The Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus. keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The Custom Stable "11 Rigid Gas Permeable Scleral Contact Lens for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is lathe cut from one of the following hydrophobic, fluoro-silicone acrylate materials:

· roflufocon D (supplied by Contamac Ltd.)
· roflufocon E (supplied by Contamac Ltd.)

AI/ML Overview

The device described is the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens. This document assesses its substantial equivalence to predicate devices rather than providing a study where the device meets acceptance criteria directly. However, based on the provided information, we can infer acceptance criteria from the performed tests and the comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Criteria/Test	Acceptance Criteria	Reported Device Performance
Bench Testing (Manufacturing Verification)	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.	All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden Testing	Colony forming units (CFU) per lens less than 100.	Colony forming units (CFU) per lens was less than 1.
Substantial Equivalence (General)	No significant differences from predicate devices in terms of safety and effectiveness. Does not raise different questions of safety and effectiveness.	Testing demonstrates no significant differences from the predicate devices, supporting the substantial equivalence claim. No new questions of safety and effectiveness are raised.
Components/Materials/Formulation	Equivalent to predicate devices (roflufocon D & E contact lens materials, and potentially others as per prednisone).	Uses roflufocon D & E contact lens materials, matching predicate devices.
FDA Classification & Group Number	Class II, Group #3 Fluoro Silicone Acrylate.	Class II, Group #3 Fluoro Silicone Acrylate.
Lathe Cut Manufacturing Process	Utilizes lathe-cut manufacturing.	Utilizes lathe-cut manufacturing process.
Large Diameter (Scleral) Design	Has a large diameter scleral design.	Has a large diameter (scleral) design.
Actions and Intended Use	Actions and intended use are equivalent to predicate devices.	Actions and intended use are equivalent to predicate devices, extending indications based on clinical case reports.
Therapeutic Indications for Use	Therapeutic indications for use are equivalent or justified compared to predicate devices.	Therapeutic indications for use include conditions like keratoconus, dystrophies, post-surgery, and ocular surface diseases, supported by clinical case reports and compared to predicates.
Physical Properties	(Implicit/Explicit from predicate and material specifications): Refractive Index, Light Transmission, Water Content, Dynamic Contact Angle, Specific Gravity, Modulus, Shore D Hardness, Oxygen Permeability (Dk), UV Light Blocking.	Roflufocon D: Refractive Index 1.4333, Light Transmission >97% (clear), >90% (tinted), Water Content <1%, Dynamic Contact Angle 3°, Specific Gravity 1.166, Modulus 697 MPa, Shore D Hardness 75, Dk 100, UV Blocking >98% UVB, >95% UVA. Roflufocon E: Refractive Index 1.4332, Light Transmission >97% (clear), >90% (tinted), Water Content <1%, Dynamic Contact Angle 6°, Specific Gravity 1.155, Modulus 77 MPa, Shore D Hardness 77, Dk 125, UV Blocking >98% UVB, >95% UVA.
Lens Parameters	(Implicit/Explicit from predicate and manufacturing capabilities): Chord Diameter, Center Thickness, Base Curve, Spherical Powers.	Chord Diameter: 14.8 mm to 17.8 mm, Center Thickness: 0.20 mm to 0.40 mm, Base Curve: 6.6 mm to 11.0 mm, Spherical Powers: -30.00 D to +30.00 D (0.125 D steps).

2. Sample Size Used for the Test Set and Data Provenance:

Bench Testing: The document does not specify a separate "test set" sample size for bench testing. It indicates "All lenses were manufactured..." suggesting testing was conducted on a representative sample or a substantial portion of manufactured lenses to verify production capabilities. The provenance of this data is internal to Valley Contax, Inc. (manufacturer), and is prospective in relation to the manufacturing verification.
Bioburden Testing: The sample size is not explicitly stated, but bioburden testing was conducted on "rigid gas permeable lenses manufactured at Valley Contax, Inc." The data provenance is internal to Valley Contax, Inc. and is prospective from the manufacturing process.
Clinical Studies: The document refers to "a series of clinical case reports" for performance demonstration. The specific sample size for these case reports is not given, nor is the country of origin. These are likely retrospective case reports from practitioners fitting the lenses.
Reference to Predicate Devices: For the bulk of safety and effectiveness, the device relies on existing data from predicate devices (K033594 - Optimum GP and K161461 - BostonSight PD). The sample sizes and provenance for those original approvals are not detailed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on a de novo clinical trial with extensive ground truth establishment by external experts for a new device's performance.

For the internal bench and bioburden testing, the "ground truth" is defined by established specifications (ANSI Z80.20 tolerance for manufacturing, less than 100 CFU for bioburden), which are likely set by industry standards and potentially internal quality assurance experts. No specific number or qualifications of "experts" are provided.
For the "series of clinical case reports," the implicit "experts" are the eye care practitioners who prescribed and managed the patients. Their qualifications are not specified but would typically be optometrists or ophthalmologists.
For the safety and effectiveness data derived from predicate devices, the "ground truth" and expert involvement would have been established during the approval process of those predicate devices, but this information is not included in the current document.

4. Adjudication Method for the Test Set:

Bench Testing & Bioburden Testing: No explicit adjudication method is mentioned beyond compliance with pre-defined acceptance criteria (e.g., ANSI standards, CFU limits). This suggests direct measurement and comparison to thresholds rather than a multi-reader review process.
Clinical Case Reports: Given they are "case reports," it's unlikely a formal adjudication method (like 2+1, 3+1 consensus) was used. Case reports typically document individual patient outcomes as observed and reported by a single practitioner or clinical team.
Predicate Device Data: No information on adjudication methods for the predicate device studies.

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 mentioned, nor is there any indication of AI involvement in this device. This is a contact lens, not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No standalone (algorithm only) performance was evaluated, as this device is a physical contact lens and does not involve an algorithm.

7. The Type of Ground Truth Used:

Bench Testing: Ground truth is based on engineering and manufacturing specifications (e.g., ANSI Z80.20 tolerance for lens parameters).
Bioburden Testing: Ground truth is based on microbiological safety standards (CFU count).
Clinical Case Reports: Ground truth is based on observed clinical outcomes and practitioner assessments of patient response to the lens (e.g., comfort, visual acuity, ocular health).
Predicate Device Data: Ground truth would have been established during the original predicate approvals, likely through clinical trials and performance testing against objective measures and clinical endpoints.

8. The Sample Size for the Training Set:

This is a physical medical device (contact lens), not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2017

Valley Contax, Inc. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn. OR 97068

Re: K170335

Trade/Device Name: Custom Stable TM Rigid Gas Permeable Scleral Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: January 30, 2017 Received: February 2, 2017

Dear Mr. Andre:

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. 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.

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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); medical device 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Denise L. Hampton -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, and Ear, Nose and Throat Devices Office of Device Evaluation Center of Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170335

Device Name

Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lenses

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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:

Applicant information:

Date Prepared:	January 30th, 2017
Name:	Valley Contax, Inc.
Address	200 South Mill St. Springfield, Oregon 97477
Contact Person:	Josh Adams
	Vice President
Phone number:	(541) 744-9393
Consultant/Correspondent:	EyeReg Consulting, Inc. Bret Andre
Phone number	(503) 372-5226
Fax number	(503) 419-4475

Device Information:

Device Classification:	Class II
Classification Number:	HQD
Classification Name:	Lenses, Rigid Gas Permeable, Daily Wear
Trade Name:	Custom StableTM Rigid Gas PermeableScleral Contact Lens

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Predicate Devices:

The Custom Stable "1" Rigid Gas Permeable Scleral Contact Lens is substantially equivalent to the following predicate device(s)

"BostonSight PD Prosthetic Device" . - Primary Predicate Manufactured by Boston Foundation for Sight 510(k) number; K161461
"Optimum GP (roflufocon A,B,C.D&E) Daily Wear Contact Lens" . - Reference Predicate Manufactured by Contamac Ltd. 510(k) number; K033594

Device Description:

· roflufocon D (supplied by Contamac Ltd.)
· roflufocon E (supplied by Contamac Ltd.)

The physical properties of the Custom Stable" Rigid Gas Permeable Scleral Contact Lens are as follows:

	ROFLUFOCON D	ROFLUFOCON E
Refractive Index	1.4333	1.4332
Light Transmission (clear)	>97%	>97%
Light Transmission (tinted)	>90%	>90%
Water Content	<1%	<1%
Dynamic Contact Angle (Receding)	3°	6°
Specific Gravity	1.166	1.155
Modulus	697 MPa	77 MPa
Shore D Hardness	75	77
Oxygen Permeability(Dk)	$100 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)	$125 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
ISO/FATT Method
contain one or more of the followingcolor additives conforming to:21 CFR Part 73 & 74, Subpart D	D & C Green No. 6, FD & C RedNo. 17,CI Solvent Yellow 18	D & C Green No. 6, FD & C RedNo. 17,CI Solvent Yellow 18
UV Light Blocking(UVB - 280nm – 315nm; UVA 316nm – 380nm)	>98% UVB>95% UVA	>98% UVB>95% UVA

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The parameters for the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens are as follows:

Chord Diameter: ન્ન્સ
Center Thickness: 米
米 Base Curve:
米 Spherical Powers:

14.8 mm to 17.8 mm 0.20 mm to 0.40 mm 6.6 mm to 11.0 mm -30.00 Diopters to +30.00 Diopters (0.125 Diopter steps)

The Custom Stable"" Rigid Gas Permeable Scleral Contact Lens may be shipped "dry" or "wet". The primary container for shipping the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens is the Bonasse Flat Bed Soaking Case, Model SC 106-with 510(k) clearance under K991206. When shipped "wet", The Custom Stable™ Rigid Gas Permeable Scleral Contact Lens is packaged and shipped in the Menicon Unique pH multipurpose solution.

Indication for Use:

The Custom Stable "11 Rigid Gas Permeable Scleral Contact Lenses for daily wear are indicated for use for the management of multiple ocular conditions, such as, degenerations that lead to an irregular corneal shape (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's Nodular Degeneration), dystrophies (e.g. Cogan's dystrophy, granular corneal dystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK, radial keratotomy), and corneal scarring. The lens may also be prescribed for the management of ocular surface diseases (e.g. dry eye syndrome, Keratoconjunctivitis Sicca (Graft vs Host Disease, Sjogren's syndrome, Filamentary Keratitis), limbal stem cell deficiency, epidermal ocular disorders, neurotrophic keratitis, and corneal exposure/lagophthalmos). When prescribed for therapeutic use, the Custom Stable RGP Scleral Lenses is also indicated for correction of refractive error in persons with myopia, hyperopia or presbyopia.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Description of Testing:

~ Non-Clinical Studies ~
Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to 510(k) K033594-Optimum GP (roflufocon A.B.C.D&E) Daily Wear Contact Lens (the predicate device).

Additionally, the following testing was performed on the finished Custom Stable™ Rigid Gas Permeable Scleral Contact Lenses:

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Valley Contac, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

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Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Valley Contax, Inc. demonstrated that the colony forming units (CFU) per lens was less than 1, which is within the established acceptance criteria of less than 100 CFU per lens.

~ Clinical Studies ~
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to 510(k) K033594-Optimum GP (roflufocon A,B,C,D&E) Daily Wear Contact Lens (the predicate device).

Additionally, a series of clinical case reports demonstrate the performance of the Custom Stable" Rigid Gas Permeable Scleral Contact Lens when prescribed for the proposed indications for use.

~ Conclusions Drawn from Testing ~

Testing presented in this submission for the Custom Stable™ Rigid Gas Permeable Scleral Contact Lenses demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim.

Substantial Equivalence:

The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is substantially equivalent to the predicate device(s), and does not raise different questions of safety and effectiveness.

The Custom Stable "" Rigid Gas Permeable Scleral Contact Lens is substantially equivalent to the BostonSight PD Prosthetic Device (predicate device) in the following key areas:

Components/Materials/Formulation (roflufocon D & E contact lens materials) ●
FDA classification and group number (Class 2, Group #3 Fluoro Silicone Acrylate)
Lathe cut manufacturing process
Large diameter (scleral) design
Actions and intended use
. Therapeutic indications for use

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The following table depicts the characteristics of the Custom Stable™ Rigid Gas Permeable Scleral Contact Lens, as well as the predicate device(s).

	Custom Stable™ Rigid GasPermeable Scleral Contact Lens	BostonSight PD ProstheticDeviceK161461	Optimum GP (roflufoconA,B,C,D&E) Daily WearContact LensK033594
	Subject Device	Predicate Device	Predicate Device
Indication for Use	Indicated for use for the management ofmultiple ocular conditions, such as,degenerations that lead to an irregular cornealshape (e.g. keratoconus, keratoglobus,pellucid marginal degeneration, Salzmann'sNodular Degeneration), dystrophies (e.g.Cogan's dystrophy, granular cornealdystrophy, Lattice Corneal Dystrophy), post-surgery (e.g. corneal transplant, LASIK,radial keratotomy), and corneal scarring. Thelens may also be prescribed for themanagement of ocular surface diseases (e.g.dry eye syndrome, Keratoconjunctivitis Sicca(Graft vs Host Disease, Sjogren's syndrome,Filamentary Keratitis), limbal stem celldeficiency, epidermal ocular disorders,neurotrophic keratitis, and cornealexposure/lagophthalmos). When prescribedfor therapeutic use, the Custom Stable RGPScleral Lenses is also indicated for correctionof refractive error in persons with myopia,hyperopia or presbyopia.	Indicated for therapeutic use in eyeswith ocular surface disease from dryeye (e.g. ocular Graft-versus-Hostdisease, Sjögren's syndrome, dry eyesyndrome), limbal stem cell deficiency(e.g.Stevens-Johnson syndrome,chemical and thermal burns, radiation),disorders of the skin (e.g. atopy,ectodermal dysplasia), neurotrophickeratitis (e.g. Herpes simplex, Herpeszoster, Familial Dysautonomia), andcorneal exposure (e.g. anatomic,paralytic) that might benefit from thepresence of an expanded tear reservoirand protection against an adverseenvironment. When prescribed fortherapeutic use for distorted cornea orocular surface disease, the BostonSightPD Prosthetic Device may incidentallyprovide correction of refractive error.	May be prescribedin otherwise non-diseasedeyes that requirea rigid gas permeable lens forthe managementof irregular corneal conditionssuch as; keratoconus, pellucidmarginal degenerationof following penetratingkeratoplasty or followingrefractive (e.g. LASIK)surgery.
Device andClassification	Class IILenses, Rigid Gas Permeable, DailyWearHQD	Class IILenses, Rigid Gas Permeable,Daily WearHQD	Class IILenses, Rigid Gas Permeable.Daily WearHQD
Production Method	Lathe-cut	Lathe-cut	Lathe-cut
USAN	Roflufocon DRoflufocon E	Roflufocon DRoflufocon EOprifocon AHexafocon B	Roflufocon ARoflufocon BRoflufocon CRoflufocon DRoflufocon E
FDA Group #	Group # 3 Fluoro Silicone Acrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate
Water Content	<1%	<1%	<1%
UV Absorber/Blockeravailable	YES	YES	YES

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.