This TDS Standard Solution is indicated for verifying the accuracy (calibration) of TDS (Total Dissolved Solids) meters. This standard solution should be used immediately before conductivity meters are used to determine the conductivity of water obtained from water purification systems used in hemodialysis. This solution is prepared from a mixture of salts comprised of 40% Sodium Bicarbonate, 40% Sodium Sufate, and 20% Sodium Chloride which is intended to mimic natural water systems. These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.

Device Description

The device consists of salts (Sodium Chloride, Sodium Bicarbonate and Sodium Sulfate) dissolved in de-ionized water. The solution is packaged into sealed polyethylene bottles.

AI/ML Overview

The document describes the acceptance criteria and supporting studies for the "TDS Standard Solution."

Here's the breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

Test	Acceptance Criteria	Reported Device Performance
Conductivity Values (25ºC) - New Device	23.8 ± 0.2 microsiemen/cm; 229 ± 2 microsiemen/cm; 2060 ± 0.02 microsiemen/cm	The new device's TDS values (15ppm, 150ppm, 1500ppm) were found to be within the tolerances of the solution and the Reference Conductivity meter. - 15ppm TDS Solution: 15.063 ppm, 15.032 ppm, 15.007 ppm, 14.988 ppm, 14.994 ppm. - 150ppm TDS Solution: 150.546 ppm, 150.480 ppm, 150.546 ppm, 150.876 ppm, 150.744 ppm. - 1500ppm TDS Solution: 1508.18 ppm, 1505.99 ppm, 1505.99 ppm, 1506.72 ppm, 14.994 ppm.
Open Bottle Shelf Life	Remained within specification for 60 days after the bottle was opened and tightly recapped.	The three values (23.8 µS/cm, 229 µS/cm, and 2060 µS/cm) were all found to be within tolerance after the bottle was opened for 60 days and then tightly resealed.
Sealed Bottle Storage Shelf Life	Remained within specification for 18 months after the bottle was sealed.	The results for 23.8 µS/cm, 229 µS/cm, and 2060 µS/cm solutions showed that they remained in tolerance for 18 months. Multiple batches were tested, demonstrating uniform properties throughout production. The goal to produce solutions with values within the lower 10% range of specifications was met to ensure values remained within specification after 18 months.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for performance tests (Conductivity Values): 5 bottles were tested for each TDS solution (15ppm, 150ppm, 1500ppm).
Sample Size for Open Bottle Shelf Life: The number of bottles tested is not explicitly stated, but it refers to "the new device" in general terms for the three specified conductivity values, suggesting at least one for each value.
Sample Size for Sealed Bottle Storage Shelf Life: For each of the three conductivity values (23.8 µS/cm, 229 µS/cm, and 2060 µS/cm), five different batches were manufactured. For each batch, 5 bottles were measured at specified intervals over 18 months.
Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective, as they involve manufacturing and then testing the new device over time for shelf life and immediate performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The ground truth for the test set (conductivity values) was established using a Reference Conductivity meter calibrated with Standard Reference Materials purchased from Cole-Palmer. The document does not mention the use of human experts to establish ground truth or their qualifications. The ground truth is based on the calibrated instrumentation and reference materials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or subjective assessment. This device's performance testing is objective (measurement of conductivity), and thus no adjudication method was used or needed. The results were directly measured by a calibrated instrument.

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. This device is a standard solution for calibrating meters, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was done. The performance of the "TDS Standard Solution" (the device itself) was evaluated by measuring its conductivity properties directly using a calibrated Reference Conductivity meter. This assessment did not involve a human-in-the-loop for the primary measurement of the solution's properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used was based on objective measurement against Standard Reference Materials using a calibrated Reference Conductivity meter. This is a form of instrumental ground truth, rather than expert consensus, pathology, or outcomes data, which are typically found in diagnostic applications.

8. The sample size for the training set

This device is a physical standard solution, not a machine learning model. Therefore, there is no training set in the context of algorithm development.

9. How the ground truth for the training set was established

Since there is no training set for an algorithm, this question is not applicable.

Summary

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August 5, 2019

Mesa Laboratories, Inc. Jamie Louie Senior Manager - Quality 12100 West 6th Avenue Lakewood. CO 80228

Re: K191496

Trade/Device Name: TDS Standard Solution Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FKH Dated: June 5, 2019 Received: June 5, 2019

Dear Jamie Louie:

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

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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) 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 (QS) 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 medical devices and radiation-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,

Carolyn Y. Neuland, Ph.D. Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastro-Renal, ObGyn, General Hospital and Urology Devices 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) K191496

Device Name TDS Standard Solution

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)

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510(k) Summary K191496

Owner:	Mesa Laboratories, Inc.12100 West 6th AvenueLakewood, CO 80228Phone: (303) 987-8000 FAX: (303) 987-8989
Contact Person:	Jamie Louie, Director of Quality
Date:	July 11, 2019
Device Name:	TDS Standard Solution
Trade Name:	TDS Standard Solution
Common Name:	Conductivity/TDS Calibrator Solution
ClassificationName:	Solution-Test Standard-Conductivity, Dialysis
DeviceClassification:	Classification: IIClassification Panels: Gastroenterology/UrologyRegulation Number: 21 CFR § 876.5820,Solution-Test Standard-Conductivity, DialysisProduct Code 78 FKH
PredicateDevice(s):	Conductivity/TDS Calibrator SolutionMesa Laboratories Inc510(k) Number K033330Cleared February 4, 2004
DeviceDescription:	The device consists of salts (Sodium Chloride, SodiumBicarbonate and Sodium Sulfate) dissolved in de-ionizedwater. The solution is packaged into sealed polyethylenebottles.
Indicationsfor Use:	This TDS Standard Solution is indicated for verifying theaccuracy (calibration) of TDS (Total Dissolved Solids)meters. This standard solution should be usedimmediately before conductivity meters are used todetermine the conductivity of water obtained from waterpurification systems used in hemodialysis. This solution isprepared from a mixture of salts comprised of 40% SodiumBicarbonate, 40% Sodium Sulfate, and 20% SodiumChloride which is intended to mimic natural water systems.

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These solutions are used remotely from the water purification equipment, and do not come into contact with the patient.

The population requiring disalysis requires that the solutions General Description of used in the dialysis machine and during the preparation of solutions used in the hemodialysis setting be verified for the Diseases or Conditions proper conductivity. The hemodialysis industry uses conductivity meters to verify the proper conductivity. The Device will treat: new device is used to verify and calibrate these meters at conductivities near the new values of the device.
Operational Use: Prior to operating the conductivity meter, the user draws the Conductivity/TDS Calibrator Solution into the meter or dips the meter sensor into the solution to verify the meter is reading the value of the solution. If meter does not read the correct value (within the tolerances of the solution and the meter), the user will calibrate the meter to read the correct value.

No components of the device come in contact with the patient or patient fluids.

The conductivity of the fluid is determined by the amount of Scientific Concepts that electrical current flow within the solution. The dissolved form the basis salts separate into positive and negative ions. The ions are of the Device: free to move and the movement resulting from a voltage difference will result in an electrical current.

Modifications to Predicate:

The following modifications were made from the predicate to the new device:

1. Additional Values
1. Use of two different salts
1. Additional Values

The new device has conductivity values of 23.8 µS/cm. 229 µS/cm and 2060 uS/cm are added to the original seven values of the predicate.

2. Use of two additional salts

The new device uses sodium bicarbonate and sodium sulfate in addition to the sodium chloride used in the predicate device.

Technological The technological Characteristics are summarized in Characteristics: the table below.

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TechnologicalCharacteristic	Mesa Laboratories, Inc. PredicateDevice 2004 510(k) K033330	Mesa Laboratories, Inc.New Device 2019 510(k) K191496
Intended Use	Conductivity/TDS Calibrator Solutionsare a secondary standard solution usedfor the calibration of conductivity/TDScells together with conductivity/TDSmeasurement instruments. Theconductivity/TDS cells and instrumentsmay be indicated for calibrating theconductivity measurement function ofhemodialysis machines and waterpurification equipment for hemodialysis,or for verifying proper function ofhemodialysis machine or waterpurification equipment measurementfunctions. These solutions are usedremotely from the hemodialysis machineor water purification equipment, and doot come into contact with the patient.	This TDS Standard Solution is indicatedfor verifying the accuracy (calibration) ofTDS (Total Dissolved Solids) meters.This standard solution should be usedimmediately before conductivity metersare used to determine the conductivityof water obtained from water purificationsystems used in hemodialysis. Thissolution is prepared from a mixture ofsalts comprised of 40% SodiumBicarbonate, 40% Sodium Sulfate, and20% Sodium Chloride which is intendedto mimic natural water systems. Thesesolutions are used remotely from thewater purification equipment, and do notcome into contact with the patient.
UserInstructions	See attached label	See attached label
AppearanceProperties	Clear, Colorless LiquidSpecific Gravity: Approx. 1- 1.04	Clear, Colorless LiquidSpecific Gravity: Approx. 1- 1.04
ChemicalProperties	Odor: OdorlessBoiling Point: Approx. 100.1℃Melting Point: Approx. -0.6-0ºCVapor Pressure: <25mmHg @ 25°CSolubility in water: Infinite	Odor: OdorlessBoiling Point: Approx. 100.1ºCMelting Point: Approx. -0.6-0ºCVapor Pressure: <25mmHg @ 25°CSolubility in water: Infinite
ConductivityValues andSpecificationsat 25ºC	150 ± 2 microsiemen/cm1.0 ± 0.002 millisiemen/cm3.9 ± 0.02 millisiemen/cm12.5 ± 0.02 millisiemen/cm13.4 ± 0.02 millisiemen/cm14.0 ± 0.02 millisiemen/cm100.0 ± 0.2 millisiemen/cm	23.8 ± 0.2 microsiemen/cm229 ± 2 microsiemen/cm2060 ± 0.02 microsiemen/cm
TDS ValuesandSpecificationsat 25ºC	Not specified	15 ppm ± 1%150 ppm ± 1%1500 ppm ± 1%
SaltComposition	NaCl (Sodium Chloride)	NaCl (Sodium Chloride)Sodium BicarbonateSodium Sulfate
Disinfectant	None	None
Bottle	High-density Polyethylene (HDPE)	High-density Polyethylene (HDPE)
Shelf Life	18 months	18 months
Open BottleShelf Life	30 Days	60 Days

The new device is similar to the predicate device in that it is drawn into the conductivity meter or the conductivity meter is exposed to the solution. The conductivity meter displays the value it measures for the conductivity.

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The new device is different in that there are three additional conductivity values. The new device is using additional two salts (Sodium Bicarbonate and Sodium Sulfate) to the single salt (Sodium Chloride) used in the predicate.

The new device and the predicate provide a secondary standard to be used in verifying or calibrating conductivity cells or instruments. For the purposes of verifying or calibrating Conductivity, the new device is substantially equivalent to the predicate device.

Materials Used in the New Device

The following materials are used in the new device. None of these materials contact the patient or any patient fluids.

Material	Where used	CommonName	CAS RegistryNumber	Manufacturer	Patient or PatientFluid Contact
De-lonizedWater	Solution	DI Water	7732-18-5	Producedin-house	No
SodiumChloride	Solution	NaCl	7440-23-5	Rocky MountainReagents	No
SodiumBicarbonate	Solution	BakingSoda	144-55-8	Rocky MountainReagents	No
SodiumSulfate	Solution	Thenardite	7757-82-6	Sigma-Aldrich	No
High-densityPolyethylene	Bottle	HDPE	9002-88-4	Silgan	No

Comparison of material use between the predicate and the new device.

Where Used	Mesa Laboratories, Inc.Predicate Device 1996510(k) K955298	Mesa Laboratories, Inc.New Device 2019510(k) K191496
De-lonized Water	Solution	Solution
Sodium Chloride	Solution	Solution
Sodium Bicarbonate	-	Solution
SodiumSulfate	-	Solution
High-densityPolyethylene	Bottle	Bottle

Validations were performed to to demonstrate that the materials performed equivalently for their required function.

Performance Testing

The following validations were performed:

VP-00020 Conductivity Values of 15ppm TDS Solutions

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ppm. The value of the 15ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.

VP-00021 Conductivity Values of 150ppm TDS Solutions

The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 150.546 ppm, 150.480 ppm, 150.546 ppm, 150.876 ppm and 150.744 ppm. The value of the 150ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.

VP-00022 Conductivity Values of 1500ppm TDS Solutions

The purpose of this test was to validate that the value of the new device were correct. A Reference Conductivity meter was used and calibrated using Standard Reference Materials purchased from Cole-Palmer. The TDS value for (5) bottles were: 1508.18 ppm, 1505.99 ppm, 1505.99 ppm, 1506.72 ppm and 14.994 ppm. The value of the 1500ppm TDS Solution was within the tolerances of the solution and the Reference Conductivity meter. This was considered acceptable as per the Validation Protocol.

VP-00030 Open Bottle Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 60 days after the bottle was opened and tightly recapped. The three values 23.8 µS/cm, 229 µS/cm, and 2060 µS/cm were all found to be within tolerance after the bottle was opened for 60 days and then tightly resealed. This was considered acceptable as per the Validation Protocol.

VP-00073 Sealed Bottle Storage Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 23.8 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. The results showed that the solution remained in tolerance for 18 months. This was used to demonstrate that the batch had uniform properties thourghout the production. This was considered acceptable as per the Validation Protocol.

VP-00074 Sealed Bottle Storage Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 229 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. The results showed that the solution remained in tolerance for 18 months. This was used to demonstrate that the

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batch had uniform properties thourghout the production. This was considered acceptable as per the Validation Protocol.

VP-00075 Sealed Bottle Storage Shelf Life

The purpose of this test was to validate that the new device would remain within specification for 18 months days after the bottle was sealed. Five different batchs of 2060 µS/cm were manufactured. The testing consisted of measuring bottles from throughout the bottling run. (5) bottles, one from the 1st 20% of the run, one from the 2nd 20% of the run, one from the 3rd 20% of the run, one from the 4th 20% of the run, and one from the last 20% of the run were measured at specified intervals over 18 months. This was used to demonstrate that the batch had uniform properties thourghout the production. The results showed that the solution remained in tolerance for 18 months. This was considered acceptable as per the Validation Protocol.

Additional batches of TDS Solutions were manufactured to demonstrate that the new device would remain within specification during the 18 months in sealed bottle storage. . The goal was to produce the solution with a value within the lower 10% range of the specification range for each TDS solution. This was done to ensure that the value after 18 months of sealed bottle storage remained with specification.

TDS Solution	15 ppmTank(uS/cm)	150 ppmTank(uS/cm)	1500 ppmTank(uS/cm)
Batch
1	23.56	226.8	2040.0
2	23.57	227.3	2040.0
3	23.56	226.8	2040.0
4	23.57	227.2	2042.0
5	23.56	226.9	2042.0
Lower Specification	23.324	226.7	2039.4
Upper Specification	24.276	231.3	2080.6

The table below shows the conductivity value of each batch of solution in the mixing tank. The lower specification and the upper specification for each TDS Solution are given in the last two rows of the table.

Nonclinical Performance: Validation of the performance of the device was performed on units equivalent to production.

Conclusions Demonstrating Safety and Effectiveness:

The results of the validations show that the new device is equivalent to the Conductivity/TDS Calibrator Solutions. The new device is substantially equivalent to the leqally marketed Conductivity/TDS Calibrator Solutions (predicate device).

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.