The NP Medical Extension Set is intended for direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.

The NP Medical Extension Set incorporates a normally closed bidirectional pressure-activated valve that prevents low pressure retrograde flow and is intended for power injector procedures to a maximum pressure of 325 psi at a flow rate of 10ml per second.

Device Description

The NP Medical Extension Set with Stabilizing Base is a sterile, single use, nonpyrogenic intravenous administration extension set comprised of a side repositionable tube bonded to a connector hub on one end and a female luer on the other end with a clamp in between. The connector hub has a locking male luer and a rotating tube connection joint. The hub houses a bidirectional Pressure-Activated Valve (PAV) and an integral stabilizer under the connector hub. The stabilizing base component (along with IV tape / adhesive) is intended to help anchor the extension set to the patient. This device is not made with plasticizers Diethylhexylphthalate (DEHP). The NP Medical Extension Set with Stabilizing Base may be used with compatible Vascular Access Devices (VAD), Needle Free Connectors, and other commercially available devices.

AI/ML Overview

Based on the provided text, the device in question is the "NP Medical nCompass Extension Set with Stabilizing Base," which is an intravascular administration set. The document is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.

The acceptance criteria and study proving the device meets these criteria are primarily based on bench performance testing and biocompatibility testing, as no clinical data was required or provided.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document doesn't provide specific numerical acceptance criteria for each test with their corresponding reported performance values. Instead, it states that the device "met all requirements" and "satisfy the acceptance criteria specified by the above applicable standards."

However, we can infer some criteria and the general reported performance:

Performance Test / Acceptance Criteria Category	Reported Device Performance (as stated in the document)	Inferable Acceptance Criteria (based on predicate comparison and industry standards)
Device Flow Rate (gravity)	"Equal to or greater than 3 L/hr."	≥ 3 L/hr. (matching predicate)
Device Flow Rate (pressurized)	"Equal to or greater than 10ml/second from the device distal end at a pressure at or below 325psi."	≥ 10 ml/second at ≤ 325 psi (matching predicate)
Retrograde Pressure Resistance	Met requirements	Prevent low pressure retrograde flow (as per Indications for Use)
Dynamic Hemolysis	Met requirements	Demonstrate substantial equivalence (per USP <788>)
Positive Pressure	Met requirements	Withstand positive pressure without failure
325psi Burst Resistance (rotating tube connection and other joints)	Met requirements	No burst at 325 psi
Extension tube bond integrity	Met requirements	Maintain integrity/no leaks
Stabilization pad bond integrity	Met requirements	Maintain integrity/proper adhesion
Extension tubing port (rotating connection) interfaces, sub-atm. pressure air leakage	Met requirements	No significant air leakage
Resistance to overriding	Met requirements	Function correctly when components are connected/operated
ESC resistance to lipids	Met requirements	Maintain integrity/functionality when exposed to lipids
PAV Robustness	Met requirements	Maintain functionality over repeated use
Particulate Contamination (sub-visible particles)	Met requirements	Conform to USP <788> for particulate limits
Biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemocompatibility, Chemical Characterization, Allowable Limits Establishment)	"All the Biocompatibility study results satisfy the acceptance criteria specified by the above applicable standards and proposed device has been found biocompatible for its intended use/indications for use."	Conformance with ISO 10993-1 and specific endpoints.
Sterilization (SAL)	"Sterility Assurance Level (SAL) of 10-6"	Achieve an SAL of 10-6 (as per ISO 11135-2014)
Sterile Barrier Packaging	Met requirements	Conform to ISO 11607-1:2019 for maintaining sterility

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document does not specify the sample size for any of the performance tests. It states that tests were conducted using "appropriate methodology" and "NP Medical established test protocols."
Data Provenance: The data is generated from bench testing conducted by NP Medical. The country of origin for the testing itself is not explicitly stated, but NP Medical is based in Clinton, Massachusetts, USA. The studies appear to be prospective in nature, as they were conducted specifically for the purpose of demonstrating substantial equivalence for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This device, being a physical medical device (extension set), does not involve diagnostic interpretations or algorithms that would require expert human review for ground truth establishment in the traditional sense of AI/imaging studies.
The "ground truth" for its performance is established through adherence to recognized consensus standards (e.g., ISO, USP) and validated bench testing protocols. The experts involved would be technical professionals (engineers, quality assurance personnel, lab technicians) performing the tests and interpreting results against the objective criteria of these standards, rather than clinical experts establishing a "truth" from patient data. Their qualifications would be in metrology, engineering, and quality systems for medical devices. The document does not specify the number or specific qualifications of these individuals.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations where multiple human readers interpret data, and a consensus or tie-breaking mechanism is needed for ground truth. For bench testing of physical device performance against objective criteria, such methods are not used. The results are quantitative measurements against predefined specifications.

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. An MRMC comparative effectiveness study is not applicable as this is a physical medical device (extension set), not an AI algorithm for diagnosis or interpretation. The document explicitly states: "VIII. CLINICAL DATA: Not applicable."

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

Not applicable. This relates to AI/software as a medical device. This product is a physical medical device.

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

The ground truth for the performance of this device is established by:
- Objective measurements against physical and chemical standards (e.g., flow rate, burst pressure, particulate count, material composition).
- Adherence to recognized consensus standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ISO 11607-1 for packaging) and FDA guidance documents.
- Comparison to the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set:

Not applicable. This device is a physical product and does not involve machine learning or AI, and therefore no "training set" in the context of data for algorithm development.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 3, 2022

NP Medical Krishna Govindarajan Global Quality Regulatory Affairs Manager 101 Union Street Clinton, Massachusetts 01510

Re: K221518

Trade/Device Name: NP Medical nCompass Extension Set with Stabilizing Base Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: October 4, 2022 Received: October 5, 2022

Dear Krishna Govindarajan:

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 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

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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 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.

David Wolloscheck, Ph.D. For Paval Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, 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) K221518

Device Name

NP Medical nCompass Extension Set with Stabilizing Base

Indications for Use (Describe)

The NP Medical Extension Set with stabilizing base is a sterile single patient use device.

The NP Medical Extension Set is intended for direction, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue abstract shape on the left, followed by the text "NP Medical" in a dark blue sans-serif font. Below the text, there is a tagline that reads "We Make Quality Patient Care Possible" in a smaller font.

510(k)Summary

The following summary is provided in accordance with 21 CFR 807.92:

I. SUBMITTER

NP Medical, Inc., 101 Union Street Clinton, MA 01510 Phone: 978-368-6854

Contact Person: Krishna Govindaraian Date Prepared: November 3, 2022

II. DEVICE

Trade/Device Name:	NP Medical nCompass™ Extension Set with Stabilizing Base
Common or Usual Name:	Extension Set
Regulation Number:	21 CFR 880.5440
Regulation Name:	Intravascular administration set
Regulatory Class:	Class II
Product Code:	FPA

III. PREDICATE DEVICE

Primary Predicate Device:

Velano Vascular Velano ExT™ Extension Set (K200439).

Reference Device:

Nexus Medical, Nexus TKO®-6P, Luer Activated Device (K130416).

IV. DEVICE DESCRIPTION

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Image /page/4/Picture/0 description: The image shows the logo for NPMedical. The logo consists of a stylized letter "D" in two shades of blue, followed by the text "NPMedical" in a dark blue sans-serif font. Below the logo is the tagline "We Make Quality Patient Care Possible" in a smaller, lighter font.

510(k)Summary

The following summary is provided in accordance with 21 CFR 807.92:

V. INDICATIONS FOR USE

The NP Medical Extension Set with stabilizing base is a sterile single patient use device.

The NP Medical Extension Set is intended for direct injection, intermittent infusion, continuous infusion or aspiration for all patients for which IV therapy is prescribed.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Primary Predicate Device:

The proposed device and primary predicate device are identical with regards to intended use and are substantially equivalent with regards to design, technological characteristics, performance, safety, and effectiveness. Both devices also have the same indications for use as extension set for direct injection, intermittent infusion, continuous infusion, or aspiration for which IV therapy is prescribed.

At a high level, the proposed and primary predicate devices are based on the following same technological elements:

Intravascular administration set/extension set
The following technological differences exist between the subject and predicate devices:
Use of rotating tube connection joint for repositionable extension tube ●
Use of integrated Pressure Activated Valve (PAV) for retrograde flow control ●

Reference Device:

The proposed device integrated Pressure Activated Valve (PAV) for retrograde flow control functionality and reference device bidirectional pressure activated valve functionality are identical with regards to operating principle, technological characteristics, performance, safety, and effectiveness. Both the proposed device and reference device include a normally closed bidirectional pressure activated valve that opens in the forward direction enabling infusion, and in the reverse direction enabling blood aspiration.

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Image /page/5/Picture/0 description: The image contains the logo for NP Medical. The logo consists of a blue icon on the left and the text "NPMedical" on the right. Below the logo, the text "We Make Quality Patient Care Possible" is displayed.

510(k)Summary

The following summary is provided in accordance with 21 CFR 807.92:

The following table provides a comparison of technological characteristics between the subject and predicate device:

ComparisonElement	Subject Device -NP Medical ExtensionSet with stabilizingbase	Predicate Device -Velano ExT™Extension Set(K200439)	Analysis of Differences
Product Code	FPA	FPA	Same
Regulation Number	880.5440	880.5440	Same
Class	ll	ll	Same
Intended Use	Intravascular ExtensionSet	IntravascularExtension Set	Same
Indications for Use	The NP MedicalExtension Set withstabilizing base is asterile single patient usedevice.The NP MedicalExtension Set is intendedfor direct injection,intermittent infusion,continuous infusion oraspiration for all patientsfor which IV therapy isprescribed.The NP MedicalExtension Setincorporates a normallyclosed bidirectionalpressure-activated valvethat prevents lowpressure retrograde flowand is intended for powerinjector procedures to amaximum pressure of325 psi at a flow rate of10ml per second.	The Velano ExT™Extension Set withneedle free connectoris for single use only.Each port of theVelano ExT™Extension Set may beused for directinjection, intermittentinfusion, continuousinfusion or aspiration.The pressure ratedport of the VelanoExT™ Extension Setmay be used withpower injectorprocedures to amaximum pressure of325 psi at a flow rateof 10ml per second.	Different. The subjectdevice does notreference elementsassociated with theneedle free connector ofthe predicate device.These excluded featuresare intended for Velano'sPIVO™ compatibility forwhich the subject devicedoes not seek to claim.Added the incorporationof a normally closedbidirectional pressure-activated valve similar toreference deviceK130416. (Performancetests leveraged from thereference device:Retrograde pressureresistance and PAVrobustness)Device Flow Rate (gravityand pressurized) andDynamic Hemolysis (perUSP <788>) testingperformed to demonstratesubstantial equivalence.
	The following summary is provided in accordance with 21 CFR 807.92:
ComparisonElement	Subject Device –NP Medical ExtensionSet with stabilizingbase	Predicate Device –Velano ExT™Extension Set(K200439)	Analysis of Differences
Extension SetComponents/Materials	Male Luer cap/HDPEMale Luer/PCMale Luer spin lockconnector/PCTubing/PVCPinch clamp/POMFemale Luer/PCFemale Luer Cap/HDPEFluid Path Body/Si, PCStabilizer/ Polystyrene,Acrylic PSA, PolycoatedLDPEPressure activatedvalve/Si	Male Luercap/HDPE MaleLuer/PCMale Luer spin lockconnector/PCTubing/PVCPinch clamp/POMFemale Luer/PCFemale LuerCap/HDPEFluid Path Body/Si, PCStabilizer/ Polystyrene,Acrylic PSA,Polycoated LDPEPressure activatedvalve/Si	Different. The subjectstabilizer uses apolystyrene fabric withacrylic PSA andPolycoated LDPE linerinstead of TPE on thepredicate.There is no T-Portconnector on subjectdevice since PIVO™compatibility is notrequired. The subjectdevice adds a PAV. ISO10993 biocompatibilitytesting was conducted todemonstrate thesechanges did not affect theproduct performance anddid not raise any questionsof safety or effectiveness.
Overall Length	Overall Length:3.7 inches (9.3cm)	Overall Length:5.0 inches (12.7cm)	Different. The subjectdevice has a shorteroverall length.Priming Volume, DeviceFlow Rate (gravity andpressurized) and DynamicHemolysis (per USP<788>) testing conducteddid not raise any questionsof safety or effectiveness.
Priming Volume	< 1 mL	< 1 mL	Same
Particulate	USP 788	USP 788	Same
Device flow rate(gravity)	Equal to or greater than3 L/hr.	Equal to or greaterthan 3 L/hr	Same
Device flow rate(pressurized)	Equal to or greater than10ml/second from thedevice distal end at apressure at or below325psi.	Use with low pressurepower injectors up to325psi and maximumflow rate of 10mL/sec	Same
Energy Source	User Operated	User Operated	Same
SterilizationMethod & MinimumSAL	Ethylene OxideMinimum SAL 1X10-6	Ethylene OxideMinimum SAL 1X10-6	Same
ComparisonElement	Subject Device -NP Medical ExtensionSet with stabilizingbase	Predicate Device -Velano ExT™Extension Set(K200439)	Analysis of Differences
Packaging	Reinforced paper /formed blister (PP/LDPE)	Reinforced paper /formed blister (nylon)	Different. The subject usesa Tyvek + PP/LDPEpackage that meets ISO11135 and ISO 11607-1requirements.
Disposable orReusable	Disposable	Disposable	Same

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Image /page/6/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a stylized blue symbol on the left, followed by the text "NPMedical" in a sans-serif font. The symbol is a geometric shape with rounded corners, and the text is in a dark blue color.

We Make Quality Patient Care Possible™

510(k)Summary

with 21 CFR 807 92: The following

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Image /page/7/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue abstract shape on the left, followed by the text "NPMedical" in a blue sans-serif font. The "NP" part of the text is in a darker shade of blue compared to the "Medical" part.

We Make Quality Patient Care Possible

510(k)Summarv

510(k)Summary

The following summary is provided in accordance with 21 CFR 807.92:

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

1. Performance Testing - Bench

The functional performance of the proposed device has been evaluated using the appropriate methodology as specified in the FDA recognized consensus standards and in conjunction with NP Medical established test protocols in accordance with the recommendations provided in the FDA quidance document titled "Intravascular Administration Sets Premarket Notification Submissions [510(k)]".

The following functional performance tests were conducted as part of the Design Verification and Validation activities:

Device flowrate (gravity and pressurized) ●
Retrograde pressure resistance
Dynamic hemolysis ●
Positive pressure ●
325psi burst resistance (for rotating tube connection and other joints) ●
Extension tube bond integrity ●
Stabilization pad bond integrity ●
Extension tubing port (rotating connection) interfaces, sub-atm. pressure air leakage ●
Resistance to overriding ●
ESC resistance to lipids ●
PAV robustness ●
Particulate contamination, sub-visible particles .

The results of the functional performance testing demonstrated that the proposed device met all requirements and the differences in design, such as rotating tube connection joint and intecrated bidirectional Pressure-Activated Valve (PAV) feature do not affect the final product performance and the safety or effectiveness of the proposed device.

2. Biocompatibility

The biocompatibility evaluation was conducted in accordance with the FDA Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", as recognized by FDA.

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Image /page/8/Picture/0 description: The image shows the logo for NP Medical. The logo consists of a blue icon on the left and the text "NP Medical" on the right. The icon is a stylized shape that resembles a rounded square with an arrow pointing to the right. The text "NP Medical" is written in a sans-serif font, with "NP" in a darker blue and "Medical" in a lighter blue.

510(k)Summarv

The following summary is provided in accordance with 21 CFR 807.92: Biocompatibility of intact skin surface device (Stabilizing Base) and indirect blood path external communicating device (Fluid Pathway) with prolonged contact duration were confirmed by evaluating the following ISO 10993-1 recommended biocompatibility evaluation endpoints.

Stabilizing Base

Cytotoxicity .
Sensitization ●
Irritation or Intracutaneous Reactivity ●

Extension Set Fluid Pathway

Chemical Characterization .
Establishment of Allowable Limits ●
Cytotoxicity ●
Sensitization ●
Irritation or Intracutaneous Reactivity
Acute Systemic Toxicity
Material Mediated Pyrogenicity ●
Hemocompatibility ●

All the Biocompatibility study results satisfy the acceptance criteria specified by the above applicable standards and proposed device has been found biocompatible for its intended use/indications for use.

3. Sterilization and Shelf Life

The sterilization validation activities have been performed using Ethylene Oxide sterilization method in accordance with ISO 11135-2014 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices to state the Sterility Assurance Level (SAL) of 10-9 for the proposed device labeled as sterile.

The stability of the package in maintaining sterility has been assessed through the transit and storage life cycles in accordance with the ISO 11607-1:2019 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.

VIII. CLINICAL DATA

Not applicable.

IX. CONCLUSIONS

NP Medical believes that the NP Medical Extension Set with Stabilizing Base is to be as safe, as effective, and substantially equivalent in performance to the above identified predicate device.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.