BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements.

BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.

Device Description

Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations:

Standard enteral extension sets, with a variation in tube length and diameter
Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length

Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines. The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations:

Enteral female to enteral female
Enteral male to enteral male

AI/ML Overview

The document you provided is a 510(k) summary for a medical device called "BD UniVia™ RightFit Extension Sets and Transitional Adapters." This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, and it typically relies on non-clinical (bench) testing rather than clinical studies.

Therefore, many of the requested categories related to clinical trials, expert adjudication, and AI performance will not be applicable or present in this context.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states: "All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements." However, specific numerical acceptance criteria and reported device performance values are not provided in this summary. It only lists the types of tests performed.

Test Type	Acceptance Criteria (Not explicitly stated in document, but implied as "met pre-determined product specifications and external standard requirements")	Reported Device Performance (Not explicitly stated in document, but implied as "all data met the acceptance criteria")
Visual	Passed (implied)	Passed (implied)
Insertion and removal force	Passed (implied)	Passed (implied)
Dimensions	Passed (implied)	Passed (implied)
Leakage	Passed (implied)	Passed (implied)
Stress cracking	Passed (implied)	Passed (implied)
Resistance to separation	Passed (implied)	Passed (implied)
Resistance to overriding	Passed (implied)	Passed (implied)
Disconnection by unscrewing	Passed (implied)	Passed (implied)
Kink resistance	Passed (implied)	Passed (implied)
Tensile force	Passed (implied)	Passed (implied)
Flow rate	Passed (implied)	Passed (implied)
Human factors	Passed (implied)	Passed (implied)
Biocompatibility (ISO 10993-1)	Passed (implied)	Passed (implied)
Sterilization (ISO 11135)	Sterility Assurance Level (SAL) of 10^-6	Met SAL of 10^-6 (implied)
Transportation and Shelf Life (ISO 11607-1)	Passed (implied)	Passed (implied)
Shelf life	Passed (implied)	Passed (implied)

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

Sample Size for Test Set: The document does not specify the sample sizes used for each of the in vitro tests.
Data Provenance: The studies were in vitro (bench testing), not clinical. The document does not specify the country of origin of the data beyond stating the submitter (MPS Medical, Inc.) is located in Brea, CA, USA. This would be considered prospective bench testing conducted specifically for this submission.

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)

Not applicable. This device is not an AI/imaging device requiring expert interpretation for ground truth. It is a physical medical device. Ground truth for its performance is established through measured physical and chemical properties in controlled lab settings against established standards.

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

Not applicable. This device is not an AI/imaging device requiring expert adjudication.

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

Not applicable. This device is not an AI-assisted diagnostic device.

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

Not applicable. This device is not an algorithm.

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

The ground truth for this device's performance is based on pre-determined product specifications and external standard requirements (e.g., ISO standards for biocompatibility, sterilization, and transportation/shelf life, as well as internal functional specifications for physical properties).

8. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, there is no ground truth to establish for it in this context.

Summary

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

July 30, 2020

MPS Medical, Inc. Paul Gasser Medical Device RA/OA Consultant 830 Challenger Street, Suite 200 Brea, CA 92821

Re: K200082

Trade/Device Name: BD Univia RightFit Enteral Extension Sets and Transitional Adapters Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF, PIO Dated: June 30, 2020 Received: July 1, 2020

Dear Paul Gasser:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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1 CFR Part 207) labeling (21 CFR Part

Page

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices 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) K200082

Device Name

BD UniVia™ RightFit Extension Sets and Transitional Adapters

Indications for Use (Describe)

BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniViaTM RightFit enteral systems.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Traditional 510(k) Summary

Submitter:	MPS Medical, Inc.830 Challenger, Suite 200Brea, CA 92821USA
Contact:	Susan GinsbergDirector, R&DMPS Medical, Inc.Telephone: 844-641-3814E-mail: sginsberg@mpsmedical-inc.com
Date Summary Prepared:	January 15, 2020
Device Trade Name:	BD UniVia™ RightFit Extension Sets and Transitional Adaptors
Common Name:	Enteral Extension Sets
Classification Name:	Gastrointestinal tube and accessories (21 CFR 876.5980)
Regulatory Class:	Class II
Product Code:	PIF, PIO
Predicate Device:	VR Medical Feeding Tube(510(k) K180236)
Reference Device:	Neomed Enteral Extension Set(510(k) K100288)

Device Description:

Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations:

Standard enteral extension sets, with a variation in tube length and diameter
. Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length

Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines.

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The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations:

Enteral female to enteral female ●
Enteral male to enteral male

Indications for Use:

BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.

Statement of Equivalence:

The subject device and the predicate share a similar intended use and have similar technological characteristics.

Key differences between the subject and predicate devices are reflected in the following table.

Characteristic	Predicate DeviceVR Medical Enteral Feeding	Subject DeviceMPS Medical Enteral Extension
	Extension Set (EFES)	Set and Transitional Adapters
Enteral Extension Sets
Length (inches)	22 - 60	8 - 60
ID/OD (mm)	Unknown	0.89/2.4, 2.1/3.5, 3.0/4.1
Connectors	Male/female per ISO 80369-3	Same
Transitional Adapters
Length (inches)	None	1.9 - 2.2
ID/OD (mm)	None	2.1/3.5
Connectors	None	Male and female connectorsper ISO 80369-3

The BD UniVia™ RightFit enteral extension sets and transitional adapters are substantially equivalent to the predicate device.

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510(k) K 200082 Page 3 of 3

Summary of Non-Clinical Performance Data:

Device evaluation consisted of in vitro testing performed pursuant to MPS Medical's risk analysis. All data met the acceptance criteria and fell within pre-determined product specifications and external standard requirements. The following testing was performed to support the determination of substantial equivalence:

Visual Insertion and removal force Dimensions Leakage Stress cracking Resistance to separation Resistance to overriding Disconnection by unscrewing Kink resistance Tensile force Flow rate Human factors

Biocompatibility Testing:

Biocompatibility testing was conducted in accordance with ISO 10993-1.

Sterilization Testing:

Sterilization testing was conducted in accordance with ISO 11135 to ensure a sterility assurance level (SAL) of 10-6.

Transportation and Shelf Life Testing:

Shipping and distribution testing was conducted in accordance with ISO 11607-1.

Shelf life testing was performed.

The data from the in vitro testing above supports the substantial equivalence of the subject device to the predicate device.

Summary of Pre-Clinical and Clinical Data:

No pre-clinical or clinical data were generated to establish substantial equivalence. Bench data are considered adequate to support a determination of substantial equivalence.

Summarv:

Based on the intended use and in vitro performance information provided in this premarket notification, the BD UniVia™ RightFit Extension Sets and Transitional Adaptors are substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.