INTENDED USEPOPULATION | GASTRIC BIOPSY FROM PATIENTSSUSPECTED OF HAVING H. PYLORI | GASTRIC BIOPSY FROM PATIENTS SUSPECTED OFHAVING H. PYLORI | |
| QUALITATIVE ORQUANTITATIVE | QUALITATIVE | QUALITATIVE | |
| CONCLUSION | VENTANA anti-Helicobacter PYLORI (SP48) IS SUBSTANTIALLY EQUIVALENT TO PYLO-PLUS IN RELEVANT CHARACTERISTICS AND THE PERFORMANCE DIFFERENCES WILL NOTADVERSELY AFFECT SAFETY AND EFFICACY. |
{1}------------------------------------------------
.
.
{2}------------------------------------------------
. . . . . . .
and the comments of the comments of the comments of the comments of
and the comments of the comments of
the country of the county of the county of
{3}------------------------------------------------
Image /page/3/Picture/0 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 a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
VENTENA Medical Systems, Inc. c/o Ms. Judy Howe Regulatory Affairs Specialist 1910 Innovation Park Drive Tucson, AZ 85755
AUG 25 2011
K 101つなん Re:
| K101234 | |
|---|---|
| Trade/Device Name: | VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal |
| Primary Antibody | |
| Regulation Number: | 21CFR §866.3110 |
| Regulation Name: | Campylobacter fetus serological reagents |
| Regulatory Class: | Class I |
| Product Code: | OWF |
| Dated: | August 10, 2011 |
| Received: | August 15, 2011 |
Dear Ms. Howe:
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 class II (Special Controls), 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 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. This letter will allow you to begin marketing your device as described in your Section
{4}------------------------------------------------
Page 2 - Ms. Judy Howe
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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to paremarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance at its toll/free no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Freddie M. Poole
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number: K101234
Device Name: VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody
Indications for Use:
VENTANA anti-Helicobacter pylori (SP48) Rabbit Monoclonal Primary Antibody (VENTANA anti-H. pylori (SP48)) is designed to qualitatively detect the presence of Helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of Helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.
This antibody is intended for in vitro diagnostic (IVD) use.
Prescription Use __________AND/OR Over-the Counter Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie Tu. Pool
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 101237
Page 1 of 1
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).