(27 days)
Mercu1717V Digital Flat Panel Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V) supports dynamic imaging and static imaging. The sensor plate of Mercu1717V is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the cable. The major function of the Mercu1717V is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Mercu1717V can get single image and it also can get dynamic image. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software. The iRay DR used for digital X-ray radiography image from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as image acquisition, image enhancement processing and editing image or information.
The provided document does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the context of clinical performance or human reader studies. Instead, it focuses on the device's technical specifications and substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis based on the available information, noting where specific details are missing:
1. Table of Acceptance Criteria and Reported Device Performance (Based on provided technical specifications for comparison with predicate devices):
The document primarily compares various technical specifications of the Mercu1717V with its predicate and reference devices, aiming to demonstrate substantial equivalence rather than explicit acceptance criteria and performance against those criteria as would be typical for clinical effectiveness. However, we can extract some performance metrics from the comparison table.
| Characteristic | Acceptance Criteria (Implied by Predicate/Reference) | Reported Device Performance (Mercu1717V) |
|---|---|---|
| Image Matrix Size | Predicate: 3072x3072 pixels Reference: 5632x2816 pixels | Min. 1024x1024 pixels (@binning 3x3) Max. 3072x3072 pixels (@binning 1x1) |
| Pixel Size | Predicate: 139μm Reference: 154μm | 139μm |
| Effective Imaging Area | Predicate: 427mmx427mm Reference: 867.5mm x 433.1mm | Min. 285mmx285mm (@zoom on) Max. 427mm x 427mm (@zoom off) |
| Spatial Resolution | Predicate: Min. 3.4 lp/mm Reference: Same as Predicate | Min. 3.4 lp/mm (Same as Predicate) |
| MTF (Modulation Transfer Function) | Predicate: 0.66 at 1 lp/mm Reference: 0.75 at 0.5lp/mm, 0.5 at 1lp/mm | 0.78 at 0.5lp/mm, 0.55 at 1lp/mm (Better than both at 0.5lp/mm, better than predicate at 1lp/mm) |
| DQE (Detective Quantum Efficiency) | Predicate: 0.28 at 1 lp/mm (RQA5, 2.5µGy) Reference: 0.28 at 0.5 lp/mm, 0.20 at 1 lp/mm (RQA5, 3.2µGy) | 0.4 at 0.5 lp/mm, 0.35 at 1 lp/mm (RQA5, 2.5µGy) (Better than both) |
| Frame Rate (Dynamic Imaging) | Predicate: / Reference: 3.5fps@1x1, 15fps@2x2, 25fps@4x4 | 5fps@1x1, 20fps@2x2, 30fps@3x3 (Generally better) |
| Electrical Safety & EMC | Standards: IEC/ES 60601-1, IEC 60601-1-2 | All test results meet standard requirements. |
Missing Information:
The document does not explicitly state acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it demonstrates an equivalence to predicate devices through technical specifications and compliance with safety standards. The "study that proves the device meets the acceptance criteria" refers to non-clinical testing performed to show substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of clinical images or patient data tests for this submission. The "test set" here refers to the actual device undergoing non-clinical technical evaluations (e.g., electrical safety, EMC, image quality parameters like MTF, DQE).
- Data Provenance: Not applicable. The evaluations are technical measurements of the physical device under specific lab conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a digital flat panel detector, a hardware component for acquiring X-ray images. The submission focuses on its physical characteristics, safety, and image quality parameters, not on the interpretation of images by experts. Ground truth in this context would relate to the objective measurement of physical properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication of diagnostic outcomes is mentioned or implied, as this is a device component clearance and not a diagnostic AI software submission.
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 MRMC comparative effectiveness study was done as this submission pertains to a digital X-ray detector, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done for diagnostic purposes. The device is a hardware component. Its "standalone" performance relates to its physical performance metrics (e.g., DQE, MTF) as measured in a lab setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical studies (e.g., MTF, DQE, electrical safety), the "ground truth" would be established by standardized measurement protocols and reference instruments, as per relevant IEC or other industry standards. It's objective, physical measurements rather than clinical ground truth from patient data.
8. The sample size for the training set:
- Not applicable. This document is for a hardware device (digital flat panel detector) and its associated software (iRayDR), which is described as image acquisition, processing, and archiving software, not a machine learning model that requires a training set of medical images.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a machine learning model or a training set. The software mentioned (iRayDR) performs image acquisition and post-processing, typical for a radiological workstation, not AI-driven diagnosis.
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October 20, 2022
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
iRay Technology Taicang Ltd. % Junjie Qian Registration & Regulation Affairs Engineer No. 33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang, Jiangsu 215434 CHINA
Re: K222886
Trade/Device Name: Mercu1717V Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 13, 2022 Received: September 23, 2022
Dear Junjie Qian:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222886
Device Name Mercu1717V
Indications for Use (Describe)
Mercul 717V Digital Flat Panel Detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
| 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 OF SAFETY AND EFFECTIVENESS
(As Required by 21 CFR 807.92) K222886
1. Date Prepared [21 CFR 807.92(a)(1)]
July 13, 2022
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | iRay Technology Taicang Ltd. |
|---|---|
| Company Address: | No.33 Xinggang Road, Taicang Port Economic andTechnological Development Zone, Jiangsu, China 215434 |
| Contact Person: | Junjie. Qian |
| Phone: | 0512-53690872 |
| Fax: | 0512-53690872 |
| Email: | junjie.qian@iraygroup.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Digital Flat Panel Detector |
|---|---|
| Common Name: | Solid State X-Ray Imager |
| Model Name: | Mercu1717V |
| Classification Name: | Stationary X-Ray System |
| Product Code: | MQB |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
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4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification predicates within this submission are as follows:
| Manufacturer: | iRay Technology Co., Ltd. |
|---|---|
| Trade Name: | Flat Panel Detectors |
| Model Name: | Venu1717X |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K221714 |
5. Identification of Reference Devices(s) [21 CFR 807.92(a)(3)[
| Manufacturer: | CareRay Digital Medical Technology Co., Ltd. |
|---|---|
| Trade Name: | X-ray Flat Panel Detectors |
| Model Name: | CareView 3600RF |
| Product Code: | MQB |
| Classification Name: | Stationary X-Ray System |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| FDA 510 (k) #: | K202995 |
6. Description of the Device [21 CFR 807.92(a)(4)]
Mercu1717V Digital Flat Panel Detectors (Hereinafter referred to as Mercu1717V) supports dynamic imaging and static imaging.
The sensor plate of Mercu1717V is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the cable.
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The major function of the Mercu1717V is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Mercu1717V can get single image and it also can get dynamic image. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.
The iRay DR used for digital X-ray radiography image from the digital flat panel detectors. iRay DR is used to handle the DICOM protocol (DICOM 3.0). iRay DR has many functions such as image acquisition, image enhancement processing and editing image or information.
7. Intended Use [21 CFR 807.92(a)(5)]
7.1. Indications for use
Mercu1717V digital flat panel detector is indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients. It is intended to replace film/screen systems in all general-purpose diagnostic procedures. The device is not intended for mammography or dental applications.
6.2. Suitable patient
It is suitable for providing digital X-ray imaging for DR system to provide general radiographic diagnosis for human anatomy including both adult and pediatric patients, but not intended for mammography or dental applications. The remaining notes depend on the DR system.
6.3. Processing of input and output
Mercu1717V Digital flat panel detector get signal from high-voltage generator, and then it gets ready to output radiographic imaging for diagnosis of disease, injury, or of any applicable health problem to iRayDR installed in PC. iRayDR get raw image and output clinical image after enhancement processing for raw image is finished.
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| Item | Predicate Device:Venu1717X DigitalFlat Panel Detector | Reference Device:CareView 3600RF X-rayFlat Panel Detector | Proposed Device:Mercu1717V Digital Flat PanelDetector |
|---|---|---|---|
| 510(K) Number | K221714 | K202995 | K222886 |
| Intended Use | This equipmentprovides digital X-rayimaging for diagnosisof disease, injury, orany applicable healthproblem. The image isobtained as the result ofX-ray passing throughthe human body anddetected by theequipment.iRay will provideequipment and softwaresupport for integrationof system. | The CareView 3600RFdetector is indicated fordigital imaging solutiondesigned for providinggeneral radiographicdiagnosis of humananatomy. It is intended toreplace radiographicfilm/screen systems in allgeneral-purposediagnostic procedures.This product is notintended formammographyapplications. | Mercu1717V Digital Flat PanelDetector is indicated for digitalimaging solution designed forproviding general radiographicsystem in all general-purposediagnostic procedures. |
| Indications forUse | Venu1717X isindicated for digitalimaging solutionsdesigned to providegeneral radiographicdiagnosis for humananatomy includingadults only. It isintended to replacefilm/screen systems in | / | Mercu1717V is indicated fordigital imaging solutionsdesigned to provide generalradiographic diagnosis forhuman anatomy including bothadult and pediatric patients. It isintended to replace film/screensystems in all general-purposediagnostic procedures. Thedevice is not intended for |
| Predicate Device: | Reference Device: | Proposed Device: | |
| Item | Venu1717X DigitalFlat Panel Detectorall general-purposediagnostic procedures. | CareView 3600RF X-rayFlat Panel Detector | Mercu1717V Digital Flat PanelDetectormammography or dentalapplications. |
| ClassificationName | Stationary X-ray system | Stationary X-ray system | Same |
| Product Code | MQB | MQB | Same |
| RegulationNumber | 21 CFR 892.1680 | 21 CFR 892.1680 | Same |
| Panel: | Radiology | Radiology | Same |
| Classification: | II | II | Same |
| X-Ray Absorber(Scintillator): | CSI | GOS | CSI |
| Installation Type: | Wired | Same | Same |
| ReadoutMechanism: | Thin Film Transistor | Same | Same |
| Image MatrixSize: | 3072 × 3072 pixels | 5632 × 2816 pixels | Min. 1024 × 1024 pixels(@binning 3×3)Max.3072 ×3072 pixels(@binning 1×1) |
| Pixel Size: | 139μm | 154 μm | 139μm |
| ADC Digitization | 16 bit | Same | Same |
| Effective ImagingArea: | 427mm×427mm | 867.5mm × 433.1 mm | Min.285mm×285mm(@zoom on)Max.427mm × 427mm(@zoom off) |
| SpatialResolution: | Min. 3.4 lp/mm | Same | Same |
| Predicate Device:Venu1717X DigitalFlat Panel Detector | Reference Device:CareView 3600RF X-rayFlat Panel Detector | Proposed Device:Mercu1717V Digital Flat PanelDetector | |
| Item | |||
| MTF | 0.66 at 1 lp/mm | 0.75 at 0.5lp/mm0.5 at 1lp/mm | 0.78 at 0.5lp/mm0.55 at 1lp/mm |
| DetectiveQuantumEfficiency(DQE) | 0.28 at 1 lp/mm(RQA5, 2.5µGy) | 0.28 at 0.5 lp/mm0.20 at 1 lp/mm(RQA5, 3.2µGy) | 0.4 at 0.5 lp/mm0.35 at 1 lp/mm(RQA5, 2.5µGy) |
| PowerConsumption: | Max. 20W | ~50W | 18 W |
| Communications: | GigabitEthernet | Same | Same |
| Imaging protectPlate: | Carbon Fiber Plate | Same | Same |
| Cooling: | Air cooling | Same | Same |
| Protection againstmatter/water | IPX1 | / | IPX1 |
| Dimensions: | 460 mm × 460 mm ×15 mm | 916.9 mm × 486.4 mm ×42.8 mm | 460 mm × 460 mm × 15mm |
| Frame rate | / | 3.5fps@1×115fps@2×225fps@4×4 | 5fps@1×120fps@2×230fps@3×3 |
| Operation: | Temperature: +5 ~+35°CHumidity: 30 ~ 80%(Non-Condensing)Atmospheric pressure:70 ~ 106 | Temperature: +10 | Temperature: +10 ~ +35°CHumidity: 20 ~ 90%(Non-Condensing)Atmospheric pressure: 700 ~1060 mbarAltitude: Max. 3000 meters |
| Item | Predicate Device:Venu1717X DigitalFlat Panel Detector | Reference Device:CareView 3600RF X-rayFlat Panel Detector | Proposed Device:Mercu1717V Digital Flat PanelDetector |
| Storage andTransportation:( detector ) | Temperature: 10 ~ +55℃Humidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure:70 ~ 106 kPaAltitude: Max. 3000 meters | Temperature: -20 ~ +55℃Humidity: 10 ~ 90%(Non-Condensing)Atmospheric pressure: 700~ 1060 hPaAltitude: Max. 3000 meters | Temperature: -10 ~ +55℃Humidity: 10 ~ 95%(Non-Condensing)Atmospheric pressure: 700 ~1060 mbarAltitude: Max. 3000 meters |
| Software | iDetector | CareRay softwareprovides a set ofpredefined APIs( ApplicationProgrammingInterfaces ) , an adapterlayer between a CareView3600RF detector and anupstream program on theclient side, commonlyknown as DROC (DigitalRadiography OperatorConsole )DROC communicateswith the CareRay | The Mercu1717V Digital FlatPanel Detector is supported bysoftware, named iRayDR.The iRayDR used for gettingdigital X-ray radiographyimages from the digital flatpanel detectors. iRay DR isused to handle the DICOMprotocol (DICOM 3.0). iRayDR has many functions such aspatient registration, imageacquisition, image display,image processing and imagearchiving. |
| Predicate Device: | Reference Device: | Proposed Device: | |
| Item | Venu1717X DigitalFlat Panel Detector | CareView 3600RF X-rayFlat Panel Detector | Mercu1717V Digital Flat PanelDetector |
| detectors via APIs. Ingeneral, APIs are providedin the form of DLL(Dynamic-LinkLibraries) files. Theupstream program importsthese DLL files and callsrelevant API commands tomanipulate a CareView3600RF detector-querystatus, select applicationmode, calibrate detector,acquire images, andpreprocess images-withoutcaring about theimplementation details ofthe algorithm or workflowunder the hood. | Image processing refers to somepost-processing tools for theacquired image, including threeparts of the common tools, theimage post-processing tools andthe measurement tools.Common tools: zoom, rotate,etc.Post-processing tools: adjustimage contrast, brightness, etc.Measurement tools: linemeasurement, anglemeasurement.iRayDR software is ofModerate level of concern. |
8. Technological Characteristic [21 CFR 807.92(a)(6)]
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iRay Technology Taicang Ltd.
[510(k)] Application
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iRay Technology Taicang Ltd.
[510(k)] Application
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iRay Technology Taicang Ltd.
[510(k)] Application
9. System requirements to operate with other radiographic system components
-
- Recommended Generator Specification: Energy range: 40
150kVp mA range: 101000mA (depending on the generator power) ms range: 106300ms to produce 0.11000mAs (depending on the generator power)
- Recommended Generator Specification: Energy range: 40
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Note: To our best knowledge, the detector is compatible with the X-ray generators with the specifications described above. If you have any questions regarding the compatibility issue for other generators, please contact the distributor or iRay's service office.
-
- Peripheral hardware: Mercu1717V connected via wired communication.
| Operating System: | Windows 10, 64bit |
|---|---|
| CPU: | Intel Core i5 8400 2.8G |
| Memory: | 16G DDR4 |
| Hard Disk: | 1T SSD |
| LAN Card: | Intel Pro EXP9301CT PROGigabit Network Adapter with PCIe interface |
-
- X-ray exposure mode
The digital flat panel detector gets ready to output image after it receive signal form high-voltage generator. The digital flat panel detector stops outputting image when there is no signal from high-voltage generator
- X-ray exposure mode
10. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
- Electrical Safety and EMC testing: 1) Electrical, mechanical, environmental safety according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC 60601-1-2. All test results are meet the standard requirements.
-
- Biological Evaluation: The digital flat panel detector is not intended to be touched by patient, so evaluation of bio-compatibility is not necessary.
-
- Non-clinical Considerations:
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The non-clinical studies have been performed and the results have shown that the Mercu1717V digital flat panel detector is substantially equivalent to the predicate devices on the Market (K221714)
Parameter about image quality is equal to or better than predicate device parameter According to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software iRayDR classifies the hazards, defines requirements specification and design specification, all the specification pass all the test cases and complies the intended design specification
-
- Clinical Consideration:
Intended use, fundamental scientific technology, regulatory requirement, non-clinical performance, labeling, quality-assurance program keep the same with those of predicate device. Additionally, as mentioned in clinical considerations in 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices',
- Clinical Consideration:
11. Conclusion [21 CFR 807.92(b)(3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, iRay Technology Taicang Ltd. concludes that Mercu1717V is substantially equivalent to predicate device with regards to safety and effectiveness.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.