The GPS-TUV device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There is no transcranial application for this device.

Device Description

The GPS-TUV Diagnostic Ultrasound System device is a PC (Computer) based and controlled real time, two-dimensional, mechancial sector and electronic array diagnostic ultrasound system which produces diagnostic ultrasonic images through a user friendly operation. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There are no transcranial applications for this device. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-TUV Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS-TUV Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes. All probes currently intended for use with the Perception Inc. GPS -TUV Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design.

AI/ML Overview

The provided 510(k) summary for the Perception Inc. GPS-TUV Diagnostic Ultrasound System (K972973) indicates that no clinical tests were performed to establish the device's performance against acceptance criteria. The submission is a "Track 1 type submission," which relies on non-clinical tests and a comparison to predicate devices to demonstrate substantial equivalence.

Therefore, the following information is not available in the provided text:

Acceptance criteria table and reported device performance based on clinical studies.
Sample size used for the test set and data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for the test set.
Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
Standalone (algorithm only) performance study.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set.
Sample size for the training set.
How the ground truth for the training set was established.

However, the document does contain information about non-clinical tests performed to demonstrate substantial equivalence, which can be interpreted as fulfilling certain "acceptance criteria" for regulatory clearance based on NEMA and FDA guidance documents.

Summary of Non-Clinical Testing (interpreted as meeting acceptance criteria for substantial equivalence):

The device's safety and effectiveness were established through non-clinical tests and a comparison to predicate devices, rather than through direct clinical performance metrics against specific acceptance criteria in a clinical study. The relevant "acceptance criteria" for this type of submission are compliance with established standards and guidance documents.

Acceptance Criteria and Reported Device Performance (Non-Clinical Focus):

Acceptance Criteria (based on regulatory standards/guidance)	Reported Device "Performance" (Compliance)
Acoustic Output:
- NEMA 1992 (UD-2) compliance	Satisfactory testing results and compliance to applicable standards.
- FDA CDHR 1985 510(k) Guide compliance	Satisfactory testing results and compliance to applicable standards.
- Maximum Acoustic Output Information	Measured and calculated per NEMA and FDA documents.
- Estimated In-Situ Intensity	Measured and calculated per NEMA and FDA documents.
- FDA In-Situ Intensity Limits	Demonstrated compliance.
- Acoustic Output Information for each system/transducer/mode combination	Measured and calculated for each combination.
Electrical Safety & EMC:
- UL-544, Third Edition compliance	Satisfactory testing results and compliance.
- Radiated and Conducted Emissions per CISPR 11	Satisfactory testing results and compliance.
- Magnetic Field Emission per MIL-STD-482D, method RE101	Satisfactory testing results and compliance.
- Electrostatic Discharge Immunity per IEC 801-2	Satisfactory testing results and compliance.
- Radiated Field Immunity (3 V/m, 26 MHz to 1 GHz, 100% Square Wave Modulation)	Satisfactory testing results and compliance.
- Steady State Voltage Fluctuations	Satisfactory testing results and compliance.
- Line Voltage Dropouts	Satisfactory testing results and compliance.
- Slow Line Voltage Sags and Surges	Satisfactory testing results and compliance.
- Fast Transients Bursts per IEC 801-4	Satisfactory testing results and compliance.
- Fast Line Voltage Surges	Satisfactory testing results and compliance.
- Conducted Energy Immunity per MIL-STD-462D, Method CS114	Satisfactory testing results and compliance.
- Magnetic Field Immunity per MIL-STD-482D, Method RS101	Satisfactory testing results and compliance.
- Quasi-Static Electric Field Immunity	Satisfactory testing results and compliance.
Overall Safety & Effectiveness:
- Compliance with "FDA November 1993 Draft Reviewer Guidance for Pre-Market notification submissions, DCRND"	No design characteristics violated requirements; met all relevant testing requirements.

Detailed breakdown of unavailable information:

Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was mentioned. The non-clinical tests were performed on the device itself and its components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth for a clinical test set was established. The "ground truth" for the non-clinical tests was adherence to the specified regulatory standards and guidance.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is an ultrasound system, not an AI-assisted diagnostic tool in the modern sense.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical study. The "ground truth" for the non-clinical tests was the specified performance limits and requirements defined by NEMA, FDA, UL, CISPR, IEC, and MIL-STD standards.
The sample size for the training set: Not applicable, as no algorithm training was described.
How the ground truth for the training set was established: Not applicable.

Conclusion from the 510(k) Summary:

The submitter concluded that the Perception Inc. GPS-TUV Diagnostic Ultrasound System is substantially equivalent to predicate devices based on:

Having the same intended use.
Satisfactory results from all non-clinical testing (acoustic output, electrical safety, EMC).
No new questions of safety or effectiveness revealed by non-clinical and biocompatibility testing.
No significant changes in intended use, method of operation, material, or design compared to predicate devices that could affect safety or effectiveness.
The device being a PC-based real-time 2D ultrasound system with M and B modes, supporting various display modes and covering general radiology, abdominal, cardiac, and vascular applications with specific probes (3.0-12.5 MHz).

The "study" that proves the device meets "acceptance criteria" in this context is the series of non-clinical engineering and performance tests conducted by a contract testing laboratory, which demonstrated compliance with recognized industry standards and FDA guidance for diagnostic ultrasound equipment at the time.

Summary

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K91271D

EXHIBIT 2

OCT 1 5 1997

510 (k) Summary

Cover PAGE
4 Pages of Summary
3 pages of Tables

8 pages Total

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K972973

EXHIBIT #2 Page 1 of 4

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the reguirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

Submitter's Identification: 1.

Perception Inc. 9344 N.W. 13th Street, Suite 200 Miami, Florida 33172 Contact Person: Mr. Jimmie Spraker

Date Summary Prepared: August 8, 1997

2. Name of the Device :.

Perception Inc. GPS-TUV Diagnostic Ultrasound System

3. Predicate Device Information:

Aloka Co., Model SSD-1700 Ultasound System and Transducers, K#963616 1)
Diasonics Ultrasound, Models Synergy (K#935024), CFM800 (K#924079) 2) and EchoPac (K#962662).
Sharplan Lasers Inc., USight 9010, K#945796. 3)

Device Description: 4.

General Description

The GPS-TUV Diagnostic Ultrasound System device is a PC (Computer) based and controlled real time, two-dimensional, mechancial sector and electronic array diagnostic ultrasound system which produces diagnostic ultrasonic images through a user friendly operation.
The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There are no transcranial applications for this device.

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User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-TUV Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS-TUV Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes.

All probes currently intended for use with the Perception Inc. GPS -TUV Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design. Transducer parameters are summarized in the following table:

PROBE	TYPE	INSP. MODES	APPLIC.
GP-3.0	MECH. SEC	M/B	Gen. Purpose/Abdominal/Cardiac
CA-3.5	CONV. ARR	B	Abdominal
PV-12.5	MECH SEC	M/B	PeripheralVascular

5. Intended Use:

6. Comparison to Predicate Devices:

We believe the Perception Inc. GPS -TUV Diagnostic Ultrasound System to be substantially equivalent to ultrasound devices currently in commercial distribution in the U.S. A table of comparison outlining similarities and differences between the Perception Inc. GPS -TUV Diaqnostic Ultrasound System and predicate devices is attached to this summary.

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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:

This 510(k) submission is intended as a Track 1 type submission. Acoustic Output Reporting was prepared utilizing the following documents.

NEMA 1992, Acoustic output measurement standard for diagnostic ultrasound . equipment, NEMA Standard UD-21992.
FDA Center for Devices and Radiological Health 1985 510(k) Guide for . Measuring and Reporting and Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985, Revised, 1989, 1990, 1991, 1993, 1994 and 1995.

Acoustic output of each system/transducer/mode/application combination was measured and calculated per the above documents. The following testing was conducted which revealed satisfactory testing results and compliance to applicable standards.

Maximum Acoustic Output Information .
Estimated In-Situ Intensity .
. FDA In-Situ Intensity Limits
Acoustic Output Information for each system/transduc.er/mode ● combination

The following testingwas conducted by a contract testing laboratory:

UL-544, Third Edition ●
Radiated and Conducted Emissions per CISPR 11 .
Magnetic Field Emission per MIL-STD-482D, method RE101 ●
Electrostatic Discharge Immunity per IEC 801-2 ●
Radiated Field Immunity (3 V/m, 26 MHZ to 1 Ghz, 100% Square ● Wave Modulation)
. Steady State Voltage Fluctuations
- Line Voltage Dropouts
- . Slow Line Voltage Sags and Surges
- Fast Transients Bursts per IEC 801-4
- Fast Line Voltage Surges
- Conducted Energy Immunity per MIL-STD-462D, Method CS114
- Magnetic Field Immunity per MIL-STD-482D, Method RS101
- Quasi-Static Electric Field Immunity .

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None of the testing demonstrated any design characteristics that violated the requirements of the "FDA November 1993 Draft Reviewer Guidance for Pre-Market notification submissions, DCRND" or resulted in any safety hazards. It was the contract testing laboratory's conclusion that the device tested met all relevant requirements of the aforementioned guidance testing requirements.

Discussion of Clinical Tests Performed: 8.

Not Applicable

9. Conclusions:

The Perception Inc. GPS-TUV Diagnostic Ultrasound System has the same intended use as a combination of all cited predicates. Al! non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. This, when compared to the predicate devices, the Perception Inc. GPS-TUV Diagnostic Ultrasound System does not incorporate any significant changes in intended use, met: od of operations, material or design that could affect safety or effectiveness.

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COMPANYSPECS	PERCEPTION INC.	ALOKA CO.	DIASONICSULTRASOUND	DIASONICSULTRASOUND	SHARPLAN
Model	GPS-TUV	SSD-1700	SYNERGY	CFM800/ECHOPAC	U SIGHT 9010
K #	---	K 963616	K935024	K 924079K 962662	K 945796
Transducer Type :
Sector	X		X		X
Convex Array	X		X
Frequencies:
3.0	X
3.5	X		2-12		X
12.5	X
Gray Scale Levels	256				256
Pre-processing	X				X
Post-processing	X				X
Digital caliper:
Distance	X			X	X
Circumference	X				X
Ellipse	X				X
Area	X				X
Display
M Mode	X				X
B Mode	X			X	X
M/B	X				X
Dual B	X	X
PC Based Architecture	X	X	X	X
Hard Disk	X		X
Icon/software user interface	X		X	X
Image Management Archiving/Retrieval	X	X	X	X
	X	X	X
Measurement Package	X	X	X	X
Storage Patient/study/settings Information	X	X	X
Report Generation	X		X	X
Patient Specific Imaging	X	X	X
Software upgradability	X		X
User Programmable Protocols	X	X
Network Communications	X	X	?	X
COMPANYSPECS	PERCEPTIONINC	ALOKA CO.	DIASONICSULTRASOUND	DIASONICSULTRASOUND	SHARPLAN
Applications :
General Radiology	X		X
Abdominal	X		X		X
Cardiac	X			X
Vascular	X		X	X
Angle	110°				110°
Image Memory	512x512x8				512x512x8
Frame Rate	6-31				6-15
Display/Labels:
Image Annotate	X				X
Patient ID	X				X
Date	X				X
Time	X				X
Hosp. Name	X				X
Application	X				X
TGC	X				X
Power	X				X
Depth	X				X
Gain	X				X
Probe ID	X				X
Softkey Controls	X				X
Display Monitor	15" (K970999)		15"		13/19"
Standard Audio/Video Outputs
Composite Color
SVHS Output	X		X		X
Left/Right Phonoconnections	X		X		X
NTSC/PAL Videocompatible	X		X		X
Video Inputs	RS-170/CCIR		RS-170/CCIR
Probe connectors	2 mechanical1 electronic		3 mechanical2 electronic
Alphanumeric Keyboard	X		X	X
COMPANYSPECS	PERCEPTIONINC.	ALOKA CO.	DIASONICSULTRASOUND	DIASONICSULTRASOUND	SHARPLAN
Options/Accessories
B/W Video	X				X
Graphic Printer
B/W VideoMonitor	X				X
S-VHS VCR	X				X
Environmental	5-40°		15-33°
	5-90% Humidity		10-90% Humidity
Power Consumption	120VAC,60Hz, 3A240VAC,50Hz,1.5A		115VAC,60Hz, 4A230VAC,50Hz,2A

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and the comments of the comments of the country of

ﻪ

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Image /page/8/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font. The text is arranged around the circumference of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 1997

Ms. Susan D. Goldstein-Falk Perception, Inc. c/o MDI Consultants, Inc. 55 Northern Blvd., Suite 410 Great Neck, NY 11021

K972973 Re:

Perception Inc. GPS-TUV Diagnostic Ultrasound System Dated: August 8, 1997 Received: August 11, 1997 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO

Dear Ms. Goldstein-Falk:

We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration. listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Perception Inc. GPS-TUV Diagnostic Ultrasound System as described in your premarket notification:

Transducer Model Number

GP-3.0 General Purpose 3.0 MHz Mechanical Sector CA-3.5 Curved Array 3.5 MHz Electronic PV-12.5 Peripheral Vascular 12.5 MHz Mechanical Sector

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices:

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Page 2 - Susan D. Goldstein-Falk

General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

This letter will allow you to begin marketing your device as described in your 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 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) 594-4591. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

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Page 3 - Susan D. Goldstein-Falk

If you have any questions regarding the content of this letter, please contact Paul Gammell at (301) 594-1212.

Sincerely yours,

Vimid Ca. Slymm
for Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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GPS-TUV Diagnostic Ultrasound System K972973 GP-3.0 General Purpose 3.0 MHz Mechanical Sector

Intended Use; Diagnostic ultrasound imaging of the human body as follows:

Clinical						Color	Power	Color	Combined	Other
Application	A	B	M	PWD	CWD	Doppler	(Amplitude)Doppler	VelocityImaging	(Specify)	(Specify)
Opthalmic
Fetal
Abdominal		x	x
Intra-Operative
(Specify)
Intra-Operative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac		x	x
Trans-
Esophagcal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
Peripheral
Vascular
Laparoscopic
Muscalo-
Skeletal
Conventional
Musculo-
Skeletal
Superficial
Other (Specify)

Additional Comments: None

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEEDED)

Prescription Use (Per 21 CFR 801.109)

Clivid A. Seymore

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devices 73 510(k) Number

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GPS-TUV Diagnostic Ultrasound System K972973

CA-3.5 Curved Array 3.5 MHz Electronic

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Opthalmic
Fetal
Abdominal		x
Intra-Operative(Specify)
Intra-OperativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-Esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
ConventionalMusculo-Skeletal
Superficial
Other (Specify)

Additional Comments: None

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use (Per 21 CFR 801.109)

David A. Bergman
(Division Sign-Off)

t Division of Reproductive, Abdominal, ENT, and Radiological Devices 972973 510(k) Number .

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GPS-TUV Diagnostic Ultrasound System K972973

PV-12.5 Peripheral Vascular 12.5 MHZ Mechanical Sector

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

Clinical						Color	Power	Color	Combined	Other
Application	A	B	M	PWD	CWD	Doppler	(Amplitude)Doppler	VelocityImaging	(Specify)	(Specify)
Ophthalmic
Fetal
Abdominal
Intra-Operative
(Specify)
Intra-Operative
Neurological
Pediatric
Small Organ
(Specify)
Neonatal
Cephalic
Adult Cephalic
Cardiac
Trans-
Esophageal
Trans-Rectal
Trans-Vaginal
Trans-Urethral
Intra-Luminal
PeripheralVascular		x	x
Laparoscopic
Musculo-Skeletal
Conventional
Musculo-Skeletal
Superficial
Other (Specify)

Additional Comments: None

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use (Pex 21 CFR 801.109)

David A. Seymore
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_

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GPS-TUV Diagnostic Ultrasound System K972973

Combined Other Power Color Color Clinical (Specify) (Specify) (Amplitude) Velocity CWD Doppler PWD A B M Application Imaging Doppler Opthalmic Fetal Abdominal × ਮ Intra-Operative (Specify) Intra-Operative Neurological Pediatric Small Organ . • (Specify) Neonatal Cophalic Adult Cephalic Cardiac X x Trans-Esophageal Trans-Rectal Trans-Vaginal Trans-Urethral Intra-Luminal Peripheral メ X Vascular Laparoscopic Musculo-Skelctal Conventional Musculo-Skeletal Superficial Other (Specify)

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

Additional Comments: None

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Usc (Per 21 CFR 801.109)

Javid A. Seymen

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K922473

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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 biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.